東北大学研究者紹介

研究者詳細

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日本語 English

顔写真

ヤマグチ　タクヒロ

山口　拓洋

Takuhiro Yamaguchi

所属

大学院医学系研究科　公衆衛生学専攻　情報健康医学講座（医学統計学分野）

職名

教授

学位

博士（保健学）（東京大学）
修士（保健学）（東京大学）

researchmap

https://researchmap.jp/TakuhiroYamaguchi

J-GLOBAL ID

200901098316344893

経歴 10

2018年4月～継続中

埼玉医科大学総合医療センターブレストケア科　客員教授
2018年4月～継続中

名古屋市立大学　客員教授
2015年7月～継続中

国立がん研究センター　支持療法開発センター　特任研究員
2011年4月～継続中

昭和薬科大学　非常勤講師
2010年4月～継続中

東北大学大学院医学系研究科医学統計学分野　教授
2008年4月～継続中

東北大学病院臨床研究推進センター臨床試験データセンター　データセンター長（東北大学教授と兼任）
2007年4月～ 2022年3月

東京大学大学院医学系研究科臨床試験データ管理学　特任研究員（2007年～客員准教授、2008年～特任准教授、2013年～特任教授、2015年～）
1999年7月～ 2007年3月

東京大学大学院医学系研究科生物統計学講座　助手
2003年9月～ 2004年8月

文部科学省（ベルギー国、European Organization for Research and Treatment of Cancer（EORTC）データセンター）　在外研究員
1997年8月～ 1999年7月

国立医薬品食品衛生研究所医薬品医療機器審査センター（現：独立行政法人医薬品医療機器総合機構）　審査官

︎全件表示 ︎最初の5件までを表示

学歴 4

東京大学　大学院医学系研究科保健学専攻博士課程

1996年4月～ 1997年7月
東京大学　大学院医学系研究科保健学専攻修士課程

1994年4月～ 1996年3月
東京大学　医学部　保健学科

～ 1994年3月
東京大学

～ 1994年

委員歴 6

日本臨床腫瘍薬学会　理事・利益相反委員会委員長

～継続中
日本薬剤疫学会　理事・評議員

～継続中
日本医療研究開発機構　科学技術調査員

～継続中
厚生労働省　薬事・食品衛生審議会委員

～継続中
医薬品医療機器総合機構　専門委員

～継続中
日本臨床試験学会　代表理事

︎全件表示 ︎最初の5件までを表示

所属学協会 24

Drug Information Association
International Society for Pharmacoepidemiology
Society for Clinical Data Management
日本がんサポーティブケア学会
レギュラトリーサイエンス学会
日本医療・病院管理学会
日本乳腺甲状腺超音波医学会
日本乳癌学会
日本公衆衛生学会
日本臨床薬理学会
日本看護科学学会
日本緩和医療学会
日本臨床試験学会
日本造血細胞移植学会
日本臨床腫瘍薬学会
日本エイズ学会
日本臨床腫瘍学会
日本医療情報学会
American Society of Clinical Oncology
American Society of Hematology
日本薬剤疫学会
日本疫学会
応用統計学会
日本計量生物学会

︎全件表示 ︎最初の5件までを表示

研究キーワード 6

アウトカム研究
品質マネジメント
医学情報管理学
医学統計学
Information Management
Biostatistics

研究分野 4

ライフサイエンス / 衛生学、公衆衛生学分野：実験系を含まない /
ライフサイエンス / 衛生学、公衆衛生学分野：実験系を含む /
ライフサイエンス / 医療管理学、医療系社会学 /
情報通信 / 統計科学 /

論文 433

CRES3T: A single-arm confirmatory trial of S-1 plus cisplatin with concurrent radical-dose radiotherapy followed by surgery for superior sulcus tumors

Kazuya Takamochi, Kenji Suzuki, Morihito Okada, Seiji Niho, Satoshi Ishikura, Shunsuke Oyamada, Takuhiro Yamaguchi, Hirotoshi Horio, Norihiko Ikeda, Fumihiro Tanaka, Satoshi Shiono, Tomohiro Haruki, Ichiro Yoshino, Hiroyuki Ito, Hidetaka Uramoto, Norihito Okumura, Hisashi Iwata, Hisashi Saji, Toshiya Fujiwara, Kazuhito Funai, Tsuyoshi Ueno, Kenji Sugio, Masahiro Tsuboi

Lung Cancer　202　108506-108506　2025年4月
出版者・発行元： Elsevier BV
DOI： 10.1016/j.lungcan.2025.108506 　

ISSN：0169-5002
Multicenter, open-label, randomized, controlled study to test the utility of electronic patient-reported outcome monitoring in patients with unresectable advanced cancers or metastatic/recurrent solid tumors. 国際誌

Naruto Taira, Naomi Kiyota, Yuichiro Kikawa, Eiki Ichihara, Kyoko Kato, Kaoru Kubota, Ryosuke Tateishi, Akinobu Nakata, Keiichiro Nakamura, Yukiya Narita, Katsuyuki Hotta, Hiroji Iwata, Akihiko Gemma, Kojiro Shimozuma, Kei Muro, Tetsuya Iwamoto, Yuki Takumoto, Takeru Shiroiwa, Takashi Fukuda, Takuhiro Yamaguchi, Yasuhiro Hagiwara, Hironobu Minami

Japanese journal of clinical oncology　2025年2月23日

DOI： 10.1093/jjco/hyaf033 　

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Electronic patient-reported outcome (ePRO) monitoring for patients undergoing cancer chemotherapy may provide qualified and early detection of adverse events or disease-related symptoms, leading to improved patient care. The aim of this study is to examine whether addition of ePRO monitoring to routine medical care contributes to improved overall survival and quality of life of cancer patients undergoing chemotherapy. Patients with unresectable advanced cancers or metastatic/recurrent solid tumors receiving systemic chemotherapy will be randomized to an ePRO monitoring group and a usual care group. The ePRO group will conduct weekly symptom monitoring using an electronic device after study enrollment until the end of the study. Monitoring results will be returned to medical personnel and used as information for patient care. The primary endpoints are overall survival and health related quality of life. The initial target sample size for the study was 1500 patients. However, due to delays in enrollment, the target was readjusted to 500 patients. Enrollment has been completed, and the study is now in the follow-up phase.
Prediction of Next-Day Survival in Imminently Dying Cancer Patients: A Multicenter Cohort Study. 国際誌

Masanori Mori, Takuhiro Yamaguchi, Isseki Maeda, Yutaka Hatano, Shih-Wei Chiu, Takashi Yamaguchi, Kengo Imai, Naosuke Yokomichi, Hiroyuki Otani, Jun Hamano, Satoru Tsuneto, David Hui, Tatsuya Morita

Journal of palliative medicine　2025年2月10日

DOI： 10.1089/jpm.2024.0334 　

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Background: Accurate prediction of next-day survival in imminently dying patients is crucial for facilitating timely end-of-life decisions. Objectives: To develop diagnostic models for predicting next-day survival in cancer patients with a Palliative Performance Scale (PPS) score of ≤20. Design: A multicenter, prospective, observational study. Setting/subjects: We enrolled advanced cancer patients at 23 palliative care units across Japan. Measurements: Clinical signs of impending death were recorded daily after patients' PPS scores decreased to ≤20, continuing until death or for up to 14 days. The developed models included the prediction of one-day survival-decision tree (P1d-Survival-DT), based on recursive partitioning analysis, the P1d-Survival-organ system score, which utilized a scoring system across four clinical systems (nervous/cardiovascular/respiratory/musculoskeletal), and the early signs model that focused on the absence of two early signs (altered consciousness and liquid dysphagia). Results: Of the 1896 patients included in the study, 1396 (74%) reached PPS ≤20. The average age was 73 ± 12 years, with 49% being female. The P1d-Survival-DT model showed next-day survival rates of 91.6% for patients with a response to verbal stimuli and no peripheral cyanosis, and 37.1% for those with no response to verbal stimuli and respiration with mandibular movement. The P1d-Survival-organ system score model revealed a 95.9% survival rate for score = 0, decreasing progressively to 46.7% for score = 4. The early signs model predicted a 95.2% survival rate in patients with normal consciousness and no liquid dysphagia. Conclusions: This study successfully developed three distinct models to predict next-day survival in cancer patients with PPS ≤20, offering vital tools for informed decision making in palliative care settings.
Nurse‐Led Screening‐Triggered Early Specialized Palliative Care Program for Patients With Advanced Lung Cancer: A Multicenter Randomized Controlled Trial

Yoshihisa Matsumoto, Shigeki Umemura, Ayumi Okizaki, Daisuke Fujisawa, Takuhiro Yamaguchi, Shunsuke Oyamada, Tempei Miyaji, Tomoe Mashiko, Naoko Kobayashi, Eriko Satomi, Daisuke Kiuchi, Tatsuya Morita, Yosuke Uchitomi, Koichi Goto, Yuichiro Ohe

Cancer Medicine　13　(22)　2024年11月18日
出版者・発行元： Wiley
DOI： 10.1002/cam4.70325 　

ISSN：2045-7634

eISSN：2045-7634

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ABSTRACT Background We aimed to examine the effectiveness of a nurse‐led, screening‐triggered early specialized palliative care intervention program for patients with advanced lung cancer. Methods Patients with advanced lung cancer who underwent initial chemotherapy were randomized to intervention and usual care groups between January 2017 and September 2019. The intervention comprised comprehensive needs assessments, counseling, and service coordination by advanced‐level nurses. Patients in the usual care group received the usual oncological care. The primary end point was a change in the trial outcome index (TOI) scores from baseline to 12 weeks. The secondary end‐points were TOI scores at week 20, depression, anxiety, and survival. Results In total, 102 patients were assigned to each group. Compared with the usual care group, no significant improvement in TOI scores was observed at 12 weeks in the intervention group (mean group difference: 2.13; 90% confidence interval: −0.70, 4.95; p = 0.107, one‐sided), whereas significant improvement was observed at 20 weeks (3.58; 90% confidence interval: 0.15, 7.00; p = 0.043). There were no significant differences in the change from baseline depression and anxiety between the groups from baseline at week 12 and 20 weeks (depression: p = 0.60 and 0.10, anxiety: p = 0.78 and 0.067). Survival did not significantly differ between the groups (median survival time: 12.1 vs. 11.1 months; p = 0.302). Conclusions Nurse‐led, screening‐triggered, early specialized palliative care did not show significant superiority over usual care during the 12‐week study period. However, it may have yielded delayed clinical benefits, such as improved quality of life and this feasible model can be acceptable in clinical practice. Trial Registration: The University Hospital Medical Information Network Clinical Trials Registry: UMIN000025491
Effectiveness and safety of low-energy shock wave therapy for digital ulcers associated with systemic sclerosis: a phase 3 pivotal clinical trial. 国際誌

Tomonori Ishii, Yasushi Kawaguchi, Osamu Ishikawa, Hiromitsu Takemori, Naruhiko Takasawa, Hitoshi Kobayashi, Yuichi Takahashi, Hidekata Yasuoka, Takao Kodera, Osamu Takai, Izaya Nakaya, Yukio Sato, Tomomasa Izumiyama, Hiroshi Fujii, Yukiko Kamogawa, Yuko Shirota, Tsuyoshi Shirai, Yoko Fujita, Shinichiro Saito, Shih-Wei Chiu, Takuhiro Yamaguchi, Hiroaki Shimokawa, Hideo Harigae

Modern rheumatology　2024年11月18日

DOI： 10.1093/mr/roae104 　

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OBJECTIVES: Systemic sclerosis is characterised by ischaemic skin ulcers on the fingertips, and low-energy shock wave therapy is suggested as a novel treatment for ischaemic lesions with angiogenic effects. We aimed to investigate the efficacy and safety of shock wave therapy for skin ulcers in patients with systemic sclerosis. METHODS: In this phase 3 pivotal study, we analysed 60 systemic sclerosis patients with digital ulcers that did not disappear after >4 weeks of existing treatment: 30 patients were treated with extracorporeal shock wave therapy and 30 with conventional treatment. The ulcer count reduction observed after an 8-week treatment period was compared between the shock wave therapy and conventional treatment groups. RESULTS: After an 8-week treatment period, the mean reduction in the number of ulcers was 0.83 (standard deviation [SD] 2.79) in the conventional treatment group compared to a more pronounced reduction of 4.47 (SD 2.65) in the shock wave therapy group. CONCLUSIONS: The study findings indicate the efficacy of extracorporeal shock wave therapy for refractory digital ulcers associated with systemic sclerosis, which has limited therapeutic options. This therapy is non-invasive and safe and can be used without restriction in combination with other therapies, thus serving as a novel therapeutic method.
術後せん妄予防に対する抑肝散の作用機序の探索リバーストランスレーショナル研究

貞廣良一, 大渕勝也, 杉本昌弘, 山口拓洋, 和田佐保, 清水研, 松岡弘道, 上園保仁

総合病院精神医学　36　(Suppl.)　S-205　2024年11月
出版者・発行元： (一社)日本総合病院精神医学会
ISSN：0915-5872
TP53 signature predicts pathological complete response after neoadjuvant chemotherapy for breast cancer: Observational and confirmational study using prospective study cohorts

Shin Takahashi, Nobuaki Sato, Kouji Kaneko, Norikazu Masuda, Masaaki Kawai, Hisashi Hirakawa, Tadashi Nomizu, Hiroji Iwata, Ai Ueda, Takashi Ishikawa, Hiroko Bando, Yuka Inoue, Takayuki Ueno, Shinji Ohno, Makoto Kubo, Hideko Yamauchi, Masahiro Okamoto, Eriko Tokunaga, Shunji Kamigaki, Kenjiro Aogi, Hideaki Komatsu, Masahiro Kitada, Yasuaki Uemoto, Tatsuya Toyama, Yutaka Yamamoto, Toshinari Yamashita, Takehiro Yanagawa, Hiroko Yamashita, Yoshiaki Matsumoto, Masakazu Toi, Minoru Miyashita, Takanori Ishida, Fumiyoshi Fujishima, Satoko Sato, Takuhiro Yamaguchi, Fumiaki Takahashi, Chikashi Ishioka

Translational Oncology　48　102060-102060　2024年10月
出版者・発行元： Elsevier BV
DOI： 10.1016/j.tranon.2024.102060 　

ISSN：1936-5233
Effectiveness of remote risk-based monitoring and potential benefits for combination with direct data capture. 国際誌

Osamu Yamada, Shih-Wei Chiu, Toru Nakazawa, Satoru Tsuda, Mitsuhide Yoshida, Toshifumi Asano, Taiki Kokubun, Kazuki Hashimoto, Munenori Takata, Suzuka Ikeda, Yosuke Kawabe, Yuko Tamura, Takuhiro Yamaguchi

Trials　25　(1)　384-384　2024年6月14日

DOI： 10.1186/s13063-024-08242-2 　

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BACKGROUND: In recent years, alternative monitoring approaches, such as risk-based and remote monitoring techniques, have been recommended instead of traditional on-site monitoring to achieve more efficient monitoring. Remote risk-based monitoring (R2BM) is a monitoring technique that combines risk-based and remote monitoring and focuses on the detection of critical data and process errors. Direct data capture (DDC), which directly collects electronic source data, can facilitate R2BM by minimizing the extent of source documents that must be reviewed and reducing the additional workload on R2BM. In this study, we evaluated the effectiveness of R2BM and the synergistic effect of combining R2BM with DDC. METHODS: R2BM was prospectively conducted with eight participants in a randomized clinical trial using a remote monitoring system that uploaded photographs of source documents to a cloud location. Critical data and processes were verified by R2BM, and later, all were confirmed by on-site monitoring to evaluate the ability of R2BM to detect critical data and process errors and the workload of uploading photographs for clinical trial staff. In addition, the reduction of the number of uploaded photographs was evaluated by assuming that the DDC was introduced for data collection. RESULTS: Of the 4645 data points, 20.9% (n = 973, 95% confidence interval = 19.8-22.2) were identified as critical. All critical data errors corresponding to 5.4% (n = 53/973, 95% confidence interval = 4.1-7.1) of the critical data and critical process errors were detectable by R2BM. The mean number of uploaded photographs and the mean time to upload them per visit per participant were 34.4 ± 11.9 and 26.5 ± 11.8 min (mean ± standard deviation), respectively. When assuming that DDC was introduced for data collection, 45.0% (95% confidence interval = 42.2-47.9) of uploaded photographs for R2BM were reduced. CONCLUSIONS: R2BM can detect 100% of the critical data and process errors without on-site monitoring. Combining R2BM with DDC reduces the workload of R2BM and further improves its efficiency.
Safety and efficacy of aceneuramic acid in GNE myopathy: open-label extension study. 国際誌

Naoki Suzuki, Madoka Mori-Yoshimura, Masahisa Katsuno, Masanori P Takahashi, Satoshi Yamashita, Yasushi Oya, Atsushi Hashizume, Shinichiro Yamada, Masayuki Nakamori, Rumiko Izumi, Masaaki Kato, Hitoshi Warita, Maki Tateyama, Hiroshi Kuroda, Ryuta Asada, Takuhiro Yamaguchi, Ichizo Nishino, Masashi Aoki

Journal of neurology, neurosurgery, and psychiatry　2024年6月5日

DOI： 10.1136/jnnp-2024-333853 　
The development and analysis of a Japanese modern comprehensive clinical data management training program. 国際誌

Takuhiro Yamaguchi, Hiroko Yaegashi, Shih-Wei Chiu, Yukari Uemura, Takuya Kawahara, Tempei Miyaji, Tomoe Mashiko, Munenori Takata

Heliyon　10　(6)　e27846　2024年3月30日

DOI： 10.1016/j.heliyon.2024.e27846 　

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BACKGROUND: Clinical data management (CDM) collects, integrates, and makes data available. It plays a vital role in clinical research. However, there are few opportunities for Japanese clinical data managers to learn about its systematic framework, particularly in academic research organizations. While Japanese-language CDM training exists, its effectiveness in a Japanese context requires clarification. OBJECTIVES: We aimed to develop an advanced program of instruction for professionals to understand CDM and to determine the effectiveness of the training program. METHODS AND RESULTS: We developed an advanced program including risk-based monitoring and the Clinical Data Interchange Standards Consortium on a trial basis for clinical data managers to provide them with a comprehensive understanding of CDM. Fifty-two people attended the program and reported that they were highly satisfied with it. CONCLUSIONS: To provide comprehensive CDM training in Japan, it is imperative to continue improving the content and develop an advanced program. Due to the recent tightening of clinical research regulations and the development and dissemination of various systems for conducting clinical research, the competency-based educational program requires further development.
How to select and understand guidelines for patient-reported outcomes: a scoping review of existing guidance. 国際誌

Takako Kaneyasu, Eri Hoshino, Mariko Naito, Yoshimi Suzukamo, Kikuko Miyazaki, Satomi Kojima, Takuhiro Yamaguchi, Takashi Kawaguchi, Tempei Miyaji, Takako Eguchi Nakajima, Kojiro Shimozuma

BMC health services research　24　(1)　334-334　2024年3月13日

DOI： 10.1186/s12913-024-10707-8 　

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BACKGROUND: Over the past few decades, patient-reported outcomes (PROs) have been used to understand patient health conditions better. Therefore, numerous PRO measures (questionnaires) and guidelines or guidance have been developed. However, it is challenging to select target guidance from among the many available guidance and to understand the chosen guidance. This study comprehensively collected the existing PRO guidance for clinical trials or studies and practices to support novice PRO users in academia, industry, clinical practice, and regulatory and reimbursement decision-making. METHODS: For the scoping review, we searched the MEDLINE, Embase, Google Books, WorldCat, and the National Library of Medicine (NLM) Bookshelf databases from 2009 to 2023. The eligibility criteria were PRO guidance for clinical trials, clinical practice, or application such as health technology assessment. Those guidance cover aspects such as quality of life (QOL), PRO, health-related QOL, health state utilities, psychometric requirements, implementation methods, analysis and interpretation, or clinical practice applications. After the systematic search, three researchers individually reviewed the collected data, and the reviewed articles and books were scrutinized using the same criteria. RESULTS: We collected the PRO guidance published in articles and books between 2009 and 2023. From the database searches, 1,455 articles and 387 books were identified, of which one book and 33 articles were finally selected. The collected PRO guidance was categorized into the adoption of PRO measures, design and reporting of trials or studies using PROs, implementation of PRO evaluation in clinical trials or studies or clinical practice, analysis and interpretation of PROs, and application of PRO evaluation. Based on this categorization, we suggest the following for novices: When selecting guidance, novices should clarify the "place" and "purpose" where the guidance will be used. Additionally, they should know that the terminology related to PRO and the scope and expectations of PROs vary by "places" and "purposes". CONCLUSIONS: From this scoping review of existing PRO guidance, we provided summaries and caveats to assist novices in selecting guidance that fits their purpose and understanding it.
Optimizing smartphone psychotherapy for depressive symptoms in patients with cancer: Multiphase optimization strategy using a decentralized multicenter randomized clinical trial (J-SUPPORT 2001 Study). 国際誌

Tatsuo Akechi, Toshiaki A Furukawa, Hisashi Noma, Hiroji Iwata, Tatsuya Toyama, Kenji Higaki, Hiromichi Matsuoka, Sadamoto Zenda, Tsuguo Iwatani, Kazuhisa Akahane, Akira Inoue, Yasuaki Sagara, Megumi Uchida, Fuminobu Imai, Kanae Momino, Gen Imaizumi, Takuhiro Yamaguchi, Tomoe Mashiko, Tempei Miyaji, Masaru Horikoshi, Naomi Sakurai, Tatsuya Onishi, Yukihide Kanemitsu, Takeshi Murata, Yumi Wanifuchi-Endo, Hiroaki Kuroda, Ryutaro Nishikawa, Minoru Miyashita, Masakazu Abe, Yosuke Uchitomi

Psychiatry and clinical neurosciences　2024年3月11日

DOI： 10.1111/pcn.13657 　

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AIM: Patients with cancer experience various forms of psychological distress, including depressive symptoms, which can impact quality of life, elevate morbidity risk, and increase medical costs. Psychotherapy and pharmacotherapy are effective for reducing depressive symptoms among patients with cancer, but most patients prefer psychotherapy. This study aimed to develop an efficient and effective smartphone psychotherapy component to address depressive symptom. METHODS: This was a decentralized, parallel-group, multicenter, open, individually randomized, fully factorial trial. Patients aged ≥20 years with cancer were randomized by the presence/absence of three cognitive-behavioral therapy (CBT) skills (behavioral activation [BA], assertiveness training [AT], and problem-solving [PS]) on a smartphone app. All participants received psychoeducation (PE). The primary outcome was change in the patient health questionnaire-9 (PHQ-9) total score between baseline and week 8. Secondary outcomes included anxiety. RESULTS: In total, 359 participants were randomized. Primary outcome data at week 8 were obtained for 355 participants (99%). The week 8 PHQ-9 total score was significantly reduced from baseline for all participants by -1.41 points (95% confidence interval [CI] -1.89, -0.92), but between-group differences in change scores were not significant (BA: -0.04, 95% CI -0.75, 0.67; AT: -0.16, 95% CI -0.87, 0.55; PS: -0.19, 95% CI -0.90, 0.52). CONCLUSION: As the presence of any of the three intervention components did not contribute to a significant additive reduction of depressive symptoms, we cannot make evidence-based recommendations regarding the use of specific smartphone psychotherapy.
Efficacy of adding levofloxacin to gemcitabine and nanoparticle-albumin-binding paclitaxel combination therapy in patients with advanced pancreatic cancer: study protocol for a multicenter, randomized phase 2 trial (T-CORE2201). 国際誌

Hiroo Imai, Yasuhiro Sakamoto, Shin Takahashi, Hiroyuki Shibata, Atsushi Sato, Kazunori Otsuka, Kenji Amagai, Masanobu Takahashi, Takuhiro Yamaguchi, Chikashi Ishioka

BMC cancer　24　(1)　262-262　2024年2月24日

DOI： 10.1186/s12885-024-11973-9 　

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BACKGROUND: Advanced pancreatic cancer is one of the leading causes of cancer-related deaths. For patients with advanced pancreatic cancer, gemcitabine and nanoparticle albumin-binding paclitaxel (nabPTX) combination (GEM/nabPTX) therapy is one of the recommended first-line treatments. Several retrospective studies have suggested that the addition of levofloxacin improves the efficacy of GEM/nabPTX therapy in patients with advanced pancreatic cancer. This prospective study aims to evaluate whether the addition of antibiotics improves the treatment efficacy of GEM/nabPTX as a first-line chemotherapy in patients with advanced pancreatic cancer. METHODS: This multicenter, prospective, randomized, phase 2 trial will included 140 patients. Patients with advanced pancreatic cancer will be randomized in a 1:1 ratio to either the GEM/nabPTX therapy group or the GEM/nabPTX plus levofloxacin group. The primary endpoint for the two groups is median progression-free survival time (mPFS) for the full analysis set (FAS). The secondary endpoints for the two groups are median overall survival (mOS), response rate (RR), disease control rate (DCR), and adverse event (AE) for the FAS and mPFS, mOS, RR, DCR, and AE for the per-protocol set. This study will enroll patients treated with GEM/nabPTX as the first-line chemotherapy for stage IV pancreatic adenocarcinoma. DISCUSSION: GEM/nabPTX is a standard first-line chemotherapy regimen for patients with advanced pancreatic cancer. Recently, the superiority of 5-fluorouracil, liposomal irinotecan, and oxaliplatin combination therapy (NALIRIFOX) to GEM/nabPTX as first-line therapy for pancreatic cancer has been reported. However, the efficacy of NALIRIFOX is inadequate. Based on previous retrospective studies, it is hypothesized that treatment efficacy will improve when levofloxacin is added to GEM/nabPTX therapy. If the AEs (such as leukopenia, neutropenia, and peripheral neuropathy) that occur at an increased rate with levofloxacin and GEM/nabPTX combination therapy can be carefully monitored and properly managed, this simple intervention can be expected to improve the prognosis of patients with advanced pancreatic cancer. TRIAL REGISTRATION: This study was registered with the Japan Registry of Clinical Trials (jRCT; registry number: jRCTs021230005).
Perceptions regarding the concept and definition of patient-reported outcomes among healthcare stakeholders in Japan with relation to quality of life: a cross-sectional study. 国際誌

Takako Kaneyasu, Shinya Saito, Kikuko Miyazaki, Yoshimi Suzukamo, Mariko Naito, Takashi Kawaguchi, Takako Eguchi Nakajima, Takuhiro Yamaguchi, Kojiro Shimozuma

Health and quality of life outcomes　22　(1)　8-8　2024年1月19日

DOI： 10.1186/s12955-023-02224-9 　

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Patient-reported outcomes (PROs) are frequently used in a variety of settings, including clinical trials and clinical practice. The definition of PRO and quality of life (QOL) and their relationship have been concluded through discussions among experts that has been the premise of PRO guidelines are not clearly stated in the guidelines. Therefore, the definition of PRO, especially in relation to QOL, is sometimes explained simply, as "PRO includes QOL," but this complicated matters. This study investigated the perceptions of PRO among various stakeholders (including patients and their families, the industry, clinicians, regulatory or health technology assessment personnel, and academic researchers) in Japan to clarify its definitions and that of QOL, including their relationship.We conducted a two-step survey: a qualitative interview survey and a web-based survey to ensure the validity of the survey. During the interviews, eight stakeholders described their perceptions and thoughts on PRO and its relationship to QOL, and their experience of using PRO. Overall 253 clinicians, 249 company employees, and 494 patients participated in the web survey to confirm how the findings of the interview survey supported the results.In the interview survey, patient advocates described various perspectives of PRO and QOL, including unexpected dynamic relationships, while the most other stakeholders explained PRO and QOL with the language used in the guidelines, but their responses were split. The web-based survey revealed that all stakeholders had a lower awareness of PRO than QOL. The most common perception of PRO, especially in the relationship to QOL, was "they did not fully overlap." Although there were differences in perceptions of the relationship between PRO and QOL among clinicians, company employees, and patients, all perceived PRO as a tool to facilitate communication in clinical practice.The present results are inconsistent with the simplified explanation of PRO, but consistent with the original PRO guideline definitions, which also considered the role of PRO in clinical practice. To make PRO a more potent tool, all stakeholders using PRO should confirm its definition and how it differs from QOL, have a unified recognition in each PRO use, and avoid miscommunication.
Evaluation and Statistical Analysis for The Acute-phase Treatment of COVID-19

Airi TAKAGI, Shih-Wei Chiu, Takayo SUZUKI, Miyuki ISHIGURO, Yuko YAMADA, Takuhiro YAMAGUCHI, Shin TAKAYAMA

Kampo Medicine　75　(3)　251-256　2024年
出版者・発行元： Japan Society for Oriental Medicine
DOI： 10.3937/kampomed.75.251 　

ISSN：0287-4857

eISSN：1882-756X
Prescription trends in Japanese advanced Parkinson's disease patients with non-motor symptoms: J-FIRST. 国際誌

Masahiro Nomoto, Yoshio Tsuboi, Kenichi Kashihara, Shih-Wei Chiu, Tetsuya Maeda, Hidemoto Saiki, Hirohisa Watanabe, Yasushi Shimo, Nobutaka Hattori, Takuhiro Yamaguchi

PloS one　19　(10)　e0309297　2024年

DOI： 10.1371/journal.pone.0309297 　

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BACKGROUND: Non-motor symptoms (NMS) are important factors when selecting treatments for patients with advanced Parkinson's disease (PD). We sought to elucidate the prescribing practices for advanced PD patients with NMS in Japanese clinical practice. METHODS: We examined the prescription rates and doses of anti-PD drugs, and the use of non-steroidal anti-inflammatory drugs (NSAIDs) in post hoc analyses of a 52-week observational study of 996 PD patients with wearing-off on levodopa-containing therapy and ≥1 NMS. RESULTS: Dopamine agonists were the most frequently prescribed drugs combined with levodopa-containing drugs, followed by entacapone, zonisamide, istradefylline, selegiline, and amantadine. The daily dose of levodopa-containing drugs, rotigotine, entacapone, istradefylline, and droxidopa, and the levodopa-equivalent dose increased during the observation period. In a subgroup analysis of patients stratified by NMS status (improved/unchanged/deteriorated), the deteriorated group had higher prescription rates of entacapone and istradefylline, whereas the improved group had higher prescription rates of NSAIDs and zonisamide at Week 52. Prescriptions varied by geographical region for anti-PD drugs and by NMS status for NSAIDs. CONCLUSIONS: There were significant changes in the prescriptions and dosing of selected anti-PD drugs, especially newer drugs. Anti-PD drug and NSAID prescriptions also varied by changes in NMS status and geographic region.
Psychological Barriers to the Use of Opioid Analgesics for Treating Pain in Patients With Advanced Recurrent Cancer: A Multicenter Cohort Study. 国際誌

Takehiko Tsuno, Takashi Kawaguchi, Ryota Yanaizumi, Junichi Kondo, Keiko Kojima, Takashi Igarashi, Masaki Inoue, Tomofumi Miura, Akime Miyasato, Kanako Azuma, Hiroshi Hamada, Tomoya Saeki, Hironori Mawatari, Hiroyuki Ogura, Akira Kotani, Takuhiro Yamaguchi, Hideki Hakamata

Palliative medicine reports　5　(1)　43-52　2024年

DOI： 10.1089/pmr.2023.0068 　

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BACKGROUND: We aimed to gain insight into psychological barriers toward initiation of strong opioid analgesic use in patients with advanced recurrent cancer. METHODS: This study included 46 patients who were prescribed with opioid analgesics for advanced recurrent cancer. The primary outcome was psychological barriers assessed using the Japanese version of the Barriers Questionnaire-II (JBQ-II). The secondary outcomes were psychological changes and pain relief one week after the induction of strong opioid analgesics. RESULTS: The mean age of participants was 63.6 years. Furthermore, 26.1% had an Eastern Cooperative Oncology Group (ECOG) performance status of ≥3. The mean JBQ-II total score was 1.97 (95% confidence interval: 1.75-2.19). At the initiation of opioid therapy, there was no difference in the total scores between the baseline and one week later. Nevertheless, there was a significant difference in the subscale "disease progression" score (mean 2.97 vs. 2.59, difference in means 0.38, standard error 0.16, p = 0.026). Personalized Pain Goal (PPG) was achieved in about half of the participants, and a trend toward a higher score in the subscale "harmful effects" (concern about adverse events) was observed in those who did not achieve PPG. CONCLUSION: This study showed that patients with advanced recurrent cancer have psychological barriers to opioid induction. The relationship between the presence of psychological barriers before and after induction of opioid analgesics and the speed of pain improvement was determined. The results may provide fundamental information for prospective intervention studies to develop individualized education programs for patients with psychological barriers to opioids.Clinical Trial Registration Number UMIN000042443.
Dexamethasone-sparing on days 2-4 with combined palonosetron, neurokinin-1 receptor antagonist, and olanzapine in cisplatin: a randomized phase III trial (SPARED Trial). 国際誌

Hiroko Minatogawa, Naoki Izawa, Kazuhiro Shimomura, Hitoshi Arioka, Hirotoshi Iihara, Mitsuhiro Sugawara, Hajime Morita, Ayako Mochizuki, Shuichi Nawata, Keisuke Mishima, Ayako Tsuboya, Tempei Miyaji, Kazunori Honda, Ayako Yokomizo, Naoya Hashimoto, Takeshi Yanagihara, Junki Endo, Takashi Kawaguchi, Naoki Furuya, Yumiko Sone, Yusuke Inada, Yasushi Ohno, Chikatoshi Katada, Naoya Hida, Kana Akiyama, Daisuke Ichikura, Akiko Konomatsu, Takashi Ogura, Takuhiro Yamaguchi, Takako Eguchi Nakajima

British journal of cancer　2023年11月16日

DOI： 10.1038/s41416-023-02493-7 　

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BACKGROUND: This study evaluated the non-inferiority of dexamethasone (DEX) on day 1, with sparing on days 2-4 in cisplatin-based chemotherapy. METHODS: Patients with malignant solid tumors who were treated with cisplatin (≥50 mg/m²) were randomly assigned (1:1) to receive either DEX on days 1-4 (Arm D4) or DEX on day 1 (Arm D1) plus palonosetron, NK-1 RA, and olanzapine (5 mg). The primary endpoint was complete response (CR) during the delayed (24-120 h) phase. The non-inferiority margin was set at -15%. RESULTS: A total of 281 patients were enrolled, 278 of whom were randomly assigned to Arm D4 (n = 139) or Arm D1 (n = 139). In 274 patients were included in the efficacy analysis, the rates of delayed CR in Arms D4 and D1 were 79.7% and 75.0%, respectively (risk difference -4.1%; 95% CI -14.1%-6.0%, P = 0.023). However, patients in Arm D1 had significantly lower total control rates during the delayed and overall phases, and more frequent nausea and appetite loss. There were no significant between-arm differences in the quality of life. CONCLUSION: DEX-sparing is an alternative option for patients receiving cisplatin; however, this revised administration schedule should be applied on an individual basis after a comprehensive evaluation. CLINICAL TRIALS REGISTRY NUMBER: UMIN000032269.
Registry study of immune-related adverse events using electronic patient-reported outcome in patients with cancer receiving immune checkpoint inhibitors: protocol for a multicentre cohort study

Taiki Hirata, Takashi Kawaguchi, Kanako Azuma, Ayako Torii, Hiroaki Usui, Soan Kim, Tatsuya Hayama, Daisuke Hirate, Yosuke Kawahara, Yuki Kumihashi, Tomomi Chisaka, Tetsuya Wako, Akinobu Yoshimura, Tempei Miyaji, Takuhiro Yamaguchi

BMJ Open　2023年11月

DOI： 10.1136/bmjopen-2023-073724 　
Prevalence of opioid-induced adverse events across opioids commonly used for analgesic treatment in Japan: a multicenter prospective longitudinal study

Yusuke Hiratsuka, Keita Tagami, Akira Inoue, Mamiko Sato, Yasufumi Matsuda, Kazuhiro Kosugi, Emi Kubo, Maika Natsume, Hiroto Ishiki, Sayaka Arakawa, Masaki Shimizu, Naosuke Yokomichi, Shih-Wei Chiu, Mayu Shimoda, Hideyuki Hirayama, Kaoru Nishijima, Kota Ouchi, Tatsunori Shimoi, Tomoko Shigeno, Takuhiro Yamaguchi, Mitsunori Miyashita, Tatsuya Morita, Eriko Satomi

Supportive Care in Cancer　31　(12)　2023年10月16日
出版者・発行元： Springer Science and Business Media LLC
DOI： 10.1007/s00520-023-08099-2 　

ISSN：0941-4355

eISSN：1433-7339

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Abstract Purpose Although opioids have been shown to be effective for cancer pain, opioid-induced adverse events (AEs) are common. To date, little is known about the differences in risks of AEs by opioid type. This study was performed to compare the prevalence of AEs across opioids commonly used for analgesic treatment in Japan. Methods This study was conducted as a preplanned secondary analysis of a multicenter prospective longitudinal study of inpatients with cancer pain who received specialized palliative care for cancer pain relief. We assessed daily AEs until termination of follow-up. We rated the severity of AEs based on the Common Terminology Criteria for Adverse Events version 5.0. We computed adjusted odds ratios for each AE (constipation, nausea and vomiting, delirium, and drowsiness) with the following variables: opioid, age, sex, renal dysfunction, and primary cancer site. Results In total, 465 patients were analyzed. Based on the descriptive analysis, the top four most commonly used opioids were included in the analysis: oxycodone, hydromorphone, fentanyl, and tramadol. With respect to the prevalence of AEs among all analyzed patients, delirium (n = 25, 6.3%) was the most frequent, followed by drowsiness (n = 21, 5.3%), nausea and vomiting (n = 19, 4.8%), and constipation (n = 28, 4.6%). The multivariate logistic analysis showed that no single opioid was identified as a statistically significant independent predictor of any AE. Conclusion There was no significant difference in the prevalence of AEs among oxycodone, fentanyl, hydromorphone, and tramadol, which are commonly used for analgesic treatment in Japan.
Protocol for the ASTRO study (SSOP-01): a multicentre prospective cohort study investigating adverse events based on electronic patient-reported outcomes in patients with breast cancer after adjuvant chemotherapy. 国際誌

Ouki Kuniyoshi, Motohiko Sano, Yasuhiro Nakano, Takashi Kawaguchi, Tomoki Hatakeyama, Yusuke Tsuchiya, Yusuke Inada, Tomohiko Harada, Miyuki Kurosaki, Tomoe Mashiko, Tempei Miyaji, Takuhiro Yamaguchi

BMJ open　13　(9)　e071500　2023年9月14日

DOI： 10.1136/bmjopen-2022-071500 　

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INTRODUCTION: Symptom-related adverse events associated with perioperative chemotherapy in patients with breast cancer include short-term adverse events such as nausea and vomiting. However, changes in the severity and duration of prolonged symptom-related adverse events have not been fully investigated. We present a protocol of a study that aims to clarify the prevalence of symptom-related adverse events in patients with breast cancer 1 year after neoadjuvant or adjuvant chemotherapy using an electronic patient-reported outcomes (ePRO) system. METHODS AND ANALYSIS: This multicentre prospective observational cohort study will include patients with breast cancer who have received preoperative or postoperative adjuvant chemotherapy. The final injection date of the cytotoxic agent will be the study initiation date. Patients will report every 2 weeks from the initiation date to 12 weeks and every 4 weeks from 12 weeks to 1 year, and they can enter this information into the ePRO system from anywhere. The primary outcome will be the prevalence of symptom-related adverse events according to the ePRO system 1 year after the date of the last injection of the cytotoxic drug used in neoadjuvant or adjuvant chemotherapy for breast cancer. To increase multi-institutional enrolment, two cohorts will be included. Cohort 1 will comprise patients with acquisition of baseline patient information regarding preoperative chemotherapy and presurgery characteristics. Cohort 2 will comprise patients without acquisition of baseline patient information. The target sample size is ≥250 per year. ETHICS AND DISSEMINATION: The study protocol has been approved by the ethics committee at each participating institution. The results will be presented at major national and international conferences and submitted to peer-reviewed journals. TRIAL STATUS: Registration was started in October 2021. By August 2022, a total of 132 participants were enrolled. Follow-up will be continued through December 2024. TRIAL REGISTRATION NUMBER: UMIN000045422.
臨床研究専門職の認定・教育・キャリアパス臨床データマネジャー認定制度の検討状況について

高田宗典, 倉本宏美, 藤澤健司, 梨本真広, 神田悟志, 宮路天平, 西基秀, 菅波秀規, 山口拓洋

薬理と治療　51　(Suppl.1)　s14-s17　2023年9月
出版者・発行元：ライフサイエンス出版(株)
ISSN：0386-3603
Cancer Pain Management in Patients Receiving Inpatient Specialized Palliative Care Services 査読有り

Keita Tagami, Shih-Wei Chiu, Kazuhiro Kosugi, Hiroto Ishiki, Yusuke Hiratsuka, Masaki Shimizu, Masanori Mori, Emi Kubo, Tomoo Ikari, Sayaka Arakawa, Tetsuya Eto, Mayu Shimoda, Hideyuki Hirayama, Kaoru Nishijima, Kota Ouchi, Tatsunori Shimoi, Tomoko Shigeno, Takuhiro Yamaguchi, Mitsunori Miyashita, Tatsuya Morita, Akira Inoue, Eriko Satomi

Journal of Pain and Symptom Management　2023年9月
出版者・発行元： Elsevier BV
DOI： 10.1016/j.jpainsymman.2023.09.015 　

ISSN：0885-3924
Efficacy confirmation study of aceneuramic acid administration for GNE myopathy in Japan 国際誌査読有り

Madoka Mori-Yoshimura, Naoki Suzuki, Masahisa Katsuno, Masanori P. Takahashi, Satoshi Yamashita, Yasushi Oya, Atsushi Hashizume, Shinichiro Yamada, Masayuki Nakamori, Rumiko Izumi, Masaaki Kato, Hitoshi Warita, Maki Tateyama, Hiroshi Kuroda, Ryuta Asada, Takuhiro Yamaguchi, Ichizo Nishino, Masashi Aoki

Orphanet Journal of Rare Diseases　18　(1)　241-241　2023年8月11日
出版者・発行元： Springer Science and Business Media {LLC}
DOI： 10.1186/s13023-023-02850-y 　

ISSN：1750-1172

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<jats:title>Abstract</jats:title><jats:sec> <jats:title>Background</jats:title> <jats:p>A rare muscle disease, GNE myopathy is caused by mutations in the <jats:italic>GNE</jats:italic> gene involved in sialic acid biosynthesis. Our recent phase II/III study has indicated that oral administration of aceneuramic acid to patients slows disease progression.</jats:p> </jats:sec><jats:sec> <jats:title>Methods</jats:title> <jats:p>We conducted a phase III, randomized, placebo-controlled, double-blind, parallel-group, multicenter study. Participants were assigned to receive an extended-release formulation of aceneuramic acid (SA-ER) or placebo. Changes in muscle strength and function over 48 weeks were compared between treatment groups using change in the upper extremity composite (UEC) score from baseline to Week 48 as the primary endpoint and the investigator-assessed efficacy rate as the key secondary endpoint. For safety, adverse events, vital signs, body weight, electrocardiogram, and clinical laboratory results were monitored.</jats:p> </jats:sec><jats:sec> <jats:title>Results</jats:title> <jats:p>A total of 14 patients were enrolled and given SA-ER (n = 10) or placebo (n = 4) tablets orally. Decrease in least square mean (LSM) change in UEC score at Week 48 with SA-ER (− 0.115 kg) was numerically smaller as compared with placebo (− 2.625 kg), with LSM difference (95% confidence interval) of 2.510 (− 1.720 to 6.740) kg. In addition, efficacy was higher with SA-ER as compared with placebo. No clinically significant adverse events or other safety concerns were observed.</jats:p> </jats:sec><jats:sec> <jats:title>Conclusions</jats:title> <jats:p>The present study reproducibly showed a trend towards slowing of loss of muscle strength and function with orally administered SA-ER, indicating supplementation with sialic acid might be a promising replacement therapy for GNE myopathy.</jats:p> <jats:p><jats:italic>Trial registration number</jats:italic>: ClinicalTrials.gov (NCT04671472).</jats:p> </jats:sec>
Contribution of traditional Japanese Kampo medicines, kakkonto with shosaikotokakikyosekko, in treating patients with mild-to-moderate coronavirus disease 2019: Further analysis of a multicenter, randomized controlled trial. 国際誌

Shin Takayama, Takao Namiki, Ryutato Arita, Rie Ono, Aikiko Kikuchi, Minoru Ohsawa, Natsumi Saito, Satoko Suzuki, Hajime Nakae, Seiichi Kobayashi, Tetsuhiro Yoshino, Tomoaki Ishigami, Koichiro Tanaka, Airi Takagi, Takuhiro Yamaguchi, Tadashi Ishii, Akito Hisanaga, Kazuo Mitani, Takashi Ito

Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy　2023年7月26日

DOI： 10.1016/j.jiac.2023.07.013 　

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We previously reported the finding of symptom relief in a randomized controlled trial with the combined use of kakkonto and shosaikotokakikyosekko added to conventional treatment in patients with coronavirus disease 2019 (COVID-19). For further evaluation, we performed post hoc analysis focused on symptom disappearance without recurrence, to determine a clearer effect of Kampo medicine. Patients with mild and moderate COVID-19 were randomly allocated to a control group receiving symptomatic therapy or a Kampo group receiving kakkonto (2.5 g) with shosaikotokakikyosekko (2.5 g) three times daily in addition to symptomatic therapy. The data of 161 patients (Kampo group, n = 81; control group, n = 80) were analyzed post hoc for the time to symptom disappearance. Kaplan-Meier and Cox proportional hazard estimates of disappearance of symptoms showed that all and each symptom targeted in this study disappeared faster in the Kampo group than in the control group, although not statistically significant (all symptomatic cases; hazard ratio [HR] 3.73, 95% confidence interval [CI] 0.46-29.98, log-rank p = 0.1763). In a supplemental assessment using covariate adjustment and competing risk analysis, fever disappeared faster in the Kampo group than in the control group (all symptomatic cases, HR 1.62, 95% CI 0.99-2.64, p = 0.0557; unvaccinated cases, HR 1.68, 95% CI 1.00-2.83, p = 0.0498) and shortness of breath disappeared significantly faster in Kampo group than in control group (all symptomatic cases, HR 1.92, 95% CI 1.07-3.42, p = 0.0278; unvaccinated cases, HR 2.15, 95% CI 1.17-3.96, p = 0.0141). These results demonstrate the advantages of Kampo treatment for acute COVID-19.
マルチキナーゼ阻害薬の手足症候群に対するハイドロコロイドドレッシング使用による予防効果の検証

柳朝子, 新井美智子, 清水陽一, 全田貞幹, 山崎直也, 高島淳生, 森実千種, 宮路天平, 益子友恵, 川口崇, 高木雄亮, 山口拓洋

木村看護教育振興財団看護研究集録　(30)　65-72　2023年7月
出版者・発行元： (公財)木村看護教育振興財団
マルチキナーゼ阻害薬の手足症候群に対するハイドロコロイドドレッシング使用による予防効果の検証

柳朝子, 新井美智子, 清水陽一, 全田貞幹, 山崎直也, 高島淳生, 森実千種, 宮路天平, 益子友恵, 川口崇, 高木雄亮, 山口拓洋

木村看護教育振興財団看護研究集録　(30)　65-72　2023年7月
出版者・発行元： (公財)木村看護教育振興財団
A multi-centre, double-blind, randomized, placebo-controlled trial to evaluate the effectiveness and safety of ramelteon for the prevention of postoperative delirium in elderly cancer patients: a study protocol for JORTC-PON2/J-SUPPORT2103/NCCH2103. 国際誌

Ryoichi Sadahiro, Kotaro Hatta, Takuhiro Yamaguchi, Enokido Masanori, Yoshinobu Matsuda, Asao Ogawa, Yusei Iwata, Akihiro Tokoro, Rika Nakahara, Takatoshi Hirayama, Yuko Yanai, Yuko Ogawa, Ayako Kayano, Keisuke Ariyoshi, Shunsuke Oyamada, Yosuke Uchitomi, Tatsuo Akechi, Noboru Yamamoto, Natsuko Okita, Eiko Yorikane, Kazuaki Shimada, Tetsuya Furukawa, Hironobu Hashimoto, Makoto Maeda, Tetsufumi Sato, Asuko Sekimoto, Chiyuki Sasaki, Eiko Saito, Yasuhito Uezono, Hiromichi Matsuoka

Japanese journal of clinical oncology　53　(9)　851-857　2023年6月20日

DOI： 10.1093/jjco/hyad061 　

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Postoperative delirium is an important issue in cancer patients, affecting surgical outcomes and the quality of life. Ramelteon is a melatonin receptor agonist with high affinity for MT1 and MT2 receptors. Clinical trials and observational studies in Japan, including in surgical cancer patients, have shown efficacy of ramelteon in delirium prevention, with no serious safety concerns. However, clinical trials from the USA have reported conflicting results. A Japanese phase II study investigated the efficacy and safety of ramelteon for delirium prevention following gastrectomy in patients aged ≥75 years, with findings suggesting the feasibility of a phase III trial. The aim of this multi-centre, double-blind, randomized placebo-controlled phase III trial is to evaluate the effectiveness and safety of oral ramelteon for postoperative delirium prevention in cancer patients aged ≥65 years as advanced medical care. The trial protocol is described here.
専門的緩和ケアががん疼痛の分類ごとに選択する鎮痛薬と効果に関する検討

小杉和博, 田上恵太, 石木寛人, 平塚裕介, 清水正樹, 森雅紀, 邱士い, 下田真優, 平山英幸, 宮下光令, 山口拓洋, 井上彰, 三浦智史, 里見絵理子

Palliative Care Research　18　(Suppl.)　S229-S229　2023年6月
出版者・発行元： (NPO)日本緩和医療学会
eISSN：1880-5302
専門的緩和ケアサービスが提供する標準的がん疼痛治療による疼痛改善理由の探索多施設共同観察研究から得られた質的データの内容分析

菅原佑菜, 田上恵太, 升川研人, 倉橋美岬, 菊池里美, 小杉和博, 石木寛人, 平塚裕介, 清水正樹, 森雅紀, 邱士い, 下田真優, 平山英幸, 山口拓洋, 井上彰, 里見絵理子, 宮下光令

Palliative Care Research　18　(Suppl.)　S196-S196　2023年6月
出版者・発行元： (NPO)日本緩和医療学会
eISSN：1880-5302
可聴領域外の音源を含むハイレゾ自然音源による進行がん患者の癒し効果及び不安などの症状に対する効果の探索的検討

下津浦康隆, 三浦智史, 石塚啓祐, 井上知謙, 原田真梨子, 梅津和恵, 久保絵美, 小杉和博, 松本禎久, 川口崇, 山口拓洋, 榎本誠也, 谷山英彦, 岩田哲郎

Palliative Care Research　18　(Suppl.)　S320-S320　2023年6月
出版者・発行元： (NPO)日本緩和医療学会
eISSN：1880-5302
Preoperative steroid for enhancing patients' recovery after head and neck cancer surgery with free tissue transfer reconstruction: protocol for a phase III, placebo-controlled, randomised, double-blind study (J-SUPPORT 2022, PreSte-HN Study). 国際誌

Takeshi Shinozaki, Takayuki Imai, Kenya Kobayashi, Seiichi Yoshimoto, Sadamoto Zenda, Takuhiro Yamaguchi, Kohtaro Eguchi, Tomoka Okano, Tomoe Mashiko, Miyuki Kurosaki, Tempei Miyaji, Kazuto Matsuura

BMJ open　13　(5)　e069303　2023年5月31日

DOI： 10.1136/bmjopen-2022-069303 　

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INTRODUCTION: There is no established methodology for the perioperative management of head and neck cancer surgery and free tissue transfer reconstruction (HNS-FTR). A single dose of corticosteroid administered immediately before surgery has been shown to reduce postoperative pain and nausea/vomiting after some types of surgery. However, the efficacy of this strategy has not been demonstrated in HNS-FTR, and the increased risk of infectious complications associated with its use cannot be ruled out. This phase III, placebo-controlled, randomised, double-blind, comparative, multicentre study seeks to determine if preoperative administration of corticosteroid hormone has an adjunctive effect in terms of reducing pain and nausea/vomiting after surgery and improving the quality of postoperative recovery. METHODS AND ANALYSIS: Using the minimisation method, patients undergoing HNS-FTR are currently being recruited and randomly assigned to a study arm at a 1:1 allocation rate. The study treatment arm consists of 8.0 mg of dexamethasone phosphate dissolved in 100 mL of saline administered as a single dose by intravenous infusion. These treatments will be administered in a double-blind fashion. All patients will receive perioperative care according to the common multicentre enhanced recovery after surgery programme. The primary endpoint is the quality of postoperative recovery, as determined by the area under the curve (AUC) for total score on the Japanese version of the Quality of Recovery Score (QOR-40J) on postoperative days 2 and 4. The point estimate and CI for the difference in the AUC between the groups on postoperative days 2 and 4 will be calculated. ETHICS AND DISSEMINATION: The study will be performed in accordance with the Declaration of Helsinki and Japan's Clinical Trials Act. The study protocol was approved by the Certified Review Board of National Cancer Center Hospital East (Reference K2021004). TRIAL REGISTRATION NUMBER: The study was registered in the Japan Registry of Clinical Trials (jRCTs031210593; V.3.0, November 2021, available at https://jrct.niph.go.jp/en-latest-detail/jRCTs031210593).
Optimization of smartphone psychotherapy for depression and anxiety among patients with cancer using the multiphase optimization strategy (MOST) framework and decentralized clinical trial system (SMartphone Intervention to LEssen depression/Anxiety and GAIN resilience: SMILE AGAIN project): a protocol for a randomized controlled trial. 国際誌

Megumi Uchida, Toshiaki A Furukawa, Takuhiro Yamaguchi, Fuminobu Imai, Kanae Momino, Fujika Katsuki, Naomi Sakurai, Tempei Miyaji, Masaru Horikoshi, Hiroji Iwata, Sadamoto Zenda, Tsuguo Iwatani, Asao Ogawa, Akira Inoue, Masakazu Abe, Tatsuya Toyama, Yosuke Uchitomi, Hiromichi Matsuoka, Hisashi Noma, Tatsuo Akechi

Trials　24　(1)　344-344　2023年5月22日

DOI： 10.1186/s13063-023-07307-y 　

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BACKGROUND: Cancer patients experience various forms of psychological distress. Their distress, mainly in the form of depression and anxiety, leads to poor quality of life, increased medical spending due to frequent visits, and decrease in treatment adherence. It is estimated that 30-50% among them would require support from mental health professionals: in reality, much less actually receive such support partly due to a shortage of qualified professionals and also due to psychological barriers in seeking such help. The purpose of the present study is to develop the easily accessible and the most efficient and effective smartphone psychotherapy package to alleviate depression and anxiety in cancer patients. METHODS: Based on the multiphase optimization strategy (MOST) framework, the SMartphone Intervention to LEssen depression/Anxiety and GAIN resilience project (SMILE-AGAIN project) is a parallel-group, multicenter, open, stratified block randomized, fully factorial trial with four experimental components: psychosocial education (PE), behavioral activation (BA), assertion training (AT), and problem-solving therapy (PS). The allocation sequences are maintained centrally. All participants receive PE and then are randomized to the presence/absence of the remaining three components. The primary outcome of this study is the Patient Health Questionnaire-9 (PHQ-9) total score, which will be administered as an electronic patient-reported outcome on the patients' smartphones after 8 weeks. The protocol was approved by the Institutional Review Board of Nagoya City University on July 15, 2020 (ID: 46-20-0005). The randomized trial, which commenced in March 2021, is currently enrolling participants. The estimated end date for this study is March 2023. DISCUSSION: The highly efficient experimental design will allow for the identification of the most effective components and the most efficient combinations among the four components of the smartphone psychotherapy package for cancer patients. Given that many cancer patients face significant psychological hurdles in seeing mental health professionals, easily accessible therapeutic interventions without hospital visits may offer benefits. If an effective combination of psychotherapy is determined in this study, it can be provided using smartphones to patients who cannot easily access hospitals or clinics. TRIAL REGISTRATION: UMIN000041536, CTR. Registered on 1 November 2020 https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000047301 .
Efficacy of Olanzapine in Addition to Standard Triplet Antiemetic Therapy for Cisplatin-Based Chemotherapy: A Secondary Analysis of the J-FORCE Randomized Clinical Trial. 国際誌

Masakazu Abe, Takuhiro Yamaguchi, Yukiyoshi Fujita, Tomoyasu Nishimura, Koichi Kitagawa, Naoki Inui, Katsuya Hirano, Yukio Sakata, Hirotoshi Iihara, Yuichi Shibuya, Kenichi Suzuki, Kazuhiko Shibata, Kensuke Hori, Haruko Daga, Toshiaki Nakayama, Yasuhiko Sakata, Takako Yanai Takahashi, Sadamoto Zenda, Hironobu Hashimoto

JAMA network open　6　(5)　e2310894　2023年5月1日

DOI： 10.1001/jamanetworkopen.2023.10894 　

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IMPORTANCE: It is unknown whether olanzapine combined with triplet antemetic therapy is effective for all patients undergoing highly emetogenic chemotherapy. A secondary analysis of randomized clinical trials using olanzapine may provide insight into the effectiveness of olanzapine for chemotherapy-induced nausea and vomiting (CINV), including cisplatin. OBJECTIVE: To examine the add-on effect of olanzapine according to risk factors for CINV. DESIGN, SETTING, AND PARTICIPANTS: This preplanned secondary analysis evaluated results of the J-FORCE trial, a large double-blind, placebo-controlled phase 3 randomized clinical trial conducted in Japan from February 9, 2017, to July 18, 2018. Participants were enrolled from 26 participating hospitals across Japan and included patients aged 20 to 75 years who had a malignant tumor and were cisplatin-naive. The efficacy analysis population of the J-FORCE trial was analyzed according to allocation adjustment factors (sex [male or female], age [≥55 years or <55 years], and cisplatin dose [≥70 mg/m2 or <70 mg/m2]) and patient-related risk factors (history of motion sickness, drinking habit [defined as alcoholic drinks consumption in excess of occasional drinking], and history of morning sickness during pregnancy). Statistical analysis was performed from February 18 to April 18, 2020. INTERVENTIONS: Patients were randomized 1:1 to receive 5 mg of olanzapine or placebo combined with standard triplet antiemetic therapy. MAIN OUTCOMES AND MEASURES: The primary end point was complete response (CR, defined as no vomiting and no use of rescue medication) in the delayed phase (24-120 hours after cisplatin-based chemotherapy administration). Secondary end points were CR, complete control, and total control in the acute, delayed, and overall phases for 6 CINV risk factors as well as time to treatment failure. The CR point estimates and 95% CIs of the differences between groups were calculated, and a Mantel-Haenszel test was performed. RESULTS: Of the 705 patients (mean [SD] age, 63.0 [9.2] years; 471 males [66.8%]) included in the efficacy analysis population; 581 patients (82.4%) were 55 years or older, and 526 (74.6%) were treated with a cisplatin dose of 70 mg/m2 or more. Risk difference (RD) for a CR in the delayed phase was significantly greater in the olanzapine group than the placebo group in males (RD, 12.6% [95% CI, 5.0%-20.1%]; P = .001); in females (RD, 14.5% [95% CI, 2.2%-26.3%]; P = .02); in those 55 years or older (RD, 11.1% [95% CI, 3.9%-18.2%]; P = .003) or younger than 55 years (RD, 23.6% [95% CI, 7.3%-38.3%]; P = .005); for a cisplatin dose of 70 mg/m2 or more (RD, 13.5% [95% CI, 5.9%-21.0%]; P < .001); for those without a history of motion sickness (RD, 13.9% [95% CI, 6.9%-20.6%]; P < .001); for those with a drinking habit (RD, 14.9% [95% CI, 6.1%-23.4%]; P = .001) or without a drinking habit (RD, 12.0% [95% CI, 2.5%-21.3%]; P = .01); and for those with a history of morning sickness during pregnancy (RD, 27.2% [9.7%-42.6%]; P = .002). In other subgroups, a delayed CR was higher in the olanzapine group than the placebo group, although not significantly higher. CONCLUSIONS AND RELEVANCE: Results of this study suggest a benefit of using 5 mg of olanzapine plus triplet antiemetic therapy to counter CINV regardless of the presence or absence of risk factors. TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry Identifier: UMIN000024676.
Phase II study of biweekly cetuximab plus mFOLFOX6 or mFOLFIRI as second-line treatment for metastatic colorectal cancer and exploratory analysis of associations between DNA methylation status and the efficacy of the anti-EGFR antibody: T-CORE1201

Shin Takahashi, Kota Ouchi, Yasuhiro Sakamoto, Takahiro Mori, Hideki Shimodaira, Masahiro Takahashi, Hisatsugu Ohori, Chieko Kudo, Yoshikazu Takahashi, Hiroo Imai, Shoko Akiyama, Masanobu Takahashi, Takeshi Suto, Yasuko Murakawa, Takayuki Oishi, Hideki Isobe, Yoshinari Okada, Sadayuki Kawai, Takashi Yoshioka, Toshihiko Sato, Yoshiaki Shindo, Shunsuke Sugiyama, Keigo Komine, Natsuko Chiba, Akira Okita, Takuhiro Yamaguchi, Chikashi Ishioka

Journal of Gastrointestinal Oncology　14　(2)　676-691　2023年4月
出版者・発行元： AME Publishing Company
DOI： 10.21037/jgo-22-862 　

ISSN：2078-6891

eISSN：2219-679X
Effectiveness of a facilitation programme using a mobile application for initiating advance care planning discussions between patients with advanced cancer and healthcare providers: protocol for a randomised controlled trial (J-SUPPORT 2104). 国際誌

Kyoko Obama, Maiko Fujimori, Masako Okamura, Midori Kadowaki, Taro Ueno, Narikazu Boku, Masanori Mori, Tatsuo Akechi, Takuhiro Yamaguchi, Shunsuke Oyamada, Ayumi Okizaki, Tempei Miyaji, Naomi Sakurai, Yosuke Uchitomi

BMJ open　13　(3)　e069557　2023年3月28日

DOI： 10.1136/bmjopen-2022-069557 　

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INTRODUCTION: Timely implementation of the discussion process of advance care planning (ACP) is recommended. The communication attitude of healthcare providers is critical in ACP facilitation; thus, improving their communication attitudes may reduce patient distress and unnecessary aggressive treatment while enhancing care satisfaction. Digital mobile devices are being developed for behavioural interventions owing to their low space and time restrictions and ease of information sharing. This study aims to evaluate the effectiveness of an intervention programme using an application intended to facilitate patient questioning behaviour on improving communication related to ACP between patients with advanced cancer and healthcare providers. METHODS AND ANALYSIS: This study uses a parallel-group, evaluator-blind, randomised controlled trial design. We plan to recruit 264 adult patients with incurable advanced cancer at the National Cancer Centre in Tokyo, Japan. Intervention group participants use a mobile application ACP programme and undergo a 30 min interview with a trained intervention provider for discussions with the oncologist at the next patient visit, while control group participants continue their usual treatment. The primary outcome is the oncologist's communication behaviour score assessed using audiorecordings of the consultation. Secondary outcomes include communication between patients and oncologists and the patients' distress, quality of life, care goals and preferences, and medical care utilisation. We will use a full analysis set including the registered participant population who receive at least a part of the intervention. ETHICS AND DISSEMINATION: The study protocol was reviewed and approved by the Scientific Advisory Board of the Japan Supportive, Palliative and Psychosocial Oncology Group (Registration No. 2104) and the Institutional Review Board of the National Cancer Centre Hospital (registration No. 2020-500). Written informed consent is obtained from the patients. The results of the trial will be published in peer-reviewed scientific journals and presented at scientific meetings. TRIAL REGISTRATION NUMBERS: UMIN000045305, NCT05045040.
Phase III study of long-term prognosis of estrogen receptor-positive early breast cancer treated with neoadjuvant endocrine therapy with/without adjuvant chemotherapy. 国際誌

Hiroji Iwata, Yutaka Yamamoto, Takehiko Sakai, Yoshie Hasegawa, Rikiya Nakamura, Hiromitsu Akabane, Shoichiro Ohtani, Masahiro Kashiwaba, Naruto Taira, Tatsuya Toyama, Tomomi Fujisawa, Norikazu Masuda, Yukiko Shibahara, Hironobu Sasano, Takuhiro Yamaguchi

Breast cancer research and treatment　199　(2)　231-241　2023年3月22日

DOI： 10.1007/s10549-023-06874-7 　

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PURPOSE: Neoadjuvant endocrine therapy (NET) is a treatment option for estrogen receptor-positive (ER+) postmenopausal early breast cancer (EBC). This phase III trial evaluated the prognosis of EBC patients treated with/without chemotherapy (CT) following NET. METHODS: ER+/HER2-, T1c-2, and clinically node-negative EBC patients were enrolled in 2008-2013 and treated with endocrine therapy (ET) in weeks 24-28. All patients, excluding those with progressive disease (PD) during NET or ≥ 4 positive lymph nodes after surgery, were randomized to ET for 4.5-5 years with/without CT. The primary endpoint was disease-free survival (DFS). Secondary endpoints included distant DFS (DDFS), overall survival (OS), and DFS/DDFS/OS according to clinical response to NET. RESULTS: Of 904 patients, 669 were randomized to CT+ET (n = 333) or ET alone (n = 336). The median follow-up was 7.8 years. DFS (CT+ET, 47 events; ET alone, 70 events) and DDFS did not reach the planned numbers of events. Eight-year DFS/DDFS rates were 86%/93% and 83%/92%, respectively. DFS was significantly better in CT+ET than ET alone in subgroups aged < 60 years (P = 0.016), T2 (P = 0.013), or Ki67 > 20% (P = 0.026). Progesterone receptor and histological grade were predictive markers for clinical responses to NET. CONCLUSION: NET may be used as standard treatment for patients with ER+EBC. Although it is difficult to decide whether to administer adjuvant CT based solely on the effect of NET, the response to NET may help to inform this decision. TRIAL REGISTRATION: This study was registered at the UMIN Clinical Trials Registry under UMIN000001090 (registered 20 March 2008).
Adherence to anti-retroviral therapy, decisional conflicts, and health-related quality of life among treatment-naïve individuals living with HIV: a DEARS-J observational study. 国際誌

Yusuke Sekine, Takashi Kawaguchi, Yusuke Kunimoto, Junichi Masuda, Ayako Numata, Atsushi Hirano, Hiroki Yagura, Masashi Ishihara, Shinichi Hikasa, Mariko Tsukiji, Tempei Miyaji, Takuhiro Yamaguchi, Ei Kinai, Kagehiro Amano

Journal of pharmaceutical health care and sciences　9　(1)　9-9　2023年3月2日

DOI： 10.1186/s40780-023-00277-y 　

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BACKGROUND: Supporting people living with HIV using anti-retroviral therapy (ART) is important due to the requirement for strict medication adherence. To date, no data from longitudinal studies evaluating adherence by treatment-naïve people living with HIV are currently available. We investigated the adherence of treatment-naïve people living with HIV over time and examined the relationships among decisional conflicts, adherence, and health-related quality of life (HRQL). METHODS: The survey items included adherence (visual analogue scale [VAS]), decisional conflict (decisional conflict scale [DCS]), and HRQL (Medical Outcomes Study HIV Health Survey [MOS-HIV]). The DCS and MOS-HIV scores and the VAS and MOS scores were collected electronically at the ART initiation time point and at 4-, 24-, and 48-week post-treatment time points. RESULTS: A total of 215 participants were enrolled. The mean DCS score was 27.3 (SD, 0.9); 23.3% of participants were in the high-score and 36.7% in the low-score groups. The mean adherence rates at 4, 24, and 48 weeks were 99.2% (standard error [SE], 0.2), 98.4% (SE, 0.4), and 96.0% (SE, 1.2), respectively. The least-square means of the MOS-HIV for the DCS (high vs. low scores) were 64.4 vs. 69.2 for general health perceptions and 57.7 vs. 64.0 for HRQL, respectively. CONCLUSION: Adherence among treatment-naïve people living with HIV was maintained at a higher level, and HRQL tended to improve with ART. People with high levels of decisional conflict tended to have lower HRQL scores. Support for people living with HIV during ART initiation may be related to HRQL.
Risk factors for developing dyskinesia among Parkinson's disease patients with wearing-off: J-FIRST

Takayasu Mishima, Shih-Wei Chiu, Hidemoto Saiki, Takuhiro Yamaguchi, Yasushi Shimo, Tetsuya Maeda, Hirohisa Watanabe, Kenichi Kashihara, Masahiro Nomoto, Nobutaka Hattori, Yoshio Tsuboi

Journal of the Neurological Sciences　120619-120619　2023年3月
出版者・発行元： Elsevier BV
DOI： 10.1016/j.jns.2023.120619 　

ISSN：0022-510X
臨床研究におけるDigital TransformationとDecentralized Clinical Trialの現状 100% Decentralized Clinical Trialの実装と課題乳がん患者を対象としたアプリ介入研究の事例

益子友恵, 宮路天平, 明智龍男, 山口拓洋

薬理と治療　50　(Suppl.2)　s96-s97　2022年12月
出版者・発行元：ライフサイエンス出版(株)
ISSN：0386-3603
臨床研究におけるDigital TransformationとDecentralized Clinical Trialの現状 100% Decentralized Clinical Trialの実装と課題乳がん患者を対象としたアプリ介入研究の事例

益子友恵, 宮路天平, 明智龍男, 山口拓洋

薬理と治療　50　(Suppl.2)　s96-s97　2022年12月
出版者・発行元：ライフサイエンス出版(株)
ISSN：0386-3603
Comparison of statistical models for estimating intervention effects based on time-to-recurrent-event in stepped wedge cluster randomized trial using open cohort design

Shunsuke Oyamada, Shih-Wei Chiu, Takuhiro Yamaguchi

BMC Medical Research Methodology　22　(1)　2022年12月
出版者・発行元： Springer Science and Business Media LLC
DOI： 10.1186/s12874-022-01552-6 　

eISSN：1471-2288

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Abstract Background There are currently no methodological studies on the performance of the statistical models for estimating intervention effects based on the time-to-recurrent-event (TTRE) in stepped wedge cluster randomised trial (SWCRT) using an open cohort design. This study aims to address this by evaluating the performance of these statistical models using an open cohort design with the Monte Carlo simulation in various settings and their application using an actual example. Methods Using Monte Carlo simulations, we evaluated the performance of the existing extended Cox proportional hazard models, i.e., the Andersen-Gill (AG), Prentice-Williams-Peterson Total-Time (PWP-TT), and Prentice-Williams-Peterson Gap-time (PWP-GT) models, using the settings of several event generation models and true intervention effects, with and without stratification by clusters. Unidirectional switching in SWCRT was represented using time-dependent covariates. Results Using Monte Carlo simulations with the various described settings, in situations where inter-individual variability do not exist, the PWP-GT model with stratification by clusters showed the best performance in most settings and reasonable performance in the others. The only situation in which the performance of the PWP-TT model with stratification by clusters was not inferior to that of the PWP-GT model with stratification by clusters was when there was a certain amount of follow-up period, and the timing of the trial entry was random within the trial period, including the follow-up period. In situations where inter-individual variability existed, the PWP-GT model consistently underperformed compared to the PWP-TT model. The AG model performed well only in a specific setting. By analysing actual examples, it was found that almost all the statistical models suggested that the risk of events during the intervention condition may be somewhat higher than in the control, although the difference was not statistically significant. Conclusions When estimating the TTRE-based intervention effects of SWCRT in various settings using an open cohort design, the PWP-GT model with stratification by clusters performed most reasonably in situations where inter-individual variability was not present. However, if inter-individual variability was present, the PWP-TT model with stratification by clusters performed best.
Anticholinergic drugs for death rattle in dying patients with cancer: multicentre prospective cohort study. 国際誌査読有り

Takashi Yamaguchi, Naosuke Yokomichi, Takuhiro Yamaguchi, Isseki Maeda, Ryo Matsunuma, Yukako Tanaka-Yagi, Asami Akatani, Kozue Suzuki, Hiroyuki Kohara, Tomohiko Taniyama, Yosuke Matsuda, Nobuhisa Nakajima, Tatsuya Morita, Satoru Tsuneto, Masanori Mori

BMJ supportive & palliative care　2022年11月10日

DOI： 10.1136/spcare-2022-003823 　

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BACKGROUND: This study aimed to investigate the effectiveness of anticholinergics (AC) for death rattle in dying patients with cancer. METHODS: This is a prospective cohort study enrolled Terminally ill adult (20 years or older) patients with cancer who developed substantial death rattle (Back score ≥2) from 23 palliative care units in Japan. AC treatment for death rattle was prescribed according to primary physician's decision. The primary outcome was the proportion of patients whose death rattle improved, which was defined as a Back score of ≤1. We compared the proportion of improved cases in patients treated with (AC group) and without (non-AC group) AC, controlling potential confounders by employing propensity score weighting. RESULTS: Of the 1896 patients enrolled, we included 196 who developed a substantial death rattle. Of these, 81 received AC. 56.8% in the AC group and 35.4% in the non-AC group had an improved death rattle at 8 hours after baseline. In the weighted analysis, AC group showed significant improvements in death rattle, with an adjusted OR of 4.47 (95% CI 2.04 to 9.78; p=0.0024). All sensitivity analyses achieved essentially the same results. In the subgroup analysis, ACs were strongly associated with death rattle improvement in men, patients with lung cancer, and type 1 death rattle (adjusted OR 5.81, 8.38 and 9.32, respectively). CONCLUSIONS: In this propensity score-weighted analysis, ACs were associated with death rattle improvement in terminally ill patients with cancer who developed substantial death rattle. TRIAL REGISTRATION NUMBER: UMIN-CTR (UMIN00002545).
Smartphone Psychotherapy Reduces Fear of Cancer Recurrence Among Breast Cancer Survivors: A Fully Decentralized Randomized Controlled Clinical Trial (J-SUPPORT 1703 Study). 国際誌

Tatsuo Akechi, Takuhiro Yamaguchi, Megumi Uchida, Fuminobu Imai, Kanae Momino, Fujika Katsuki, Naomi Sakurai, Tempei Miyaji, Tomoe Mashiko, Masaru Horikoshi, Toshi A Furukawa, Akiyo Yoshimura, Shinji Ohno, Natsue Uehiro, Kenji Higaki, Yoshie Hasegawa, Kazuhisa Akahane, Yosuke Uchitomi, Hiroji Iwata

Journal of clinical oncology : official journal of the American Society of Clinical Oncology　41　(5)　JCO2200699-1078　2022年11月2日

DOI： 10.1200/JCO.22.00699 　

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PURPOSE: Fear of cancer recurrence (FCR) is a common distressing condition. We investigated the efficacy of smartphone problem-solving therapy and behavioral activation applications in breast cancer survivors. METHODS: This was a decentralized randomized trial. Participants were disease-free breast cancer survivors age 20-49 years who were randomly assigned to the smartphone-based intervention or waitlist control. Both groups received treatment as usual. The control group could access the smartphone apps during weeks 8-24. The intervention comprised smartphone problem-solving therapy and behavioral activation apps. The primary end point was the Concerns About Recurrence Scale at week 8. Secondary outcomes included the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF), the Hospital Anxiety and Depression Scale (HADS), the Short-form Supportive Care Needs Survey (SCNS-SF34), and the Posttraumatic Growth Inventory at weeks 8 and 24 (trial registration: UMIN-CTR: UMIN000031140). RESULTS: The intervention group included 223 participants, and the control group included 224 participants. Primary outcome data were obtained for 444 participants, and 213 participants in the intervention arm completed the week 24 assessment. The intervention group had statistically greater improvements than controls at week 8 on the Concerns About Recurrence Scale (difference -1.39; 95% CI, -1.93 to -0.85; P < .001), FCRI-SF (difference -1.65; 95% CI, -2.41 to -0.89; P < .001), HADS depression (difference -0.49; 95% CI, -0.98 to 0; P < .05), and SCNS-SF34 psychological domain (difference -1.49; 95% CI, -2.67 to -0.32; P < .05). These scores at week 24 were not statistically significant compared with week 8 although the HADS depression score at week 24 was significantly reduced (P = .03). CONCLUSION: Novel smartphone psychotherapy offers a promising way to reduce FCR given the large number of survivors and a limited number of therapists to competently conduct psychotherapy.
乳がんサバイバーの再発恐怖に対するスマートフォン精神療法の有効性分散型無作為割付比較試験

明智龍男, 山口拓洋, 内田恵, 今井文信, 樅野香苗, 香月富士日, 桜井なおみ, 宮路天平, 益子友恵, 堀越優, 古川壽亮, 吉村章代, 大野真司, 植弘奈津江, 檜垣健司, 長谷川善枝, 赤羽和久, 内富庸介, 岩田広治

総合病院精神医学　34　(Suppl.)　S-156　2022年10月
出版者・発行元： (一社)日本総合病院精神医学会
ISSN：0915-5872
Availability of and factors related to interventional procedures for refractory pain in patients with cancer: a nationwide survey 国際誌

Yuko Uehara, Yoshihisa Matsumoto, Toshifumi Kosugi, Miyuki Sone, Naoki Nakamura, Akio Mizushima, Mitsunori Miyashita, Tatsuya Morita, Takuhiro Yamaguchi, Eriko Satomi

BMC Palliative Care　21　(1)　166-166　2022年9月26日

DOI： 10.1186/s12904-022-01056-6 　

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BACKGROUND: Cancer pain may be refractory to standard pharmacological treatment. Interventional procedures are important for quality of analgesia. The aim of the present study was to clarify the availability of four interventional procedures (celiac plexus neurolysis/splanchnic nerve neurolysis, phenol saddle block, epidural analgesia, and intrathecal analgesia), the number of procedures performed by specialists, and their associated factors. In addition, we aimed to establish how familiar home hospice physicians and oncologists are with the different interventional procedures available to manage cancer pain. METHODS: A cross-sectional survey using a self-administered questionnaire was conducted. Subjects were certified pain specialists, interventional radiologists, home hospice physicians, and clinical oncologists. RESULTS: The numbers of valid responses/mails were 545/1,112 for pain specialists, 554/1,087 for interventional radiology specialists, 144/308 for home hospice physicians, and 412/800 for oncologists. Among pain specialists, depending on intervention, 40.9-75.2% indicated that they perform each procedure by themselves, and 47.5-79.8% had not performed any of the procedures in the past 3 years. Pain specialists had performed the four procedures 4,591 times in the past 3 years. Among interventional radiology specialists, 18.1% indicated that they conduct celiac plexus neurolysis/splanchnic nerve neurolysis by themselves. Interventional radiology specialists had performed celiac plexus neurolysis/splanchnic nerve neurolysis 202 times in the past 3 years. Multivariate analysis revealed that the number of patients seen for cancer pain and the perceived difficulty in gaining experience correlated with the implementation of procedures among pain specialists. Among home hospice physicians and oncologists, depending on intervention, 3.5-27.1% responded that they were unfamiliar with each procedure. CONCLUSIONS: Although pain specialists responded that the implementation of each intervention was possible, the actual number of the interventions used was limited. As interventional procedures are well known, it is important to take measures to ensure that pain specialists and interventional radiology physicians are sufficiently utilized to manage refractory cancer pain.
S-1 + Cisplatin with Concurrent Radiotherapy Followed by Surgery for Stage IIIA (N2) Lung Squamous Cell Carcinoma: Results of a Phase II Trial 査読有り

Kazuya Takamochi, Masahiro Tsuboi, Morihito Okada, Seiji Niho, Satoshi Ishikura, Shunsuke Oyamada, Takuhiro Yamaguchi, Kenji Suzuki, Fumihiro Tanaka, Masanori Tsuchida, Ichiro Yoshino, Satoshi Shiono, Hiroyuki Oizumi, Tomohiro Haruki, Norihito Okumura, Funai Kazuhito, Hiroyuki Ito, Hirotoshi Horio, Motoki Matsuura, Tsuyoshi Ueno, Tetsuzo Tagawa

Annals of Surgical Oncology　2022年9月12日
出版者・発行元：
DOI： 10.1245/s10434-022-12490-4 　

ISSN：1068-9265

eISSN：1534-4681

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Background: To date, no clinical trials on the use of induction therapy before surgery have focused solely on lung squamous cell carcinoma (LSCC). We report the results of the Personalized Induction Therapy-2 (PIT-2) trial, a multicenter phase II study, performed to investigate the efficacy and safety of S-1 + cisplatin with concurrent thoracic radiotherapy (TRT) followed by surgery in patients with stage IIIA (N2) LSCC. Methods: Patients with pathologically proven stage IIIA (N2) LSCC received induction therapy comprising three cycles of S-1 + cisplatin with concurrent TRT (45 Gy in 25 fractions) followed by surgery. S-1 was administered orally at a dose of 40 mg/m2 twice daily on days 1-14, in addition to intravenous infusion of cisplatin (60 mg/m2) on day 1. The primary endpoint was 2-year progression-free survival (PFS) rate. Results: Of 45 registered patients, 43 underwent induction therapy. Of the 43 patients, 39 (91%) underwent surgery (35 lobectomies, 3 pneumonectomies, and 1 wedge resection). The 2-year PFS, 2-year overall survival, objective response rate, and pathological complete response rates were 67% (90% confidence interval [CI] 54-78%), 70% (95% CI 53-81%), 86% (95% CI 76-96%), and 39% (95% CI 23-54%), respectively. No new treatment-related adverse events occurred during the induction therapy. One case of 90-day postoperative mortality involving a patient who underwent right pneumonectomy and developed pneumonia after discharge occurred. Conclusions: Induction therapy using S-1 + cisplatin with concurrent TRT followed by surgery is a feasible and promising treatment approach for stage IIIA (N2) LSCC.
Incidence and predictors of recurrent sick leave in survivors who returned to work after allogeneic hematopoietic cell transplantation. 国際誌

Saiko Kurosawa, Takuhiro Yamaguchi, Ayako Mori, Tomoko Matsuura, Masayoshi Masuko, Makoto Murata, Haruko Tashiro, Shinichi Kako, Atsushi Satake, Maki Hagihara, Shuichi Ota, Takeshi Saito, Kumiko Kagawa, Yayoi Matsuo, Hidehiro Itonaga, Nobuhiko Uoshima, Hiroki Yamaguchi, Kensuke Naito, Miyako Takahashi, Takahiro Fukuda

Journal of cancer survivorship : research and practice　2022年9月1日

DOI： 10.1007/s11764-022-01250-8 　

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BACKGROUND: Although rather favorable probabilities of return to work have been reported after allogeneic hematopoietic cell transplantation (allo-HCT), survivors often have difficulty continuing to work because of their immunocompromised status and diverse late effects after allo-HCT. We evaluated the incidence of and risk factors for recurrent sick leave in allo-HCT survivors after they initially returned to work. METHODS: We targeted allo-HCT survivors who were employed at diagnosis, aged 20-64 at survey, and survived for ≥ 2 years without relapse. Of the 1904 survivors who were informed of the study, 1148 returned the questionnaire (60%), and 1048 eligible participants were included in the overall analysis. In the present study that considered recurrent sick leave after return to work, we targeted 896 participants who returned to work at least once after allo-HCT. Participants stated if they had recurrent sick leave after returning to work and its reasons, as well as associated patient-, HCT/HCT center-, and work-related factors and clinical events after allo-HCT. A logistic regression analysis was conducted to explore correlated factors for recurrent sick leave. RESULTS: In survivors who returned to work, 30% required recurrent sick leave. The most frequent causes of recurrent leave were physical issues (72%), and analysis of free descriptions demonstrated that these were mainly associated with graft-versus-host disease, infection, or readmission. Other reasons included work-related issues such as gap between physical and working conditions. Multivariate analysis showed that cord blood transplantation, longer employment duration, and counseling from healthcare professionals were associated with a lower risk of recurrent leave. Readmission, immunosuppressant use, and symptoms involving the respiratory system, gut, and joints and muscles were associated with a higher risk. CONCLUSIONS: Our results drawn from a large cohort study should help healthcare professionals identify and assist at-risk patients. Multi-professional teams that provide continuous support and effective communication with the workplace are necessary to improve long-term outcomes after allo-HCT. IMPLICATIONS FOR CANCER SURVIVORS: In order to continue working after the initial return to work, it is important to receive counseling from healthcare professionals and obtain reasonable accommodation from workplace.
Prevention of delirium with agitation by yokukansan in older adults after cancer surgery

Ryoichi Sadahiro, Saho Wada, Yutaka J Matsuoka, Yosuke Uchitomi, Takuhiro Yamaguchi, Tetsufumi Sato, Minoru Esaki, Seiichi Yoshimoto, Hiroyuki Daiko, Yukihide Kanemitsu, Akira Kawai, Tomoyasu Kato, Hiroyuki Fujimoto, Yasuhito Uezono, Ken Shimizu, Hiromichi Matsuoka

Japanese Journal of Clinical Oncology　2022年7月30日
出版者・発行元： Oxford University Press (OUP)
DOI： 10.1093/jjco/hyac123 　

eISSN：1465-3621

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Abstract Objective Preventing postoperative delirium with agitation is vital in the older population. We examined the preventive effect of yokukansan on postoperative delirium with agitation in older adult patients undergoing highly invasive cancer resection. Methods We performed a secondary per-protocol analysis of 149 patients’ data from a previous clinical trial. Patients underwent scheduled yokukansan or placebo intervention 4–8 days presurgery and delirium assessment postoperatively. Delirium with agitation in patients aged ≥75 years was assessed using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, and the Japanese version of the Delirium Rating Scale-Revised-98. We assessed odds ratios for yokukansan (TJ-54) compared with placebo for the manifestation of postoperative delirium with agitation across patients of all ages (n = 149) and those aged ≥65 years (n = 82) and ≥ 75 years (n = 21) using logistic regression. Results Delirium with agitation manifested in 3/14 and 5/7 patients in the TJ-54 and placebo groups, respectively, among those aged ≥75 years. The odds ratio for yokukansan vs. placebo was 0.11 (95% confidence interval: 0.01–0.87). An age and TJ-54 interaction effect was detected in patients with delirium with agitation. No intergroup differences were observed in patients aged ≥65 years or across all ages for delirium with agitation. Conclusions This is the first study investigating the preventive effect of yokukansan on postoperative delirium with agitation in older adults. Yokukansan may alleviate workforce burdens in older adults caused by postoperative delirium with agitation following highly invasive cancer resection.
がん疼痛に対するメサドン内服治療の実態、障壁日本在宅医療連合学会認定専門医対象全国質問紙調査

松本禎久, 上原優子, 小杉寿文, 曽根美雪, 中村直樹, 森田達也, 水嶋章郎, 宮下光令, 山口拓洋, 里見絵理子

日本在宅医療連合学会大会プログラム・講演抄録集　4回　262-262　2022年7月
出版者・発行元： (一社)日本在宅医療連合学会
がん疼痛に対するメサドン内服治療の実態、障壁、教育がん診療連携拠点病院対象全国質問紙調査

上原優子, 松本禎久, 小杉寿文, 曽根美雪, 中村直樹, 森田達也, 水嶋章郎, 宮下光令, 山口拓洋, 里見絵理子

Palliative Care Research　17　(Suppl.)　S.222-S.222　2022年7月
出版者・発行元： (NPO)日本緩和医療学会
eISSN：1880-5302
がん疼痛に対するメサドン内服治療の実態、障壁がん診療連携拠点病院以外の病院および在宅療養支援診療所を対象とした全国質問紙調査

松本禎久, 上原優子, 小杉寿文, 曽根美雪, 中村直樹, 森田達也, 水嶋章郎, 宮下光令, 山口拓洋, 里見絵理子

Palliative Care Research　17　(Suppl.)　S.222-S.222　2022年7月
出版者・発行元： (NPO)日本緩和医療学会
eISSN：1880-5302
がん疼痛に対するメサドン内服治療の実態、障壁、教育緩和医療専門医・認定医対象全国質問紙調査

里見絵理子, 松本禎久, 上原優子, 水嶋章郎, 曽根美雪, 小杉寿文, 中村直樹, 森田達也, 宮下光令, 山口拓洋

Palliative Care Research　17　(Suppl.)　S.229-S.229　2022年7月
出版者・発行元： (NPO)日本緩和医療学会
eISSN：1880-5302
専門的緩和ケアサービスによるがん疼痛の症状緩和治療に関する実態調査多施設共同前向き観察研究

田上恵太, 小杉和博, 石木寛人, 平塚裕介, 清水正樹, 森雅紀, 邱士い, 下田真優, 平山英幸, 佐藤麻美子, 松田泰史, 猪狩智生, 宮下光令, 山口拓洋, 井上彰, 里見絵理子

Palliative Care Research　17　(Suppl.)　S.210-S.210　2022年7月
出版者・発行元： (NPO)日本緩和医療学会
eISSN：1880-5302
持続的鎮静によって患者がコミュニケーションできる機会は失われるか

横道直佑, 山口拓洋, 森田達也, 羽多野裕, 今井堅吾, 木澤義之, 恒藤暁, 志摩泰夫, 升川研人, 宮下光令, 森雅紀

Palliative Care Research　17　(Suppl.)　S.184-S.184　2022年7月
出版者・発行元： (NPO)日本緩和医療学会
eISSN：1880-5302
がん疼痛に対する侵襲的鎮痛法のコンサルト状況と障壁施設対象全国質問紙調査

松本禎久, 上原優子, 水嶋章郎, 小杉寿文, 曽根美雪, 宮下光令, 山口拓洋, 里見絵理子

日本ペインクリニック学会誌　29　(プログラム号)　92-92　2022年6月
出版者・発行元： (一社)日本ペインクリニック学会
ISSN：1340-4903

eISSN：1884-1791
Effect of paracentesis on the survival of patients with terminal cancer and ascites: a propensity score-weighted analysis of the East Asian Collaborative Cross-cultural Study to Elucidate the Dying Process. 国際誌

Ken Masuda, Hiroto Ishiki, Naosuke Yokomichi, Takuhiro Yamaguchi, Tetsuya Ito, Hana Takatsu, Koji Amano, Shuji Hiramoto, Toshihiro Yamauchi, Takashi Kawaguchi, Masanori Mori, Yosuke Matsuda, Takashi Yamaguchi

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer　30　(7)　6233-6241　2022年4月21日

DOI： 10.1007/s00520-022-07057-8 　

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PURPOSE: Paracentesis is among the most widely utilized treatments for malignant ascites (MA). However, paracentesis in patients with MA has the potential to be associated with life-shortening effects. Thus, this study aimed to investigate whether paracentesis affected the duration of survival in such patients. METHODS: We performed a post hoc analysis of a prospective multicenter observational study investigating the dying process and end-of-life care in patients with terminal cancer, admitted to 23 palliative care units in Japan. Survival duration was compared between patients who did (paracentesis group) and did not undergo paracentesis (non-paracentesis group). We used inverse probability of treatment weighting (IPTW) to control for baseline covariates between groups. RESULTS: Among the 1896 initially enrolled patients, 568 with ascites were included in the study cohort. Eighty-five (15.0%) patients underwent paracentesis. The primary tumor site was the pancreas (51.9%, n = 295), followed by the gastrointestinal tract (22.7%, n = 129). Non-adjusted median durations of survival were 22 days (95% confidence interval [CI]: 16-25) and 12 days (95% CI: 11-13) in the paracentesis and non-paracentesis groups, respectively (hazard ratio [HR]: 0.69, 95% CI: 0.54-0.88; p = 0.003). The IPTW-adjusted median survival durations were 22 (95% CI: 16-25) and 16 days (95% CI: 12-22) in the paracentesis and non-paracentesis groups, respectively (HR: 0.89, 95% CI: 0.64-1.24; p = 0.492). No serious adverse events occurred in the paracentesis group. CONCLUSIONS: Paracentesis does not negatively affect the survival of patients with cancer and MA and can be a standard treatment in palliative care settings.
Cisplatin Plus Capecitabine After Adjuvant S-1 in Metastatic Gastric Cancer: A Phase II T-CORE1102 Trial. 国際誌

Takashi Yoshioka, Masanobu Takahashi, Yasuhiro Sakamoto, Akira Okita, Tadahisa Fukui, Yasuko Murakawa, Yoshiaki Shindo, Hiroo Imai, Hisatsugu Ohori, Hidekazu Shirota, Natsuko Chiba, Yuriko Ito Sasahara, Takashi Nomura, Norimasa Fukushima, Takuhiro Yamaguchi, Hideki Shimodaira, Chikashi Ishioka

Anticancer research　42　(4)　2009-2015　2022年4月

DOI： 10.21873/anticanres.15680 　

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BACKGROUND/AIM: This phase II study assessed the efficacy of capecitabine plus cisplatin in patients with advanced gastric cancer refractory to adjuvant S-1. PATIENTS AND METHODS: This single-arm, open-label, multicenter, phase II study was conducted by Tohoku Clinical Oncology Research and Education Society (T-CORE) in Japan. Patients aged ≥20 years with advanced HER2-negative gastric cancer that was refractory to S-1 were enrolled. Patients received 80 mg/m2 cisplatin on day 1 intravenously and 1,000 mg/m2 capecitabine twice daily from day 1 to day 14, in 3-week cycles. The primary endpoint was progression-free survival (PFS). The threshold overall response rate (ORR) was estimated to be 15%. The secondary endpoints were overall survival (OS), time to treatment failure, ORR, and toxicities. RESULTS: In total, 21 patients were enrolled from seven hospitals. The median patient age was 63 years. Nineteen patients received the protocol treatment. Median PFS was 3.7 months [90% confidence interval (CI)=2.7-5.6 months], which did not reach the predefined threshold of 4.0 months. ORR was 5.9% (95%CI=0.0-17.1%). Median OS was 11.9 months (95% CI 6.3-19.4 months). Febrile neutropenia was observed in 5.3% of patients. The most frequently observed grade 3 non-hematologic toxicities were nausea (15.8%) and hyponatremia (15.8%). CONCLUSION: The addition of a fluoropyrimidine to a platinum agent after adjuvant therapy is not suitable for gastric cancer.
Feasibility and usefulness of recommended screenings at long-term follow-up clinics for hematopoietic cell transplant survivors. 国際誌

Saiko Kurosawa, Takuhiro Yamaguchi, Ayako Mori, Mayumi Tsukagoshi, Ikue Okuda, Masako Ikeda, Takao Ueno, Yutaka Saito, Yukiko Aihara, Yuko Matsuba, Shigeo Fuji, Takuya Yamashita, Chitose Ogawa, Ayumu Ito, Takashi Tanaka, Yoshihiro Inamoto, Sung-Won Kim, Takahiro Fukuda

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer　30　(3)　2767-2776　2022年3月

DOI： 10.1007/s00520-021-06698-5 　

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PURPOSE: Advances in allogeneic hematopoietic cell transplantation (allo-HCT) have resulted in a growing number of transplant survivors; however, long-term survivors are at risk of developing late complications, and published guidelines recommend screening of this population. We conducted a single-center prospective study to evaluate the adherence to and usefulness of recommended screenings at a long-term follow-up (LTFU) clinic. METHODS: We included consecutive patients who received allo-HCT at our center from 2014, as well as post-HCT patients visiting our outpatient clinic. Visits and screenings were planned at 3 months, 6 months, and 1 year after allo-HCT, and annually thereafter. Outcomes were reported by physicians including the incidence of findings at each screening that led to interventions. RESULTS: Among the 216 participants, 95% visited the LTFU clinic, and 94% completed planned screenings. However, the rate of secondary cancer screenings targeting high-risk subjects was lower (38% to 68%). The overall percentage of screening results leading to interventions was 4.5%, with higher percentages (> 10%) for bone density testing, ophthalmological examinations, dental assessment, upper gastrointestinal endoscopy, and colonoscopy, with two patients diagnosed with secondary cancers. CONCLUSIONS: Although the overall screening rate was high, it should be possible to improve the detection rate of late complications by decreasing screening failures, especially the screening for secondary cancers limited for high-risk survivors. A nationwide effort to educate HCT survivors and health practitioners using standardized nationwide LTFU tools may be effective, along with the development of institutional, local, and nationwide networks to maintain effective follow-up systems.
Psychological barriers to the use of opioid analgesics for treating pain in patients with advanced recurrent cancer (BAROC): protocol for a multicentre cohort study

Takehiko Tsuno, Tatsuhiro Fujimiya, Takashi Kawaguchi, Ryota Yanaizumi, Keiko Kojima, Akime Miyasato, Kanako Azuma, Tomoya Saeki, Hironori Mawatari, Takashi Igarashi, Tomofumi Miura, Hiroyuki Ogura, Junichi Kondo, Tadashi Tanoue, Hiroshi Hamada, Yu Oyama, Akira Kotani, Takuhiro Yamaguchi, Hideki Hakamata

BMJ Open　12　(3)　e054914-e054914　2022年3月
出版者・発行元： BMJ
DOI： 10.1136/bmjopen-2021-054914 　

ISSN：2044-6055

eISSN：2044-6055

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Introduction Opioid analgesics are essential for treating cancer pain. However, patients are sometimes reluctant to use them because of concerns about addiction and dependence. Rapid pain relief following opioid administration may help overcome the psychological barriers to opioid analgesic use. This study aims to determine the relationship between psychological resistance to strong opioid analgesic use and pain amelioration speed in patients with advanced recurrent cancer. Methods and analysis This ongoing, multicentre, observational study enrols patients aged 20 years or older with distant metastasis or advanced recurrent cancer receiving strong opioid analgesics for cancer pain for the first time. All participants, both inpatient and outpatient, were recruited from five Japanese hospitals. We are investigating the relationship between psychological barriers at the start of treatment and pain relief during the first week of treatment in these patients. The primary outcome is the Japanese version of the Barriers Questionnaire-II score at baseline. The secondary outcomes are the relationships between psychological barriers to strong opioid analgesic use and changes in pain over time. The participants are asked to fill out an electronic patient-reported outcome daily during the first week of treatment. The sample size was determined based on the number of patients in the year prior to study commencement who used strong opioid analgesics, met the eligibility criteria and could be expected to consent to participate in the study. Ethics and dissemination The study protocol was approved by the ethics committee (approval ID B200600091) of Yokohama City University on 24 August 2020. The protocol has been reviewed by the institutional review boards at the four participating study sites. The results will be published in a peer-reviewed journal and will be presented at a relevant meeting. Trial registration number UMIN000042443.
Phase III, international, multicentre, double-blind, dose increment, parallel-arm, randomised controlled trial of duloxetine versus pregabalin for opioid-unresponsive neuropathic cancer pain: a JORTC-PAL16 trial protocol

Hiromichi Matsuoka, Katherine Clark, Belinda Fazekas, Shunsuke Oyamada, Linda Brown, Hiroto Ishiki, Yoshinobu Matsuda, Hideaki Hasuo, Keisuke Ariyoshi, Jessica Lee, Brian Le, Peter Allcroft, Slavica Kochovska, Noriko Fujiwara, Tempei Miyaji, Melanie Lovell, Meera Agar, Takuhiro Yamaguchi, Eriko Satomi, Satoru Iwase, Jane Phillips, Atsuko Koyama, David C Currow

BMJ Open　12　(2)　e050182-e050182　2022年2月
出版者・発行元： BMJ
DOI： 10.1136/bmjopen-2021-050182 　

ISSN：2044-6055

eISSN：2044-6055

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<sec><title>Introduction</title>Management of neuropathic cancer pain (NCP) refractory to regular opioids remains an important challenge. The efficacy of pregabalin for NCP except chemotherapy-induced peripheral neuropathy (CIPN) has already been confirmed in two randomised controlled trials (RCTs) compared with placebo. Duloxetine offers the potential of analgesia in opioid refractory NCP. However, there are no RCT of duloxetine for the management of opioid-refractory NCP as a first line treatment. Both classes of drugs have the potential to reduce NCP, but there has been no head-to-head comparison for the efficacy and safety, especially given differing side effect profiles. </sec><sec><title>Methods and analysis</title>An international, multicentre, double-blind, dose increment, parallel-arm, RCT is planned. Inclusion criteria include: adults with cancer experiencing NCP refractory to opioids; Brief Pain Inventory (BPI)-item 3 (worst pain) of ≥4; Neuropathic Pain on the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale of ≥12 despite of an adequate trial of regular opioid medication (≥60 mg/day oral morphine equivalent dose). Patients with CIPN are excluded. The study will recruit from palliative care teams (both inpatients and outpatients) in Japan and Australia. Participants will be randomised (1:1 allocation ratio) to duloxetine or pregabalin arm. Dose escalation is until day 14 and from day 14 to 21 is a dose de-escalation period to avoid withdrawal effects. The primary endpoint is defined as the mean difference in BPI item 3 for worst pain intensity over the previous 24 hours at day 14 between groups. A sample size of 160 patients will be enrolled between February 2020 and March 2023. </sec><sec><title>Ethics and dissemination</title>Ethics approval was obtained at Osaka City University Hospital Certified Review Board and South Western Sydney Local Health District Human Research Ethics Committee. The results of this study will be submitted for publication in international journals and the key findings presented at international conferences. </sec><sec><title>Trial registration numbers</title>jRCTs051190097, ACTRN12620000656932. </sec>
Effect of continuous deep sedation on survival in the last days of life of cancer patients: A multicenter prospective cohort study. 国際誌

Naosuke Yokomichi, Takuhiro Yamaguchi, Isseki Maeda, Masanori Mori, Kengo Imai, Akemi Shirado Naito, Takashi Yamaguchi, Toru Terabayashi, Yusuke Hiratsuka, Takayuki Hisanaga, Tatsuya Morita

Palliative medicine　36　(1)　189-199　2022年1月

DOI： 10.1177/02692163211057754 　

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BACKGROUND: Continuous deep sedation is ethically controversial with respect to whether it shortens a patient's life. AIM: To examine whether continuous deep sedation shortens patient survival from the day of Palliative Performance Scale decline to 20 (PPS20). DESIGN: A part of a multicenter prospective cohort study (EASED study). SETTING/PARTICIPANTS: We recruited consecutive adult patients with advanced cancer admitted to 23 participating palliative care units in 2017 in Japan. We compared survival from PPS20 between those who did and did not receive continuous deep sedation. Continuous deep sedation was defined as the continuous administration of sedative medication with the intention to keep a patient continuously unconscious to alleviate otherwise uncontrollable symptoms, but the dose of sedatives was adjusted to achieve adequate symptom relief for each patient. The propensity score-weighting method was used to control for potential confounders, and five sensitivity analyses were performed. RESULTS: A total of 1926 patients were enrolled. Patients discharged alive were excluded, and we analyzed 1625 patients of whom 156 (9.6%) received continuous deep sedation. Median survival from PPS20 of 1625 patients was 81 h (95% CI: 77-88). The RASS scores decreased to ⩽-4 was 66% at 24 h. Continuous deep sedation was not associated with a significant survival risk (adjusted hazard ratio: 1.06, 95% CI: 0.85-1.33). All sensitivity analyses, including continuous deep sedation defined as the RASS score was ⩽-4 achieved the essentially the same results. CONCLUSIONS: Continuous deep sedation with careful dose adjustment was not associated with shorter survival in the last days of life in patients with advanced cancer.
Morphine for dyspnoea in chronic obstructive pulmonary disease: A before-after efficacy study

Yoshinobu Matsuda, Tatsuya Morita, Hirotaka Matsumoto, Keita Hosoi, Kayo Kusama, Yasuo Kohashi, Hiroshi Morishita, Sawako Kaku, Keisuke Ariyoshi, Shunsuke Oyamada, Yoshikazu Inoue, Satoru Iwase, Takuhiro Yamaguchi, Mitsunori Nishikawa

BMJ Supportive and Palliative Care　11　(4)　427-432　2021年12月1日
出版者・発行元： BMJ Publishing Group
DOI： 10.1136/bmjspcare-2019-001929 　

ISSN：2045-4368 2045-435X
ISPORタスクフォース報告書臨床アウトカム評価概念的基盤 ISPOR臨床アウトカム評価報告書アウトカム研究のための新たな実施基準タスクフォース

Walton Marc K., Powers III John H., Hobart Jeremy, Patrick Donald, Marquis Patrick, Vamvakas Spiros, Isaac Maria, Molsen Elizabeth, Cano Stefan, Burke Laurie B., 山口拓洋, 川口崇, 宮路天平, 全田貞幹

薬理と治療　49　(12)　2007-2026　2021年12月
出版者・発行元：ライフサイエンス出版(株)
ISSN：0386-3603
ISPORタスクフォース報告書臨床アウトカム評価概念的基盤 ISPOR臨床アウトカム評価報告書アウトカム研究のための新たな実施基準タスクフォース

Walton Marc K., Powers III John H., Hobart Jeremy, Patrick Donald, Marquis Patrick, Vamvakas Spiros, Isaac Maria, Molsen Elizabeth, Cano Stefan, Burke Laurie B., 山口拓洋, 川口崇, 宮路天平, 全田貞幹

薬理と治療　49　(12)　2007-2026　2021年12月
出版者・発行元：ライフサイエンス出版(株)
ISSN：0386-3603
Randomized phase II trial of pemetrexed-cisplatin plus bevacizumab or thoracic radiotherapy followed by surgery for stage IIIA (N2) nonsquamous non–small cell lung cancer 査読有り

Kazuya Takamochi, Kenji Suzuki, Masahiro Tsuboi, Seiji Niho, Satoshi Ishikura, Shunsuke Oyamada, Takuhiro Yamaguchi, Morihito Okada, Ichiro Yoshino, Hiroyuki Ito, Norihito Okumura, Fumihiro Tanaka, Hisashi Saji, Masanori Tsuchida, Hirotoshi Horio, Satoshi Shiono, Motoki Matsuura, Norihiko Ikeda, Toshiki Tanaka, Hisashi Iwata, Tomohiro Haruki, Hiroyuki Suzuki, Yoshimasa Maniwa, Hiroyuki Oizumi

The Journal of Thoracic and Cardiovascular Surgery　2021年12月
出版者・発行元：
DOI： 10.1016/j.jtcvs.2021.11.079 　

ISSN：0022-5223
Is the 1-day surprise question a useful screening tool for predicting prognosis in patients with advanced cancer?-a multicenter prospective observational study. 国際誌

Tomoo Ikari, Yusuke Hiratsuka, Takuhiro Yamaguchi, Masanori Mori, Yu Uneno, Tomohiko Taniyama, Yosuke Matsuda, Kiyofumi Oya, Koji Amano, Keita Tagami, Akira Inoue

Annals of palliative medicine　10　(11)　11278-11287　2021年11月

DOI： 10.21037/apm-21-1718 　

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BACKGROUND: For cancer patients nearing death, the prediction of their prognosis by physicians is crucial. This study examined the usefulness of the 1-Day Surprise Question (1DSQ). METHODS: This study was conducted as part of a multicenter prospective observational study. The physicians answered the 1DSQ "Would I be surprised if this patient died in the next 1 day?" when patients have palliative performance scale (PPS) ≤20. We calculated the sensitivity and specificity of the 1DSQ. Moreover, using multivariate analysis, we evaluated the characteristics of patients who died among those whose physicians answered the 1DSQ as "not surprised". RESULTS: Overall, 1,896 patients were enrolled, and 1,411 (74.4%) were analyzed between January and December 2017. Among these, 847 (60.0%) patients were placed in the "not surprised" group. The sensitivity, specificity, and positive and negative predictive values of the 1DSQ were 82.0% [95% confidence interval (CI): 77.5-85.8%], 45.5% (95% CI: 44.4-46.4%), 27.4% (95% CI: 25.9-28.7%), and 91.0% (95% CI: 88.9-92.9%), respectively. Multivariate analysis revealed that urine output over last 12 hours <100 mL, decreased response to visual stimuli, respiration with mandibular movement, pulselessness of radial artery, and saturation of percutaneous oxygen <90% were characteristics of patients who died as predicted by the physicians. CONCLUSIONS: The 1DSQ is a helpful screening tool for identifying cancer patients with impending death.
悪性腹水を有する終末期がん患者に対する腹水穿刺が予後に与える影響

増田健, 石木寛人, 横道直佑, 山口拓洋, 伊藤哲也, 鷹津英, 天野晃滋, 平本秀二, 山内敏宏, 川口崇, 森雅紀, 松田洋祐, 山口崇

日本癌治療学会学術集会抄録集　59回　O79-1　2021年10月
出版者・発行元： (一社)日本癌治療学会
Influence of istradefylline on non-motor symptoms of Parkinson's disease: A subanalysis of a 1-year observational study in Japan (J-FIRST). 国際誌

Yasushi Shimo, Tetsuya Maeda, Shih-Wei Chiu, Takuhiro Yamaguchi, Kenichi Kashihara, Yoshio Tsuboi, Masahiro Nomoto, Nobutaka Hattori, Hirohisa Watanabe, Hidemoto Saiki

Parkinsonism & related disorders　91　115-120　2021年10月

DOI： 10.1016/j.parkreldis.2021.09.015 　

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INTRODUCTION: The non-motor symptoms (NMSs) of Parkinson's disease (PD) significantly impact the patient's health-related quality of life. This subanalysis of the J-FIRST study evaluated the effect of istradefylline, a selective adenosine A2A receptor antagonist, on NMSs in istradefylline-naïve Japanese patients with PD. METHODS: Patients with PD and ≥1 NMS and 'wearing-off' with their current antiparkinsonian treatment were observed for up to 52 weeks. The effect of istradefylline on NMSs was measured in terms of changes in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 1 total, individual sub-items scores and the 8 item PD questionnaire (PDQ-8) estimated by the marginal structural model. RESULTS: Overall, 732 patients were istradefylline-naïve prior to the study, of whom 171 were treated with istradefylline for ≥8 weeks during the observation period (istradefylline-treated patients). At baseline, istradefylline-treated patients were more likely to have a dyskinesia (49.7% vs 40.8%) and received a significantly higher daily dose of levodopa (462.8 mg vs 413.0 mg) than those who did not receive istradefylline (n = 561). MDS-UPDRS Part 1 total score at the end of the 52-week observational period slightly increased in patients who received istradefylline and those who did not (0.49 ± 0.41 vs 0.07 ± 0.20; P = 0.36). There were no statistically significant differences between the two groups of patients in terms of changes in the MDS-UPDRS Part 1 total score or any sub-items, or in the PDQ-8 total score. CONCLUSION: NMSs remained generally controlled in istradefylline-treated Japanese patients with PD who exhibited wearing-off with their current antiparkinsonian treatment. Istradefylline could be a feasible treatment option for patients with advanced PD, without worsening existing NMSs.
A decision tree prediction model for a short-term outcome of delirium in patients with advanced cancer receiving pharmacological interventions: A secondary analysis of a multicenter and prospective observational study (Phase-R)

Ken Kurisu, Shuji Inada, Isseki Maeda, Asao Ogawa, Satoru Iwase, Tatsuo Akechi, Tatsuya Morita, Shunsuke Oyamada, Takuhiro Yamaguchi, Kengo Imai, Rika Nakahara, Keisuke Kaneishi, Nobuhisa Nakajima, Masahiko Sumitani, Kazuhiro Yoshiuchi

Palliative and Supportive Care　1-6　2021年9月30日
出版者・発行元： Cambridge University Press (CUP)
DOI： 10.1017/s1478951521001565 　

ISSN：1478-9515

eISSN：1478-9523

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<title>Abstract</title> <sec id="S1478951521001565_sec_a1"> <title>Objective</title> There is no widely used prognostic model for delirium in patients with advanced cancer. The present study aimed to develop a decision tree prediction model for a short-term outcome. </sec> <sec id="S1478951521001565_sec_a2" sec-type="methods"> <title>Method</title> This is a secondary analysis of a multicenter and prospective observational study conducted at 9 psycho-oncology consultation services and 14 inpatient palliative care units in Japan. We used records of patients with advanced cancer receiving pharmacological interventions with a baseline Delirium Rating Scale Revised-98 (DRS-R98) severity score of ≥10. A DRS-R98 severity score of <10 on day 3 was defined as the study outcome. The dataset was randomly split into the training and test dataset. A decision tree model was developed using the training dataset and potential predictors. The area under the curve (AUC) of the receiver operating characteristic curve was measured both in 5-fold cross-validation and in the independent test dataset. Finally, the model was visualized using the whole dataset. </sec> <sec id="S1478951521001565_sec_a3" sec-type="results"> <title>Results</title> Altogether, 668 records were included, of which 141 had a DRS-R98 severity score of <10 on day 3. The model achieved an average AUC of 0.698 in 5-fold cross-validation and 0.718 (95% confidence interval, 0.627–0.810) in the test dataset. The baseline DRS-R98 severity score (cutoff of 15), hypoxia, and dehydration were the important predictors, in this order. </sec> <sec id="S1478951521001565_sec_a4"> <title>Significance of results</title> We developed an easy-to-use prediction model for the short-term outcome of delirium in patients with advanced cancer receiving pharmacological interventions. The baseline severity of delirium and precipitating factors of delirium were important for prediction. </sec>
Diagnostic models for impending death in terminally ill cancer patients: A multicenter cohort study. 国際誌

Masanori Mori, Takuhiro Yamaguchi, Isseki Maeda, Yutaka Hatano, Takashi Yamaguchi, Kengo Imai, Ayako Kikuchi, Yosuke Matsuda, Kozue Suzuki, Satoru Tsuneto, David Hui, Tatsuya Morita

Cancer medicine　10　(22)　7988-7995　2021年9月29日

DOI： 10.1002/cam4.4314 　

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BACKGROUND: Accurately predicting impending death is essential for clinicians to clarify goals of care. We aimed to develop diagnostic models to predict death ≤3 days in cancer patients. METHODS: In this multicenter cohort study, we consecutively enrolled advanced cancer patients admitted to 23 inpatient hospices in 2017. Fifteen clinical signs related to impending death were documented daily from the day when the Palliative Performance Scale (PPS) declined to ≤20-14 days later. We conducted recursive partitioning analysis using the entire data set and performed cross-validation to develop the model (prediction of 3-day impending death-decision tree [P3did-DT]). Then, we summed the number of systems (nervous/cardiovascular/respiratory/musculoskeletal), where any sign was present to underpin P3did score (range = 0-4). RESULTS: Data following PPS ≤20 were obtained from 1396 of 1896 inpatients (74%). The mean age was 73 ± 12 years, and 399 (29%) had gastrointestinal tract cancer. The P3did-DT was based on three variables and had four terminal leaves: urine output (u/o) ≤200 ml/day and decreased response to verbal stimuli, u/o ≤200 ml/day and no decreased response to verbal stimuli, u/o >200 ml/day and Richmond Agitation-Sedation Scale (RASS) ≤-2, and u/o >200 ml/day and RASS ≥-1. The 3-day mortality rates were 80.3%, 53.3%, 39.9%, and 20.6%, respectively (accuracy = 68.3%). In addition, 79.6%, 62.9%, 47.2%, 32.8%, and 17.4% of patients with P3did scores of 4, 3, 2, 1, and 0, respectively, died ≤3 days. CONCLUSION: We successfully developed diagnostic models for death ≤3 days. These may further help clinicians predict impending death and help patients/families prepare for their final days.
Phase II study of trifluridine/tipiracil (TAS-102) therapy in elderly patients with colorectal cancer (T-CORE1401): geriatric assessment tools and plasma drug concentrations as possible predictive biomarkers

Masanobu Takahashi, Yasuhiro Sakamoto, Hisatsugu Ohori, Yasushi Tsuji, Michio Kuroki, Satoshi Kato, Kazunori Otsuka, Keigo Komine, Masahiro Takahashi, Shin Takahashi, Hidekazu Shirota, Kota Ouchi, Yoshikazu Takahashi, Hiroo Imai, Hiroyuki Shibata, Takashi Yoshioka, Masaki Tanaka, Hiroaki Yamaguchi, Takuhiro Yamaguchi, Hideki Shimodaira, Chikashi Ishioka

Cancer Chemotherapy and Pharmacology　88　(3)　393-402　2021年9月

DOI： 10.1007/s00280-021-04277-3 　

ISSN：0344-5704

eISSN：1432-0843
Resignation and return to work in patients receiving allogeneic hematopoietic cell transplantation close up. 国際誌

Saiko Kurosawa, Takuhiro Yamaguchi, Ayako Mori, Tomoko Matsuura, Takehiko Mori, Masatsugu Tanaka, Tadakazu Kondo, Yukari Umemoto, Hideki Goto, Satoshi Yoshioka, Shinichiro Machida, Takahiko Sato, Yuta Katayama, Seiko Kato, Katsuhiro Shono, Ishikazu Mizuno, Shin-Ichiro Fujiwara, Akio Kohno, Miyako Takahashi, Takahiro Fukuda

Journal of cancer survivorship : research and practice　2021年8月27日

DOI： 10.1007/s11764-021-01092-w 　

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PURPOSE: To characterize the issues regarding work and employment specific to allogeneic hematopoietic cell transplantation (allo-HCT) survivors, we conducted a nationwide cross-sectional questionnaire survey. METHODS: We targeted allo-HCT survivors employed at diagnosis, aged 20-64 at survey, and survived ≥2 years without relapse. The questionnaire included the timing of and reasons for resignation (termination of employment contract), and patient-related, HCT-related, work-related, and HCT center-related factors. RESULTS: A total of 1048 eligible participants were included in the analysis (response rate, 60%). The median time after allo-HCT was 5 years (range, 2-30) at the time of survey. After diagnosis, 41% of participants resigned from work throughout the course of treatment. The most frequent timing of the first resignation was "after discharge post-HCT" (46%), followed by "from diagnosis to initial treatment" (27%). Factors significantly associated with resignation included female gender, older age, and part-time employment. Favorable factors included the presence of occupational health staff at the workplace, employment of ≥10 years, and self-employed/freelance. After resignation, the overall incidence of return to work with some accommodations was 76% at 5 years after HCT, but it was 52% without any accommodation. CONCLUSIONS: Overall, the rate of resignation was 41%, and the most frequent timing of resignation was after discharge post-HCT, accounting for approximately half of the resignations (46%). Workplace accommodations increased the rate of return to work from 52% to 76%. IMPLICATIONS FOR CANCER SURVIVORS: Early detection of employment-related concerns and support throughout the treatment process are necessary for patients receiving allo-HCT.
Palliative care physicians' recognition of patients after immune checkpoint inhibitors and immune-related adverse events. 国際誌

Yuko Usui, Tomofumi Miura, Takashi Kawaguchi, Kazuhiro Kosugi, Yuko Uehara, Masashi Kato, Toshifumi Kosugi, Miyuki Sone, Naoki Nakamura, Akio Mizushima, Mitsunori Miyashita, Tatsuya Morita, Takuhiro Yamaguchi, Yoshihisa Matsumoto, Eriko Satomi

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer　30　(1)　775-784　2021年8月12日

DOI： 10.1007/s00520-021-06482-5 　

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PURPOSE: This study investigated the experience of palliative care physicians (PCPs) and their knowledge and recognition of immune checkpoint inhibitors (ICIs) and immune-related adverse events (irAEs) in clinical practice as well as the need to provide palliative care services for patients after ICI treatments. METHODS: A cross-sectional survey with self-administered questionnaires was conducted between February and April 2020. A total of 759 questionnaires were sent to PCPs in Japan. The changes in the PCPs' knowledge and recognition of ICIs and irAEs due to the increased experiences of treating patients after ICI treatments were analyzed. RESULTS: Four hundred ninety-two responses (64.8%) were analyzed. Only 15.0% of respondents had no experience of patients after ICI treatments, while 53.9% had experience of more than six patients. On the other hand, 40% of respondents had no experience of patients with suspected irAEs, while only 13.4% had experience of more than six patients. Respondents with more experience of patients after ICI treatments or those with suspected irAEs had extensive knowledge of ICIs and irAEs, were more confident in treating these patients, and tended to consider irAEs as therapeutic indications. The majority of respondents required guidelines and efficient consultation systems with oncologists. CONCLUSION: This study demonstrated that PCPs with experience had extensive knowledge and confidence of ICIs and irAEs and tended to recognize irAEs as therapeutic indications. The establishment of a more intimate relationship between PCPs and oncologists is important for providing better treatment for these patients.
Prevalence of Extrapyramidal Symptoms in Cancer Patients Referred to Palliative Care: A Multicenter Observational Study (JORTC PAL12)

Hiroto Ishiki, Jun Hamano, Hiroka Nagaoka, Yoshinobu Matsuda, Akihiro Tokoro, Hiromichi Matsuoka, Hiroaki Izumi, Akihiro Sakashita, Yoshiyuki Kizawa, Shunsuke Oyamada, Takuhiro Yamaguchi, Satoru Iwase

American Journal of Hospice and Palliative Medicine®　38　(7)　823-829　2021年7月
出版者・発行元： SAGE Publications
DOI： 10.1177/1049909120960441 　

ISSN：1049-9091

eISSN：1938-2715

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<sec><title>Background:</title> Neuroleptics are commonly used in palliative care settings. However, adverse events of neuroleptics, known as extrapyramidal symptoms (EPSs), might be overlooked in clinical practice. We conducted this study to explore the prevalence of EPSs in palliative care setting. </sec><sec><title>Methods:</title> This multicenter, prospective, observational study included patients who 1) were referred to either a specialist palliative care team or a palliative care unit, 2) had a diagnosis of cancer, and 3) were ≥20 years of age. We investigated the prevalence of EPSs and medications used. The primary outcome was the overall Drug-Induced Extrapyramidal Symptom Scale (DIEPSS) score. </sec><sec><title>Results:</title> Between November 2015 and October 2016, 149 patients from 5 centers in Japan were enrolled. The median age was 67 years (range: 21–88 years) and the study population included 81 men (54.4%). The cancer types included lung (55 patients, 36.9%), upper gastrointestinal tract (5, 3.3%), hepatobiliary (19, 12.8%); breast (12, 8.1%); head and neck (10, 6.7%), gynecologic (10, 6.7%), genitourinary (10, 6.7%), and others (28, 18.8%). The median Karnofsky performance status was 60 (20–100). Most patients (86.6%) did not experience delirium. Thirty-nine (26.2%) patients received one or more EPS-inducing medications. EPSs occurred in 4 (2.7%) patients with a cutoff score of 5 points for 5 parkinsonism items in DIEPSS. </sec><sec><title>Conclusion:</title> A lower frequency (<3%) of patients than expected in this population had EPSs. Therefore, we concluded that an interventional study is not feasible. However, medications that cause EPSs are often used in palliative care; therefore, a longitudinal study is warranted. </sec><sec><title>Trial registration:</title> This study was registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) (UMIN000019810) on 16, November, 2015. </sec>
在宅医療専門医のがん疼痛治療の知識と経験全国質問紙調査

松本禎久, 上原優子, 加藤雅志, 小杉寿文, 曽根美雪, 中村直樹, 森田達也, 水嶋章郎, 宮下光令, 山口拓洋, 里見絵理子

Palliative Care Research　16　(Suppl.)　S245-S245　2021年6月
出版者・発行元： (NPO)日本緩和医療学会
eISSN：1880-5302
緩和ケアにおける苦痛を表現する方言緩和医療専門医・認定医に対する質問紙調査

三輪聖, 森田達也, 上原優子, 加藤雅志, 小杉寿文, 曽根美雪, 水嶋章郎, 宮下光令, 山口拓洋, 松本禎久, 里見絵理子

Palliative Care Research　16　(Suppl.)　S277-S277　2021年6月
出版者・発行元： (NPO)日本緩和医療学会
eISSN：1880-5302
難治性がん疼痛に対する侵襲的鎮痛法の実施状況と実施に関連する因子ペインクリニック専門医対象全国調査

上原優子, 松本禎久, 水嶋章郎, 小杉寿文, 曽根美雪, 宮下光令, 山口拓洋, 里見絵理子

日本ペインクリニック学会誌　28　(プログラム号)　O12-6　2021年6月
出版者・発行元： (一社)日本ペインクリニック学会
ISSN：1340-4903

eISSN：1884-1791
終末期がん患者に対する至適な腹腔穿刺排液量の探索

伊藤哲也, 横道直佑, 石木寛人, 川口崇, 増田健, 森雅紀, 山口拓洋

Palliative Care Research　16　(Suppl.)　S250-S250　2021年6月
出版者・発行元： (NPO)日本緩和医療学会
eISSN：1880-5302
Phase 3 Randomized Trial of Topical Steroid Versus Placebo for Prevention of Radiation Dermatitis in Patients With Head and Neck Cancer Receiving Chemoradiation

Tomoya Yokota, Sadamoto Zenda, Ichiro Ota, Tomoko Yamazaki, Takuhiro Yamaguchi, Takenori Ogawa, Hiroyuki Tachibana, Takashi Toshiyasu, Akihiro Homma, Tempei Miyaji, Tomoe Mashiko, Satoshi Hamauchi, Kuniko Tominaga, Shinobu Ishii, Yui Otani, Noriko Orito, Yosuke Uchitomi

International Journal of Radiation Oncology*Biology*Physics　2021年6月
出版者・発行元： Elsevier BV
DOI： 10.1016/j.ijrobp.2021.05.133 　

ISSN：0360-3016
終末期がん患者に対する至適な腹腔穿刺排液量の探索

伊藤哲也, 横道直佑, 石木寛人, 川口崇, 増田健, 森雅紀, 山口拓洋

Palliative Care Research　16　(Suppl.)　S250-S250　2021年6月
出版者・発行元： (NPO)日本緩和医療学会
eISSN：1880-5302
Study protocol for a randomised, placebo-controlled, single-blind phase II study of the efficacy of morphine for dyspnoea in patients with interstitial lung disease (JORTC-PAL 15)

Yoshinobu Matsuda, Tatsuya Morita, Shunsuke Oyamada, Keisuke Ariyoshi, Takuhiro Yamaguchi, Satoru Iwase

BMJ Open　11　(5)　e043156-e043156　2021年5月
出版者・発行元： BMJ
DOI： 10.1136/bmjopen-2020-043156 　

ISSN：2044-6055

eISSN：2044-6055

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<sec><title>Introduction</title>Dyspnoea is common in patients with interstitial lung disease (ILD) and often refractory to conventional treatment. Little is known about the efficacy of systemic morphine for dyspnoea in patients with ILD. The aim of this study is to estimate the efficacy of a single subcutaneous morphine injection for dyspnoea in patients with ILD. </sec><sec><title>Methods and analysis</title>We will conduct a multicentre, prospective, randomised, placebo-controlled, single-blinded phase II study of a single subcutaneous morphine injection for dyspnoea in patients with ILD. In patients with ILD who have dyspnoea at rest refractory to conventional treatment will be eligible for participation in this study. The morphine dose will be 2 mg. The primary endpoint is changes in dyspnoea intensity from baseline to 60 min after treatment as measured using an 11-point Numerical Rating Scale and compared between the morphine and placebo groups. </sec><sec><title>Ethics and dissemination</title>Ethical approval has been obtained by the Osaka City University Certified Review Board. The results of this study will be submitted for publication in an international peer-reviewed journal and the findings will be presented at international scientific conferences. </sec><sec><title>Trial registration number</title>jRCTs051190030; pre-results. </sec>
An Individual-Level Meta-Analysis Using Real-World and Pivotal Studies on Mortality From the Use of Paclitaxel-Containing Devices in Japanese Femoropopliteal Disease Patients.

Masato Nakamura, Munenori Takata, Hiroyoshi Yokoi, Takafumi Ueno, Yuka Suzuki, Koji Ikeda, Takuhiro Yamaguchi

Circulation journal : official journal of the Japanese Circulation Society　2021年4月29日

DOI： 10.1253/circj.CJ-21-0171 　

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BACKGROUND: The effect of treatment with paclitaxel-containing devices (PTXD) on mortality in patients with peripheral artery disease remains controversial.Methods and Results:An independent patient-level meta-analysis of 12 clinical trials (1,389 PTXD patients and 1,192 non-PTXD patients) was conducted. This study included 7 pivotal trials and 5 post-marketing surveillance studies on endovascular treatment for femoropopliteal artery by 6 companies. The primary endpoint was all-cause death, and 5-year cumulative mortality was estimated by a Kaplan-Meier curve. Cox proportional hazard model was used to calculate the hazard ratio (HR) and confidential interval (CI). During the median follow up of 3.0 years, 459 patients died. The cumulative 5-year mortality for the entire cohort was significantly lower in the PTXD than in the non-PTXD group (24.4% vs. 27.4%, respectively; HR, 0.81; 95% CI, 0.67-0.97; P=0.023), but this difference was no longer significant after adjustment for relevant covariates (HR, 1.01; 95% CI, 0.39-2.58; P=0.987). The Cox proportional hazard model revealed that sex, hyperlipidemia, Type 2 diabetes, hemodialysis, Rutherford category, and age above 75 years were significantly associated with 5-year mortality, but treatment with PTXD was not. CONCLUSIONS: This large individual meta-analysis of patients with femoropopliteal artery disease found that the use of PTXD does not have a negative effect on 5-year mortality.
Optimal paracentesis volume for terminally ill cancer patients with ascites. 国際誌

Tetsuya Ito, Naosuke Yokomichi, Hiroto Ishiki, Takashi Kawaguchi, Ken Masuda, Hiroaki Tsukuura, Hiromi Funaki, Kozue Suzuki, Kiyofumi Oya, Jun Nakagawa, Masanori Mori, Takuhiro Yamaguchi

Journal of pain and symptom management　2021年4月29日

DOI： 10.1016/j.jpainsymman.2021.04.010 　

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CONTEXT: Patients with malignant ascites often suffer from distressing symptoms, especially in their end-of-life stage. Although paracentesis is the most common treatment modality to alleviate such symptoms, the optimal volume of paracentesis is not known. OBJECTIVES: To explore the efficacy and safety of paracentesis by the drainage volume for terminally ill cancer patients with malignant ascites. METHODS: This was part of a multicenter prospective observational study (EASED study). Consecutive adult patients with advanced cancer admitted to 23 participating palliative care units were eligible. We analyzed patients with malignant ascites who received paracentesis. We compared paracentesis-free survival (PFS) using Cox regression among 3 groups with different paracentesis volumes: minimum: <=1500 mL, small: 1500-2500 mL, and moderate: >2500 mL. Trends of the difference in the numerical rating scale of abdominal distension (0-10) and adverse events were compared among the 3 groups. RESULTS: Of the 1926 patients enrolled, 673 developed ascites (symptomatic, N=374 and asymptomatic, N=299). Finally, we analyzed 87 patients with paracentesis. Median PFS was 7 days. Compared with a moderate volume, small-volume paracentesis was not a significant risk for shorter PFS (HR: 1.14, 95% CI: 0.69-1.93), while a minimum volume was a significant risk (HR: 2.34). The abdominal distension intensity significantly decreased after paracentesis (median: 7.5 to 4.0), while the difference did not significantly increase as the volume of paracentesis rose (p=0.61). No severe adverse event was observed. CONCLUSION: Even small-volume paracentesis could alleviate abdominal distension of terminally ill cancer patients with malignant ascites without shortening the paracentesis interval compared with moderate-volume paracentesis. Small-volume paracentesis was a well-balanced treatment for these patients.
Conventional and Kampo medicine in the treatment of mild to moderate COVID‐19: A multicenter, retrospective observational study protocol by the Integrative Management in Japan for Epidemic Disease (IMJEDI study‐Observation) 招待有り査読有り

8　(1)　106-110　2021年4月22日

DOI： 10.1002/tkm2.1271 　

eISSN：2053-4515
Establishment of a research policy for supportive and palliative care in Japan

Sadamoto Zenda, Yosuke Uchitomi, Tatsuya Morita, Takuhiro Yamaguchi, Akira Inoue

Japanese Journal of Clinical Oncology　51　(4)　538-543　2021年4月1日
出版者・発行元： Oxford University Press
DOI： 10.1093/jjco/hyab008 　

ISSN：1465-3621 0368-2811
疼痛緩和IVRのニーズを知る、ニーズに応える IVR専門医が行うがん疼痛に対するインターベンショナル治療の実態全国質問紙調査 IVR医への期待

松本禎久, 曽根美雪, 上原優子, 加藤雅志, 小杉寿文, 森田達也, 水嶋章郎, 宮下光令, 山口拓洋, 中村直樹, 里見絵理子

日本インターベンショナルラジオロジー学会雑誌　36　(Suppl.)　127-127　2021年4月
出版者・発行元： (一社)日本インターベンショナルラジオロジー学会
ISSN：1340-4520

eISSN：2185-6451
Clinical trial monitoring effectiveness: Remote risk-based monitoring versus on-site monitoring with 100% source data verification. 国際誌

Osamu Yamada, Shih-Wei Chiu, Munenori Takata, Michiaki Abe, Mutsumi Shoji, Eri Kyotani, Chiyo Endo, Minami Shimada, Yuko Tamura, Takuhiro Yamaguchi

Clinical trials (London, England)　18　(2)　158-167　2021年4月

DOI： 10.1177/1740774520971254 　

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BACKGROUND/AIMS: Traditional on-site monitoring of clinical trials via frequent site visits and 100% source data verification is cost-consuming, and it still cannot guarantee data quality effectively. Depending on the types and designs of clinical trials, an alternative would be combining several monitoring methods, such as risk-based monitoring and remote monitoring. However, there is insufficient evidence of its effectiveness. This research compared the effectiveness of risk-based monitoring with a remote monitoring system with that of traditional on-site monitoring. METHODS: With a cloud-based remote monitoring system called beagle View®, we created a remote risk-based monitoring methodology that focused only on critical data and processes. We selected a randomized controlled trial conducted at Tohoku University Hospital and randomly sampled 11 subjects whose case report forms had already been reviewed by data managers. Critical data and processes were verified retrospectively by remote risk-based monitoring; later, all data and processes were confirmed by on-site monitoring. We compared the ability of remote risk-based monitoring to detect critical data and process errors with that of on-site monitoring with 100% source data verification, including an examination of clinical trial staff workload and potential cost savings. RESULTS: Of the total data points (n = 5617), 19.7% (n = 1105, 95% confidence interval = 18.7-20.7) were identified as critical. The error rates of critical data detected by on-site monitoring, remote risk-based monitoring, and data review by data managers were 7.6% (n = 84, 95% CI = 6.2-9.3), 7.6% (n = 84, 95% confidence interval = 6.2-9.3), and 3.9% (n = 43, 95% confidence interval = 2.9-5.2), respectively. The total number of critical process errors detected by on-site monitoring was 14. Of these 14, 92.9% (n = 13, 95% confidence interval = 68.5-98.7) and 42.9% (n = 6, 95% confidence interval = 21.4-67.4) of critical process errors were detected by remote risk-based monitoring and data review by data managers, respectively. The mean time clinical trial staff spent dealing with remote risk-based monitoring was 9.9 ± 5.3 (mean ± SD) min per visit per subject. Our calculations show that remote risk-based monitoring saved between 9 and 41 on-site monitoring visits, corresponding to a cost of between US$13,500 and US$61,500 per trial site. CONCLUSION: Remote risk-based monitoring was able to detect critical data and process errors as well as on-site monitoring with 100% source data verification, saving travel time and monitoring costs. Remote risk-based monitoring offers an effective alternative to traditional on-site monitoring of clinical trials.
Effect of donor type on volume of blood transfusions required after allogeneic hematopoietic cell transplantation.

Saiko Kurosawa, Takuhiro Yamaguchi, Saori Nakabayashi, Moemi Kasane, Misato Tsubokura, Nao Iwashita, Yuki Minakawa, Ryuzaburo Ohtake, Kimihiko Kawamura, Yukiko Nishioka, Wataru Takeda, Tuneaki Hirakawa, Jun Aoki, Ayumu Ito, Takashi Tanaka, Yoshihiro Inamoto, Sung-Won Kim, Minoru Kojima, Minoko Takanashi, Takahiro Fukuda

International journal of hematology　113　(4)　518-529　2021年4月

DOI： 10.1007/s12185-020-03041-2 　

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We reviewed blood product use in 729 consecutive allogeneic hematopoietic cell transplantation (allo-HCT) recipients at our center to assess the volume of red blood cells (RBCs) and platelets required after allo-HCT. The median number of bags required by day 30 was 4 for RBCs (range 0-22) and 9.5 for platelets (0-53). Multivariate analysis showed that related peripheral blood stem cell transplantation (PBSCT) required a significantly lower RBC transfusion volume by day 30 compared to unrelated bone marrow transplantation (UBMT). PBSCT from haplo-identical related donors and cord blood transplantation (CBT) required a significantly greater RBC transfusion volume. For platelet transfusion, related and unrelated PBSCT required a significantly lower volume than UBMT, and CBT a greater volume. Other factors independently associated with greater RBC transfusion volume were male sex, disease status other than complete remission, and major ABO mismatch. For platelet transfusion, these were male sex, disease status, and HCT-specific comorbidity index of 1. Although the burden of blood transfusions may not be the most important factor when choosing a donor type, our findings may provide a foundation for nationwide strategies to prepare blood products and inform aspects of national healthcare expenditures.
An observational study on nutrition status in gastric cancer patients receiving ramucirumab plus taxane: BALAST study

Takuro Mizukami, Tempei Miyaji, Yukiya Narita, Tomohiro Matsushima, Takashi Ogura, Hiromichi Miyagaki, Ryohei Kawabata, Yoshiki Horie, Takashi Kawaguchi, Kei Muro, Hiroki Hara, Takuhiro Yamaguchi, Takako E Nakajima

Future Oncology　2021年3月25日
出版者・発行元： Future Medicine Ltd
DOI： 10.2217/fon-2021-0076 　

ISSN：1479-6694

eISSN：1744-8301

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Limited data are available regarding the efficacy of nutrition support in advanced gastric cancer (AGC) patients receiving a standard second-line combination chemotherapy. The BALAST study is conducted as a prospective, multicenter observational study to evaluate the efficacy of nutrition support for patients with AGC treated with ramucirumab plus taxane as second-line treatment. As part of the routine care, patients who are malnourished or at risk of malnutrition will receive nutrition support from dietitians. We will enroll a total of 26 patients to estimate weight control rate at 12 weeks as primary end point. This study will generate valuable data reinforcing the role of nutrition support therapy for AGC patients receiving second-line chemotherapy.
"3-Day Surprise Question" to predict prognosis of advanced cancer patients with impending death: Multicenter prospective observational study. 国際誌

Tomoo Ikari, Yusuke Hiratsuka, Takuhiro Yamaguchi, Isseki Maeda, Masanori Mori, Yu Uneno, Tomohiko Taniyama, Yosuke Matsuda, Kiyofumi Oya, Keita Tagami, Akira Inoue

Cancer medicine　10　(3)　1018-1026　2021年2月

DOI： 10.1002/cam4.3689 　

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BACKGROUND: The study aimed to clarify the efficacy of the "3-Day Surprise Question (3DSQ)" in predicting the prognosis for advanced cancer patients with impending death. PATIENTS AND METHODS: This study was a part of multicenter prospective observational study which investigated the dying process in advanced cancer patients in Japan. For patients with a Palliative Performance Scale ≤20, the 3DSQ "Would I be surprised if this patient died in the next 3 days?" was answered by their physicians. In addition to the sensitivity and specificity of the 3DSQ, the characteristics of patients who survived longer than expected were examined via multivariate analysis. RESULTS: Among the 1896 patients enrolled, 1411 were evaluated. Among 1179 (83.6%) patients who were classified into the "Not surprised" group, 636 patients died within 3 days. Among 232 (16.4%) patients of "Yes surprised" group, 194 patients lived longer than 3 days. The sensitivity, specificity, positive predictive value, and negative predictive value of the 3DSQ were 94.3% (95% confidence interval [CI]: 92.7% to 95.8%), 26.3% (95% CI: 24.8% to 27.6%), 53.9% (95% CI: 53.0% to 54.7%), and 83.6% (95% CI: 78.7% to 87.7%), respectively. Multivariate analysis showed palpable radial artery, absent respiration with mandibular movement, SpO2 ≥ 90%, opioid administration, and no continuous deep sedation as characteristics of patients who lived longer than expected. CONCLUSIONS: The 3-Day Surprise Question can be a useful screening tool to identify advanced cancer patients with impending death.
Protocol for a multicentre, prospective, cohort study to investigate patient satisfaction and quality of life after immediate breast reconstruction in Japan: the SAQLA study

Miho Saiga, Yuko Hosoya, Hiroki Utsunomiya, Yukiko Kuramoto, Satoko Watanabe, Koichi Tomita, Yukiko Aihara, Mayu Muto, Makoto Hikosaka, Takashi Kawaguchi, Tempei Miyaji, Takuhiro Yamaguchi, Sadamoto Zenda, Aya Goto, Minoru Sakuraba, Taro Kusano, Kenta Miyabe, Tomoaki Kuroki, Tomoyuki Yano, Mifue Taminato, Mitsuru Sekido, Yui Tsunoda, Toshihiko Satake, Hiroyoshi Doihara, Yoshihiro Kimata

BMJ Open　11　(2)　e042099-e042099　2021年2月
出版者・発行元： BMJ
DOI： 10.1136/bmjopen-2020-042099 　

ISSN：2044-6055

eISSN：2044-6055

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<sec><title>Introduction</title>The aim of breast reconstruction (BR) is to improve patients’ health-related quality of life (HRQOL). Therefore, measuring patient-reported outcomes (PROs) would clarify the value and impact of BR on a patient’s life and thus would provide evidence-based information to help decision-making. The Satisfaction and Quality of Life After Immediate Breast Reconstruction study aimed to investigate satisfaction and HRQOL in Japanese patients with breast cancer who undergo immediate breast reconstruction (IBR). </sec><sec><title>Methods and analysis</title>This ongoing prospective, observational multicentre study will assess 406 patients who had unilateral breast cancer and underwent mastectomy and IBR, and were recruited from April 2018 to July 2019. All participants were recruited from seven hospitals: Okayama University Hospital, Iwate Medical University Hospital, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Showa University Hospital, University of Tsukuba Hospital, Osaka University Hospital and Yokohama City University Medical Center. The patients will be followed up for 36 months postoperatively. The primary endpoint of this study will be the time-dependent changes in BREAST-Q satisfaction with breast subscale scores for 12 months after reconstructive surgery, which will be collected via an electronic PRO system. </sec><sec><title>Ethics and dissemination</title>This study will be performed in accordance with the Ethical Guidelines for Medical and Health Research Involving Human Subjects published by Japan’s Ministry of Education, Science and Technology and the Ministry of Health, Labour and Welfare, the modified Act on the Protection of Personal Information and the Declaration of Helsinki. This study protocol was approved by the institutional ethics committee at the Okayama University Graduate School of Medicine, Dentistry, on 2 February 2018 (1801-039) and all other participating sites. The findings of this trial will be submitted to an international peer-reviewed journal. </sec><sec><title>Trial registration number</title>UMIN000032177. </sec>
Effects of an Indomethacin Oral Spray on Pain Due to Oral Mucositis in Cancer Patients Treated With Radiotherapy and Chemotherapy: A Double-Blind, Randomized, Placebo-Controlled Trial (JORTC-PAL04). 国際誌

Hiroka Nagaoka, Kenji Momo, Jun Hamano, Tempei Miyaji, Shunsuke Oyamada, Takashi Kawaguchi, Masato Homma, Takuhiro Yamaguchi, Tatsuya Morita, Yosiyuki Kizawa

Journal of pain and symptom management　62　(3)　537-544　2021年1月28日

DOI： 10.1016/j.jpainsymman.2021.01.123 　

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CONTEXT: Oral mucositis (OM) pain due to anticancer chemo- and radiotherapy has a very negative impact on patient quality of life. However, no high-quality studies have been performed regarding the analgesic efficacy of indomethacin (IM) oral spray for OM pain. OBJECTIVES: This randomized, placebo-controlled, double-blind trial aimed to evaluate the analgesic efficacy of IM oral spray for OM pain due to anticancer chemo- and radiotherapy. METHODS: From July 2015 to December 2016, we enrolled adult cancer patients with OM pain that was due to anticancer chemo- or radiotherapy and was rated 4 or higher on Brief Pain Inventory (BPI) Item 5. Patients were randomly assigned in a 1:1 ratio to receive either IM oral spray or placebo. The primary endpoint was the change in the BPI Item 6 ("current pain") score from before to 30 minutes after treatment. Secondary endpoints were the areas under the curves of BPI Item 6 at 15, 60, 120, 180, and 240 minutes after treatment; five items related to meals and conversation from the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire, Head and Neck Module 35; the Clinical Global Impressions-Improvement (CGI-I) scale; and adverse events. RESULTS: A total of 60 patients were assigned to receive IM oral spray (n = 33) or placebo spray (n = 27). The average change in the BPI item 6 score from before to 30 minutes after treatment was -1.85 (95% confidence interval: -2.37 to -1.32) in the IM spray group and -0.59 (-1.02 to -0.16) in the placebo group, indicating a significant difference (-1.26, -1.94 to -0.57, P < 0.01). The pain improvement persisted for 180 minutes. The intergroup differences in ability to drink liquids, ease in conversing, and CGI-I were all significant (P = 0.03, P = 0.02, and P < 0.01, respectively). No serious adverse events were reported. CONCLUSION: IM oral spray alleviated short-term OM pain due to anticancer chemo- and radiotherapy, and may reduce the difficulty in eating meals.
Dexamethasone 8 mg for Cancer-Related Fatigue in Inpatients with Advanced Cancer Undergoing Palliative Care: A Multicenter Phase II Trial. 国際誌

Tomofumi Miura, Ayumi Okizaki, Hideaki Hasuo, Eriko Satomi, Keita Tagami, Kengo Imai, Takashi Kojima, Hironaga Satake, Hiroto Ishiki, Akira Inoue, Takuhiro Yamaguchi

Palliative medicine reports　2　(1)　316-323　2021年

DOI： 10.1089/pmr.2021.0053 　

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Objective: No standard treatment for cancer-related fatigue (CRF) for inpatients in a palliative care setting exists. The aim of this study was to validate the previous study-derived efficacy of dexamethasone 8 mg for CRF among inpatients in a palliative care setting. Methods: Inpatients with moderate fatigue (≥4/10) were enrolled in a multicenter phase II trial. Dexamethasone 8 mg p.o. or 6.6 mg i.v. was administered for seven days and 4 mg p.o. or 3.3 mg i.v. for seven consecutive days. The primary endpoint was a threshold average change of Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue subscale score of 3. The secondary endpoints were evaluated with the anorexia-cachexia subscale (ACS), and the Edmonton symptom assessment scale-revised Japanese version. Results: A total of 32 patients were enrolled. On day 8, the mean change of FACIT-fatigue subscale from day 1 was 5.2 (95% confidence interval 0.8-10.0), in which the lower bound was above 0 but not above the prespecified threshold value of 3.0 (p = 0.72). Edmonton symptom assessment system (ESAS)-fatigue was significantly improved by day 3 (p = 0.02), but not on day 8 or day 15. ACS, physical well-being, and ESAS-lack of appetite significantly improved by day 8 and day 15. Adverse events were tolerable. Conclusion: This study showed that dexamethasone 8 mg failed to achieve the preset efficacy for CRF among inpatients in a palliative care setting. However, this treatment improved fatigue and would be an option for CRF. jRCT (jRCTs031180068).
緩和ケア医が苦痛の評価を行う上で知っておくことが必要と考える方言緩和医療専門医・認定医に対する質問紙調査

三輪聖, 森田達也, 松本禎久, 上原優子, 加藤雅志, 小杉寿文, 曽根美雪, 中村直樹, 水嶋章郎, 宮下光令, 山口拓洋, 里見絵理子

Palliative Care Research　16　(4)　281-287　2021年
出版者・発行元： (NPO)日本緩和医療学会
eISSN：1880-5302
Yokukansan for Treatment of Preoperative Anxiety and Prevention of Postoperative Delirium in Cancer Patients Undergoing Highly Invasive Surgery. J-SUPPORT 1605 (ProD Study): A Randomized, Double-Blind, Placebo-Controlled Trial. 国際誌

Saho Wada, Ryoichi Sadahiro, Yutaka J Matsuoka, Yosuke Uchitomi, Takuhiro Yamaguchi, Tetsufumi Sato, Kazuaki Shimada, Seiichi Yoshimoto, Hiroyuki Daiko, Yukihide Kanemitsu, Akira Kawai, Tomoyasu Kato, Hiroyuki Fujimoto, Ken Shimizu

Journal of pain and symptom management　61　(1)　71-80　2021年1月

DOI： 10.1016/j.jpainsymman.2020.07.009 　

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CONTEXT: No standard preventive or therapeutic methods have been established for preoperative anxiety and postoperative delirium in patients with cancer. OBJECTIVES: To clarify the therapeutic effect of yokukansan for perioperative psychiatric symptoms in patients with cancer as well as to confirm its safety profile. METHODS: This is a randomized, double-blind, and placebo-controlled trial conducted at a single center in Tokyo, Japan. About 195 patients with cancer scheduled to undergo tumor resection took one packet of the study drug, which was administered orally. Coprimary outcomes were change in preoperative anxiety assessed with the Hospital Anxiety and Depression Scale-Anxiety and incidence of postoperative delirium assessed with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Interim analysis was performed with one-third (n = 74) of the target number of registered patients. RESULTS: Because this trial was canceled based on the results of the interim analysis and the protocol treatment was discontinued in patients who were already registered, conclusions were based on the full analysis set of 160 participants. There were no significant differences between groups in the change of mean Hospital Anxiety and Depression Scale-Anxiety score (intervention group [SD] 0.4 [3.0] vs. placebo group 0.5 [3.0]; P = 0.796) or the incidence of postoperative delirium (32% vs. 30%; P = 0.798). There were no serious adverse events in either group. CONCLUSION: In patients with cancer undergoing highly invasive surgeries, yokukansan demonstrated no significant efficacy for the treatment of preoperative anxiety or the prevention of postoperative delirium. Yokukansan is already used in daily practice in Japan, but we should be careful with its future use.
Phase ii study of the reuse of trastuzumab with docetaxel beyond progression after first-line treatment in second-line treatment for unresectable, metastatic gastric cancer (T-core1203)

Masanobu Takahashi, Yasuhiro Sakamoto, Kazunori Otsuka, Mariko Kanbe, Hisatsugu Ohori, Yoshiaki Shindo, Hiroshi Honda, Ken Saijo, Kota Ouchi, Yasuko Murakawa, Hidekazu Takahashi, Sadayuki Kawai, Yuichi Tanaka, Takuhiro Yamaguchi, Hideki Shimodaira, Takashi Yoshioka, Chikashi Ishioka

Tohoku Journal of Experimental Medicine　254　(1)　49-55　2021年

DOI： 10.1620/tjem.254.49 　

ISSN：0040-8727

eISSN：1349-3329
Development of Japanese Versions of the Control Preferences Scale and Information Needs Questionnaire: Role of Decision-Making and Information Needs for Japanese Breast Cancer Patients. 国際誌

Kanako Azuma, Takashi Kawaguchi, Takuhiro Yamaguchi, Sayuri Motegi, Kimito Yamada, Kenji Onda, Satoru Iwase, Sakae Unezaki, Hironori Takeuchi

Patient preference and adherence　15　1017-1026　2021年

DOI： 10.2147/PPA.S295383 　

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Purpose: The importance of shared decision-making (SDM) between physicians and patients is increasingly recognized. In Japan, patients have shown more willingness to participate in treatment if medical professionals provide sufficient information; however, relationships between physicians and patients have traditionally been asymmetric, with patients accepting information from physicians without discussion. To explore the benefits of SDM in cancer treatment, including confidence in treatment decisions, satisfaction with treatment, and trust in healthcare providers, this study developed Japanese versions of the Control Preference Scale (CPS) and Information Needs Questionnaire (INQ). Patients and Methods: Reliability and validity of the CPS and INQ were tested with 49 breast cancer patients. Results: The CPS showed good test-retest reliability (kappa coefficient: 0.61, weighted kappa coefficient: 0.61, Kendall's tau coefficient: 0.61) and acceptable criterion validity. The INQ showed adequate consistency; the mean number of circular triads and coefficient of consistency were 3 (range 0-19) and 0.9 (range 0.37-1), respectively. Using the CPS and INQ to identify patients' roles in decision-making and information needs, results further suggested that breast cancer patients in Japan want to participate in SDM. Medical issues, including disease spread and cure, were found to be of high interest, while social and psychological issues, including sexual attractiveness, genetic risk, and family impact, tended to be low. Conclusion: The Japanese CPS and INQ can be used to assess patients' needs to improve care. Further, as patients' information needs change along the care trajectory, these tools should be used throughout treatment.
Predictors of Morphine Efficacy for Dyspnea in Inpatients with Chronic Obstructive Pulmonary Disease: A Secondary Analysis of JORTC-PAL 07

Yoshinobu Matsuda, Tatsuya Morita, Hirotaka Matsumoto, Keita Hosoi, Kayo Kusama, Yasuo Kohashi, Hiroshi Morishita, Sawako Kaku, Keisukie Ariyoshi, Shunsuke Oyamada, Yoshikazu Inoue, Satoru Iwase, Takuhiro Yamaguchi, Mitsunori Nishikawa

Palliative Medicine Reports　2　(1)　15-20　2021年1月1日
出版者・発行元： Mary Ann Liebert Inc
DOI： 10.1089/pmr.2020.0078 　

eISSN：2689-2820
Study protocol for SPARED trial: randomised non-inferiority phase III trial comparing dexamethasone on day 1 with dexamethasone on days 1-4, combined with neurokinin-1 receptor antagonist, palonosetron and olanzapine (5 mg) in patients receiving cisplatin-based chemotherapy. 国際誌

Hiroko Minatogawa, Naoki Izawa, Takashi Kawaguchi, Tempei Miyaji, Kazuhiro Shimomura, Honda Kazunori, Hirotoshi Iihara, Yasushi Ohno, Yusuke Inada, Hitoshi Arioka, Hajime Morita, Naoya Hida, Mitsuhiro Sugawara, Chikatoshi Katada, Shuichi Nawata, Hiroo Ishida, Ayako Tsuboya, Takashi Tsuda, Takuhiro Yamaguchi, Takako Eguchi Nakajima

BMJ open　10　(12)　e041737　2020年12月17日

DOI： 10.1136/bmjopen-2020-041737 　

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INTRODUCTION: Dexamethasone (DEX) is administered for multiple days to prevent chemotherapy-induced nausea and vomiting for patients receiving highly emetogenic chemotherapy (HEC); however, its notorious side effects have been widely reported. Although our multicentre randomised double-blind comparative study verified non-inferiority of sparing DEX after day 2 of chemotherapy when combined with neurokinin-1 receptor antagonist (NK1-RA) and palonosetron (Palo) for patients receiving HEC regimen, DEX sparing was not non-inferior in patients receiving cisplatin (CDDP)-based HEC regimens in subgroup analysis. Recently, the efficacy of the addition of olanzapine (OLZ) to standard triple antiemetic therapy on HEC has been demonstrated by several phase III trials. This study aims to confirm non-inferiority of DEX sparing when it is combined with NK-1RA, Palo and OLZ in patients receiving CDDP-based HEC regimens. METHODS AND ANALYSIS: This is a randomised, double-blind, phase III trial. Patients who are scheduled to receive CDDP ≥50 mg/m2 as initial chemotherapy are eligible. Patients are randomly assigned to receive either DEX on days 1-4 or DEX on day 1 combined with NK1-RA, Palo and OLZ (5 mg). The primary endpoint is complete response (CR) rate, defined as no emesis and no rescue medications during the delayed phase (24-120 hours post-CDDP administration). The non-inferiority margin is set at -15.0%. We assume that CR rates would be 75% in both arms. Two hundred and sixty-two patients are required for at least 80% power to confirm non-inferiority at a one-sided significance level of 2.5%. After considering the possibility of attrition, we set our final required sample size of 280. ETHICS AND DISSEMINATION: The institutional review board approved the study protocol at each of the participating centres. The trial result will be presented at international conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: UMIN000032269.
Randomised controlled trial of conditioning regimen for cord blood transplantation for adult myeloid malignancies comparing high-dose cytarabine/cyclophosphamide/total body irradiation with versus without G-CSF priming: G-CONCORD study protocol. 国際誌

Seitaro Terakura, Takaaki Konuma, Masatsugu Tanaka, Yukiyasu Ozawa, Makoto Onizuka, Satoshi Nanno, Yasushi Onishi, Nobuyuki Aotsuka, Tadakazu Kondo, Toshiro Kawakita, Jun Kato, Takeshi Kobayashi, Tetsuya Nishida, Takuhiro Yamaguchi, Yachiyo Kuwatsuka, Satoshi Takahashi

BMJ open　10　(12)　e040467　2020年12月4日

DOI： 10.1136/bmjopen-2020-040467 　

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INTRODUCTION: A better long-term quality of life after umbilical cord blood transplantation (CBT) is observed compared with transplants from other alternative donors, whereas graft failure and relapses after CBT are still major issues. To minimise graft failure and relapse after CBT, intensification of conditioning by the addition of high-dose cytosine arabinoside (CA) and concomitant continuous use of granulocyte-colony stimulating factor (G-CSF) are reported to convey a significantly better survival after CBT in some retrospective studies. To confirm the effect of G-CSF plus CA combination, in addition to the standard conditioning regimen, cyclophosphamide (CY)/total body irradiation (TBI), we design a randomised controlled study comparing CA/CY/TBI with versus without G-CSF priming (G-CSF combined conditioned cord blood transplantation [G-CONCORD] study). METHODS AND ANALYSIS: This is a multicentre, open-label, randomised phase III study that aimed to compare G-CSF+CA/CY/TBI as a conditioning regimen for CBT with CA/CY/TBI. Patients with acute myeloid leukaemia or myelodysplastic syndrome, aged 16-55 years, are eligible. The target sample size is 160 and the registration period is 4 years. The primary endpoint is the 2-year disease-free survival rate after CBT. The secondary endpoints are overall survival, relapse, non-relapse mortality, acute and chronic graft-versus-host disease, engraftment rate, time to neutrophil recovery, short-term adverse events, incidence of infections and causes of death.This study employs a single one-to-one web-based randomisation between the with-G-CSF versus without-G-CSF groups after patient registration. Combination of high-dose CA and CY/TBI in both groups is used for conditioning. ETHICS AND DISSEMINATION: The study protocol was approved by the central review board, Nagoya University Certified Review Board, after the enforcement of the Clinical Trials Act in Japan. The manuscripts presenting data from this study will be submitted for publication in quality peer-reviewed medical journals. Study findings will be disseminated via presentations at national/international conferences and peer-reviewed journals. TRIAL REGISTRATION NUMBERS: UMIN000029947 and jRCTs041180059.
世界と未来のデータサイエンスデータマネジメントの教育とキャリアパス

高田宗典, 宮路天平, 林行和, 山口拓洋

薬理と治療　48　(Suppl.2)　s96-s99　2020年12月
出版者・発行元：ライフサイエンス出版(株)
ISSN：0386-3603
Nurse-led, screening-triggered, early specialised palliative care intervention programme for patients with advanced lung cancer: study protocol for a multicentre randomised controlled trial. 国際誌

Daisuke Fujisawa, Shigeki Umemura, Ayumi Okizaki, Eriko Satomi, Takuhiro Yamaguchi, Tempei Miyaji, Tomoe Mashiko, Naoko Kobayashi, Hiroya Kinoshita, Masanori Mori, Tatsuya Morita, Yosuke Uchitomi, Koichi Goto, Yuichiro Ohe, Yoshihisa Matsumoto

BMJ open　10　(11)　e037759　2020年11月26日

DOI： 10.1136/bmjopen-2020-037759 　

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INTRODUCTION: It has been suggested that palliative care integrated into standard cancer treatment from the early phase of the disease can improve the quality of life of patients with cancer. In this paper, we present the protocol for a multicentre randomised controlled trial to examine the effectiveness of a nurse-led, screening-triggered, early specialised palliative care intervention programme for patients with advanced lung cancer. METHODS AND ANALYSIS: A total of 206 patients will be randomised (1:1) to the intervention group or the control group (usual care). The intervention, triggered with a brief self-administered screening tool, comprises comprehensive need assessments, counselling and service coordination by advanced-level nurses. The primary outcome is the Trial Outcome Index of the Functional Assessment of Cancer Therapy (FACT) at 12 weeks. The secondary outcomes include participants' quality of life (FACT-Lung), depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder-7), illness perception (Prognosis and Treatment Perceptions Questionnaire), medical service use and survival. A mixed-method approach is expected to provide an insight about how this intervention works. ETHICS AND DISSEMINATION: This study has been approved by the Institutional Review Board of the National Cancer Center Japan (approval number: 2016-235). The findings will be disseminated through peer-reviewed publications and conference presentations and will be reflected on to the national healthcare policy. TRIAL REGISTRATION NUMBER: UMIN000025491.
Developing a Japanese version of the 'scale of attitudes toward pharmacist-physician collaboration'. 国際誌

Kanayuki Kitahara, Takeshi Uchikura, Yuta Nio, Satoko Katsuragi, Keinosuke Okazaki, Yoshiko Nishi, Takashi Kawaguchi, Takuhiro Yamaguchi, Tadanori Sasaki

Journal of interprofessional care　1-7　2020年11月15日

DOI： 10.1080/13561820.2020.1834369 　

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There are many reports that pharmacotherapy has been optimized to ensure collaboration between physicians and pharmacists. Various scales assess the relationship between physicians and pharmacists as well as medical students and pharmacy students. The Scale of Attitudes Toward Physician-Pharmacist Collaboration (SATP2C) can be applied not only to the physician-pharmacist relationship but also to the medical-pharmacy student relationship. As there is no Japanese version of the SATP2C, we developed one and examined its psychometric properties. SATP2C scores were measured before and after interprofessional education (IPE) to verify responsiveness. The scale showed confirmed reliability: Cronbach's alphas were 0.79 for Responsibility and Accountability, 0.68 for Shared Authority, and 0.67 for Interdisciplinary Education. Pre and post-IPE, each mean subscale score increased: Responsibility and Accountability, 0.7 ± 0.4; Shared Authority, 0.2 ± 0.3; and Interdisciplinary Education, 0.3 ± 0.2. Although the total score increased (1.2 ± 0.7), this was non-significant. The Japanese version of the SATP2C can be considered, at least initially, to have reached an acceptable level of reliability and validity. The new measure is currently the only scale in Japan that can evaluate attitudes toward physician-pharmacist collaboration regarding IPE. Further studies are needed to confirm responsiveness pre- and post-IPE.
抗HIV療法における意思決定とアドヒアランスに関する多施設共同研究(DEARS-J study)

増田純一, 関根祐介, 國本雄介, 矢倉裕輝, 平野淳, 日笠真一, 築地茉莉子, 石原正志, 岩崎藍, 押賀充則, 又村了輔, 櫛田宏幸, 福島直子, 島袋翔多, 沼田理子, 川口崇, 山口拓洋, 天野景裕, 岡慎一, 白阪琢磨, 今村淳治

日本エイズ学会誌　22　(4)　442-442　2020年11月
出版者・発行元： (一社)日本エイズ学会
ISSN：1344-9478
Between-group difference in mean values or changes in pain intensity? Evaluating the distribution of change from baseline in a neuropathic cancer pain clinical trial. 国際誌

Hiromichi Matsuoka, Tatsuya Morita, Shunsuke Oyamada, Takuhiro Yamaguchi, Atsuko Koyama

Annals of palliative medicine　9　(6)　4398-4402　2020年11月

DOI： 10.21037/apm-20-930 　
Efficacy and Safety of Low-Molecular-Weight Heparin on Prevention of Venous Thromboembolism after Laparoscopic Operation for Gastrointestinal Malignancy in Japanese Patients: A Multicenter, Open-Label, Prospective, Randomized Controlled Trial

Tamotsu Obitsu, Naoki Tanaka, Atsushi Oyama, Tatsuya Ueno, Masaaki Saito, Takuhiro Yamaguchi, Airi Takagi, Toshiki Rikiyama, Michiaki Unno, Takeshi Naitoh, Hiromune Shimamura, Takeshi Suto, Fumito Saijo, Junichiro Yamauchi, Koh Miura

Journal of the American College of Surgeons　231　(5)　501-509.e2　2020年11月
出版者・発行元： Elsevier BV
DOI： 10.1016/j.jamcollsurg.2020.08.734 　

ISSN：1072-7515
A multi-center, randomized controlled trial by the Integrative Management in Japan for Epidemic Disease (IMJEDI study-RCT) on the use of Kampo medicine, kakkonto with shosaikotokakikyosekko, in mild-to-moderate COVID-19 patients for symptomatic relief and prevention of severe stage: a structured summary of a study protocol for a randomized controlled trial. 国際誌

Shin Takayama, Takao Namiki, Takashi Ito, Ryutaro Arita, Hajime Nakae, Seiichi Kobayashi, Tetsuhiro Yoshino, Tomoaki Ishigami, Koichiro Tanaka, Mosaburo Kainuma, Kotaro Nochioka, Airi Takagi, Masaru Mimura, Takuhiro Yamaguchi, Tadashi Ishii

Trials　21　(1)　827-827　2020年10月2日

DOI： 10.1186/s13063-020-04746-9 　

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OBJECTIVES: We aimed to test our hypothesis that additional administration of traditional Japanese (Kampo) medicine, kakkonto (kakkon-to: KT) and shosaikotokakikyosekko (sho-saiko-to-ka-kikyo-sekko: SSKKS), is more effective in relieving symptoms and preventing the onset of severe infection in mild-to-moderate COVID-19 patients compared to those treated only with conventional treatment. TRIAL DESIGN: The study is designed as a multi-center, interventional, parallel-group, randomized (1:1 ratio), investigator-sponsored, two-arm study. PARTICIPANTS: Patients and inpatients will be recruited from 8 Japanese academic and non-academic hospitals. The inclusion and exclusion criteria are as follows: Inclusion criteria: 1. Diagnosed as positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 2. Clinical stages of mild-to-moderate COVID-19 3. Symptomatic 4. ≥ 20 years of age 5. Male or female 6. Ability to communicate in Japanese 7. Outpatients and inpatients 8. Provided informed consent Exclusion criteria: 1. Difficulty in providing informed consent due to dementia, psychosis, or psychiatric symptoms 2. Allergic to Kampo or Western medicines used in this study 3. Pregnant and lactating 4. Unable to follow up 5. Participating in another clinical trial or interventional study 6. Hypokalemic or taking oral furosemide or steroids 7. Determined unsuitable for this study by the physician INTERVENTION AND COMPARATOR: Patients in the control group will receive conventional treatment with antipyretics, painkillers, or antitussives for symptoms that occurred after they contracted the SARS-CoV-2 infection. Patients in the Kampo group will receive 2.5 g of KT (TJ-1@TSUMURA and Co.) and 2.5 g of SSKKS (TJ-109@TSUMURA and Co.) 3 times a day, orally, for 14 days in addition to the conventional treatment as mentioned above. MAIN OUTCOMES: The number of days till at least one of the symptoms (fever, cough, sputum, malaise, shortness of breath) improves in the first 14 days of treatment. To assess the cough, sputum, malaise, and shortness of breath, a numeric rating scale will be used to define improvement in terms of a 2-point decrease in the number of days from the start of treatment for at least 2 days. Fever will be defined as an improvement when the temperature is less than 37 °C. RANDOMIZATION: Patients are randomized (1:1 ratio) to each group using the minimization method, with balancing of the arms with severity of disease stage and patient age (< 65, 65 to < 75, or ≥ 75 years). Computer-generated random numbers will be used for the minimization method. BLINDING (MASKING): Open-label with no blinding NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): The main research hypothesis of this study is that the combination of Kampo medicine and conventional treatment will significantly improve the patients' symptoms (fever, fatigue, cough, sputum, and shortness of breath) during the first 14 days of treatment as compared with conventional treatment alone. Concerning the analysis of the primary endpoint, the duration of time before improvement of at least one of the common cold-like symptoms (fever, malaise, cough, sputum, and shortness of breath) will be estimated using the Kaplan-Meier method, and the survival curves will be compared between groups using the log-rank test. Assuming this method of analysis and based on previous studies reporting the efficacy of Kampo medicine for COVID-19 and H1N1 influenza patients, the median survival time in the Kampo medicine group is estimated as 3 days; this time will be 1.5 times longer in the control group. Assuming a one-sided significance level of 5%, a power of 70%, and an allocation ratio of 1:1, the required sample size is calculated as 126 cases. To compensate for a loss in follow-up, we plan to include 150 cases in both groups (Kampo group = 75, control group = 75). TRIAL STATUS: Protocol version 1.2 as of August 20, 2020 Recruitment start (expected): October 1, 2020 Recruitment finish (expected): October 31, 2023 TRIAL REGISTRATION: Japan Registry of Clinical Trials (jRCT) jRCTs021200020 . Registered on August 25, 2020 FULL PROTOCOL: The full protocol is attached as an additional file and is accessible from the Trials website (Additional file 1). In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
未承認医薬品等の使用に向けての医薬品安全管理体制の構築と薬剤師の役割

近藤直樹, 阿部直樹, 濃沼政美, 中川貴之, 中澤寛仁, 山口拓洋, 米村雅人

日本病院薬剤師会雑誌　56　(10)　1199-1206　2020年10月
出版者・発行元： (一社)日本病院薬剤師会
ISSN：1341-8815
Population pharmacokinetics and renal toxicity of cisplatin in cancer patients with renal dysfunction

Tomoko Morita-Ogawa, Hiroki Sugita, Hironobu Minami, Takuhiro Yamaguchi, Kazuhiko Hanada

Cancer Chemotherapy and Pharmacology　86　(4)　559-566　2020年10月
出版者・発行元： Springer Science and Business Media LLC
DOI： 10.1007/s00280-020-04147-4 　

ISSN：0344-5704

eISSN：1432-0843
Hydrocolloid dressing as a prophylactic use for hand–foot skin reaction induced by multitargeted kinase inhibitors: protocol of a phase 3 randomised self-controlled study

Sadamoto Zenda, Asako Ryu, Atsuo Takashima, Michiko Arai, Yusuke Takagi, Tempei Miyaji, Tomoe Mashiko, Yoichi Shimizu, Naoya Yamazaki, Chigusa Morizane, Takuhiro Yamaguchi, Takashi Kawaguchi, Akiko Hanai, Yosuke Uchitomi, Fukuko Oshiba

BMJ Open　10　(10)　e038276-e038276　2020年10月
出版者・発行元： BMJ
DOI： 10.1136/bmjopen-2020-038276 　

ISSN：2044-6055

eISSN：2044-6055

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<sec><title>Introduction</title>Although topical use of moisturisers is slightly effective for the prevention and avoiding the aggravation of hand–foot syndrome induced by multikinase inhibitors, there is still room for improvement. Hydrocolloid dressing is a type of wound dressing often used for wounds such as decubitus ulcers. The purpose of this study is to verify the usefulness of application of hydrocolloid dressings as prophylaxis against development of hand–foot syndrome induced by multikinase inhibitors by comparing the effects of this dressing and standard supportive care (moisturising care alone) within the same individuals. </sec><sec><title>Methods</title>This study is a phase 3 randomised, self-controlled study to compare prophylactic moisturising care with or without hydrocolloid dressing for hand–foot syndrome induced by multikinase inhibitors. Patients with radically unresectable advanced or recurrent colorectal carcinoma, gastrointestinal stromal tumour and hepatocellular carcinoma who scheduled to receive regorafenib or sorafenib therapy are eligible for enrolment. Supportive care for hand–foot syndrome will consist of basic moisturising care with or without hydrocolloid dressing. If hand–foot syndrome occurs, a steroid ointment will be applied two times per day at the affected sites. The primary endpoint is an incidence rate of grade 2 or more severe hand–foot syndrome (soles of the feet only) assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events V.4.0. Grading of hand–foot syndrome will be performed by central review using photographs taken weekly by blinded trained physicians. The ethical approval was obtained from National Cancer Center Hospital. The results of this study will be submitted for publication in international peer-reviewed journals and the key findings will be presented at international scientific conference. </sec><sec><title>Discussion</title>If the positive results are found in this study, it is shown that hydrocolloid dressing is effective not only as a symptom management but also as a prevention in hand–foot syndrome induced by multikinase. </sec><sec><title>Trial status</title>The enrolment was started in January 2019, and planned to closed in January 2021. As of February 2020, 26 patients enrolled in this study. </sec><sec><title>Trial registration number</title>UMIN Clinical Trial Registry (UMIN000034853). </sec><sec><title>Protocol version</title>V.1.4, 9 January 2020. </sec>
Integrated communication support program for oncologists, caregivers and patients with rapidly progressing advanced cancer to promote patient-centered communication: J-SUPPORT 1904 study protocol for a randomised controlled trial. 国際誌

Maiko Fujimori, Ayako Sato, Sayaka Jinno, Takuji Okusaka, Takuhiro Yamaguchi, Masafumi Ikeda, Makoto Ueno, Masato Ozaka, Yukiko Takayama, Tempei Miyaji, Yoshiyuki Majima, Yosuke Uchitomi

BMJ open　10　(9)　e036745　2020年9月23日

DOI： 10.1136/bmjopen-2019-036745 　

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INTRODUCTION: Communication is an essential aspect of care for patients with progressive serious illnesses. This study aims to evaluate the efficacy of a new, integrated communication support program for oncologists, patients with rapidly progressing advanced cancer and their caregivers. METHODS AND ANALYSIS: The proposed integrated communication support programme is in the randomised control trial stage. It comprises a cluster of oncologists from comprehensive cancer centre hospitals in a metropolitan area in Japan. A total of 20 oncologists, 200 patients with advanced pancreatic cancer and the patients' caregivers are enrolled in this study as of the writing of this protocol report. Oncologists are randomly assigned to the intervention group (IG) or control group (CG). Patients and caregivers are allocated to the same group as their oncologists. The IG oncologists receive a 2.5-hour individual communication skills training, and patients and caregivers receive a half-hour coaching intervention to facilitate prioritising and discussing questions and concerns; the CG participants do not receive any training. Follow-up data will be collected quarterly for 6 months for a year and then annually for up to 3 years. The primary endpoint is the intergroup difference between before-intervention and after-intervention patient-centred communication behaviours during oncology visits. ETHICS AND DISSEMINATION: This study is conducted in accordance with the ethical guidelines for clinical studies published by Japan's Ministry of Education, Cultural, Sports, Science and Technology, the Ministry of Health, Labour and Welfare, and the ethical principles established for research on humans stipulated in the Declaration of Helsinki and further amendments thereto. The protocol was approved by the Institutional Review Board of National Cancer Center, Japan on 4 July 2018 (ID: 2017-474). TRIAL STATUS: This study is currently enrolling participants. Enrolment period ends 31 July 2020; estimated follow-up date is 31 March 2023. TRIAL REGISTRATION NUMBER: UMIN Clinical Trial Registry (UMIN000033612); pre-results.
Safety and effectiveness of antipsychotic medication for delirium in patients with advanced cancer: A large-scale multicenter prospective observational study in real-world palliative care settings. 国際誌査読有り

Isseki Maeda, Asao Ogawa, Kazuhiro Yoshiuchi, Tatsuo Akechi, Tatsuya Morita, Shunsuke Oyamada, Takuhiro Yamaguchi, Kengo Imai, Akihiro Sakashita, Yoshihisa Matsumoto, Keiichi Uemura, Rika Nakahara, Satoru Iwase, Phase-R Delirium, Study Group

General hospital psychiatry　2020年9月14日

DOI： 10.1016/j.genhosppsych.2020.09.001 　

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<h4>Objective</h4>To clarify the safety and effectiveness of antipsychotic medication for delirium in patients with advanced cancer receiving palliative care.<h4>Methods</h4>This was a prospective observational study involving consecutive patients with advanced cancer and delirium receiving antipsychotics in inpatient hospices or psycho-oncology settings. Adjusted mean scores of the Delirium Rating Scale Revised-98 (DRS; range: 0-39) were calculated at baseline and Day 3 using generalized estimating equations. Adverse events over 7 days were evaluated.<h4>Results</h4>Data from 756 patients were analyzed (Mage = 72 ± 11 years, 62% male, 48% bedridden). The adjusted mean DRS score significantly decreased after antipsychotics administration (21.5 [95% confidence interval 19.5 to 23.4] to 20.8 [18.9 to 22.8], p = 0.03, effect size [ES] = 0.02). Significant improvement was associated with age of 75 or older (ES = 0.07), better performance status (0.32), longer estimated prognosis (0.25), psycho-oncological consultation settings (0.20), hyperactive (0.14) or mix-motor subtypes (0.24) of delirium, and quetiapine administration (0.19); significant deterioration was observed in patients with "days" prognosis (0.18). Extrapyramidal symptoms (9.8%) and somnolence (8.5%) were the most prevalent adverse events.<h4>Conclusions</h4>The use of antipsychotics as part of comprehensive delirium management was safe and may provide some symptomatic benefits for patients with terminal illness and delirium. Along with adequate non-pharmacological interventions, judicious use of antipsychotics is still recommended.
【患者報告型アウトカム〜患者の体験をケアに活かす〜】がん看護において患者報告型アウトカムとして使われる主なツール PRO-CTCAE

川口崇, 山口拓洋

がん看護　25　(7)　630-632　2020年9月
出版者・発行元： (株)南江堂
ISSN：1342-0569

eISSN：2432-8723
【患者報告型アウトカム〜患者の体験をケアに活かす〜】がん看護において患者報告型アウトカムとして使われる主なツール ePROと電子カルテその連携と活用

宮路天平, 川口崇, 山口拓洋

がん看護　25　(7)　636-638　2020年9月
出版者・発行元： (株)南江堂
ISSN：1342-0569

eISSN：2432-8723
チーム医療において放射線治療に期待するもの放射線治療への期待:難治性がん疼痛に対する専門医対象質問紙調査

松本禎久, 上原優子, 中村直樹, 小杉寿文, 曽根美雪, 水嶋章郎, 加藤雅志, 宮下光令, 山口拓洋, 里見絵理子

Palliative Care Research　15　(Suppl.)　S153-S153　2020年8月
出版者・発行元： (NPO)日本緩和医療学会
eISSN：1880-5302
がん疼痛に対する鎮痛補助薬を化学的に究明するがん性神経障害性疼痛患者におけるデュロキセチンへの効果予測因子ランダム化比較試験の二次解析

松岡弘道, 岩瀬哲, 宮路天平, 川口崇, 有吉恵介, 小山田隼佑, 山口拓洋, 石木寛人, 蓮尾英明, 松田能宣

Palliative Care Research　15　(Suppl.)　S45-S45　2020年8月
出版者・発行元： (NPO)日本緩和医療学会
eISSN：1880-5302
急速進行性がん患者・家族と医師の共感的コミュニケーション促進のための統合支援プログラムの有効性を検証する無作為化比較試験

佐藤綾子, 藤森麻衣子, 神野彩香, 奥坂拓志, 山口拓洋, 池田公史, 上野誠, 尾阪将人, 高山敬子, 宮路天平, 眞島喜幸, 内富庸介

Palliative Care Research　15　(Suppl.)　S724-S724　2020年8月
出版者・発行元： (NPO)日本緩和医療学会
eISSN：1880-5302
緩和ケア病棟入院中の進行がん患者における機能的予後予測指標の開発

平塚裕介, 山口拓洋, 前田一石, 森田達也, 森雅紀, 横道直佑, 平本秀二, 松田洋祐, 小原弘之, 鈴木梢, 田上恵太, 井上彰

Palliative Care Research　15　(Suppl.)　S271-S271　2020年8月
出版者・発行元： (NPO)日本緩和医療学会
eISSN：1880-5302
マルチキナーゼ阻害薬の手足症候群に対するハイドロコロイドドレッシング使用による予防効果の検証同一個体内ランダム化第3相比較試験(J-SUPPORT1701:APRON study)

柳朝子, 全田貞幹, 平松玉江, 山崎直也, 高島淳生, 森実千種, 宮路天平, 川口崇, 益子友恵, 高木雄亮, 山口拓洋, 新井美智子, 清水陽一, 華井明子, 内富庸介, 大柴福子

Palliative Care Research　15　(Suppl.)　S510-S510　2020年8月
出版者・発行元： (NPO)日本緩和医療学会
eISSN：1880-5302
がん疼痛に対する鎮痛補助薬を化学的に究明するがん性神経障害性疼痛患者におけるデュロキセチンへの効果予測因子ランダム化比較試験の二次解析

松岡弘道, 岩瀬哲, 宮路天平, 川口崇, 有吉恵介, 小山田隼佑, 山口拓洋, 石木寛人, 蓮尾英明, 松田能宣

Palliative Care Research　15　(Suppl.)　S45-S45　2020年8月
出版者・発行元： (NPO)日本緩和医療学会
eISSN：1880-5302
マルチキナーゼ阻害薬の手足症候群に対するハイドロコロイドドレッシング使用による予防効果の検証同一個体内ランダム化第3相比較試験(J-SUPPORT1701:APRON study)

柳朝子, 全田貞幹, 平松玉江, 山崎直也, 高島淳生, 森実千種, 宮路天平, 川口崇, 益子友恵, 高木雄亮, 山口拓洋, 新井美智子, 清水陽一, 華井明子, 内富庸介, 大柴福子

Palliative Care Research　15　(Suppl.)　S510-S510　2020年8月
出版者・発行元： (NPO)日本緩和医療学会
eISSN：1880-5302
The prognostic impact of FLT3-ITD, NPM1 and CEBPa in cytogenetically intermediate-risk AML after first relapse. 査読有り

Saiko Kurosawa, Hiroki Yamaguchi, Takuhiro Yamaguchi, Keiko Fukunaga, Shunsuke Yui, Heiwa Kanamori, Kensuke Usuki, Nobuhiko Uoshima, Masamitsu Yanada, Jin Takeuchi, Ishikazu Mizuno, Junya Kanda, Hiroshi Okamura, Shingo Yano, Haruko Tashiro, Takero Shindo, Shigeru Chiba, Junji Tomiyama, Koiti Inokuchi, Takahiro Fukuda

International journal of hematology　112　(2)　200-209　2020年8月

DOI： 10.1007/s12185-020-02894-x 　

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We evaluated the impact of FLT3-ITD, NPM1 mutations, and double mutant CEBPa (dmCEBPa) on overall survival (OS) after relapse in patients with cytogenetically intermediate-risk acute myeloid leukemia (AML) who were treated with chemotherapy alone in the first remission (CR1). Patients aged 16-65 years diagnosed with cytogenetically intermediate-risk AML, and who achieved CR1 were included. We retrospectively analyzed FLT3-ITD, NPM1 mutations and CEBPa using samples obtained at diagnosis, which therefore did not affect the therapeutic decisions. Among 235 patients who had achieved CR1, 152 relapsed, and 52% of them achieved second CR. The rate of achieving second CR was significantly higher (85%) in those with dmCEBPa. Patients with FLT3-ITD had significantly worse OS after relapse than those without (19% vs 41%, p = 0.002), while OS was comparable between patients with and without NPM1 mutations (37% vs 34%, p = 0.309). Patients with dmCEBPa had improved OS than those without (61% vs 32%, p = 0.006). By multivariate analysis, FLT3-ITD was independently associated with worse OS after relapse [hazard ratio (HR) 1.99, 95% CI 1.27-3.12, p = 0.003], and dmCEBPa with improved OS (HR 0.40, 95% CI 0.17-0.93, p = 0.033). Our data show that screening for these mutations at diagnosis is useful for facilitating effective therapeutic decision-making even after relapse.
Olanzapine versus Metoclopramide for Treatment of Nausea and Vomiting in Advanced Cancer Patients with Incomplete Malignant Bowel Obstruction 査読有り

Keisuke Kaneishi, Kengo Imai, Kazunori Nishimura, Norio Sakurai, Hiroyuki Kohara, Hiroto Ishiki, Yoshiaki Kanai, Shunsuke Oyamada, Takuhiro Yamaguchi, Tatsuya Morita, Satoru Iwase

Journal of Palliative Medicine　23　(7)　880-881　2020年7月1日
出版者・発行元： Mary Ann Liebert Inc
DOI： 10.1089/jpm.2020.0101 　

ISSN：1096-6218

eISSN：1557-7740
Predictors of duloxetine response in patients with neuropathic cancer pain: a secondary analysis of a randomized controlled trial-JORTC-PAL08 (DIRECT) study. 国際誌査読有り

Hiromichi Matsuoka, Satoru Iwase, Tempei Miyaji, Takashi Kawaguchi, Keisuke Ariyoshi, Shunsuke Oyamada, Eriko Satomi, Hiroto Ishiki, Hideaki Hasuo, Hiroko Sakuma, Akihiro Tokoro, Yoshinobu Matsuda, Kazuki Tahara, Hiroyuki Otani, Yoichi Ohtake, Hiroaki Tsukuura, Yoshihisa Matsumoto, Yoshikazu Hasegawa, Yuki Kataoka, Masatomo Otsuka, Kiyohiro Sakai, Miki Nakura, Tatsuya Morita, Takuhiro Yamaguchi, Atsuko Koyama

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer　28　(6)　2931-2939　2020年6月

DOI： 10.1007/s00520-019-05138-9 　

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PURPOSE: Duloxetine has some effect against cancer neuropathic pain (CNP); however, predictors of duloxetine response are unclear. This study sought to identify predictors of duloxetine response in patients with CNP. METHODS: Patients (N = 70) with CNP unresponsive to or intolerant of opioid-pregabalin combination therapy, with a brief pain inventory-short form (BPI-SF) Item 5 score (average pain) ≥ 4, and with a total hospital anxiety and depression scale score < 20, were randomized to a duloxetine or a placebo group. Multiple linear regression analysis was conducted to identify predictors of duloxetine response as a secondary analysis with the change in the average pain score on day 10 from day 0 as the dependent variable, and the following five covariates; baseline (day 0) average pain score, baseline opioid dose, continuation/discontinuation of pregabalin, and items 20 and 21 score of the short-form McGill pain questionnaire 2 (SF-MPQ-2) as independent variables. RESULTS: Of the four domains (continuous pain, intermittent pain, neuropathic pain, and affective descriptors) score of SF-MPQ-2 on day 0, significant differences were observed in the neuropathic pain domain (p = 0.040) in change on the average pain between day 10 and day 0 in the duloxetine group. Multiple linear regression analysis revealed that patients with a high score for SF-MPQ-2 Item 21 (tingling pain) on day 0 had a significantly greater change in average pain between day 10 and day 0 (p = 0.046). CONCLUSION: Patients with a high score for SF-MPQ-2 Item 21 might benefit more from duloxetine.
乳癌カレントトピックスがん領域におけるePRO electronic Patient Reported Outcome(ePRO)in Oncology

山口拓洋, 川口崇, 宮路天平

Cancer Board of the Breast　6　(1)　52-55　2020年5月
出版者・発行元： (株)メディカルレビュー社
ISSN：2189-356X
Real-World Nonmotor Changes in Patients with Parkinson's Disease and Motor Fluctuations: J-FIRST. 国際誌

Hirohisa Watanabe, Hidemoto Saiki, Shih-Wei Chiu, Takuhiro Yamaguchi, Kenichi Kashihara, Yoshio Tsuboi, Masahiro Nomoto, Nobutaka Hattori, Tetsuya Maeda, Yasushi Shimo

Movement disorders clinical practice　7　(4)　431-439　2020年5月

DOI： 10.1002/mdc3.12939 　

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Background: Nonmotor symptoms (NMSs) of Parkinson's disease (PD) impair health-related quality of life. Objectives: To identify changes in NMSs during 52 weeks in Japanese PD patients exhibiting motor fluctuations. Methods: In PD patients with ≥1 NMS and wearing-off, changes in total/subscore of the Movement Disorder Society Unified PD Rating Scale (MDS-UPDRS) Part I and 8-item PD Questionnaire were assessed. Group-based trajectory models were used to characterize longitudinal patterns of MDS-UPDRS Part I. Results: Data from 996 patients were analyzed. MDS-UPDRS Part I subscores for cognitive function decreased linearly over time. Total and subscores for apathy and lightheadedness on standing significantly deteriorated with fluctuations, whereas other subscores fluctuated without significant deterioration. Changes in the MDS-UPDRS Part I total score correlated with changes in the 8-item PD Questionnaire total score. Based on group-based trajectory models, longitudinal pattern analysis of MDS-UPDRS Part I scores yielded the following 3 separate groups: unchanged (63.8%), deteriorated (20.1%), and improved (16.2%). The improved group had significantly more NMSs at baseline, significantly higher MDS-UPDRS Part I/8-item PD Questionnaire total scores, and modified Hoehn and Yahr scores, and had received treatment for NMSs. The multivariate analysis revealed significant associations between severe motor disability and receiving any treatment for NMSs at baseline and improvement of MDS-UPDRS Part I total scores. Conclusions: Changes in MDS-UPDRS Part I scores were variable and related to changes in health-related quality of life in PD patients with motor fluctuations.
Efficacy of a silicone plug for patulous eustachian tube: A prospective, multicenter case series 査読有り

Ryoukichi Ikeda, Takeshi Oshima, Kunihiro Mizuta, Maki Arai, Shiori Endo, Ryoji Hirai, Koji Ikeda, Satoki Kadota, Yuki Otsuka, Takuhiro Yamaguchi, Tetsuaki Kawase, Toshimitsu Kobayashi

Laryngoscope　130　(5)　1304-1309　2020年5月1日

DOI： 10.1002/lary.28229 　

ISSN：0023-852X

eISSN：1531-4995
Reno-protective effects of oral alkalizing agents in chronic kidney disease with aciduria: protocol for a randomized cohort study. 国際誌査読有り

Michiaki Abe, Tetsuya Akaishi, Mutsumi Shoji, Takuhiro Yamaguchi, Takashi Miki, Fumitoshi Satoh, Shin Takayama, Satomi Yamasaki, Kazuhiko Kawaguchi, Hiroshi Sato, Tadashi Ishii, Sadayoshi Ito

BMC nephrology　21　(1)　144-144　2020年4月22日

DOI： 10.1186/s12882-020-01807-8 　

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BACKGROUND: Aciduria caused by urinary excretion of acidic metabolic wastes produced in daily life is known to be augmented in patients with chronic kidney disease (CKD). To evaluate the reno-protective effect of oral alkalizing agents for the improvement of metabolic acidosis and neutralization of intratubular pH in the patients with mild stages of CKD. Also, to identify reno-protective surrogate markers in the serum and urine that can closely associate the effect of urine alkalization. METHODS: In this single-centered, open-labeled, randomized cohort study, patients with CKD stages G2, G3a and G3b, who visited and were treated at Tohoku University Hospital during the enrollment period were registered. We administered sodium bicarbonate or sodium-potassium citrate as the oral alkalinizing agents. A total of 150 patients with CKD will be randomly allocated into the following three groups: sodium bicarbonate, sodium-potassium citrate and standard therapy group without any alkalinizing agents. The data of performance status, venous blood test, spot urine test, venous blood-gas test, electrocardiogram, renal arterial ultrasonography and chest X-ray will be collected at 0, 6, 12 and 24 weeks (short-term study) from starting the interventions. These data will be also collected at 1 and 2 years (long-term study). The samples of plasma and serum and early-morning urine at every visit will be acquired for the analysis of renal function and surrogate uremic biomarkers. The recruitment for this cohort study terminated in March, 2018, and the follow-up period for all the enrolled subjects will be terminated in December, 2020. The primary endpoint will be the development of originally-defined significant renal dysfunction or the occurrence of any cerebrovascular disease in the short-term study. The secondary endpoint will be the same endpoints as in the long-term study, or the patients with significant changes in the suggested the surrogate biomarkers. DISCUSSION: The findings of this study will address the importance of taking oral alkalizing agents in the patients with early stages of CKD, furthermore they could address any new surrogate biomarkers that can be useful from early stage CKD. TRIAL REGISTRATION: Registered Report Identifier: UMIN000010059 and jRCT021180043. The trial registration number; 150. Date of registration; 2013/02/26.
The Functional Palliative Prognostic Index: a scoring system for functional prognostication of patients with advanced cancer. 国際誌査読有り

Yusuke Hiratsuka, Takuhiro Yamaguchi, Isseki Maeda, Tatsuya Morita, Masanori Mori, Naosuke Yokomichi, Shuji Hiramoto, Yosuke Matsuda, Hiroyuki Kohara, Kozue Suzuki, Keita Tagami, Takashi Yamaguchi, Akira Inoue

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer　28　(12)　6067-6074　2020年4月17日

DOI： 10.1007/s00520-020-05408-x 　

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PURPOSE: For appropriate advance care planning, functional prognostication is necessary. However, there are no studies of functional prognostication in patients with cancer. The aim of this study was to develop a functional prognostic scoring system for patients with advanced cancer. METHODS: In this multicenter prospective observational study, 1896 patients were enrolled. First, Cox regression analysis and the combination of forward and backward variable selection were used to identify the best subset of predictors. Second, the prognostic score value was defined from each regression coefficient of a significant prognostic factor. The Functional Palliative Prognostic Index (FPPI) was calculated by summing the prognostic scores. RESULTS: Patients were classified into three groups by the FPPI. For walking, the 14-day functional survival probability was > 72.8% for group A (score 0), 28.4-72.8% for group B (score 1), and < 28.4% for group C (score 2-3). For eating, the 14-day functional survival probability was > 71.8% for group A (score 0-3), 29.6-71.8% for group B (score 3.5-5.5), and < 29.6% for group C (score 6-9). For communicating, the 14-day functional survival probability was > 76.6% for group A (score 0-6.5), 22.6-76.6% for group B (score 7-10), and < 22.6% for group C (score 10.5-16). Regarding each item, group B functionally survived significantly longer than group C, and group A functionally survived significantly longer than either of the others. CONCLUSION: We firstly developed a functional prognostic scoring system for patients with advanced cancer. This FPPI system promises to be helpful in advance care planning.
Patient-generated health data collection using a wearable activity tracker in cancer patients-a feasibility study. 国際誌査読有り

Tempei Miyaji, Takashi Kawaguchi, Kanako Azuma, Shinya Suzuki, Yoko Sano, Moe Akatsu, Ayako Torii, Tadamasa Kamimura, Yuki Ozawa, Akihiko Tsuchida, Daisuke Eriguchi, Mizuha Hashiguchi, Makoto Nishino, Motohide Nishi, Yumi Inadome, Tsutomu Yamazaki, Takahiro Kiuchi, Takuhiro Yamaguchi

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer　28　(12)　5953-5961　2020年4月12日

DOI： 10.1007/s00520-020-05395-z 　

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PURPOSE: Incorporation of patient-generated health data (PGHD) into clinical research requires an investigation of the validity of outcomes and feasibility of implementation. This single-arm pilot trial investigated the feasibility of using a commercially available activity tracking wearable device in cancer patients to assess adherence to the device and real-time PGHD collection in a clinical research setting. METHODS: From July to November 2017, enrolled adult patients were asked to wear a wristband-style device. Brief Fatigue Inventory (BFI) and MD Anderson Symptom Inventory (MDASI) were assessed at baseline and on day 29. Furthermore, 29-day Pittsburgh Sleep Quality Index, global impression of the devices, and NCI CTCAE v4 were evaluated. RESULTS: Of 30 patients (mean age, 58.6 years; male, 21 [70%]), 15 (50%) and 11 (36.7%) had gastrointestinal and lung cancer, respectively, and 27 (90%, 95% CI: 0.74-0.98) were well adhered (> 70%) to the device for 28 days. The mean adherence was 84.9% (range: 41.7-95.2%). More frequent PGHD synchronization tended to show better device adherence, with moderate correlation (r = 0.62, 95% CI: 0.33-0.80, p < 000.1). CONCLUSIONS: The feasibility of using a wearable activity tracker was confirmed in cancer patients receiving chemotherapy for a month. For future implementation in clinical trials, there is a need for further comprehensive assessment of the validity and reliability of wearable activity trackers. TRIAL REGISTRATION: This trial was registered at the University Hospital Medical Information Network Clinical Trials Registry as UMIN: UMIN000027575.
【看護研究における報告ガイドライン2】看護研究で念頭に置いておきたい報告ガイドライン30 SPIRIT-PRO 臨床試験実施プロトコールに患者報告アウトカムを組み込むためのガイドライン SPIRIT-PRO拡張版

川口崇, 宮路天平, 山口拓洋

看護研究　53　(2)　134-135　2020年4月
出版者・発行元： (株)医学書院
ISSN：0022-8370

eISSN：1882-1405
Fluorescein Angiography Scoring System Using Ultra-Wide-Field Fluorescein Angiography Versus Standard Fluorescein Angiography in Patients with Sarcoid Uveitis. 国際誌

Rie Tanaka, Toshikatsu Kaburaki, Atsushi Yoshida, Mitsuko Takamoto, Tempei Miyaji, Takuhiro Yamaguchi

Ocular immunology and inflammation　29　(7-8)　1-5　2020年3月12日

DOI： 10.1080/09273948.2020.1737141 　

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Purpose: To compare standard fluorescein angiography (FA) and ultra-wide-field (UWF) FA in evaluating sarcoid uveitis activity using the scoring system adopted by the Angiography Scoring for Uveitis Working Group (ASUWG).Methods: Standard and UWF FA images of 36 eyes with sarcoid uveitis were acquired on the same day. Three graders independently graded 72 FA images using the ASUWG scoring system. We evaluated inter-observer variability using the intra-class correlation coefficient (ICC) and compared scores of each angiographic sign.Results: The ICC was 0.77 for standard FA and 0.87 for UWF FA, with respective total scores of 12.0 and 14.6. UWF FA had higher scores than standard FA for optic disc hyperfluorescence, posterior retinal vascular staining and/or leakage, and peripheral capillary leakage.Conclusions: The scores for UWF FA had a higher ICC than those for standard FA in evaluating sarcoid uveitis. Peripheral capillary leakage scores were particularly high for UWF FA.
A decision analysis comparing unrelated bone marrow transplantation and cord blood transplantation in patients with aggressive adult T-cell leukemia-lymphoma.

Shigeo Fuji, Saiko Kurosawa, Yoshihiro Inamoto, Tatsunori Murata, Atae Utsunomiya, Kaoru Uchimaru, Satoshi Yamasaki, Yoshitaka Inoue, Yukiyoshi Moriuchi, Ilseung Choi, Masao Ogata, Michihiro Hidaka, Takuhiro Yamaguchi, Takahiro Fukuda

International journal of hematology　111　(3)　427-433　2020年3月

DOI： 10.1007/s12185-019-02777-w 　

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Patients with aggressive adult T-cell leukemia-lymphoma (ATL) have dismal outcomes with intensive chemotherapy. Early up-front allogeneic hematopoietic stem cell transplantation (allo-HSCT) is generally recommended. However, the choice of stem cell source, i.e., unrelated bone marrow transplant (UBMT) or cord blood transplantation (CBT), when an HLA-matched related donor is unavailable remains controversial. Thus, we undertook a decision analysis to compare the outcomes of two therapeutic strategies: chemotherapy followed by up-front UBMT at 6 months, and chemotherapy followed by up-front CBT at 3 months. Patients were stratified into low-, intermediate-, and high-risk groups according to the modified ATL-prognostic index. The model simulated life expectancy (LE) and quality-adjusted LE (QALE). LE following up-front UBMT was higher than that following up-front CBT in the low-risk group (2.63 vs. 2.28 years), but was comparable in the intermediate- (2.06 vs. 2.01 years) and high-risk groups (1.25 vs. 1.30 years). The Monte Carlo simulation for LE and QALE in each risk group showed that there was significant uncertainty in all categories. In conclusion, up-front UBMT was superior to up-front CBT in the low-risk group, but the strategies were comparable in the intermediate- and high-risk groups.
Olanzapine 5 mg plus standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting (J-FORCE): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. 国際誌

Hironobu Hashimoto, Masakazu Abe, Osamu Tokuyama, Hideaki Mizutani, Yosuke Uchitomi, Takuhiro Yamaguchi, Yukari Hoshina, Yasuhiko Sakata, Takako Yanai Takahashi, Kazuhisa Nakashima, Masahiko Nakao, Daisuke Takei, Sadamoto Zenda, Koki Mizukami, Satoru Iwasa, Michiru Sakurai, Noboru Yamamoto, Yuichiro Ohe

The Lancet. Oncology　21　(2)　242-249　2020年2月

DOI： 10.1016/S1470-2045(19)30678-3 　

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BACKGROUND: Olanzapine 10 mg added to standard antiemetic therapy including aprepitant, palonosetron, and dexamethasone has been recommended for the prevention of chemotherapy-induced nausea and vomiting. Guidelines suggest that a dose reduction to 5 mg should be considered to prevent sedation. In several phase 2 studies, olanzapine 5 mg has shown equivalent activity to olanzapine 10 mg and a favourable safety profile in relation to somnolence. We evaluated the efficacy of olanzapine 5 mg combined with standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting caused by cisplatin-based chemotherapy. METHODS: This was a randomised, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy of olanzapine 5 mg with triplet-combination antiemetic therapy done in 26 hospitals in Japan. Key inclusion criteria were patients with a malignant tumour (excluding those with a haemopoietic malignancy) who were scheduled to be treated with cisplatin (≥50 mg/m2) for the first time, age between 20 and 75 years, and with Eastern Cooperative Oncology Group performance status of 0-2. Eligible patients were randomly assigned (1:1) to receive either oral olanzapine 5 mg or placebo once daily on days 1-4 combined with aprepitant, palonosetron, and dexamethasone (dosage based on the standard antiemetic therapy against highly emetogenic chemotherapy). Patients were randomly assigned to interventions by use of a web entry system and the minimisation method with a random component, with sex, dose of cisplatin, and age as factors of allocation adjustment. Patients, medical staff, investigators, and individuals handling data were all masked to treatment assignment. The primary endpoint was the proportion of patients who achieved a complete response, defined as absence of vomiting and no use of rescue medications in the delayed phase (24-120 h). All randomly assigned patients who satisfied eligibility criteria received a dose of cisplatin 50 mg/m2 or more, and at least one study treatment, were included in efficacy analysis. All patients who received any treatment in this study were assessed for safety. This study is registered at UMIN Clinical Trials Registry, number UMIN000024676. FINDINGS: Between Feb 9, 2017, and July 13, 2018, 710 patients were enrolled; 356 were randomly assigned to receive olanzapine and 354 were assigned to receive placebo. All eligible patients were observed 120 h after cisplatin initiation. One patient in the olanzapine group and three in the placebo group did not receive treatment and were excluded from all analyses. One patient in the olanzapine group discontinued treatment on day 1 and was excluded from the efficacy analysis. In the delayed phase, the proportion of patients who achieved a complete response was 280 (79% [95% CI 75-83] of 354 patients in the olanzapine group and 231 (66% [61-71] of 351 patients in the placebo group (p<0·0001). One patient had grade 3 constipation and one patient had grade 3 somnolence related to treatment in the olanzapine group. INTERPRETATION: Olanzapine 5 mg combined with aprepitant, palonosetron, and dexamethasone could be a new standard antiemetic therapy for patients undergoing cisplatin-based chemotherapy. FUNDING: Japan Agency for Medical Research and Development.
Efficacy of a Community Health Worker-Based Intervention in Improving Dietary Habits Among Community-Dwelling Older People: A Controlled, Crossover Trial in Japan. 国際誌査読有り

Hiroshi Murayama, Atsuko Taguchi, Michael S Spencer, Takuhiro Yamaguchi

Health education & behavior : the official publication of the Society for Public Health Education　47　(1)　47-56　2020年2月

DOI： 10.1177/1090198119891975 　

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Background. Community health workers (CHWs), often called "health promotion volunteers" in Japan, are individuals who act as a natural helping resource in the community. Aim. This study tested the efficacy of a CHW-based intervention to improve dietary habits among community-dwelling older people in Japan, using a controlled, crossover design. Method. Seventy-eight people aged 65 to 74 years with poor dietary variety living in four administrative districts in Hikone City (Shiga Prefecture, Japan) were nonrandomly allocated to an immediate-intervened group (IIG; n = 41) or a delayed-intervened group (DIG; n = 37). Participants joined a biweekly, four-session program (120 minutes/session), comprising "CHW drama-style lectures," "group discussion among participants and CHWs," "tasting of dishes," and "take-home practical activities." For the initial 2-month period, the IIG received the intervention and the DIG did not. The groups were crossed over for the subsequent 2-month period. The primary outcome measure was participants' dietary variety score (score range: 0-10). Results. The dietary variety score in the IIG significantly increased in the initial 2-month period compared with the DIG (effect size 1.60 points; 95% confidence interval: 0.75, 2.45). The intervention had a similar effect in the DIG in the subsequent 2-month period. Moreover, an analysis within the IIG showed that the intervention effects persisted for at least 2 months after the intervention. Conclusions. The CHW-based intervention improved dietary habits among older people. Our findings provide evidence that a CHW-based natural helping approach is a possible solution to promote healthy aging in the community.
The association between health-related quality of life and achievement of personalized symptom goal. 国際誌査読有り

Keita Tagami, Takashi Kawaguchi, Tomofumi Miura, Takuhiro Yamaguchi, Yoshihisa Matsumoto, Yuki Sumazaki Watanabe, Yuko Uehara, Ayumi Okizaki, Akira Inoue, Tatsuya Morita, Hiroya Kinoshita

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer　28　(10)　4737-4743　2020年1月22日

DOI： 10.1007/s00520-020-05316-0 　

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PURPOSE: The aim of study was to explore the potential association between patient's self-reported physical symptom management goals as personalized symptom goal (PSGs) and health-related quality of life (HRQOL) in cancer patients. The secondary outcome was to investigate the relationship between number of physical symptoms not achieving the PSGs and HRQOL in cancer patients. METHODS: This single-center prospective observational study comprised 140 consecutive outpatients. We evaluated the PSGs and HRQOL using the Functional Assessment of Cancer Therapy-General (FACT-G). Patients were administered a self-report questionnaire, including reports on their physical symptom intensity and PSGs using Edmonton Symptom Assessment System-revised (ESAS-r) scores. We investigated the correlation between PSGs achievement (ESAS-r score ≤ PSG score) and FACT-G total scores, and relationship between and number of physical symptoms not achieving the PSGs (ESAS-r score > PSG score) and FACT-G total scores. RESULTS: The patients who did not achieve PSGs of pain, tiredness, lack of appetite, and shortness of breath had a lower FACT-G total score (p < 0.05). Multivariate linear regression showed that higher number of physical symptoms not achieving the PSGs correlated with lower FACT-G scores (decreasing by 1.826 points for each such symptom, p < 0.01). Predictors of increased number of physical symptoms not achieving the PSGs were younger age and a higher symptom intensity of anxiety. CONCLUSION: PSGs achievement was associated with HRQOL in cancer patients. Additionally, the number of unachieved PSGs were independent determinant of poor HRQOL, particularly in younger cancer patients and those with higher symptom intensity of anxiety.
未承認医薬品等の使用に向けての医薬品安全管理体制の構築と薬剤師の役割

近藤直樹, 阿部直樹, 中澤寛仁, 濃沼政美, 山口拓洋, 中川貴之, 米村雅人

日本病院薬剤師会雑誌　55　(10)　1143-1148　2019年10月
出版者・発行元： (一社)日本病院薬剤師会
ISSN：1341-8815
A comparison between 2- and 3-dimensional approaches to solid component measurement as radiological criteria for sublobar resection in lung adenocarcinoma ≤ 2 cm in size.

Yukihiro Yoshida, Toshiki Manaka, Jun-Ichi Nitadori, Aya Shinozaki-Ushiku, Takehito Doke, Toki Saito, Jiro Sato, Tempei Miyaji, Takuhiro Yamaguchi, Hiroshi Oyama, Masashi Fukayama, Yoshikazu Nakajima, Jun Nakajima

Surgery today　49　(10)　828-835　2019年10月

DOI： 10.1007/s00595-019-01806-9 　

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PURPOSE: We compared three-dimensional (3D) and two-dimensional (2D) measurements of the solid component to determine radiological criteria for sublobar resection of lung adenocarcinoma ≤ 2 cm in size. METHODS: We included 233 surgical cases. The maximum size of the solid component for 3D measurement was calculated by delineating the solid component on successive axial images and reconstructing the 3D surface model. RESULTS: The predictive performance for adenocarcinoma in situ (n = 43) and minimally invasive adenocarcinoma (n = 77) were equivalent to areas under the curve of 0.871 and 0.857 for 2D and 3D measurements (p = 0.229), respectively. A solid component of 5 mm had a prognostic impact on both measurements ( ≤ 5 mm versus > 5 mm; p = 0.003 for 2D and p = 0.002 for 3D, log-rank test). Survival rates at 5 years were 94.7-96.9% following lobectomy and sublobar resection among patients with a solid component ≤ 5 mm in size. Sublobar resection resulted in worse survival rates, with declines at 5 years of 15.8% on 2D and 11.5% on 3D measurements, than lobectomy in patients with a solid component > 5 mm in size. CONCLUSIONS: A solid component ≤ 5 mm in size is an appropriate criterion for sublobar resection for both measurements. In addition, 2D measurement is justified because of its simple implementation.
Explicit prognostic disclosure to Asian women with breast cancer: A randomized, scripted video-vignette study (J-SUPPORT1601). 査読有り

Mori M, Fujimori M, van Vliet LM, Yamaguchi T, Shimizu C, Kinoshita T, Morishita-Kawahara M, Inoue A, Inoguchi H, Matsuoka Y, Bruera E, Morita T, Uchitomi Y

Cancer　125　(19)　3320-3329　2019年10月
出版者・発行元：
DOI： 10.1002/cncr.32327 　

ISSN：0008-543X

eISSN：1097-0142
How successful are we in relieving terminal dyspnea in cancer patients? A real-world multicenter prospective observational study. 国際誌査読有り

Mori M, Morita T, Matsuda Y, Yamada H, Kaneishi K, Matsumoto Y, Matsuo N, Odagiri T, Aruga E, Watanabe H, Tatara R, Sakurai H, Kimura A, Katayama H, Suga A, Nishi T, Shirado AN, Watanabe T, Kuchiba A, Yamaguchi T, Iwase S

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer　28　(7)　3051-3060　2019年10月

DOI： 10.1007/s00520-019-05081-9 　

ISSN：0941-4355
がん領域における患者報告アウトカム

山口拓洋, 川口崇, 宮路天平

癌と化学療法　46　(9)　1345-1356　2019年9月
出版者・発行元： (株)癌と化学療法社
ISSN：0385-0684
[Patient Reported Outcome(PRO)in Oncology]. 査読有り

Takuhiro Yamaguchi, Takashi Kawaguchi, Tempei Miyaji

Gan to kagaku ryoho. Cancer & chemotherapy　46　(9)　1345-1356　2019年9月

ISSN：0385-0684

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In recent years, the importance of patient-reported outcomes(PRO)in addition to clinician-outcome assessment has been particularly recognized in clinical trials and routine clinical care of practice. PRO is defined as "any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else". For example, in oncology field, NCI-CTCAE has conventionally been used for adverse event assessment. However, it has been pointed out that the adverse event reported by medical staffs tends to underestimate as compared by patients themselves. Hence, PRO version of the Common Terminology Criteria for Adverse Events(PRO-CTCAE), is expected to play an important role. In this article, the background of importance of PRO in oncology, the role of PRO in clinical outcome assessments, the difference between PRO and QOL, significance that PRO evaluation brings to patients and clinical practice, PRO-CTCAE and recent methodology of PRO research will be overviewed.
Resolved versus Active Chronic Graft-versus-Host Disease: Impact on Post-Transplantation Quality of Life

Saiko Kurosawa, Takuhiro Yamaguchi, Kumi Oshima, Atsumi Yanagisawa, Takahiro Fukuda, Heiwa Kanamori, Takehiko Mori, Satoshi Takahashi, Tadakazu Kondo, Akio Kohno, Koichi Miyamura, Yukari Umemoto, Takanori Teshima, Shuichi Taniguchi, Takuya Yamashita, Yoshihiro Inamoto, Yoshinobu Kanda, Shinichiro Okamoto, Yoshiko Atsuta

Biology of Blood and Marrow Transplantation　25　(9)　1851-1858　2019年9月
出版者・発行元： Elsevier BV
DOI： 10.1016/j.bbmt.2019.05.016 　

ISSN：1083-8791
保育士による発達上「気になる子」の保護者への支援の実態と関連要因の探索発達上の課題の伝達に着目して査読有り

佐藤日菜, 田口敦子, 山口拓洋, 大森純子

日本公衆衛生雑誌　66　(7)　356-369　2019年7月
出版者・発行元：日本公衆衛生学会
ISSN：0546-1766

eISSN：2187-8986
閉経後乳癌における術前内分泌療法の意義 NEOS試験から得たエビデンス

増田慎三, 大谷彰一郎, 藤澤知巳, 柏葉匡寛, 遠山竜也, 山本豊, 平成人, 山口拓洋, 笹野公伸, 岩田広治

日本乳癌学会総会プログラム抄録集　27回　324-324　2019年7月
出版者・発行元： (一社)日本乳癌学会
Additive Duloxetine for Cancer-Related Neuropathic Pain Nonresponsive or Intolerant to Opioid-Pregabalin Therapy: A Randomized Controlled Trial (JORTC-PAL08). 査読有り

Matsuoka H, Iwase S, Miyaji T, Kawaguchi T, Ariyoshi K, Oyamada S, Satomi E, Ishiki H, Hasuo H, Sakuma H, Tokoro A, Shinomiya T, Otani H, Ohtake Y, Tsukuura H, Matsumoto Y, Hasegawa Y, Kataoka Y, Otsuka M, Sakai K, Matsuda Y, Morita T, Koyama A, Yamaguchi T

Journal of pain and symptom management　58　(4)　645-653　2019年6月
出版者・発行元：
DOI： 10.1016/j.jpainsymman.2019.06.020 　

ISSN：0885-3924
Smartphone problem-solving therapy to reduce fear of cancer recurrence among breast cancer survivors: an open single-arm pilot study. 国際誌査読有り

Imai F, Momino K, Katsuki F, Horikoshi M, Furukawa TA, Kondo N, Toyama T, Yamaguchi T, Akechi T

Japanese journal of clinical oncology　49　(6)　537-544　2019年6月

DOI： 10.1093/jjco/hyz005 　

ISSN：0368-2811
Benefits of a Nationwide Palliative Care Education Program on Lung Cancer Physicians. 査読有り

Inoue A, Yamaguchi T, Tanaka K, Sakashita A, Aoe K, Seki N, Hagiwara K

Internal medicine (Tokyo, Japan)　58　(10)　1399-1403　2019年5月

DOI： 10.2169/internalmedicine.0872-18 　

ISSN：0918-2918
Yokukansan for perioperative psychiatric symptoms in cancer patients undergoing high invasive surgery. J-SUPPORT 1605 (ProD Study): study protocol for a randomized controlled trial. 国際誌

Saho Wada, Ryoichi Sadahiro, Yutaka J Matsuoka, Yosuke Uchitomi, Takuhiro Yamaguchi, Ken Shimizu

Trials　20　(1)　110-110　2019年2月8日

DOI： 10.1186/s13063-019-3202-1 　

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BACKGROUND: Preoperative anxiety and postoperative delirium affect both short- and long-term prognoses in patients with cancer; therefore, these conditions require early prevention and treatment. However, no standard preventive or therapeutic methods have been established for them. Yokukansan, a Japanese herbal medicine for the treatment of insomnia and anxiety, causes relatively few adverse drug reactions and effectively improves the behavioral and psychological symptoms of dementia. Thus, it is expected to be useful for treating and/or preventing perioperative psychiatric symptoms in patients with cancer. The objective of this study is to clarify the therapeutic effect of Yokukansan for preoperative anxiety and its preventive effect on postoperative delirium in cancer patients, as well as to confirm its safety profile. METHODS: This study is a randomized, double-blind, placebo-controlled study in cancer patients scheduled to undergo tumor resection. Patients who provide consent are randomly allocated to receive oral administration of Yokukansan or placebo, and study drug administration is continued for 4 days or longer prior to surgery. We defined two primary endpoints, change in preoperative anxiety and incidence of postoperative delirium. Secondary endpoints are severity score of postoperative delirium, duration of postoperative delirium, amount of benzodiazepines used prior to surgery, amount of antipsychotic agents used after surgery, and number of postoperative hospitalization days. We plan to complete the analysis on March 31, 2021. The target number of registered patients is 110 per group, or 220 in total. DISCUSSION: This study is the first randomized, double-blind, placebo-controlled study intended to clarify the effects of a Japanese herbal medicine, Yokukansan, in the prevention and treatment of perioperative psychiatric symptoms in patients with cancer. The trial was initiated on August 14, 2017, with 195 subjects randomized by October 5, 2018. TRIAL REGISTRATION: UMIN Clinical Trials Registry (UMIN-CTR), UMIN000027561 . Registered on 31 May 2017.
[Factors related to support provided by preschool personnel for parents rearing children with special needs: Focus on communicating about the child's developmental problems]. 査読有り

Hina Sato, Atsuko Taguchi, Takuhiro Yamaguchi, Junko Omori

[Nihon koshu eisei zasshi] Japanese journal of public health　66　(7)　356-369　2019年

DOI： 10.11236/jph.66.7_356 　

ISSN：0546-1766

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Objectives Developmental disorders can hinder the acquisition of cognitive function, verbal ability, gross motor skills, and social skills. Therefore, it is necessary to detect them as soon as possible and to consider methods of providing support. Under these circumstances, preschool teachers are responsible for facilitating the support system. This study aimed to describe and classify the support provided by preschool personnel to parents of children with special needs, and to consider the measures necessary to promote support for such parents.Methods Self-administered questionnaires were distributed to authorized preschool principals and teachers. The questionnaire for principals addressed facility factors within the preschool support system, and that for preschool teachers addressed the teaching factors related to their knowledge and attitude, collaboration among those inside and outside the facility, and support for parents of children with special needs. In addition, we examined the status of support provided to parents for each of the children with special needs picked up by a preschool teacher. To investigate the factors related to the implementation of support to parents, we conducted a multiple logistic regression analysis with the facility and preschool teaching factors as independent variables, and the presence or absence of preschool teachers' support for parents from as a dependent variable.Results Overall, 10.8% of the children in the surveyed preschools had special needs. Among the surveyed principals and teachers, 73.4% responded that they provided support to parents by "developing a healthy relationship," while 39.5% reported that they provided support by "communicating about the child's developmental problems." In the generalized regression analysis on 535 children with special needs excluding missing values, factors associated with "communicating about the child's developmental problems" were "reflecting on the support that was offered in the teacher-parent conference," "collaborating with other professional staff to a high degree," and "being confident in providing support to parents."Conclusion This study revealed factors related to providing support for parents of children of concern. The findings suggested that, to promote the provision of support for parents and to establish an early support system for children with developmental disorders, it is necessary to examine ways to conduct a support conference to review actions of preschool teachers retrospectively and to strengthen cooperation with other institutions. It might be effective to solve problems related to developmental disorders at the preschool level through the Community Association for Supporting Developmental Disorders.
A multicenter survey of temporal changes in chemotherapy-induced hair loss in breast cancer patients. 国際誌

Takanori Watanabe, Hiroshi Yagata, Mitsue Saito, Hiroko Okada, Tamiko Yajima, Nao Tamai, Yuko Yoshida, Tomoko Takayama, Hirohisa Imai, Keiko Nozawa, Takafumi Sangai, Akiyo Yoshimura, Yoshie Hasegawa, Takuhiro Yamaguchi, Kojiro Shimozuma, Yasuo Ohashi

PloS one　14　(1)　e0208118　2019年

DOI： 10.1371/journal.pone.0208118 　

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PURPOSE: Many breast cancer patients suffer from chemotherapy-induced hair loss. Accurate information about temporal changes in chemotherapy-induced hair loss is important for supporting patients scheduled to receive chemotherapy, because it helps them to prepare. However, accurate information, on issues such as the frequency of hair loss after chemotherapy, when regrowth starts, the condition of regrown hair, and the frequency of incomplete hair regrowth, is lacking. This study aimed to clarify the long-term temporal changes in chemotherapy-induced hair loss using patient-reported outcomes for chemotherapy-induced hair loss. METHODS: We conducted a multicenter, cross-sectional questionnaire survey. Disease-free patients who had completed adjuvant chemotherapy consisting of anthracycline and/or taxanes for breast cancer within the prior 5 years were enrolled from 47 hospitals and clinics in Japan. Descriptive statistics were obtained in this study. The study is reported according to the STROBE criteria. RESULTS: The response rate was 81.5% (1511/1853), yielding 1478 questionnaires. Hair loss occurred in 99.9% of patients. The mean time from chemotherapy until hair loss was 18.0 days. Regrowth of scalp hair occurred in 98% of patients. The mean time from the completion of chemotherapy to the beginning of regrowth was 3.3 months. Two years after chemotherapy completion, the scalp-hair recovery rate was <30% in approximately 4% of patients, and this rate showed no improvement 5 years after chemotherapy. Eighty-four percent of the patients initially used wigs, decreasing to 47% by 1 year after chemotherapy and 15.2% after 2 years. The mean period of wig use was 12.5 months. However, a few patients were still using wigs 5 years after completing chemotherapy. CONCLUSIONS: Our survey focused on chemotherapy-induced hair loss in breast cancer patients. We believe these results to be useful for patients scheduled to receive chemotherapy.
Low Phase Angle Is Correlated With Worse General Condition in Patients with Advanced Cancer. 国際誌査読有り

Tomofumi Miura, Yoshihisa Matsumoto, Takashi Kawaguchi, Yuto Masuda, Ayumi Okizaki, Hiroko Koga, Keita Tagami, Yuki Sumazaki Watanabe, Yuko Uehara, Takuhiro Yamaguchi, Tatsuya Morita

Nutrition and cancer　71　(1)　83-88　2019年

DOI： 10.1080/01635581.2018.1557216 　

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OBJECTIVES: Phase angle (PA) is a poor prognostic factor in patients with advanced cancer. This study aimed to identify possible correlations between PA and symptoms, quality of life, fluid retention, and laboratory data in cancer patients in palliative care settings. METHODS: Individuals who visited the outpatient clinic or were admitted to the palliative care unit were eligible. Patients with a performance status of 4 and/or those unable to complete questionnaires were excluded. PA was evaluated using a bioanalyzer device. The correlation coefficient between PA and the variables of interest was analyzed. RESULTS: A total of 102 patients were analyzed. PA was weakly correlated with age (ρ = -0.22), performance status (ρ = -0.30), functional well-being (ρ = 0.20), anorexia/cachexia subscale (ρ = 0.22), and Functional Assessment of Anorexia/Cachexia Therapy trial outcome index (ρ = 0.26). PA was also correlated with fluid retention (ρ = -0.34) and albumin (ρ = 0.32), C-reactive protein (ρ = -0.31), and hemoglobin (ρ = 0.41) levels. Sub-analysis stratified according to sex revealed that males demonstrated the same results; however, female sex demonstrated a correlation between PA and social well-being (ρ = -0.43). CONCLUSIONS: PA was correlated with physical condition, but not with psychological well-being.
VCAP-AMP-VECP as a preferable induction chemotherapy in transplant-eligible patients with aggressive adult T-cell leukemia-lymphoma: a propensity score analysis. 査読有り

Fuji S, Yamaguchi T, Inoue Y, Utsunomiya A, Moriuchi Y, Owatari S, Miyagi T, Sawayama Y, Otsuka E, Yoshida SI, Fukuda T

Bone marrow transplantation　2019年1月

DOI： 10.1038/s41409-019-0446-z 　

ISSN：0268-3369
Validation of the 21-gene test as a predictor of clinical response to neoadjuvant hormonal therapy for ER+, HER2-negative breast cancer: the TransNEOS study. 国際誌

Hiroji Iwata, Norikazu Masuda, Yutaka Yamamoto, Tomomi Fujisawa, Tatsuya Toyama, Masahiro Kashiwaba, Shoichiro Ohtani, Naruto Taira, Takehiko Sakai, Yoshie Hasegawa, Rikiya Nakamura, Hiromitsu Akabane, Yukiko Shibahara, Hironobu Sasano, Takuhiro Yamaguchi, Kentaro Sakamaki, Helen Bailey, Diana B Cherbavaz, Debbie M Jakubowski, Naoko Sugiyama, Calvin Chao, Yasuo Ohashi

Breast cancer research and treatment　173　(1)　123-133　2019年1月

DOI： 10.1007/s10549-018-4964-y 　

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PURPOSE: The Recurrence Score test is validated to predict benefit of adjuvant chemotherapy. TransNEOS, a translational study of New Primary Endocrine-therapy Origination Study (NEOS), evaluated whether Recurrence Score results can predict clinical response to neoadjuvant letrozole. METHODS: NEOS is a phase 3 clinical trial of hormonal therapy ± adjuvant chemotherapy for postmenopausal patients with ER+, HER2-negative, clinically node-negative breast cancer, after six months of neoadjuvant letrozole and breast surgery. TransNEOS patients had tumors ≥ 2 cm and archived core-biopsy samples taken before neoadjuvant letrozole and subsequently sent for Recurrence Score testing. The primary endpoint was to evaluate clinical (complete or partial) response to neoadjuvant letrozole for RS < 18 versus RS ≥ 31. Secondary endpoints included evaluation of clinical response and rate of breast-conserving surgery (BCS) by continuous Recurrence Score result, ESR1 and PGR single-gene scores, and ER gene-group score. RESULTS: Of 295 TransNEOS patients (median age 63 years; median tumor size 25 mm; 66% grade 1), 53.2% had RS < 18, 28.5% had RS18-30, and 18.3% had RS ≥ 31. Clinical response rates were 54% (RS < 18), 42% (RS18-30), and 22% (RS ≥ 31). A higher proportion of patients with RS < 18 had clinical responses (p < 0.001 vs. RS ≥ 31). In multivariable analyses, continuous Recurrence Score result (p < 0.001), ESR1 score (p = 0.049), PGR score (p < 0.001), and ER gene-group score (p < 0.001) were associated with clinical response. Recurrence Score group was significantly associated with rate of BCS after neoadjuvant treatment (RS < 18 vs. RS ≥ 31, p = 0.010). CONCLUSION: The Recurrence Score test is validated to predict clinical response to neoadjuvant letrozole in postmenopausal patients with ER+, HER2-negative, clinically node-negative breast cancer.
Morphine for Refractory Dyspnea in Interstitial Lung Disease: A Phase I Study (JORTC-PAL 05). 国際誌

Yoshinobu Matsuda, Tatsuya Morita, Tempei Miyaji, Tomoko Ogawa, Kuniko Kato, Takashi Kawaguchi, Akihiro Tokoro, Satoru Iwase, Takuhiro Yamaguchi, Yoshikazu Inoue

Journal of palliative medicine　21　(12)　1718-1723　2018年12月

DOI： 10.1089/jpm.2018.0272 　

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Background: Dyspnea is common in interstitial lung disease (ILD) patients and often refractory to conventional treatment. Little is known regarding the safety of systemic morphine in ILD patients. Objective: The objective of this study is to evaluate the safety of a single subcutaneous morphine injection and to determine the recommended dose of morphine for alleviating dyspnea in ILD patients. Design: We conducted a dose-escalation Phase I study for investigating the recommended dose of a single subcutaneous morphine injection to alleviate dyspnea in ILD patients. Setting/Subjects: Eligible subjects were ILD inpatients with dyspnea at rest who were refractory to conventional dyspnea treatment. The morphine doses used were 1 mg and 2 mg in cohort 1 and cohort 2, respectively. The primary endpoint was dose-limiting toxicity, which was defined as (1) respiratory depression, that is, 30% reduction of respiratory rate and 10 Torr increase of PaCO2 compared with baseline; (2) hypotension, that is, 20% reduction of systemic blood pressure compared with baseline and presentation of hypotension-related symptoms; or (3) grade 3, 4, or 5 treatment-emergent adverse events graded by Common Terminology Criteria for Adverse Events (version 4). Results: A total of six patients were enrolled, with three patients each in cohorts 1 and 2. No dose-limiting toxicities were observed; three patients experienced worsened somnolence, but no patients experienced sedation. Conclusion: We conclude that 2 mg of morphine has a tolerable safety profile in ILD patients with dyspnea, and can be tested in further clinical trials.
A combination of routine laboratory findings and vital signs can predict survival of advanced cancer patients without physician evaluation: a fractional polynomial model. 国際誌

Jun Hamano, Ayano Takeuchi, Takuhiro Yamaguchi, Mika Baba, Kengo Imai, Masayuki Ikenaga, Yoshihisa Matsumoto, Ryuichi Sekine, Takashi Yamaguchi, Takeshi Hirohashi, Tsukasa Tajima, Ryohei Tatara, Hiroaki Watanabe, Hiroyuki Otani, Hiroka Nagaoka, Masanori Mori, Yo Tei, Shuji Hiramoto, Tatsuya Morita

European journal of cancer (Oxford, England : 1990)　105　50-60　2018年12月

DOI： 10.1016/j.ejca.2018.09.037 　

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INTRODUCTION: There have been no reports about predicting survival of patients with advanced cancer constructed entirely with objective variables. We aimed to develop a prognostic model based on laboratory findings and vital signs using a fractional polynomial (FP) model. METHODS: A multicentre prospective cohort study was conducted at 58 specialist palliative care services in Japan from September 2012 to April 2014. Eligible patients were older than 20 years and had advanced cancer. We developed models for predicting 7-day, 14-day, 30-day, 56-day and 90-day survival by using the FP modelling method. RESULTS: Data from 1039 patients were analysed to develop each prognostic model (Objective Prognostic Index for advanced cancer [OPI-AC]). All models included the heart rate, urea and albumin, while some models included the respiratory rate, creatinine, C-reactive protein, lymphocyte count, neutrophil count, total bilirubin, lactate dehydrogenase and platelet/lymphocyte ratio. The area under the curve was 0.77, 0.81, 0.90, 0.90 and 0.92 for the 7-day, 14-day, 30-day, 56-day and 90-day model, respectively. The accuracy of the OPI-AC predicting 30-day, 56-day and 90-day survival was significantly higher than that of the Palliative Prognostic Score or the Prognosis in Palliative Care Study model, which are based on a combination of symptoms and physician estimation. CONCLUSION: We developed highly accurate prognostic indexes for predicting the survival of patients with advanced cancer from objective variables alone, which may be useful for end-of-life management. The FP modelling method could be promising for developing other prognostic models in future research.
Multi-centre, randomised, double-blind, placebo-controlled trial of additive duloxetine for cancer-related neuropathic pain refractory to opioids and gabapentinoids 査読有り

Matsuoka Hiromichi, Iwase Satoru, Miyaji Tempei, Kawaguchi Takashi, Ariyoshi Keisuke, Oyamada Shunsuke, Satomi Eriko, Ishiki Hiroto, Hasuo Hideaki, Sakuma Hiroko, Tokoro Akihiro, Shinomiya Toshiaki, Otani Hiroyuki, Otake Yoichi, Hiroaki Tsukuura, Matsumoto Yoshihisa, Hasegawa Yoshikazu, Kataoka Yuki, Otsuka Masatomo, Sakai Kiyohiro, Matsuda Yoshinobu, Morita Tatsuya, Koyama Atsuko, Yamaguchi Takuhiro

ASIA-PACIFIC JOURNAL OF CLINICAL ONCOLOGY　14　161-162　2018年11月

ISSN：1743-7555

eISSN：1743-7563
Multicenter double-blind randomized controlled trial to evaluate the effectiveness and safety of bortezomib as a treatment for refractory systemic lupus erythematosus. 国際誌

Tomonori Ishii, Yoshiya Tanaka, Atsushi Kawakami, Kazuyoshi Saito, Kunihiro Ichinose, Hiroshi Fujii, Yuko Shirota, Tsuyoshi Shirai, Yoko Fujita, Ryu Watanabe, Shih-Wei Chiu, Takuhiro Yamaguchi, Hideo Harigae

Modern rheumatology　28　(6)　986-992　2018年11月

DOI： 10.1080/14397595.2018.1432331 　

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OBJECTIVES: The objective of this study is to evaluate the efficacy and safety of bortezomib for treating systemic lupus erythematosus (SLE), in patients whose disease activity could not be controlled. METHODS: Fourteen SLE patients with persistent disease activity were selected, who required prednisolone doses of >10 mg/d despite concomitant immunosuppressive therapy. Patients were randomly administered either bortezomib or a placebo, eight times. The primary and secondary end-points were a change in anti-dsDNA antibody titer at week 24 and the SLE Responder Index (SRI), respectively. RESULTS: In the bortezomib group, four out of eight patients discontinued the trial; three others failed to complete the minimum protocol treatment due to adverse reactions. The changes in anti-dsDNA antibody titers at week 24 were 4.24% and -1.96%, for the bortezomib and placebo groups, respectively, disconfirming bortezomib's efficacy. In contrast, the corresponding SRI at week 12 was 75% and 40%. CONCLUSIONS: As bortezomib therapy for SLE is associated with many adverse reactions, treatment indications should be selected carefully, and protocols should aim to prevent these occurrences. Although the change in anti-dsDNA antibody titer did not support the efficacy of bortezomib as a treatment for SLE, high SRI in the treatment group suggests bortezomib may utilize mechanisms other than inhibition of anti-dsDNA antibody production.
Longitudinal characteristics of resilience among adolescents: A high school student cohort study to assess the psychological impact of the Great East Japan Earthquake 国際誌

Okuyama J, Funakoshi S, Tomita H, Yamaguchi T, Matsuoka H

Psychiatry Clin Neurosci　72　(11)　821-835　2018年11月

DOI： 10.1111/pcn.12772 　
Factors distinguishing important identified risks from important potential risks in orphan and nonorphan drugs: An analysis of safety specifications of Japan and European Union risk management plans

Hirota S, Yamaguchi T

Pharmacoepidemiol Drug Saf　27　(11)　1231-1238　2018年11月

DOI： 10.1002/pds.4646 　
Smartphone problem-solving and behavioural activation therapy to reduce fear of recurrence among patients with breast cancer (SMartphone Intervention to LEssen fear of cancer recurrence: SMILE project): protocol for a randomised controlled trial 国際誌

Akechi T, Yamaguchi T, Uchida M, Imai F, Momino K, Katsuki F, Sakurai N, Miyaji T, Horikoshi M, Furukawa TA, Iwata H, Uchitomi Y

BMJ Open　8　(11)　e024794　2018年11月

DOI： 10.1136/bmjopen-2018-024794 　
インターネット認知行動療法をRCTで検証する乳がん患者の再発不安・恐怖に対するスマートフォン問題解決療法および行動活性化療法の有効性無作為割付比較試験

明智龍男, 山口拓洋, 宮路天平, 内田恵, 今井文信, 樅野香苗, 香月富士日, 桜井なおみ, 堀越勝, 古川壽亮, 内富庸介

日本認知療法・認知行動療法学会プログラム・抄録集　18回　159-159　2018年10月
出版者・発行元：日本認知療法・認知行動療法学会
PRO-CTCAEの集計方法による有害事象評価の差異に関する検討

東加奈子, 川口崇, 宮路天平, 徳田芳稀, 佐野元彦, 金素安, 河原陽介, 山口拓洋

日本薬剤疫学会学術総会抄録集　24回　152-152　2018年10月
出版者・発行元： (一社)日本薬剤疫学会
抗レトロウイルス療法のアドヒアランスに関する研究におけるBring your own deviceを用いたePROによるデータ収集(Trial in progress)

関根祐介, 川口崇, 岩崎藍, 國本雄介, 増田純一, 冨島公介, 平野淳, 日笠真一, 築地茉莉子, 石原正志, 宮路天平, 山口拓洋, 天野景裕

日本薬剤疫学会学術総会抄録集　24回　153-154　2018年10月
出版者・発行元： (一社)日本薬剤疫学会
支持・緩和・心のケアの臨床試験体制構築がん患者の神経障害性疼痛に対するDuloxetineの効果無作為化二重盲検Placebo比較試験

松岡弘道, 岩瀬哲, 宮路天平, 川口崇, 有吉恵介, 小山田隼介, 里見絵理子, 石木寛人, 蓮尾英明, 所昭宏, 松田能宣, 四宮敏章, 森田達也, 小山敦子, 山口拓洋

日本癌治療学会学術集会抄録集　56回　PD19-3　2018年10月
出版者・発行元： (一社)日本癌治療学会
支持・緩和・心のケアの臨床試験体制構築乳がん患者の再発不安に対するスマートフォン問題解決療法および行動活性化療法

明智龍男, 山口拓洋, 内田恵, 今井文信, 樅野香苗, 香月富士日, 桜井なおみ, 宮路天平, 堀越勝, 古川壽亮, 岩田広治, 内富庸介

日本癌治療学会学術集会抄録集　56回　PD19-4　2018年10月
出版者・発行元： (一社)日本癌治療学会
Fan Therapy Is Effective in Relieving Dyspnea in Patients With Terminally Ill Cancer: A Parallel-Arm, Randomized Controlled Trial. 国際誌

Jun Kako, Tatsuya Morita, Takuhiro Yamaguchi, Masamitsu Kobayashi, Asuko Sekimoto, Hiroya Kinoshita, Asao Ogawa, Sadamoto Zenda, Yosuke Uchitomi, Hironobu Inoguchi, Eisuke Matsushima

Journal of pain and symptom management　56　(4)　493-500　2018年10月

DOI： 10.1016/j.jpainsymman.2018.07.001 　

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CONTEXT: Dyspnea is a common distressing symptom among patients with advanced cancer. OBJECTIVE: The objective of this study was to determine the effect of fan therapy on dyspnea in patients with terminally ill cancer. METHODS: This parallel-arm, randomized controlled trial included 40 patients with advanced cancer from a palliative care unit at the National Cancer Center Hospital in Japan. All patients experienced dyspnea at rest with a score of at least three points on a subjective 0- to 10-point Numerical Rating Scale (NRS), showed peripheral oxygen saturation levels of ≥90%, had an Eastern Cooperative Oncology Group grade of 3 or 4, and were aged 20 years or more. In one group, a fan was directed to blow air on the patient's face for five minutes. This group was compared to a control group wherein air was blown to the patient's legs. Patients were randomly assigned to each group. The main outcome measure was the difference in dyspnea NRS scores between fan-to-face and fan-to-legs groups. RESULTS: No significant differences were seen in baseline dyspnea NRS between groups (mean score, 5.3 vs. 5.1, P = 0.665). Mean dyspnea changed by -1.35 points (95% CI, -1.86 to -0.84) in patients assigned to receive fan-to-face and by -0.1 points (-0.53 to 0.33) in patients assigned to receive fan-to-legs (P < 0.001). The proportion of patients with a one-point reduction in dyspnea NRS was significantly higher in the fan-to-face arm than in the fan-to-legs arm (80% [n = 16] vs. 25% [n = 5], P = 0.001). CONCLUSION: Fan-to-face is effective in alleviating dyspnea in patients with terminally ill cancer.
Study protocol for J-SUPPORT 1604 (J-FORCE): a randomized, double blind, placebo-controlled Phase III study evaluating olanzapine (5 mg) plus standard triple antiemetic therapy for prevention of chemotherapy induced nausea and vomiting in patients receivi

Hashimoto H, Abe M, Yanai T, Yamaguchi T, Zenda S, Uchitomi Y, Fukuda H, Mori M, Iwasa S, Yamamoto N, Ohe Y

Jpn J Clin Oncol　48　(10)　950-952　2018年10月

DOI： 10.1093/jjco/hyy114 　
Employment status was highly associated with quality of life after allogeneic hematopoietic cell transplantation, and the association may differ according to patient age and graft-versus-host disease status: analysis of a nationwide QOL survey 国際誌

Kurosawa S, Yamaguchi T, Oshima K, Yanagisawa A, Fukuda T, Kanamori H, Mori T, Takahashi S, Kondo T, Fujisawa S, Onishi Y, Yano S, Onizuka M, Kanda Y, Mizuno I, Taniguchi S, Yamashita T, Inamoto Y, Okamoto S, Atsuta Y

Bone Marrow Transplant　54　(4)　611-615　2018年10月

DOI： 10.1038/s41409-018-0343-x 　
Assessment of bleeding in patients with disseminated intravascular coagulation after receiving surgery and recombinant human soluble thrombomodulin: A cohort study using a database 国際誌

Yamaguchi T, Kitajima Y, Miyauchi Y, Izawa K, Tanaka M, Hirata M, Sadatsuki Y, Ogawa Y

PLoS One　13　(10)　e0205146　2018年10月

DOI： 10.1371/journal.pone.0205146 　
アグレッシブATLに対する初回化学療法におけるmLSG15とCHOPの比較Propensity score analysis(VCAP-AMP-VECP versus CHOP for aggressive adult T-cell leukemia-lymphoma: a propensity score analysis)

藤重夫, 山口拓洋, 井上明威, 宇都宮與, 森内幸美, 大渡五月, 宮城敬, 澤山靖, 大塚英一, 吉田真一郎, 福田隆浩

臨床血液　59　(9)　1598-1598　2018年9月
出版者・発行元： (一社)日本血液学会-東京事務局
ISSN：0485-1439

eISSN：1882-0824
Phase I clinical trial results of aceneuramic acid for GNE myopathy in Japan 査読有り

Naoki Suzuki, Masaaki Kato, Hitoshi Warita, Rumiko Izumi, Maki Tateyama, Hiroshi Kuroda, Ryuta Asada, Akifumi Suzuki, Takuhiro Yamaguchi, Ichizo Nishino, Masashi Aoki

Translational Medicine Communications　3　(7)　2018年9月
Topical steroid versus placebo for the prevention of radiation dermatitis in head and neck cancer patients receiving chemoradiotherapy: the study protocol of J-SUPPORT 1602 (TOPICS study), a randomized double-blinded phase 3 trial 国際誌

Zenda S, Yamaguchi T, Yokota T, Miyaji T, Mashiko T, Tanaka M, Yonemura M, Takeno M, Okano T, Kawasaki T, Nakamori Y, Ishii S, Shimada S, Kanamaru M, Uchitomi Y

BMC Cancer　18　(1)　873-873　2018年9月

DOI： 10.1186/s12885-018-4763-1 　
Clinical impact of underweight status at diagnosis on elderly patients with acute myeloid leukemia: a retrospective study of JALSG GML200

Kaito Harada, Noriko Doki, Yasushi Miyazaki, Atsushi Wakita, Shigeki Ohtake, Satoru Takada, Hirokazu Komatsu, Kohmei Kubo, Akihiro Takeshita, Yoko Adachi, Hitoshi Kiyoi, Takuhiro Yamaguchi, Minoru Yoshida, Tomoki Naoe, Kazuteru Ohashi

Annals of Hematology　97　(8)　1481-1483　2018年8月1日
出版者・発行元： Springer Verlag
DOI： 10.1007/s00277-018-3281-1 　

ISSN：1432-0584 0939-5555
Phase III Trial Comparing Intraperitoneal and Intravenous Paclitaxel Plus S-1 Versus Cisplatin Plus S-1 in Patients With Gastric Cancer With Peritoneal Metastasis: PHOENIX-GC Trial 国際誌

Ishigami H, Fujiwara Y, Fukushima R, Nashimoto A, Yabusaki H, Imano M, Imamoto H, Kodera Y, Uenosono Y, Amagai K, Kadowaki S, Miwa H, Yamaguchi H, Yamaguchi T, Miyaji T, Kitayama J

J Clin Oncol　36　(19)　1922-1929　2018年7月

DOI： 10.1200/JCO.2018.77.8613 　
がん患者の神経障害性疼痛に対するデュロキセチンの有用性無作為化二重盲検プラセボ比較試験(JORTC-PAL08試験、DIRECT Study)

蓮尾英明, 松岡弘道, 岩瀬哲, 宮路天平, 川口崇, 山口拓洋, 有吉恵介, 小山田隼佑, 松田能宣, 田原一樹, 里見絵理子

Palliative Care Research　13　(Suppl.)　S296-S296　2018年6月
出版者・発行元： (NPO)日本緩和医療学会
eISSN：1880-5302
Patient reported outcomes (PRO) results for prophylactic effect of dexamethasone on regorafenib-related fatigue and/or malaise: a randomized, placebo-controlled, double-blind clinical study in patients with unresectable metastatic colorectal cancer: KSCC1 査読有り

Shimokawa Mototsugu, Oki Eiji, Yamaguchi Takuhiro, Tanioka Hiroaki, Miyamoto Yuji, Tsuji Akihito

JOURNAL OF CLINICAL ONCOLOGY　36　(15)　2018年5月20日

DOI： 10.1200/JCO.2018.36.15_suppl.10094 　

ISSN：0732-183X

eISSN：1527-7755
Effect of early palliative care: complex intervention and complex results

Hiroto Ishiki, Takuhiro Yamaguchi, Yoshihisa Matsumoto, Daisuke Kiuchi, Eriko Satomi

The Lancet Oncology　19　(5)　e221　2018年5月1日
出版者・発行元： Lancet Publishing Group
DOI： 10.1016/S1470-2045(18)30238-9 　

ISSN：1474-5488 1470-2045

eISSN：1474-5488
Outcomes of patients with relapsed aggressive adult T-cell leukemia-lymphoma: Clinical effectiveness of anti-CCR4 antibody and allogeneic hematopoietic stem cell transplantation

Shigeo Fuji, Atae Utsunomiya, Yoshitaka Inoue, Takashi Miyagi, Satsuki Owatari, Yasushi Sawayama, Yukiyoshi Moriuchi, Ilseung Choi, Takero Shindo, Shin-Ichiro Yoshida, Satoshi Yamasaki, Takuhiro Yamaguchi, Takahiro Fukuda

Haematologica　103　(5)　e211-e214　2018年4月30日
出版者・発行元： Ferrata Storti Foundation
DOI： 10.3324/haematol.2017.184564 　

ISSN：1592-8721 0390-6078
Recurrent Stroke and Bleeding Events after Acute Cardioembolic Stroke—Analysis Using Japanese Healthcare Database from Acute-Care Institutions

Masahiro Yasaka, Yukihiro Koretsune, Takeshi Yamashita, Eisei Oda, Daisuke Matsubayashi, Kaori Ota, Masafumi Kobayashi, Yasuyuki Matsushita, Jumpei Kaburagi, Kei Ibusuki, Atsushi Takita, Mikio Iwashita, Takuhiro Yamaguchi

Journal of Stroke and Cerebrovascular Diseases　27　(4)　1012-1024　2018年4月1日
出版者・発行元： W.B. Saunders
DOI： 10.1016/j.jstrokecerebrovasdis.2017.11.002 　

ISSN：1532-8511 1052-3057
医薬品開発教育コースの紹介とそのネットワーキングの可能性についてデータマネジャー等の臨床研究支援者の教育育成プログラムの紹介

山口拓洋, 宮路天平

臨床医薬　34　(2)　96-99　2018年2月
出版者・発行元： (株)臨床医薬研究協会
ISSN：0910-8211
Evaluation of the Appropriate Washout Period Following Fan Therapy for Dyspnea in Patients With Advanced Cancer: A Pilot Study. 国際誌

Jun Kako, Tatsuya Morita, Takuhiro Yamaguchi, Asuko Sekimoto, Masamitsu Kobayashi, Hiroya Kinoshita, Asao Ogawa, Sadamoto Zenda, Yosuke Uchitomi, Hironobu Inoguchi, Eisuke Matsushima

The American journal of hospice & palliative care　35　(2)　293-296　2018年2月

DOI： 10.1177/1049909117707905 　

詳細を見る詳細を閉じる

OBJECTIVES: To clarify the duration required for dyspnea to return to baseline severity after fan therapy, to evaluate whether fan-to-legs therapy or no fan therapy would be a suitable control therapy, and to investigate changes in patients' face surface temperature after fan therapy. METHODS: In this pilot study, all participants received 3 interventions in the following order: no fan, fan to legs, and fan to face. Participants used a fan for 5 minutes, and they scored their dyspnea at 10-minute intervals for 60 minutes or until the score had returned to its baseline value, whichever occurred first. Nine patients with advanced cancer admitted to a palliative care unit were included; they had dyspnea at rest and rated its severity as at least 3 points on a 0- to 10-point numerical rating scale. Descriptive statistics and the Wilcoxon signed rank test were used to analyze the data. RESULTS: All patients completed the study. Of the 9 participants, 6 experienced a clinical benefit from using a fan to their faces. Of these patients, only 2 participants' (2 of 6) dyspnea scores returned to baseline by the end of the 60-minute assessment period after exposure to fan-to-face therapy. In fan-to-legs and no fan settings, there was no change in the dyspnea scores. There were significant differences between the baseline face surface temperature and that after fan-to-face and fan-to-legs settings. CONCLUSION: When using a crossover design to investigate the effect of fan therapy on dyspnea, 1 hour is an insufficient washout period.
Role of up-front allogeneic hematopoietic stem cell transplantation for patients with aggressive adult T-cell leukemia-lymphoma: a decision analysis

Shigeo Fuji, Saiko Kurosawa, Yoshihiro Inamoto, Tatsunori Murata, Atae Utsunomiya, Kaoru Uchimaru, Satoshi Yamasaki, Yoshitaka Inoue, Yukiyoshi Moriuchi, Ilseung Choi, Masao Ogata, Michihiro Hidaka, Takuhiro Yamaguchi, Takahiro Fukuda

Bone Marrow Transplantation　53　(7)　1-4　2018年1月25日
出版者・発行元： Nature Publishing Group
DOI： 10.1038/s41409-017-0082-4 　

ISSN：1476-5365 0268-3369
mHealth を用いた臨床研究における Patient Generated Health Data の効率的なデータ収集、管理方法の検討

宮路天平, 川口崇, 東加奈子, 眞鍋萌, 鈴木信也, 武谷倫太郎, 西基秀, 山口拓洋

薬剤疫学　23　s155-s155　2018年
出版者・発行元：一般社団法人日本薬剤疫学会
DOI： 10.3820/jjpe.23.s155 　

ISSN：1342-0445
医薬品リスクマネジメントにおける「DRiFOs」の活用方法の検討

秋山哲也, 村上忠司, 宮路天平, 山口拓洋

薬剤疫学　23　s129-s129　2018年
出版者・発行元：一般社団法人日本薬剤疫学会
DOI： 10.3820/jjpe.23.s129 　

ISSN：1342-0445
Prophylactic Effect of Dexamethasone on Regorafenib-Related Fatigue and/or Malaise: A Randomized, Placebo-Controlled, Double-Blind Clinical Study in Patients with Unresectable Metastatic Colorectal Cancer (KSCC1402/HGCSG1402). 国際誌

Hiroaki Tanioka, Yuji Miyamoto, Akihito Tsuji, Masako Asayama, Takeshi Shiraishi, Satoshi Yuki, Masahito Kotaka, Akitaka Makiyama, Mototsugu Shimokawa, Takayuki Shimose, Satohiro Masuda, Takuhiro Yamaguchi, Yoshito Komatsu, Hiroshi Saeki, Yasunori Emi, Hideo Baba, Eiji Oki, Yoshihiko Maehara

Oncology　94　(5)　289-296　2018年

DOI： 10.1159/000486624 　

詳細を見る詳細を閉じる

BACKGROUND: Regorafenib is an oral multikinase inhibitor with a proven survival benefit for metastatic colorectal cancer patients. The KSCC1402/HGCSG1402 study investigated the prophylactic effect of oral dexamethasone (DEX) on regorafenib-related fatigue and/or malaise. PATIENTS AND METHODS: Patients who progressed after standard chemotherapy were randomized 1: 1 to a DEX group (2 mg/day; days 1-28) with regorafenib or a placebo group with regorafenib. The primary endpoint was the incidence of fatigue and/or malaise, based on version 4.0 of the National Cancer Institute's CTCAE (Common Terminology Criteria for Adverse Events). One of the secondary endpoints was the in-cidence of fatigue and/or malaise based on the CTCAE assessed by patient-reported outcome (PRO). RESULTS: The incidence of any grade of fatigue and/or malaise assessed by the investigators was 58.8% in the DEX group and 61.1% in the placebo group (p = 0.8101), and that assessed by PRO was 47.2 and 58.3%, respectively (p = 0.3450). The incidence of grade ≥2 fatigue and/or malaise, as assessed by the investigators, was 19.4% for the DEX group and 38.9% for the placebo group (p = 0.0695), and that assessed by PRO was 27.8 and 52.8%, respectively (p = 0.0306). CONCLUSION: Our results suggest that prophylactic oral DEX is clinically effective in improving regorafenib-related fatigue and/or malaise.
Pragmatic Clinical Trialへの誘い(いざない) Explanatory or Pragmatic?

山口拓洋, 宮路天平

薬理と治療　45　(Suppl.2)　s66-s67　2017年11月
出版者・発行元：ライフサイエンス出版(株)
ISSN：0386-3603
The relationship between cancer patients' place of death and bereaved caregivers' mental health status

Yutaka Hatano, Maho Aoyama, Tatsuya Morita, Takuhiro Yamaguchi, Isseki Maeda, Yoshiyuki Kizawa, Satoru Tsuneto, Yasuo Shima, Mitsunori Miyashita

PSYCHO-ONCOLOGY　26　(11)　1959-1964　2017年11月

DOI： 10.1002/pon.4412 　

ISSN：1057-9249

eISSN：1099-1611
日本版PRO-CTCAEの信頼性・妥当性に関する研究

河原陽介, 川口崇, 宮路天平, 東加奈子, 佐野元彦, 金素安, 鳥居綾子, 山田裕里, 鮎原秀明, 石橋敬一郎, 大久保淳史, 山口拓洋

日本癌治療学会学術集会抄録集　55回　O32-1　2017年10月
出版者・発行元： (一社)日本癌治療学会
PRO-CTCAEおよびCTCAEを用いた医療者と患者における有害事象評価の不一致に関する研究

金素安, 川口崇, 宮路天平, 東加奈子, 佐野元彦, 河原陽介, 佐野陽子, 下平智秀, 関貴之, 石橋敬一郎, 閔貴善, 山口拓洋

日本癌治療学会学術集会抄録集　55回　O32-2　2017年10月
出版者・発行元： (一社)日本癌治療学会
Quality of Life after Allogeneic Hematopoietic Cell Transplantation According to Affected Organ and Severity of Chronic Graft-versus-Host Disease

Saiko Kurosawa, Kumi Oshima, Takuhiro Yamaguchi, Atsumi Yanagisawa, Takahiro Fukuda, Heiwa Kanamori, Takehiko Mori, Satoshi Takahashi, Tadakazu Kondo, Akio Kohno, Koichi Miyamura, Yukari Umemoto, Takanori Teshima, Shuichi Taniguchi, Takuya Yamashita, Yoshihiro Inamoto, Yoshinobu Kanda, Shinichiro Okamoto, Yoshiko Atsuta

BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION　23　(10)　1749-1758　2017年10月

DOI： 10.1016/j.bbmt.2017.06.011 　

ISSN：1083-8791

eISSN：1523-6536
がん支持療法の現状と展望がん支持療法の臨床研究を支える方法論

山口拓洋, 宮路天平, 川口崇

日本癌学会総会記事　76回　SS3-4　2017年9月
出版者・発行元： (一社)日本癌学会
ISSN：0546-0476
GvHD prophylaxis after single-unit reduced intensity conditioning cord blood transplantation in adults with acute leukemia 査読有り

S. Terakura, Y. Kuwatsuka, S. Yamasaki, A. Wake, J. Kanda, Y. Inamoto, S. Mizuta, T. Yamaguchi, N. Uchida, Y. Kouzai, N. Aotsuka, H. Ogawa, H. Kanamori, K. Nishiwaki, S. Miyakoshi, M. Onizuka, I. Amano, T. Fukuda, T. Ichinohe, Y. Atsuta, M. Murata, T. Teshima

Bone Marrow Transplantation　52　(9)　1261-1267　2017年9月1日
出版者・発行元： Nature Publishing Group
DOI： 10.1038/bmt.2017.116 　

ISSN：1476-5365 0268-3369
Mental health and school-based intervention among adolescent exposed to the 2011 Great East Japan Earthquake and tsunami 査読有り

Junko Okuyama, Shunichi Funakoshi, Hiroaki Tomita, Takuhiro Yamaguchi, Hiroo Matsuoka

INTERNATIONAL JOURNAL OF DISASTER RISK REDUCTION　24　183-188　2017年9月

DOI： 10.1016/j.ijdrr.2017.06.012 　

ISSN：2212-4209
Phase I study of nivolumab combined with IFN-β for patients with advanced melanoma

Fujimura T, Hidaka T, Kambayashi Y, Furudate S, Kakizaki A, Tono H, Tsukada A, Haga T, Hashimoto A, Morimoto R, Yamaguchi T, Takano T, Aiba S

Oncotarget　8　(41)　71181-71187　2017年9月

DOI： 10.18632/oncotarget.17090 　

ISSN：1949-2553

eISSN：1949-2553
Adjunctive antimicrobial chemotherapy based on hydrogen peroxide photolysis for non-surgical treatment of moderate to severe periodontitis: a randomized controlled trial

Taro Kanno, Keisuke Nakamura, Kirika Ishiyama, Yasutomo Yamada, Midori Shirato, Yoshimi Niwano, Chie Kayaba, Koji Ikeda, Airi Takagi, Takuhiro Yamaguchi, Keiichi Sasaki

SCIENTIFIC REPORTS　7　(1)　12247　2017年9月

DOI： 10.1038/s41598-017-12514-0 　

ISSN：2045-2322
Additive effect of rikkunshito, an herbal medicine, on chemotherapy-induced nausea, vomiting, and anorexia in uterine cervical or corpus cancer patients treated with cisplatin and paclitaxel: results of a randomized phase II study (JORTC KMP-02)

Shunsuke Ohnishi, Hidemichi Watari, Maki Kanno, Yoko Ohba, Satoshi Takeuchi, Tempei Miyaji, Shunsuke Oyamada, Eiji Nomura, Hidenori Kato, Toru Sugiyama, Masahiro Asaka, Noriaki Sakuragi, Takuhiro Yamaguchi, Yasuhito Uezono, Satoru Iwase

JOURNAL OF GYNECOLOGIC ONCOLOGY　28　(5)　e44　2017年9月

DOI： 10.3802/jgo.2017.28.e44 　

ISSN：2005-0380

eISSN：2005-0399
Study protocol for a multi-institutional, randomised, double-blinded, placebo-controlled phase III trial investigating additive efficacy of duloxetine for neuropathic cancer pain refractory to opioids and gabapentinoids: the DIRECT study

Hiromichi Matsuoka, Hiroto Ishiki, Satoru Iwase, Atsuko Koyama, Takashi Kawaguchi, Yoshiyuki Kizawa, Tatsuya Morita, Yoshinobu Matsuda, Tempei Miyaji, Keisuke Ariyoshi, Takuhiro Yamaguchi

BMJ OPEN　7　(8)　e017280　2017年8月

DOI： 10.1136/bmjopen-2017-017280 　

ISSN：2044-6055
Predictors of venous thromboembolism recurrence and the bleeding events identified using a Japanese healthcare database 査読有り

Mashio Nakamura, Norikazu Yamada, Eisei Oda, Daisuke Matsubayashi, Kaori Ota, Masafumi Kobayashi, Yasuyuki Matsushita, Jumpei Kaburagi, Kei Ibusuki, Atsushi Takita, Mikio Iwashita, Takuhiro Yamaguchi

JOURNAL OF CARDIOLOGY　70　(1-2)　155-162　2017年7月

DOI： 10.1016/j.jjcc.2016.10.012 　

ISSN：0914-5087

eISSN：1876-4738
School-Based Interventions Aimed at the Prevention and Treatment of Adolescents Affected by the 2011 Great East Japan Earthquake: A Three-Year Longitudinal Study

Junko Okuyama, Shunichi Funakoshi, Hiroaki Tomita, Takuhiro Yamaguchi, Hiroo Matsuoka

TOHOKU JOURNAL OF EXPERIMENTAL MEDICINE　242　(3)　203-213　2017年7月

DOI： 10.1620/tjem.242.203 　

ISSN：0040-8727

eISSN：1349-3329
Clinical predictors of the estimated glomerular filtration rate 1 year after radical nephrectomy in Japanese patients. 国際誌

Shuichi Shimada, Hideo Saito, Yoshihide Kawasaki, Shinichi Yamashita, Hisanobu Adachi, Narihiko Kakoi, Takashige Namima, Masahiko Sato, Atsushi Kyan, Koji Mitsuzuka, Akihiro Ito, Takuhiro Yamaguchi, Yoichi Arai

Investigative and clinical urology　58　(4)　228-234　2017年7月

DOI： 10.4111/icu.2017.58.4.228 　

詳細を見る詳細を閉じる

PURPOSE: To evaluate renal function 1 year after radical nephrectomy (RN) for renal cell carcinoma, the preoperative predictors of postnephrectomy renal function were investigated by sex, and equations to predict the estimated glomerular filtration rate (eGFR) 1 year after RN were developed. MATERIALS AND METHODS: A total of 525 patients who underwent RN between May 2007 and August 2011 at Tohoku University Hospital and its affiliated hospitals were prospectively evaluated. Overall, 422 patients were analyzed in this study. RESULTS: Independent preoperative factors associated with postnephrectomy renal function were different in males and females. Preoperative eGFR, age, tumor size, and body mass index (BMI) were independent factors in males, while tumor size and BMI were not independent factors in females. The equations developed to predict eGFR 1 year after RN were: Predicted eGFR in males (mL/min/1.73 m2)=27.99-(0.196×age)+(0.497×eGFR)+(0.744×tumor size)-(0.339×BMI); and predicted eGFR in females=44.57-(0.275×age)+(0.298×eGFR). The equations were validated in the validation dataset (R2=0.63, p<0.0001 and R2=0.31, p<0.0001, respectively). CONCLUSIONS: The developed equations by sex enable better prediction of eGFR 1 year after RN. The equations will be useful for preoperative patient counseling and selection of the type of surgical procedure in elective partial or RN cases.
Effects of End-of-Life Discussions on the Mental Health of Bereaved Family Members and Quality of Patient Death and Care

Takashi Yamaguchi, Isseki Maeda, Yutaka Hatano, Masanori Mori, Yasuo Shima, Satoru Tsuneto, Yoshiyuki Kizawa, Tatsuya Morita, Takuhiro Yamaguchi, Maho Aoyama, Mitsunori Miyashita

JOURNAL OF PAIN AND SYMPTOM MANAGEMENT　54　(1)　17-+　2017年7月

DOI： 10.1016/j.jpainsymman.2017.03.008 　

ISSN：0885-3924

eISSN：1873-6513
The role of specific visual subfields in collisions with oncoming cars during simulated driving in patients with advanced glaucoma

Shiho Kunimatsu-Sanuki, Aiko Iwase, Makoto Araie, Yuki Aoki, Takeshi Hara, Takeo Fukuchi, Sachiko Udagawa, Shinji Ohkubo, Kazuhisa Sugiyama, Chota Matsumoto, Toru Nakazawa, Takuhiro Yamaguchi, Hiroshi Ono

BRITISH JOURNAL OF OPHTHALMOLOGY　101　(7)　896-901　2017年7月

DOI： 10.1136/bjophthalmol-2016-308754 　

ISSN：0007-1161

eISSN：1468-2079
Development of a modified prognostic index for patients with aggressive adult T-cell leukemia-lymphoma aged 70 years or younger: possible risk-adapted management strategies including allogeneic transplantation

Shigeo Fuji, Takuhiro Yamaguchi, Yoshitaka Inoue, Atae Utsunomiya, Yukiyoshi Moriuchi, Kaoru Uchimaru, Satsuki Owatari, Takashi Miyagi, Jun Taguchi, Ilseung Choi, Eiichi Otsuka, Sawako Nakachi, Hisashi Yamamoto, Saiko Kurosawa, Kensei Tobinai, Takahiro Fukuda

HAEMATOLOGICA　102　(7)　1258-1265　2017年7月

DOI： 10.3324/haematol.2017.164996 　

ISSN：0390-6078
Usefulness of a healthcare database for epidemiological research in atrial fibrillation

Yukihiro Koretsune, Takeshi Yamashita, Masahiro Yasaka, Eisei Oda, Daisuke Matsubayashi, Kaori Ota, Masafumi Kobayashi, Yasuyuki Matsushita, Jumpei Kaburagi, Kei Ibusuki, Atsushi Takita, Mikio Iwashita, Takuhiro Yamaguchi

JOURNAL OF CARDIOLOGY　70　(1-2)　169-179　2017年7月

DOI： 10.1016/j.jjcc.2016.10.015 　

ISSN：0914-5087

eISSN：1876-4738
間質性肺疾患の呼吸困難に対するモルヒネの安全性に関する第1相試験 JORTC-PAL05

松田能宣, 森田達也, 宮路天平, 小川智子, 加藤邦子, 武田ヒサ, 所昭宏, 井上義一, 山口拓洋, 岩瀬哲

Palliative Care Research　12　(Suppl.)　S355-S355　2017年6月
出版者・発行元： (NPO)日本緩和医療学会
eISSN：1880-5302
Clinical manifestations of nonmotor symptoms in 1021 Japanese Parkinson's disease patients from 35 medical centers

Tetsuya Maeda, Yasushi Shimo, Shih-Wei Chiu, Takuhiro Yamaguchi, Kenichi Kashihara, Yoshio Tsuboi, Masahiro Nomoto, Nobutaka Hattori, Hirohisa Watanabe, Hidemoto Saiki

PARKINSONISM & RELATED DISORDERS　38　54-60　2017年5月

DOI： 10.1016/j.parkreldis.2017.02.024 　

ISSN：1353-8020

eISSN：1873-5126
ULTRASOUND IMAGE CLASSIFICATION OF DUCTAL CARCINOMA IN SITU (DCIS) OF THE BREAST: ANALYSIS OF 705 DCIS LESIONS

Takanori Watanabe, Takuhiro Yamaguchi, Hiroko Tsunoda, Setsuko Kaoku, Eriko Tohno, Hidemitsu Yasuda, Kanako Ban, Koichi Hirokaga, Kumiko Tanaka, Takeshi Umemoto, Toshitaka Okuno, Yasuhisa Fujimoto, Shuichi Nakatani, Jun Ito, Ei Ueno

ULTRASOUND IN MEDICINE AND BIOLOGY　43　(5)　918-925　2017年5月

DOI： 10.1016/j.ultrasmedbio.2017.01.008 　

ISSN：0301-5629

eISSN：1879-291X
Incidence of venous thromboembolism and bleeding events in patients with lower extremity orthopedic surgery: a retrospective analysis of a Japanese healthcare database

Takeshi Fuji, Masao Akagi, Yasuyuki Abe, Eisei Oda, Daisuke Matsubayashi, Kaori Ota, Masafumi Kobayashi, Yasuyuki Matsushita, Jumpei Kaburagi, Kei Ibusuki, Atsushi Takita, Mikio Iwashita, Takuhiro Yamaguchi

JOURNAL OF ORTHOPAEDIC SURGERY AND RESEARCH　12　(1)　55　2017年4月

DOI： 10.1186/s13018-017-0549-4 　

ISSN：1749-799X
Use of mycophenolate mofetil and a calcineurin inhibitor in allogeneic hematopoietic stem-cell transplantation from HLA-matched siblings or unrelated volunteer donors: Japanese multicenter phase II trials

Takahiko Nakane, Hirohisa Nakamae, Takuhiro Yamaguchi, Saiko Kurosawa, Atsuo Okamura, Michihiro Hidaka, Shigeo Fuji, Akio Kohno, Takeshi Saito, Yasutaka Aoyama, Kazuo Hatanaka, Yoshio Katayama, Kimikazu Yakushijin, Toshimitsu Matsui, Motohiro Yamamori, Akiyoshi Takami, Masayuki Hino, Takahiro Fukuda

INTERNATIONAL JOURNAL OF HEMATOLOGY　105　(4)　485-496　2017年4月

DOI： 10.1007/s12185-016-2154-4 　

ISSN：0925-5710

eISSN：1865-3774
Efficacy of low-density lipoprotein apheresis combined with corticosteroids for cholesterol crystal embolism

Katsuya Ishiyama, Toshinobu Sato, Takuhiro Yamaguchi, Yoshio Taguma

CLINICAL AND EXPERIMENTAL NEPHROLOGY　21　(2)　228-235　2017年4月

DOI： 10.1007/s10157-016-1272-x 　

ISSN：1342-1751

eISSN：1437-7799
Exploratory research for optimal GvHD prophylaxis after single unit CBT in adults: short-term methotrexate reduced the incidence of severe GvHD more than mycophenolate mofetil 査読有り

S. Terakura, A. Wake, Y. Inamoto, M. Murata, R. Sakai, T. Yamaguchi, S. Takahashi, N. Uchida, Y. Onishi, K. Ohashi, Y. Ozawa, H. Kanamori, H. Yamaguchi, T. Fukuda, T. Ichinohe, M. Takanashi, Y. Atsuta, T. Teshima

BONE MARROW TRANSPLANTATION　52　(3)　423-430　2017年3月

DOI： 10.1038/bmt.2016.255 　

ISSN：0268-3369

eISSN：1476-5365
Aqueous cytokine levels are associated with reduced macular thickness after intravitreal ranibizumab for diabetic macular edema

Tomoyasu Shiraya, Satoshi Kato, Fumiyuki Araki, Takashi Ueta, Tempei Miyaji, Takuhiro Yamaguchi

PLOS ONE　12　(3)　e0174340　2017年3月

DOI： 10.1371/journal.pone.0174340 　

ISSN：1932-6203
A Diagnostic Scoring System for Sacroiliac Joint Pain Originating from the Posterior Ligament

Daisuke Kurosawa, Eiichi Murakami, Hiroshi Ozawa, Hiroaki Koga, Toyohiko Isu, Yasuhiro Chiba, Eiji Abe, Eiki Unoki, Yoshiro Musha, Keisuke Ito, Shinsuke Katoh, Takuhiro Yamaguchi

PAIN MEDICINE　18　(2)　228-238　2017年2月

DOI： 10.1093/pm/pnw117 　

ISSN：1526-2375

eISSN：1526-4637
Explanatory or pragmatic?

Takuhiro Yamaguchi, Tempei Miyaji

Japanese Pharmacology and Therapeutics　45　s66-s67　2017年

ISSN：0386-3603
Adjustment for Propensity Score in Nonrandomized Clinical Studies: Comparison of Sivelestat Versus Conventional Therapy for Acute Lung Injury in Acute Respiratory Distress Syndrome 査読有り

Satoru Fukimbara, Kouji Niibe, Michio Yamamoto, Takuhiro Yamaguchi

THERAPEUTIC INNOVATION & REGULATORY SCIENCE　51　(1)　89-99　2017年1月

DOI： 10.1177/2168479016659103 　

ISSN：2168-4790

eISSN：2168-4804
The Japanese version of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE): psychometric validation and discordance between clinician and patient assessments of adverse events. 国際誌

Takashi Kawaguchi, Kanako Azuma, Motohiko Sano, Soan Kim, Yosuke Kawahara, Yoko Sano, Tomohide Shimodaira, Keiichiro Ishibashi, Tempei Miyaji, Ethan Basch, Takuhiro Yamaguchi

Journal of patient-reported outcomes　2　(1)　2-2　2017年

DOI： 10.1186/s41687-017-0022-5 　

詳細を見る詳細を閉じる

Background: The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) was developed by the National Cancer Institute as an adverse event assessment system to evaluate patients' symptoms, which tend to be underestimated in cancer clinical trials. The aim of this study was to assess the psychometric properties of the Japanese version of the PRO-CTCAE and the degree of adverse event assessment discordance between clinicians and patients. Methods: A total of 187 cancer patients receiving systemic therapy were enrolled. Reproducibility, criterion validity, and responsiveness of the Japanese version of PROCTCAE were assessed. The EORTC QLQ-C30 was used as an external anchor. Discordance of assessment of adverse events between clinician and patients were also assessed using the CTCAE and PRO-CTCAE. Results: A total of 187 participants (187 for criterion validity, 80 for reproducibility, and 100 for responsiveness), were analyzed (Mage = 62.4 years). All patients responded to at least one symptom item (M = 16). The mean (SD) intra-class correlation coefficients of overall reproducibility for the Japanese PRO-CTCAE was 0.63 (0.02). The correlation coefficient for the corresponding items in the EORTC QLQ-C30 and the Japanese PRO-CTCAE was high (Pearson r = 0.56-0.76). The analysis of responsiveness revealed significant dose-response trends (Jonckheere-Terpstra test, ps < 0.001). Depending on the adverse events, a discrepancy was observed in evaluation between the clinician and patient. Conclusions: These results revealed that there is underestimation in the assessment of adverse events in Japan, and that the Japanese version of the PRO-CTCAE had acceptable reliability and validity for common and clinically important symptoms.
Japanese translation and linguistic validation of the US National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). 国際誌

Tempei Miyaji, Yukiko Iioka, Yujiro Kuroda, Daigo Yamamoto, Satoru Iwase, Yasushi Goto, Masahiro Tsuboi, Hiroki Odagiri, Yu Tsubota, Takashi Kawaguchi, Naoko Sakata, Ethan Basch, Takuhiro Yamaguchi

Journal of patient-reported outcomes　1　(1)　8-8　2017年

DOI： 10.1186/s41687-017-0012-7 　

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Background: The US National Cancer Institute (NCI) has developed the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to capture patients' self-reported symptomatic adverse events in cancer clinical trials. The aim of this study was to develop and linguistically validate a Japanese translation of PRO-CTCAE. Forward- and back-translations were produced, and an independent review was performed by the Japan Clinical Oncology Group (JCOG) Executive Committee and the US NCI. We then conducted cognitive interviews with 21 patients undergoing cancer treatment. Participants were asked to complete the PRO-CTCAE and were interviewed using semi-structured scripts and predetermined probes to investigate whether any items were difficult to understand or answer. The interviews were recorded and transcribed, and a thematic analysis was performed. The data were split into two categories: 1) remarks on the items and 2) remarks on the questionnaire in general. Results: Twenty-one cancer patients undergoing chemotherapy or hormone therapy were interviewed at the University of Tokyo Hospital and the Kansai Medical University Hirakata Hospital during 2011 and 2012. Thirty-three PRO-CTCAE items were evaluated as "difficult to understand," and 65 items were evaluated as "difficult to answer" by at least one respondent. However, on further investigation, only 24 remarks were categorized as "comprehension difficulties" or "clarity" issues. Most of these remarks concerned patients' difficulties with rating their experience of individual symptomatic events. Conclusions: The study provides preliminary evidence supporting the linguistic validity of the Japanese version of PRO-CTCAE. Further cognitive interviewing is warranted for PRO-CTCAE items relating to sexuality and anxiety and for response options on severity attribute items.
Interactive Effectiveness of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers or Their Combination on Survival of Hemodialysis Patients

Ryo Kido, Tadao Akizawa, Masafumi Fukagawa, Yoshihiro Onishi, Takuhiro Yamaguchi, Shunichi Fukuhara

AMERICAN JOURNAL OF NEPHROLOGY　46　(6)　439-447　2017年

DOI： 10.1159/000482013 　

ISSN：0250-8095

eISSN：1421-9670
Predictors of venous thromboembolism recurrence and the bleeding events identified using a Japanese healthcare database

Nakamura M, Yamada N, Oda E, Matsubayashi D, Ota K, Kobayashi M, Matsushita Y, Kaburagi J, Ibusuki K, Takita A, Iwashita M, Yamaguchi T

Journal of Cardiology　38　54-60　2017年
Micropapillary histological subtype in lung adenocarcinoma of 2 cm or less: impact on recurrence and clinical predictors

Yoshida Y, Nitadori JI, Shinozaki-Ushiku A, Sato J, Miyaji T, Yamaguchi T, Fukayama M, Nakajima J

General Thoracic and Cardiovascular Surgery　65　(5)　273-279　2017年

DOI： 10.1007/s11748-017-0747-3 　
Quality of life and functional status of terminally ill head and neck cancer patients: a nation-wide, prospective observational study at tertiary cancer centers in Japan

Takeshi Shinozaki, Mitsuru Ebihara, Satoru Iwase, Takuhiro Yamaguchi, Hitoshi Hirakawa, Wataru Shimbashi, Tomoyuki Kamijo, Makito Okamoto, Takeshi Beppu, Junichiro Ohori, Kazuto Matsuura, Motoyuki Suzuki, Hiroshi Nishino, Yuichiro Sato, Hiroto Ishiki

JAPANESE JOURNAL OF CLINICAL ONCOLOGY　47　(1)　47-53　2017年1月

DOI： 10.1093/jjco/hyw138 　

ISSN：0368-2811

eISSN：1465-3621
Current situation regarding central venous port implantation procedures and complications: a questionnaire-based survey of 11,693 implantations in Japan

Masatoshi Shiono, Shin Takahashi, Masanobu Takahashi, Takuhiro Yamaguchi, Chikashi Ishioka

International Journal of Clinical Oncology　21　(6)　1172-1182　2016年12月

DOI： 10.1007/s10147-016-1003-z 　

ISSN：1341-9625

eISSN：1437-7772
Changes in Relatives' Perspectives on Quality of Death, Quality of Care, Pain Relief, and Caregiving Burden Before and After a Region-Based Palliative Care Intervention

Isseki Maeda, Mitsunori Miyashita, Akemi Yamagishi, Hiroya Kinoshita, Yutaka Shirahige, Noriko Izumi, Takuhiro Yamaguchi, Miyuki Igarashi, Masashi Kato, Tatsuya Morita

JOURNAL OF PAIN AND SYMPTOM MANAGEMENT　52　(5)　637-645　2016年11月

DOI： 10.1016/j.jpainsymman.2016.03.022 　

ISSN：0885-3924

eISSN：1873-6513
End-of-life discussions with advanced cancer patients and their effects on bereaved families' mental health.

Takashi Yamaguchi, Isseki Maeda, Yutaka Hatano, Masanori Mori, Yasuo Shima, Satoru Tsuneto, Yoshiyuki Kizawa, Tatsuya Morita, Takuhiro Yamaguchi, Maho Aoyama, Mitsunori Miyashita

JOURNAL OF CLINICAL ONCOLOGY　34　(26)　2016年10月

DOI： 10.1200/jco.2016.34.26_suppl.3 　

ISSN：0732-183X

eISSN：1527-7755
臨床試験においてRisk Based Monitoringを実装する上で各部門が担うべき役割の検討

長澤景太, 宮路天平, 近藤秀宣, 長尾典明, 藤澤健司, 平野忠則, 冨金原悟, 菅波秀規, 林行和, 乙黒俊也, 山口拓洋

臨床薬理　47　(Suppl.)　S275-S275　2016年10月
出版者・発行元： (一社)日本臨床薬理学会
ISSN：0388-1601

eISSN：1882-8272
Longer latency of sensory response to intravenous odor injection predicts olfactory neural disorder

Shu Kikuta, Yu Matsumoto, Akihito Kuboki, Tsuguhisa Nakayama, Daiya Asaka, Nobuyoshi Otori, Hiromi Kojima, Takashi Sakamoto, Kashio Akinori, Kaori Kanaya, Rumi Ueha, Ryoji Kagoya, Hironobu Nishijima, Makiko Toma-Hirano, Yayoi Kikkawa, Kenji Kondo, Koichi Tsunoda, Tempei Miyaji, Takuhiro Yamaguchi, Kazunori Kataoka, Kensaku Mori, Tatsuya Yamasoba

SCIENTIFIC REPORTS　6　35361　2016年10月

DOI： 10.1038/srep35361 　

ISSN：2045-2322
Pretransplantation Anti-CCR4 Antibody Mogamulizumab Against Adult T-Cell Leukemia/Lymphoma Is Associated With Significantly Increased Risks of Severe and Corticosteroid-Refractory Graft-Versus-Host Disease, Nonrelapse Mortality, and Overall Mortality

Shigeo Fuji, Yoshitaka Inoue, Atae Utsunomiya, Yukiyoshi Moriuchi, Kaoru Uchimaru, Ilseung Choi, Eiichi Otsuka, Hideho Henzan, Koji Kato, Takeaki Tomoyose, Hisashi Yamamoto, Saiko Kurosawa, Ken-ichi Matsuoka, Takuhiro Yamaguchi, Takahiro Fukuda

JOURNAL OF CLINICAL ONCOLOGY　34　(28)　3426-+　2016年10月

DOI： 10.1200/JCO.2016.67.8250 　

ISSN：0732-183X

eISSN：1527-7755
シンポジウム34 薬剤師が前向き臨床研究をするためには何が必要か—～職種を超えた体制作りから、デザイン、倫理まで～

山口拓洋, 東加奈子, 木村利美, 佐野元彦

日本医療薬学会年会講演要旨集　26　18-12-S34-18-12-S34　2016年9月17日
出版者・発行元：一般社団法人日本医療薬学会
DOI： 10.20825/amjsphcs.26.0_18-12-s34 　

eISSN：2424-2470
An analysis of the relationship between metastases and cachexia in lung cancer patients

Masatoshi Shiono, Kan Huang, Robert J. Downey, Nikita Consul, Nicolas Villanueva, Kristen Beck, Kathleen Fenn, Donald Dietz, Takuhiro Yamaguchi, Shunsuke Kato, Chaitanya Divgi, Kevin Kalinsky, Ying Wei, Yuan Zhang, Alain C. Borczuk, Akira Inoue, Balazs Halmos, Swarnali Acharyya

CANCER MEDICINE　5　(9)　2641-2648　2016年9月

DOI： 10.1002/cam4.841 　

ISSN：2045-7634
Acute megakaryoblastic leukemia, unlike acute erythroid leukemia, predicts an unfavorable outcome after allogeneic HSCT

Ken Ishiyama, Takuhiro Yamaguchi, Tetsuya Eto, Kazuteru Ohashi, Naoyuki Uchida, Heiwa Kanamori, Takahiro Fukuda, Koichi Miyamura, Yoshiko Inoue, Jun Taguchi, Takehiko Mori, Koji Iwato, Yasuo Morishima, Tokiko Nagamura-Inoue, Yoshiko Atsuta, Hisashi Sakamaki, Akiyoshi Takami

LEUKEMIA RESEARCH　47　47-53　2016年8月

DOI： 10.1016/j.leukres.2016.04.017 　

ISSN：0145-2126

eISSN：1873-5835
Differential Activation in Amygdala and Plasma Noradrenaline during Colorectal Distention by Administration of Corticotropin-Releasing Hormone between Healthy Individuals and Patients with Irritable Bowel Syndrome

Yukari Tanaka, Motoyori Kanazawa, Michiko Kano, Joe Morishita, Toyohiro Hamaguchi, Lukas Van Oudenhove, Huynh Giao Ly, Patrick Dupont, Jan Tack, Takuhiro Yamaguchi, Kazuhiko Yanai, Manabu Tashiro, Shin Fukudo

PLOS ONE　11　(7)　e0157347　2016年7月

DOI： 10.1371/journal.pone.0157347 　

ISSN：1932-6203
Decision Analysis of Postremission Therapy in Cytogenetically Intermediate-Risk Acute Myeloid Leukemia: The Impact of FLT3 Internal Tandem Duplication, Nucleophosmin, and CCAAT/Enhancer Binding Protein Alpha

Saiko Kurosawa, Hiroki Yamaguchi, Takuhiro Yamaguchi, Keiko Fukunaga, Shunsuke Yui, Satoshi Wakita, Heiwa Kanamori, Kensuke Usuki, Nobuhiko Uoshima, Masamitsu Yanada, Katsuhiro Shono, Toshimitsu Ueki, Ishikazu Mizuno, Shingo Yano, Jin Takeuchi, Junya Kanda, Hiroshi Okamura, Yoshihiro Inamoto, Koiti Inokuchi, Takahiro Fukuda

BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION　22　(6)　1125-1132　2016年6月

DOI： 10.1016/j.bbmt.2016.03.015 　

ISSN：1083-8791

eISSN：1523-6536
Use of olanzapine for the relief of nausea and vomiting in patients with advanced cancer: a multicenter survey in Japan

Keisuke Kaneishi, Kazunori Nishimura, Norio Sakurai, Kengo Imai, Naoki Matsuo, Naoko Takahashi, Kenichiro Okamoto, Akihiko Suga, Hiromi Sano, Isseki Maeda, Haruhiro Nishina, Takuhiro Yamaguchi, Tatsuya Morita, Satoru Iwase

SUPPORTIVE CARE IN CANCER　24　(6)　2393-2395　2016年6月

DOI： 10.1007/s00520-016-3101-x 　

ISSN：0941-4355

eISSN：1433-7339
A randomized, double-blind, placebo-controlled phase II study of prophylactic dexamethasone (dex) therapy for fatigue and malaise due to regorafenib in patient (pts) with metastatic colorectal cancer (mCRC): (KSCC1402/HGCSG1402). 査読有り

Yuji Miyamoto, Satoshi Yuki, Mototsugu Shimokawa, Hiroaki Tanioka, Akihito Tsuji, Masako Asayama, Takeshi Shiraishi, Masahito Kotaka, Akitaka Makiyama, Yoshito Komatsu, Satohiro Masuda, Takuhiro Yamaguchi, Hiroshi Saeki, Eiji Oki, Yasunori Emi, Hideo Baba, Yoshihiko Maehara

JOURNAL OF CLINICAL ONCOLOGY　34　(15)　2016年5月

DOI： 10.1200/JCO.2016.34.15_suppl.10127 　

ISSN：0732-183X

eISSN：1527-7755
Telomerase activity in pancreatic juice differentiates pancreatic cancer from chronic pancreatitis: A meta-analysis

Tatsuo Hata, Masaharu Ishida, Fuyuhiko Motoi, Takuhiro Yamaguchi, Takeshi Naitoh, Yu Katayose, Shinichi Egawa, Michiaki Unno

PANCREATOLOGY　16　(3)　372-381　2016年5月

DOI： 10.1016/j.pan.2016.01.007 　

ISSN：1424-3903

eISSN：1424-3911
Post-traumatic growth of children affected by the Great East Japan Earthquake and their attitudes to memorial services and media coverage

Hirokazu Yoshida, Natsuko Kobayashi, Nami Honda, Hiroo Matsuoka, Takuhiro Yamaguchi, Hiroaki Homma, Hiroaki Tomita

PSYCHIATRY AND CLINICAL NEUROSCIENCES　70　(5)　193-201　2016年5月

DOI： 10.1111/pcn.12379 　

ISSN：1323-1316

eISSN：1440-1819
PTH-dependence of the effectiveness of cinacalcet in hemodialysis patients with secondary hyperparathyroidism

Tadao Akizawa, Noriaki Kurita, Masahide Mizobuchi, Masafumi Fukagawa, Yoshihiro Onishi, Takuhiro Yamaguchi, Alan R. Ellis, Shingo Fukuma, M. Alan Brookhart, Takeshi Hasegawa, Kiyoshi Kurokawa, Shunichi Fukuhara

SCIENTIFIC REPORTS　6　19612　2016年4月

DOI： 10.1038/srep19612 　

ISSN：2045-2322
Effects of a nurse-led medication self-management programme in cancer patients: Protocol for a mixed-method randomised controlled trial

Hiroko Komatsu, Kaori Yagasaki, Takuhiro Yamaguchi

BMC Nursing　15　(1)　9　2016年2月8日
出版者・発行元： BioMed Central Ltd.
DOI： 10.1186/s12912-016-0130-1 　

ISSN：1472-6955
Efficacy and safety of an amino acid jelly containing coenzyme Q10 and L-carnitine in controlling fatigue in breast cancer patients receiving chemotherapy: a multi-institutional, randomized, exploratory trial (JORTC-CAM01)

Satoru Iwase, Takashi Kawaguchi, Daisuke Yotsumoto, Takako Doi, Kyuichiro Miyara, Hiroki Odagiri, Kaoru Kitamura, Keisuke Ariyoshi, Tempei Miyaji, Hiroto Ishiki, Kenichi Inoue, Chizuko Tsutsumi, Yoshiaki Sagara, Takuhiro Yamaguchi

SUPPORTIVE CARE IN CANCER　24　(2)　637-646　2016年2月

DOI： 10.1007/s00520-015-2824-4 　

ISSN：0941-4355

eISSN：1433-7339
A prospective multicenter study of unrelated bone marrow transplants using a reduced-intensity conditioning regimen with low-dose ATG-F 国際誌査読有り

Fuji S, Kim S-W, Yano S, Hagiwara S, Nakamae H, Hidaka M, Ito T, Ohashi K, Hatanaka K, Takami A, Kurosawa S, Yamashita T, Yamaguchi T, Fukuda T

BONE MARROW TRANSPLANTATION　51　(3)　451-453　2016年

DOI： 10.1038/bmt.2015.268} 　
Institutional variation in short- and long-term outcomes after surgery for gastric or esophagogastric junction adenocarcinoma: correlative study of two randomized phase III trials (JCOG9501 and JCOG9502)

Kurokawa Y, Yamaguchi T, Sasako M, Sano T, Mizusawa J, Nakamura K, Fukuda H

Gastric Cancer　20　(3)　508-516　2016年
出版者・発行元： International Gastric Cancer Association, Japanese Gastric Cancer Association [編]
ISSN：1436-3291
Extracorporeal Shock Wave Therapy for Digital Ulcers of Systemic Sclerosis: A Phase 2 Pilot Study

Shinichiro Saito, Tomonori Ishii, Yukiko Kamogawa, Ryu Watanabe, Tsuyoshi Shirai, Yoko Fujita, Yuko Shirota, Hiroshi Fujii, Kenta Ito, Hiroaki Shimokawa, Takuhiro Yamaguchi, Yasushi Kawaguchi, Hideo Harigae

TOHOKU JOURNAL OF EXPERIMENTAL MEDICINE　238　(1)　39-47　2016年1月

DOI： 10.1620/tjem.238.39 　

ISSN：0040-8727

eISSN：1349-3329
Sensitivity and specificity of mammography and adjunctive ultrasonography to screen for breast cancer in the Japan Strategic Anti-cancer Randomized Trial (J-START): a randomised controlled trial

Noriaki Ohuchi, Akihiko Suzuki, Tomotaka Sobue, Masaaki Kawai, Seiichiro Yamamoto, Ying-Fang Zheng, Yoko Narikawa Shiono, Hiroshi Saito, Shinichi Kuriyama, Eriko Tohno, Tokiko Endo, Akira Fukao, Ichiro Tsuji, Takuhiro Yamaguchi, Yasuo Ohashi, Mamoru Fukuda, Takanori Ishida

LANCET　387　(10016)　341-348　2016年1月

DOI： 10.1016/S0140-6736(15)00774-6 　

ISSN：0140-6736

eISSN：1474-547X
Outcomes of allogeneic hematopoietic cell transplantation in patients with biphenotypic acute leukemia

Jinichi Mori, Ken Ishiyama, Takuhiro Yamaguchi, Junji Tanaka, Naoyuki Uchida, Takeshi Kobayashi, Takahiro Fukuda, Heiwa Kanamori, Koichi Miyamura, Satoshi Takahashi, Tetsuya Eto, Makoto Hirokawa, Shinichiro Mori, Tokiko Nagamura, Yoshiko Atsuta, Akiyoshi Takami

ANNALS OF HEMATOLOGY　95　(2)　295-300　2016年1月

DOI： 10.1007/s00277-015-2536-3 　

ISSN：0939-5555

eISSN：1432-0584
Reassessment of the risk factors for biochemical recurrence in D'Amico intermediate-risk prostate cancer treated using radical prostatectomy

Shintaro Narita, Koji Mitsuzuka, Norihiko Tsuchiya, Takuya Koie, Sadafumi Kawamura, Chikara Ohyama, Tatsuo Tochigi, Takuhiro Yamaguchi, Yoichi Arai, Tomonori Habuchi

INTERNATIONAL JOURNAL OF UROLOGY　22　(11)　1029-1035　2015年11月

DOI： 10.1111/iju.12898 　

ISSN：0919-8172

eISSN：1442-2042
Cytomegalovirus Reactivation after Allogeneic Hematopoietic Stem Cell Transplantation is Associated with a Reduced Risk of Relapse in Patients with Acute Myeloid Leukemia Who Survived to Day 100 after Transplantation: The Japan Society for Hematopoietic Cell Transplantation Transplantation-related Complication Working Group

Katsuto Takenaka, Tetsuya Nishida, Yuki Asano-Mori, Kumi Oshima, Kazuteru Ohashi, Takehiko Mori, Heiwa Kanamori, Koichi Miyamura, Chiaki Kato, Naoki Kobayashi, Naoyuki Uchida, Hirohisa Nakamae, Tatsuo Ichinohe, Yasuo Morishima, Ritsuro Suzuki, Takuhiro Yamaguchi, Takahiro Fukuda

BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION　21　(11)　2008-2016　2015年11月

DOI： 10.1016/j.bbmt.2015.07.019 　

ISSN：1083-8791

eISSN：1523-6536
Comparison of burn sizes resulting from photocoagulation using a transpupillary laser and an endolaser

Tomoyasu Shiraya, Satoshi Kato, Fumiaki Araki, Takuhiro Yamaguchi, Tadayoshi Kaiya

ACTA OPHTHALMOLOGICA　93　(7)　E595-+　2015年11月

DOI： 10.1111/aos.12656 　

ISSN：1755-375X

eISSN：1755-3768
Patient-reported quality of life after allogeneic hematopoietic cell transplantation or chemotherapy for acute leukemia. 査読有り

Kurosawa S, Yamaguchi T, Mori T, Kanamori H, Onishi Y, Emi N, Fujisawa S, Kohno A, Nakaseko C, Saito B, Kondo T, Hino M, Nawa Y, Kato S, Hashimoto A, Fukuda T

Bone marrow transplantation　50　(9)　1241-1249　2015年9月

DOI： 10.1038/bmt.2015.137 　

ISSN：0268-3369
Assessment of Cancer-Related Fatigue, Pain, and Quality of Life in Cancer Patients at Palliative Care Team Referral: A Multicenter Observational Study (JORTC PAL-09)

Satoru Iwase, Takashi Kawaguchi, Akihiro Tokoro, Kimito Yamada, Yoshiaki Kanai, Yoshinobu Matsuda, Yuko Kashiwaya, Kae Okuma, Shuji Inada, Keisuke Ariyoshi, Tempei Miyaji, Kanako Azuma, Hiroto Ishiki, Sakae Unezaki, Takuhiro Yamaguchi

PLOS ONE　10　(8)　e0134022　2015年8月

DOI： 10.1371/journal.pone.0134022 　

ISSN：1932-6203
Improvements in Physicians' Knowledge, Difficulties, and Self-Reported Practice After a Regional Palliative Care Program

Yoshiyuki Kizawa, Tatsuya Morita, Mitsunori Miyashita, Takuya Shinjo, Akemi Yamagishi, Satoshi Suzuki, Hiroya Kinoshita, Yutaka Shirahige, Takuhiro Yamaguchi, Kenji Eguchi

JOURNAL OF PAIN AND SYMPTOM MANAGEMENT　50　(2)　232-240　2015年8月

DOI： 10.1016/j.jpainsymman.2015.02.025 　

ISSN：0885-3924

eISSN：1873-6513
特集岐路に立つ臨床研究 -新たな品質管理基準の動向- ２.臨床研究の品質マネジメント

山口拓洋, 宮路天平

化学療法の領域　31　(8)　36-40　2015年7月25日
出版者・発行元：医薬ジャーナル社
DOI： 10.20837/2201508036 　

ISSN：0913-2384
【岐路に立つ臨床研究-新たな品質管理基準の動向-】臨床研究の品質マネジメント

山口拓洋, 宮路天平

化学療法の領域　31　(8)　1644-1648　2015年7月
出版者・発行元： (株)医薬ジャーナル社
ISSN：0913-2384
Characteristic correlations of the structure-function relationship in different glaucomatous disc types

Kazuko Omodaka, Naoko Takada, Takuhiro Yamaguchi, Hidetoshi Takahashi, Makoto Araie, Toru Nakazawa

JAPANESE JOURNAL OF OPHTHALMOLOGY　59　(4)　223-229　2015年7月

DOI： 10.1007/s10384-015-0379-z 　

ISSN：0021-5155

eISSN：1613-2246
Randomized study of orally administered fluorinated pyrimidines (capecitabine versus S-1) in women with metastatic or recurrent breast cancer: Japan Breast Cancer Research Network 05 Trial 査読有り

D. Yamamoto, S. Iwase, Y. Tsubota, K. Ariyoshi, T. Kawaguchi, T. Miyaji, N. Sueoka, C. Yamamoto, S. Teramoto, H. Odagiri, K. Kitamura, Y. Nagumo, T. Yamaguchi

Cancer Chemotherapy and Pharmacology　75　(6)　1183-1189　2015年6月26日
出版者・発行元： Springer Verlag
DOI： 10.1007/s00280-015-2738-3 　

ISSN：1432-0843 0344-5704

eISSN：1432-0843
Risk Factors for Age-Related Macular Degeneration in an Elderly Japanese Population: The Hatoyama Study

Aya Aoki, Xue Tan, Reiko Yamagishi, Shoji Shinkai, Ryo Obata, Tempei Miyaji, Takuhiro Yamaguchi, Jiro Numaga, Hideki Ito, Yasuo Yanagi

INVESTIGATIVE OPHTHALMOLOGY & VISUAL SCIENCE　56　(4)　2580-2585　2015年4月

DOI： 10.1167/iovs.14-16339 　

ISSN：0146-0404

eISSN：1552-5783
Tramadol and Its Metabolite M1 Selectively Suppress Transient Receptor Potential Ankyrin 1 Activity, but Not Transient Receptor Potential Vanilloid 1 Activity

Kanako Miyano, Kouichiro Minami, Toru Yokoyama, Katsuya Ohbuchi, Takuhiro Yamaguchi, Satoshi Murakami, Seiji Shiraishi, Masahiro Yamamoto, Motohiro Matoba, Yasuhito Uezono

ANESTHESIA AND ANALGESIA　120　(4)　790-798　2015年4月

DOI： 10.1213/ANE.0000000000000625 　

ISSN：0003-2999
埼玉県鳩山町における加齢黄斑変性の危険因子の検討

青木彩, 譚雪, 山岸麗子, 新開省二, 小畑亮, 宮路天平, 山口拓洋, 沼賀二郎, 井藤英喜, 柳靖雄

日本眼科学会雑誌　119　(臨増)　322-322　2015年3月
出版者・発行元： (公財)日本眼科学会
ISSN：0029-0203
Place of Death and the Differences in Patient Quality of Death and Dying and Caregiver Burden

Hiroya Kinoshita, Isseki Maeda, Tatsuya Morita, Mitsunori Miyashita, Akemi Yamagishi, Yutaka Shirahige, Toru Takebayashi, Takuhiro Yamaguchi, Ayumi Igarashi, Kenji Eguchi

JOURNAL OF CLINICAL ONCOLOGY　33　(4)　357-U105　2015年2月

DOI： 10.1200/JCO.2014.55.7355 　

ISSN：0732-183X

eISSN：1527-7755
21-8-O18-07 服薬カウンセリングに対する支払意思に関する研究(がん薬物療法(その他),口頭発表,一般演題,医療薬学の進歩と未来-次の四半世紀に向けて-) 査読有り

東加奈子, 山田公人, 松永忠東, 竹内裕紀, 畝崎榮, 明石貴雄, 川口崇, 山口拓洋, 佐野陽子, 下平智秀, 鳥居綾子, 鮎原秀明, 山田裕理, 岩瀬哲

日本医療薬学会年会講演要旨集　25　(0)　213-213　2015年
出版者・発行元：一般社団法人日本医療薬学会
DOI： 10.20825/amjsphcs.25.0_213_2 　
Randomized double-blind placebo-controlled multicenter trial of Yokukansan for neuropsychiatric symptoms in Alzheimer's disease

Furukawa K, Tomita N, Uematsu D, Okahara K, Shimada H, Ikeda M, Matsui T, Kozaki K, Fujii M, Ogawa T, Umegaki H, Urakami K, Nomura H, Kobayashi N, Nakanishi A, Washimi Y, Yonezawa H, Takahashi S, Kubota M, Wakutani Y, Ito D, Sasaki T, Matsubara E, Une K, Ishiki A, Yahagi Y, Shoji M, Sato H, Terayama Y, Kuzuya M, Araki N, Kodama M, Yamaguchi T, Arai H

Geriatrics & Gerontology International　17　(2)　211-218　2015年
The extent of stretched lamellar cleavage and visual acuity in macular pseudoholes

Toyama T, Roggia MF, Yamaguchi T, Noda Y, Ueta T

British Journal of Ophthalmology　100　(9)　1227-1231　2015年
Effect of continuous deep sedation on survival in patients with advanced cancer (J-Proval): a propensity score-weighted analysis of a prospective cohort study

Maeda I, Morita T, Yamaguchi T, Inoue S, Ikenaga M, Matsumoto Y, Sekine R, Yamaguchi T, Hirohashi T, Tajima T, Tatara R, Watanabe H, Otani H, Takigawa C, Matsuda Y, Nagaoka H, Mori M, Tei Y, Kikuchi A, Baba M, Kinoshita H

Lancet Oncology　17　(1)　115-122　2015年
Effects of cyclophosphamide on the prognosis of Japanese patients with renal vasculitis associated with anti-neutrophil cytoplasmic antibody-positive microscopic polyangiitis

Iwabuchi M, Nakaya I, Tsuchiya Y, Shibagaki Y, Yamaguchi T, Fukuhara S, Oe Y, Sakuma T, Sato T, Taguma Y, Soma J

Clinical and Experimental Nephrology　20　(5)　712-719　2015年
An assessment of driving fitness in patients with visual impairment to understand the elevated risk of motor vehicle accidents

Shiho Kunimatsu-Sanuki, Aiko Iwase, Makoto Araie, Yuki Aoki, Takeshi Hara, Toru Nakazawa, Takuhiro Yamaguchi, Hiroshi Ono, Tomoyuki Sanuki, Makoto Itoh

BMJ OPEN　5　(2)　e006379　2015年

DOI： 10.1136/bmjopen-2014-006379 　

ISSN：2044-6055
The Epidemiological Study of Venous Thromboembolism and Bleeding Events Using a Japanese Healthcare Database – Validation Study –

Yamaguchi T, Fuji T, Akagi M, Abe Y, Nakamura M, Yamada N, Oda E, Matsubayashi D, Ota K, Kobayashi M, Matsui D, Kaburagi J, Matsushita Y, Harada A

Iyakuhin Johogaku　17　(2)　87-93　2015年
出版者・発行元：一般社団法人日本医薬品情報学会
DOI： 10.11256/jjdi.17.87 　

ISSN：1345-1464

詳細を見る詳細を閉じる

Objective: The aim of this study was to establish the proper definitions of venous thromboembolism (VTE) and bleeding events for a healthcare database in Japan.<br>Study Design: Validation study.<br>Methods: The study comprised patients with VTE or who had undergone orthopedic surgery of the lower extremities and whose outpatient or inpatient medical information from April 1, 2008 to September 30, 2013 was available. The source population of the database was derived from 100 acute-care hospitals. The endpoints were VTE events (deep venous thrombosis [DVT], pulmonary thromboembolism [PE]) and bleeding events (bleeding requiring blood transfusion, intracranial hemorrhage, intraocular hemorrhage, upper gastrointestinal [GI] bleeding, and lower GI bleeding). The frequent events with laboratory data were randomly extracted and evaluated, while all the infrequent events with laboratory data were extracted and evaluated. Positive predictive value (PPV) was defined as the proportion of events judged to be clinical by medical experts of all the extracted events. First, we conducted a test with a small number of cases and then revised the definitions of events. Second, we extracted and evaluated data in 50 patients for VTE and bleeding events patients, based on which we defined the target PPV level between 60 and 70%.<br>Results: Of the 5,044,743 patients in the database, 36,947 patients underwent orthopedic surgeries of the lower extremities and 3,578 patients experienced a VTE event. The PPV at the first evaluation was 80.0% (8/10) for DVT, 57.1% (4/7) for PE, and 27.3% (6/22) for bleeding events. At the second evaluation using the revised definitions, the PPV were 75.0% (42/56) for VTE and 73.3% (33/45) for bleeding events. Overall, the PPVs for VTE and bleeding events were over 70%. The PPV of the VTE events were 76.9% (30/39) for DVT and 70.6% (12/17) for PE. The PPVs of each type of bleeding event were over 70% except for intracranial hemorrhage (44.4%, 4/9).<br>Conclusion: The PPV was high for VTE events (75.0%) and bleeding events (73.3%). The definitions used in this study are rational for the identification of VTE, DVT, PE, and bleeding events in the healthcare database in Japan. The definition for each type of bleeding event should be investigated in further studies.
Oral Nutritional Support Can Shorten the Duration of Parenteral Hydration in End-of-Life Cancer Patients: A Randomized Controlled Trial

Hiroto Ishiki, Satoru Iwase, Yasuaki Gyoda, Yoshiaki Kanai, Keisuke Ariyoshi, Tempei Miyaji, Yukiko Tahara, Takashi Kawaguchi, Mieko Chinzei, Takuhiro Yamaguchi

NUTRITION AND CANCER-AN INTERNATIONAL JOURNAL　67　(1)　105-111　2015年1月

DOI： 10.1080/01635581.2015.976312 　

ISSN：0163-5581

eISSN：1532-7914
Cannabinoid-based medicinesの歴史と本邦における規制について

宮路天平, 山口拓洋, 津谷喜一郎

薬史学雑誌　49　(2)　234-234　2014年12月
出版者・発行元：日本薬史学会
ISSN：0285-2314

eISSN：2435-7529
Nurse Education Program on Meaninglessness in Terminally Ill Cancer Patients: A Randomized Controlled Study of a Novel Two-Day Workshop

Tatsuya Morita, Keiko Tamura, Etsuko Kusajima, Sayuri Sakai, Masako Kawa, Chizuru Imura, Kaori Ichihara, Mitsunori Miyashita, Takuhiro Yamaguchi, Yosuke Uchitomi

JOURNAL OF PALLIATIVE MEDICINE　17　(12)　1298-1305　2014年12月

DOI： 10.1089/jpm.2013.0559 　

ISSN：1096-6218

eISSN：1557-7740
Low Percentage of Free Prostate-specific Antigen (PSA) Is a Strong Predictor of Later Detection of Prostate Cancer Among Japanese Men With Serum Levels of Total PSA of 4.0 ng/mL or Less

Mitsuharu Sasaki, Shigeto Ishidoya, Akihiro Ito, Hideo Saito, Shigeyuki Yamada, Koji Mitsuzuka, Yasuhiro Kaiho, Daisuke Shibuya, Takuhiro Yamaguchi, Yoichi Arai

UROLOGY　84　(5)　1163-1167　2014年11月

DOI： 10.1016/j.urology.2014.04.055 　

ISSN：0090-4295

eISSN：1527-9995
Anastrozole versus tamoxifen as adjuvant therapy for Japanese postmenopausal patients with hormone-responsive breast cancer: efficacy results of long-term follow-up data from the N-SAS BC 03 trial

Tomohiko Aihara, Isao Yokota, Yasuo Hozumi, Kenjiro Aogi, Hiroji Iwata, Motoshi Tamura, Atsushi Fukuuchi, Haruhiko Makino, Ryungsa Kim, Masashi Andoh, Koichiro Tsugawa, Shinji Ohno, Takuhiro Yamaguchi, Yasuo Ohashi, Toru Watanabe, Yuichi Takatsuka, Hirofumi Mukai

BREAST CANCER RESEARCH AND TREATMENT　148　(2)　337-343　2014年11月

DOI： 10.1007/s10549-014-3155-8 　

ISSN：0167-6806

eISSN：1573-7217
Preferences for Pharmacist Counselling in Patients with Breast Cancer: A Discrete Choice Experiment

Takashi Kawaguchi, Kanako Azuma, Takuhiro Yamaguchi, Satoru Iwase, Tadaharu Matsunaga, Kimito Yamada, Hironobu Miyamatsu, Hironori Takeuchi, Norio Kohno, Takao Akashi, Sakae Unezaki

BIOLOGICAL & PHARMACEUTICAL BULLETIN　37　(11)　1795-1802　2014年11月

ISSN：0918-6158
Donor Lymphocyte Infusion for the Treatment of Relapsed Acute Myeloid Leukemia after Allogeneic Hematopoietic Stem Cell Transplantation: A Retrospective Analysis by the Adult Acute Myeloid Leukemia Working Group of the Japan Society for Hematopoietic Cell Transplantation

Akiyoshi Takami, Shingo Yano, Hiroki Yokoyama, Yachiyo Kuwatsuka, Takuhiro Yamaguchi, Yoshinobu Kanda, Yasuo Morishima, Takahiro Fukuda, Yasushi Miyazaki, Hirohisa Nakamae, Junji Tanaka, Yoshiko Atsuta, Heiwa Kanamori

BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION　20　(11)　1785-1790　2014年11月

DOI： 10.1016/j.bbmt.2014.07.010 　

ISSN：1083-8791

eISSN：1523-6536
Systemic Vascular Safety of Ranibizumab for Age-Related Macular Degeneration

Takashi Ueta, Yasuo Noda, Taku Toyama, Takuhiro Yamaguchi, Shiro Amano

OPHTHALMOLOGY　121　(11)　2193-2203　2014年11月

DOI： 10.1016/j.ophtha.2014.05.022 　

ISSN：0161-6420

eISSN：1549-4713
Comparison of burn size after retinal photocoagulation by conventional and high-power short-duration methods

Tomoyasu Shiraya, Satoshi Kato, Takashi Shigeeda, Takuhiro Yamaguchi, Tadayoshi Kaiya

ACTA OPHTHALMOLOGICA　92　(7)　e585-e586　2014年11月

DOI： 10.1111/aos.12393 　

ISSN：1755-375X

eISSN：1755-3768
Changes in Quality of Care and Quality of Life of Outpatients With Advanced Cancer After a Regional Palliative Care Intervention Program

Akemi Yamagishi, Kazuki Sato, Mitsunori Miyashita, Yasuo Shima, Yoshiyuki Kizawa, Megumi Umeda, Hiroya Kinoshita, Yutaka Shirahige, Miki Akiyama, Takuhiro Yamaguchi, Tatsuya Morita

JOURNAL OF PAIN AND SYMPTOM MANAGEMENT　48　(4)　602-610　2014年10月

DOI： 10.1016/j.jpainsymman.2013.11.016 　

ISSN：0885-3924

eISSN：1873-6513
Feasibility study of gemcitabine plus docetaxel in advanced or recurrent uterine leiomyosarcoma and undifferentiated endometrial sarcoma in Japan

Tadao Takano, Hitoshi Niikura, Kiyoshi Ito, Satoru Nagase, Hiroki Utsunomiya, Takeo Otsuki, Masafumi Toyoshima, Hideki Tokunaga, Michiko Kaiho-Sakuma, Naomi Shiga, Tomoyuki Nagai, Sota Tanaka, Ai Otsuki, Hiroki Kurosawa, Shogo Shigeta, Keita Tsuji, Takuhiro Yamaguchi, Nobuo Yaegashi

INTERNATIONAL JOURNAL OF CLINICAL ONCOLOGY　19　(5)　897-905　2014年10月

DOI： 10.1007/s10147-013-0627-5 　

ISSN：1341-9625

eISSN：1437-7772
Insights into the Classification of Myasthenia Gravis

Tetsuya Akaishi, Takuhiro Yamaguchi, Yasushi Suzuki, Yuriko Nagane, Shigeaki Suzuki, Hiroyuki Murai, Tomihiro Imai, Masakatsu Motomura, Kazuo Fujihara, Masashi Aoki, Kimiaki Utsugisawa

PLOS ONE　9　(9)　e106757　2014年9月

DOI： 10.1371/journal.pone.0106757 　

ISSN：1932-6203
A multicenter, open-label study of an intravenous short-acting β1-adrenergic receptor antagonist landiolol hydrochloride for coronary computed tomography angiography by 16-slice multi-detector computed tomography in Japanese patients with suspected ischem

Hirano M, Yamashina A, Hara K, Ikari Y, Jinzaki M, Iino M, Yamaguchi T, Tanimoto M, Kuribayashi S, Landiolol Hydrochloride Study Group

Drugs in R&D　14　(3)　185-194　2014年9月1日
出版者・発行元：
DOI： 10.1007/s40268-014-0056-6 　

ISSN：1179-6901 1174-5886
Does a regional comprehensive palliative care program improve pain in outpatient cancer patients?

Tatsuya Morita, Kazuki Sato, Mitsunori Miyashita, Akemi Yamagishi, Yoshiyuki Kizawa, Yasuo Shima, Hiroya Kinoshita, Satoshi Suzuki, Yutaka Shirahige, Takuhiro Yamaguchi, Kenji Eguchi

SUPPORTIVE CARE IN CANCER　22　(9)　2445-2455　2014年9月

DOI： 10.1007/s00520-014-2232-1 　

ISSN：0941-4355

eISSN：1433-7339
A Prospective Stratified Case-Cohort Study on Statins and Multiple Adverse Events in Japan

Nobuhiro Ooba, Tsugumichi Sato, Akira Wakana, Takao Orii, Masaki Kitamura, Akira Kokan, Hideaki Kurata, Yoshihiro Shimodozono, Kenichi Matsui, Hiroshi Yoshida, Takuhiro Yamaguchi, Shigeru Kageyama, Kiyoshi Kubota

PLOS ONE　9　(5)　e96919　2014年5月

DOI： 10.1371/journal.pone.0096919 　

ISSN：1932-6203
Health-related quality of life and psychological distress during neoadjuvant endocrine therapy with letrozole to determine endocrine responsiveness in postmenopausal breast cancer

Naruto Taira, Hiroji Iwata, Yoshie Hasegawa, Takehiko Sakai, Kenji Higaki, Kiyohiro Kihara, Takuhiro Yamaguchi, Shozo Ohsumi, Kojiro Shimozuma, Yasuo Ohashi

BREAST CANCER RESEARCH AND TREATMENT　145　(1)　155-164　2014年5月

DOI： 10.1007/s10549-014-2935-5 　

ISSN：0167-6806

eISSN：1573-7217
埼玉県鳩山町における加齢黄斑変性の有病率の検討及び栄養疫学調査

青木彩, 譚雪, 小畑亮, 沼賀二郎, 新開省二, 井藤英喜, 宮路天平, 山口拓洋, 柳靖雄

日本眼科学会雑誌　118　(臨増)　332-332　2014年3月
出版者・発行元： (公財)日本眼科学会
ISSN：0029-0203
Abnormal mineral metabolism and mortality in hemodialysis patients with secondary hyperparathyroidism: Evidence from marginal structural models used to adjust for time-dependent confounding 国際誌査読有り

Fukagawa M, Kido R, Komaba H, Onishi Y, Yamaguchi T, Hasegawa T, Kurita N, Fukuma S, Akizawa T, Fukuhara S

American Journal of Kidney Diseases　63　(6)　979-987　2014年

DOI： 10.1053/j.ajkd.2013.08.011 　
Effects of lifestyle factors on urinary oxidative stress and serum antioxidant markers in pregnant Japanese women: A cohort study

Masayo Matsuzaki, Megumi Haruna, Erika Ota, Ryoko Murayama, Tokio Yamaguchi, Izuru Shioji, Shinya Sasaki, Takuhiro Yamaguchi, Sachiyo Murashima

BIOSCIENCE TRENDS　8　(3)　176-184　2014年

DOI： 10.5582/bst.2014.01014 　

ISSN：1881-7815

eISSN：1881-7823
Phase II Trial of Cetuxirnab plus Irinotecan for Oxaliplatin- and Irinotecan-Based Chemotherapy-Refractory Patients with Advanced and/or Metastatic Colorectal Cancer: Evaluation of Efficacy and Safety Based on KRAS Mutation Status (T-CORE0801)

Hiroshi Soeda, Hideki Shimodaira, Makio Gamoh, Hideaki Ando, Hideki Isobe, Takeshi Suto, Shin Takahashi, Yuichi Kakudo, Kenji Amagai, Takahiro Mori, Mika Watanabe, Takuhiro Yamaguchi, Shunsuke Kato, Chikashi Ishioka

ONCOLOGY　87　(1)　7-20　2014年

DOI： 10.1159/000360989 　

ISSN：0030-2414

eISSN：1423-0232
Clinical and bacteriological influence of diabetes mellitus on deep neck infection: A systematic review and meta-analysis

Hidaka H, Yamaguchi T, Hasegawa J, Yano H, Kakuta R, Ozawa D, Nomura K, Katori Y

Head Neck　37　(10)　1536-1546　2014年
Identification of the need for home visiting nurse: development of a new assessment tool

Atsuko Taguchi, Satoko Nagata, Takashi Naruse, Yuki Kuwahara, Takuhiro Yamaguchi, Sachiyo Murashima

INTERNATIONAL JOURNAL OF INTEGRATED CARE　14　e008　2014年1月

ISSN：1568-4156
A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Short-Acting β1-Adrenergic Receptor Blocker Landiolol Hydrochloride for Coronary Computed Tomography Angiography in Japanese Patients with Suspected Ischemic Cardiac Disease

Hirano M, Yamashina A, Hara K, Ikari Y, Jinzaki M, Iino M, Yamaguchi T, Tanimoto M, Kuribayashi S, Landiolol Hydrochloride Study Group

Clinical Drug Investigation　34　(1)　53-62　2014年

DOI： 10.1007/s40261-013-0149-y 　

ISSN：1173-2563

eISSN：1179-1918
Effectiveness of a Breastfeeding Self-efficacy Intervention: Do Hospital Practices Make a Difference?

Keiko Otsuka, Masataka Taguri, Cindy-Lee Dennis, Kiriko Wakutani, Masayo Awano, Takuhiro Yamaguchi, Masamine Jimba

MATERNAL AND CHILD HEALTH JOURNAL　18　(1)　296-306　2014年1月

DOI： 10.1007/s10995-013-1265-2 　

ISSN：1092-7875

eISSN：1573-6628
同種造血幹細胞移植後の長期フォローアップシステム:単施設の実現可能性調査

黒澤彩子, 森文子, 塚越真由美, 山口拓洋, 金成元, 藤重夫, 山下卓也, 田野崎隆二, 福田隆浩

日本造血細胞移植学会雑誌　3　(2)　49-58　2014年
Use of glucose solution for the alleviation of gemcitabine-induced vascular pain: A double-blind randomized crossover study

Hiroki Nagai, Toshiyuki Kitano, Takafumi Nishimura, Hiroyasu Yasuda, Kazumi Nakata, Sachie Takashima, Masashi Kanai, Shigemi Matsumoto, Yukiko Mori, Yuichi Kakudo, Hiroyasu Sato, Takuhiro Yamaguchi, Kaoru Kameno, Young Hak Kim, Michiaki Mishima, Kazuhiro Yanagihara

Supportive Care in Cancer　21　(12)　3271-3278　2013年12月

DOI： 10.1007/s00520-013-1901-9 　

ISSN：0941-4355 1433-7339
Intravesical Seeding of Upper Urinary Tract Urothelial Carcinoma Cells During Nephroureterectomy: An Exploratory Analysis from the THPMG Trial

Akihiro Ito, Ichiro Shintaku, Makoto Satoh, Naomasa Ioritani, Tatsuo Tochigi, Isao Numata, Takashige Namima, Koichi Kambe, Atsushi Kyan, Seiji Ueno, Shinnosuke Katoh, Hisanobu Adachi, Shinichi Yamashita, Takuhiro Yamaguchi, Yoichi Arai

JAPANESE JOURNAL OF CLINICAL ONCOLOGY　43　(11)　1139-1144　2013年11月

DOI： 10.1093/jjco/hyt129 　

ISSN：0368-2811

eISSN：1465-3621
Simulated Visual Fields Produced from Macular RNFLT Data in Patients with Glaucoma

Mai Takahashi, Kazuko Omodaka, Kazuichi Maruyama, Takuhiro Yamaguchi, Noriko Himori, Yukihiro Shiga, Morin Ryu, Hiroshi Kunikata, Toru Nakazawa

CURRENT EYE RESEARCH　38　(11)　1133-1141　2013年11月

DOI： 10.3109/02713683.2013.807932 　

ISSN：0271-3683
Effect of Active Hexose-Correlated Compound in Women Receiving Adjuvant Chemotherapy for Breast Cancer: A Retrospective Study

Sho Hangai, Satoru Iwase, Takashi Kawaguchi, Yasunori Kogure, Tempei Miyaji, Tadaharu Matsunaga, Yoshinori Nagumo, Takuhiro Yamaguchi

JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE　19　(11)　905-910　2013年11月

DOI： 10.1089/acm.2012.0914 　

ISSN：1075-5535

eISSN：1557-7708
Prognosis of patients with core binding factor acute myeloid leukemia after first relapse

Saiko Kurosawa, Shuichi Miyawaki, Takuhiro Yamaguchi, Heiwa Kanamori, Toru Sakura, Yukiyoshi Moriuchi, Fumiaki Sano, Takeshi Kobayashi, Atsushi Yasumoto, Kazuo Hatanaka, Masamitsu Yanada, Yuichiro Nawa, Jin Takeuchi, Yukinori Nakamura, Shin Fujisawa, Hirohiko Shibayama, Ikuo Miura, Takahiro Fukuda

HAEMATOLOGICA　98　(10)　1525-1531　2013年10月

DOI： 10.3324/haematol.2012.078030 　

ISSN：0390-6078
患者自己評価式有害事象評価(PRO-CTCAE)日本語版の予備的調査査読有り

高津優人, 橋本浩伸, 矢内貴子, 久保晶子, 岩佐悟, 本間義崇, 高島淳生, 加藤健, 濱口哲弥, 山田康秀, 安西奈津美, 川口崇, 山口拓洋, 島田安博, 林憲一

日本癌治療学会誌　48　(3)　2588-2588　2013年9月
出版者・発行元： (一社)日本癌治療学会
ISSN：0021-4671
Impact of body mass index on clinicopathological outcome and biochemical recurrence after radical prostatectomy. 査読有り

Narita S, Mitsuzuka K, Yoneyama T, Tsuchiya N, Koie T, Kakoi N, Kawamura S, Kaiho Y, Ohyama C, Tochigi T, Yamaguchi T, Habuchi T, Arai Y

Prostate Cancer Prostatic Dis　16　(3)　271-276　2013年9月

DOI： 10.1038/pcan.2013.16 　

ISSN：1365-7852

eISSN：1476-5608
Changes in Indications and Oncological Outcomes of Radical Prostatectomy After 2000-Data From 1268 Japanese Patients Treated with Radical Prostatectomy Between 2000 and 2009

Koji Mitsuzuka, Takuya Koie, Shintaro Narita, Yasuhiro Kaiho, Takahiro Yoneyama, Norihiko Tsuchiya, Narihiko Kakoi, Sadafumi Kawamura, Tatsuo Tochigi, Chikara Ohyama, Tomonori Habuchi, Takuhiro Yamaguchi, Yoichi Arai

JAPANESE JOURNAL OF CLINICAL ONCOLOGY　43　(8)　821-826　2013年8月

DOI： 10.1093/jjco/hyt072 　

ISSN：0368-2811
終末期がん患者に対するアミノ酸ゼリーの有用性を調べる前向き探索試験

石木寛人, 岩瀬哲, 行田泰明, 金井良晃, 有吉恵介, 宮路天平, 田原由紀子, 川口崇, 山口拓洋

日本緩和医療学会学術大会プログラム・抄録集　18回　326-326　2013年6月
出版者・発行元： (NPO)日本緩和医療学会
A randomized, double-blind, placebo-controlled, phase II dose-finding study of the short acting β1-blocker, landiolol hydrochloride, in patients with suspected ischemic cardiac disease

Jinzaki M, Hirano M, Hara K, Suzuki T, Yamashina A, Ikari Y, Iino M, Yamaguchi T, Kuribayashi S

International journal of cardiovascular imaging　29　(s1)　7-20　2013年6月

DOI： 10.1007/s10554-013-0253-3 　

ISSN：1569-5794

eISSN：1573-0743
Effects of a programme of interventions on regional comprehensive palliative care for patients with cancer: A mixed-methods study

Tatsuya Morita, Mitsunori Miyashita, Akemi Yamagishi, Miki Akiyama, Nobuya Akizuki, Kei Hirai, Chizuru Imura, Masashi Kato, Yoshiyuki Kizawa, Yutaka Shirahige, Takuhiro Yamaguchi, Kenji Eguchi

The Lancet Oncology　14　(7)　638-646　2013年6月

DOI： 10.1016/S1470-2045(13)70127-X 　

ISSN：1470-2045 1474-5488
Congenital cholesteatoma is predominantly found in the posterior-superior quadrant in the Asian population: Systematic review and meta-analysis, including our clinical experience

Hiroshi Hidaka, Takuhiro Yamaguchi, Hiromitsu Miyazaki, Kazuhiro Nomura, Toshimitsu Kobayashi

Otology and Neurotology　34　(4)　630-638　2013年6月

DOI： 10.1097/MAO.0b013e31828dae89 　

ISSN：1531-7129 1537-4505
Phase II trial of cetuximab (Cmab) plus irinotecan (CPT-11) for chemorefractory Japanese patients with advanced and/or metastatic colorectal cancer (mCRC), to evaluate the efficacy and safety based on KRAS, BRAF, PIK3CA, NRAS, and AKT1 mutation status (T-CORE0801) 査読有り

Hideki Shimodaira, Hiroshi Soeda, Hisatsugu Ohori, Shoko Akiyama, Mariko Kambe, Yasuko Murakawa, Takao Suzuki, Satoshi Kato, Jugoh Itoh, Mika Watanabe, Takuhiro Yamaguchi, Shunsuke Kato, Chikashi Ishioka

JOURNAL OF CLINICAL ONCOLOGY　31　(15)　2013年5月

ISSN：0732-183X

eISSN：1527-7755
Claims-Based Definition of Death in Japanese Claims Database: Validity and Implications

Nobuhiro Ooba, Soko Setoguchi, Takashi Ando, Tsugumichi Sato, Takuhiro Yamaguchi, Mayumi Mochizuki, Kiyoshi Kubota

PLOS ONE　8　(5)　e66116　2013年5月

DOI： 10.1371/journal.pone.0066116 　

ISSN：1932-6203
Effect of severity of vestibular dysfunction on postural instability in idiopathic bilateral vestibulopathy

Chisato Fujimoto, Toshihisa Murofushi, Yasuhiro Chihara, Munetaka Ushio, Mitsuya Suzuki, Takuhiro Yamaguchi, Tatsuya Yamasoba, Shinichi Iwasaki

ACTA OTO-LARYNGOLOGICA　133　(5)　454-461　2013年5月

DOI： 10.3109/00016489.2012.742565 　

ISSN：0001-6489
Prospective Randomized Phase II Trial of a Single Early Intravesical Instillation of Pirarubicin (THP) in the Prevention of Bladder Recurrence After Nephroureterectomy for Upper Urinary Tract Urothelial Carcinoma: The THP Monotherapy Study Group Trial

Akihiro Ito, Ichiro Shintaku, Makoto Satoh, Naomasa Ioritani, Masataka Aizawa, Tatsuo Tochigi, Sadafumi Kawamura, Hiroshi Aoki, Isao Numata, Atsushi Takeda, Shunichi Namiki, Takashige Namima, Yoshihiro Ikeda, Koichi Kambe, Atsushi Kyan, Seiji Ueno, Kazuhiko Orikasa, Shinnosuke Katoh, Hisanobu Adachi, Satoru Tokuyama, Shigeto Ishidoya, Takuhiro Yamaguchi, Yoichi Arai

JOURNAL OF CLINICAL ONCOLOGY　31　(11)　1422-1427　2013年4月

DOI： 10.1200/JCO.2012.45.2128 　

ISSN：0732-183X
A novel Internet-based blended learning programme providing core competency in clinical research

Yukio Tsugihashi, Naoki Kakudate, Yoko Yokoyama, Yosuke Yamamoto, Hiroki Mishina, Norio Fukumori, Fumiaki Nakamura, Misa Takegami, Shinya Ohno, Takafumi Wakita, Kazuhiro Watanabe, Takuhiro Yamaguchi, Shunichi Fukuhara

Journal of Evaluation in Clinical Practice　19　(2)　250-255　2013年4月

DOI： 10.1111/j.1365-2753.2011.01808.x 　

ISSN：1356-1294 1365-2753
Development program for the Japanese version of the PRO-CTCAE

Takuhiro Yamaguchi, Satoru Iwase, Yasushi Goto, Masahiro Tsuboi, Daigo Yamamoto, Hiroki Odagiri, Yu Tsubota, Yukiko Iioka, Takashi Kawaguchi, Natsumi Anzai, Tempei Miyaji, Tetsuya Hamaguchi, Yuto Takatsu, Yasuhiro Shimada, Sandra Mitchell, Ethan Basch

Japanese Pharmacology and Therapeutics　41　(SUPPL. 2)　2013年

ISSN：0386-3603
Recent decrease in non-relapse mortality due to GVHD and infection after allogeneic hematopoietic cell transplantation in non-remission acute leukemia 査読有り

Kurosawa S, Yakushijin K, Yamaguchi T, Atsuta Y, Nagamura-Inoue T, Akiyama H, Taniguchi S, Miyamura K, Takahashi S, Eto T, Ogawa H, Kurokawa M, Tanaka J, Kawa K, Kato K, Suzuki R, Morishima Y, Sakamaki H, Fukuda T

Bone Marrow Transplantation　48　(9)　1198-1204　2013年

DOI： 10.1038/bmt.2013.42 　
Changes in incidence and causes of non-relapse mortality after allogeneic hematopoietic cell transplantation in patients with acute leukemia/ myelodysplastic syndrome: An analysis of the Japan Transplant Outcome Registry 査読有り

Kurosawa S, Yakushijin K, Yamaguchi T, Atsuta Y, Nagamura-Inoue T, Akiyama H, Taniguchi S, Miyamura K, Takahashi S, Eto T, Ogawa H, Kurokawa M, Tanaka J, Kawa K, Kato K, Suzuki R, Morishima Y, Sakamaki H, Fukuda T

Bone Marrow Transplantation　48　(4)　529-536　2013年

DOI： 10.1038/bmt.2012.172 　
患者の治療選択における意思決定の葛藤を指標とした薬剤師の服薬カウンセリング効果の定量的評価法:―HIV感染症患者を対象とした解析―

川口崇, 畝崎榮, 関根祐介, 東加奈子, 山口拓洋, 添田博, 竹内裕紀, 天野景裕, 福武勝幸, 明石貴雄

医療薬学　39　(12)　689-699　2013年
出版者・発行元：一般社団法人日本医療薬学会
DOI： 10.5649/jjphcs.39.689 　

ISSN：1346-342X

詳細を見る詳細を閉じる

The purpose of this before-after study was to examine the psychometric properties of the Japanese version of the Decisional Conflict Scale (DCS) and to analyze the impact of pharmacist counseling on decisional conflict for patients infected with the human immunodeficiency virus (HIV). Internal consistency reliability was calculated. Multi-trait scaling and cluster analyses were performed to measure construct validity. In addition, decisional conflict in the patients infected with HIV was assessed before and after they received information from pharmacists. Data collected from 69 patients who were recommended a new anti-retroviral therapy were analyzed. A high degree of internal consistency was observed for the five subscales of the DCS (Cronbach's alpha = 0.78 - 0.90). Multi-trait scaling and cluster analyses indicated good construct validity. After the pharmacist counseling, the mean total DCS score decreased significantly (ie, from 46.3 to 26.5, P < 0.0001, paired t-test). Scores on all subscales of the DCS showed statistically significant improvement (Ps < 0.0001, paired t-test). This paper concludes that the Japanese version of the DCS is psychometrically sound for patients infected with HIV. Before initiating anti-retroviral therapy, these patients have high decisional conflict, which can be improved by pharmacist counseling.
The diagnostic value of vestibular evoked myogenic potentials in patients with Meniere's disease

Naoya Egami, Munetaka Ushio, Tatsuya Yamasoba, Takuhiro Yamaguchi, Toshihisa Murofushi, Shinichi Iwasaki

JOURNAL OF VESTIBULAR RESEARCH-EQUILIBRIUM & ORIENTATION　23　(4-5)　249-257　2013年

DOI： 10.3233/VES-130484 　

ISSN：0957-4271

eISSN：1878-6464
The clinical utility of makeshift beds in disaster shelters

Masayuki Nara, Shinsaku Ueda, Masashi Aoki, Tsutomu Tamada, Takuhiro Yamaguchi, Michio Hongo

Disaster Medicine and Public Health Preparedness　7　(6)　573-577　2013年
出版者・発行元： Lippincott Williams and Wilkins
DOI： 10.1017/dmp.2013.107 　

ISSN：1938-744X 1935-7893
Development and validation of the Japanese version of the Decisional Conflict Scale to investigate the value of pharmacists' information: a before and after study.

Takashi Kawaguchi, Kanako Azuma, Takuhiro Yamaguchi, Hiroshi Soeda, Yusuke Sekine, Masayoshi Koinuma, Hironori Takeuchi, Takao Akashi, Sakae Unezaki

BMC Med. Inf. & Decision Making　13　(1)　50-50　2013年

DOI： 10.1186/1472-6947-13-50 　
The clinical use of Kampo medicines (traditional Japanese herbal treatments) for controlling cancer patients' symptoms in Japan: a national cross-sectional survey

Satoru Iwase, Takuhiro Yamaguchi, Tempei Miyaji, Kiyoshi Terawaki, Akio Inui, Yasuhito Uezono

BMC COMPLEMENTARY AND ALTERNATIVE MEDICINE　12　222　2012年11月

DOI： 10.1186/1472-6882-12-222 　

ISSN：1472-6882
Prescription Patterns and Mineral Metabolism Abnormalities in the Cinacalcet Era: Results from the MBD-5D Study

Masafumi Fukagawa, Shingo Fukuma, Yoshihiro Onishi, Takuhiro Yamaguchi, Takeshi Hasegawa, Tadao Akizawa, Kiyoshi Kurokawa, Shunichi Fukuhara

CLINICAL JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY　7　(9)　1473-1480　2012年9月

DOI： 10.2215/CJN.13081211 　

ISSN：1555-9041

eISSN：1555-905X
Allogeneic cord blood transplantation for adult acute lymphoblastic leukemia: retrospective survey involving 256 patients in Japan 査読有り

T. Matsumura, M. Kami, T. Yamaguchi, K. Yuji, E. Kusumi, S. Taniguchi, S. Takahashi, M. Okada, H. Sakamaki, H. Azuma, M. Takanashi, H. Kodo, S. Kai, T. Inoue-Nagamura, K. Kato, S. Kato

LEUKEMIA　26　(7)　1482-1486　2012年7月

DOI： 10.1038/leu.2012.11 　

ISSN：0887-6924
Randomized comparison of fixed-schedule versus response-oriented individualized induction therapy and use of ubenimex during and after consolidation therapy for elderly patients with acute myeloid leukemia: the JALSG GML200 Study

Atsushi Wakita, Shigeki Ohtake, Satoru Takada, Fumiharu Yagasaki, Hirokazu Komatsu, Yasushi Miyazaki, Kohmei Kubo, Yukihiko Kimura, Akihiro Takeshita, Yoko Adachi, Hitoshi Kiyoi, Takuhiro Yamaguchi, Minoru Yoshida, Kazunori Ohnishi, Shuichi Miyawaki, Tomoki Naoe, Ryuzo Ueda, Ryuzo Ohno

INTERNATIONAL JOURNAL OF HEMATOLOGY　96　(1)　84-93　2012年7月

DOI： 10.1007/s12185-012-1105-y 　

ISSN：0925-5710
Treatment of Graves' Disease with Antithyroid Drugs in the First Trimester of Pregnancy and the Prevalence of Congenital Malformation

Ai Yoshihara, JaedukYoshimura Noh, Takuhiro Yamaguchi, Hidemi Ohye, Shiori Sato, Kenichi Sekiya, Yuka Kosuga, Miho Suzuki, Masako Matsumoto, Yo Kunii, Natsuko Watanabe, Koji Mukasa, Kunihiko Ito, Koichi Ito

JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM　97　(7)　2396-2403　2012年7月

DOI： 10.1210/jc.2011-2860 　

ISSN：0021-972X
臨床研究に関するブレンデッド型遠隔学習プログラムの教育効果測定の試み

角舘直樹, 次橋幸男, 横山葉子, 山本洋介, 三品浩基, 中村文明, 福森則男, 竹上未紗, 大野慎也, 佐藤恵子, 脇田貴文, 渡部一宏, 山口拓洋, 福原俊一

医学教育 = Medical education　43　(3)　205-210　2012年6月25日
出版者・発行元： Japan Society for Medical Education
DOI： 10.11307/mededjapan.43.205 　

ISSN：0386-9644

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我が国では臨床研究のデザインから解析までの基礎知識（臨床研究コア・コンピテンシー）を理解する医療者は少ない．我々は，臨床現場で働く多忙な医療者が，臨床研究コア・コンピテンシーを学ぶための対面授業と遠隔学習システムを組み合わせたブレンデッド型遠隔学習プログラムを開発した．今回は，本プログラムの教育効果について報告する．<br>1）本プログラム終了から4か月経過時点で，対象者の64％が臨床研究に取り組み始めていた．<br>2）本プログラムは，臨床研究について議論できる仲間の数を増やすことにも寄与している可能性が示唆された．<br>3）本プログラムは，受講者の臨床研究に対する自信（自己効力感）を高めている可能性が示唆された．
がん患者の症状コントロールを目的とした医療用漢方薬の使用実態についての全国アンケート調査

岩瀬哲, 山口拓洋, 宮路天平, 上園保仁

日本緩和医療学会学術大会プログラム・抄録集　17回　529-529　2012年6月
出版者・発行元： (NPO)日本緩和医療学会
Effect of Parenteral Hydration Therapy Based on the Japanese National Clinical Guideline on Quality of Life, Discomfort, and Symptom Intensity in Patients With Advanced Cancer

Takashi Yamaguchi, Tatsuya Morita, Takuya Shinjo, Satoshi Inoue, Chizuko Takigawa, Etsuko Aruga, Kazuhiko Tani, Takashi Hara, Yoichiro Tamura, Akihiko Suga, Seiji Adachi, Hideki Katayama, Iwao Osaka, Yoshiyuki Saito, Nobuhisa Nakajima, Takashi Higashiguchi, Tatsuhiko Hayashi, Takeshi Okabe, Hiroyuki Kohara, Tomohiro Tamaki, Yoshikazu Chinone, Hideki Aragane, Yoshiaki Kanai, Natsuki Tokura, Takuhiro Yamaguchi, Takashi Asada, Yosuke Uchitomi

JOURNAL OF PAIN AND SYMPTOM MANAGEMENT　43　(6)　1001-1012　2012年6月

DOI： 10.1016/j.jpainsymman.2011.06.028 　

ISSN：0885-3924
Prognosis of acute myeloid leukemia harboring monosomal karyotype in patients treated with or without allogeneic hematopoietic cell transplantation after achieving complete remission

Masamitsu Yanada, Saiko Kurosawa, Takuhiro Yamaguchi, Takuya Yamashita, Yukiyoshi Moriuchi, Hiroatsu Ago, Jin Takeuchi, Hirohisa Nakamae, Jun Taguchi, Toru Sakura, Yasushi Takamatsu, Fusako Waki, Hiroki Yokoyama, Masato Watanabe, Nobuhiko Emi, Takahiro Fukuda

HAEMATOLOGICA-THE HEMATOLOGY JOURNAL　97　(6)　915-918　2012年6月

DOI： 10.3324/haematol.2011.058289 　

ISSN：0390-6078
Caffeine Increases Tear Volume Depending on Polymorphisms within the Adenosine A2a Receptor Gene and Cytochrome P450 1A2

Reiko Arita, Yasuo Yanagi, Norihiko Honda, Shuji Maeda, Koshi Maeda, Aya Kuchiba, Takuhiro Yamaguchi, Yoshitsugu Yanagihara, Hiroshi Suzuki, Shiro Amano

OPHTHALMOLOGY　119　(5)　972-978　2012年5月

DOI： 10.1016/j.ophtha.2011.11.033 　

ISSN：0161-6420
Perceptions and attitudes of Japanese gynecologic cancer patients to Kampo (Japanese herbal) medicines

Takashi Takeda, Takuhiro Yamaguchi, Nobuo Yaegashi

INTERNATIONAL JOURNAL OF CLINICAL ONCOLOGY　17　(2)　143-149　2012年4月

DOI： 10.1007/s10147-011-0271-x 　

ISSN：1341-9625

eISSN：1437-7772
カフェインによる涙液量の増加はADORA2AとCYP1A2遺伝子多型と関連する

有田玲子, 柳靖雄, 本田紀彦, 前田修司, 前田耕志, 口羽文, 山口拓洋, 柳原良次, 鈴木博, 天野史郎

日本眼科学会雑誌　116　(臨増)　260-260　2012年3月
出版者・発行元： (公財)日本眼科学会
ISSN：0029-0203
The effects of an intervention program for promoting interorganizational network building between multidisciplinary agencies and community-based organizations: a cluster trial in Japan

Hiroshi Murayama, Takuhiro Yamaguchi, Satoko Nagata, Sachiyo Murashima

BMC PUBLIC HEALTH　12　178　2012年3月

DOI： 10.1186/1471-2458-12-178 　

ISSN：1471-2458
P1-125 抗がん剤治療を受けるがん患者が抱える葛藤に薬剤師の服薬説明が与える影響(がん薬物療法(服薬指導・情報提供),ポスター,一般演題,岐路に立つ医療～千年紀の目覚め～よみがえれ!ニッポン!薬の改革は我らが手で!) 査読有り

東加奈子, 明石貴雄, 川口崇, 鮎原秀明, 江田理子, 大西正美, 山口拓洋, 濃沼政美, 竹内裕紀, 畝崎榮

日本医療薬学会年会講演要旨集　22　(0)　287-287　2012年
出版者・発行元：一般社団法人日本医療薬学会
DOI： 10.20825/amjsphcs.22.0_287_5 　
P1-126 『意思決定の葛藤尺度(DCS)』日本語版作成とその信頼性および妥当性の検討(がん薬物療法(服薬指導・情報提供),ポスター,一般演題,岐路に立つ医療～千年紀の目覚め～よみがえれ!ニッポン!薬の改革は我らが手で!) 査読有り

佐野陽子, 畝崎榮, 明石貴雄, 添田博, 濱田泰子, 東加奈子, 川口崇, 山口拓洋, 恩田健二, エリックスカイヤー, 竹内裕紀

日本医療薬学会年会講演要旨集　22　(0)　287-287　2012年
出版者・発行元：一般社団法人日本医療薬学会
DOI： 10.20825/amjsphcs.22.0_287_6 　
遺族調査に基づく自宅死亡を希望していると推定されるがん患者数

森田達也, 宮下光令, 井上芙蓉子, 佐藤一樹, 五十嵐歩, 五十嵐美幸, 山口拓洋, 橋本修二

Palliat Care Res (Web)　7　(2)　403-407 (J-STAGE)-407　2012年
出版者・発行元： Japanese Society for Palliative Medicine
DOI： 10.2512/jspm.7.403 　

ISSN：1880-5302

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本研究の目的は, 全国4地域を対象とした緩和ケアの普及に関する地域介入研究で取得された実際の死亡場所と死亡数, 遺族調査のデータをもとに, 自宅死亡を希望していると考えられるがん患者数の推定を行うことである. 死亡場所・死亡数のデータは人口動態統計などの資料から収集した. 遺族調査は全国4地域52施設の遺族1,137名を対象として実施された. 「自宅死亡の希望推定数」を, 自宅死亡した患者で遺族が患者はそれを望んでいたと推測した数, および一般病棟・緩和ケア病棟で死亡した患者で, 遺族が患者は自宅で死亡することを望んでいたいと推測した数から求めた. 自宅死亡の希望推定数は, 対象地域ではがん死亡の32.8％［95％信頼区間: 31.7, 33.9］であり, 全国数値に基づくと11.1万人(がん死亡の31.2％［95％信頼区間: 31.1, 31.4］)であった.
Effects of a multi-method discharge planning educational program for medical staff nurses

Shigemi Suzuki, Satoko Nagata, Joyce Zerwekh, Takuhiro Yamaguchi, Hikari Tomura, Yukie Takemura, Sachiyo Murashima

JAPAN JOURNAL OF NURSING SCIENCE　9　(2)　201-215　2012年

DOI： 10.1111/j.1742-7924.2011.00203.x 　

ISSN：1742-7932
Moderate renal dysfunction may not require a cisplatin dose reduction: a retrospective study of cancer patients with renal impairment

Ogawa T, Niho S, Nagai S, Kojima T, Nishimura Y, Ohe Y, Kondo N, Yamaguchi T, Endo K, Izumi K, Minami H

International Journal of Clinical Oncology　18　(6)　977-982　2012年
Risk Assessment for Acute Kidney Injury after Allogeneic Hematopoietic Stem Cell Transplantation Based on Acute Kidney Injury Network Criteria

Jinichi Mori, Kazuteru Ohashi, Takuhiro Yamaguchi, Minoru Ando, Yuka Hirashima, Takeshi Kobayashi, Kazuhiko Kakihana, Hisashi Sakamaki

INTERNAL MEDICINE　51　(16)　2105-2110　2012年

DOI： 10.2169/internalmedicine.51.7418 　

ISSN：0918-2918
Safety Verification Trials of mFOLFIRI and Sequential IRIS plus Bevacizumab as First- or Second-Line Therapies for Metastatic Colorectal Cancer in Japanese Patients

Shunsuke Kato, Hideaki Andoh, Makio Gamoh, Takuhiro Yamaguchi, Yasuko Murakawa, Hideki Shimodaira, Shin Takahashi, Takahiro Mori, Hisatsugu Ohori, Shun-ichi Maeda, Takao Suzuki, Satoshi Kato, Shoko Akiyama, Yuka Sasaki, Takashi Yoshioka, Chikashi Ishioka

ONCOLOGY　83　(2)　101-107　2012年

DOI： 10.1159/000339541 　

ISSN：0030-2414
Association of body temperature and antipyretic treatments with mortality of critically ill patients with and without sepsis: multi-centered prospective observational study

Byung Ho Lee, Daisuke Inui, Gee Young Suh, Jae Yeol Kim, Jae Young Kwon, Jisook Park, Keiichi Tada, Keiji Tanaka, Kenichi Ietsugu, Kenji Uehara, Kentaro Dote, Kimitaka Tajimi, Kiyoshi Morita, Koichi Matsuo, Koji Hoshino, Koji Hosokawa, Kook Hyun Lee, Kyoung Min Lee, Makoto Takatori, Masaji Nishimura, Masamitsu Sanui, Masanori Ito, Moritoki Egi, Naofumi Honda, Naoko Okayama, Nobuaki Shime, Ryosuke Tsuruta, Satoshi Nogami, Seok-Hwa Yoon, Shigeki Fujitani, Shin Ok Koh, Shinhiro Takeda, Shinsuke Saito, Sung Jin Hong, Takeshi Yamamoto, Takeshi Yokoyama, Takuhiro Yamaguchi, Tomoki Nishiyama, Toshiko Igarashi, Yasuyuki Kakihana, Younsuck Koh

CRITICAL CARE　16　(1)　R33　2012年

DOI： 10.1186/cc11211 　

ISSN：1466-609X

eISSN：1364-8535
A region-based palliative care intervention trial using the mixed-method approach: Japan OPTIM study

Tatsuya Morita, Mitsunori Miyashita, Akemi Yamagishi, Nobuya Akizuki, Yoshiyuki Kizawa, Yutaka Shirahige, Miki Akiyama, Kei Hirai, Motohiro Matoba, Masako Yamada, Taketoshi Matsumoto, Takuhiro Yamaguchi, Kenji Eguchi

BMC PALLIATIVE CARE　11　2　2012年1月

DOI： 10.1186/1472-684X-11-2 　

ISSN：1472-684X
Antithyroid Drug-Induced Hematopoietic Damage: A Retrospective Cohort Study of Agranulocytosis and Pancytopenia Involving 50,385 Patients with Graves' Disease

Natsuko Watanabe, Hiroto Narimatsu, Jaeduk Yoshimura Noh, Takuhiro Yamaguchi, Kazuhiko Kobayashi, Masahiro Kami, Yo Kunii, Koji Mukasa, Kunihiko Ito, Koichi Ito

JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM　97　(1)　E49-E53　2012年1月

DOI： 10.1210/jc.2011-2221 　

ISSN：0021-972X

eISSN：1945-7197
Erythropoiesis-Stimulating Agent Responsiveness and Mortality in Hemodialysis Patients: Results from a Cohort Study From the Dialysis Registry in Japan

Shingo Fukuma, Takuhiro Yamaguchi, Seiji Hashimoto, Shigeru Nakai, Kunitoshi Iseki, Yoshiharu Tsubakihara, Shunichi Fukuhara

AMERICAN JOURNAL OF KIDNEY DISEASES　59　(1)　108-116　2012年1月

DOI： 10.1053/j.ajkd.2011.07.014 　

ISSN：0272-6386

eISSN：1523-6838
Stroke and Anti-VEGF Therapy

Takashi Ueta, Harushi Mori, Akira Kunimatsu, Takuhiro Yamaguchi, Yasuhiro Tamaki, Yasuo Yanagi

OPHTHALMOLOGY　118　(10)　2093-U247　2011年10月

ISSN：0161-6420
Decreases in PTH in Japanese Hemodialysis Patients with Secondary Hyperparathyroidism: Associations with Changing Practice Patterns

Tadao Akizawa, Ryo Kido, Masafumi Fukagawa, Yoshihiro Onishi, Takuhiro Yamaguchi, Takeshi Hasegawa, Shunichi Fukuhara, Kiyoshi Kurokawa

CLINICAL JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY　6　(9)　2280-2288　2011年9月

DOI： 10.2215/CJN.11501210 　

ISSN：1555-9041
Development of a novel scale to assess the quality of life in type 1 diabetic patients for beta cell replacement therapy 査読有り

Nobuyo Hatanaka, Morihito Takita, Takuhiro Yamaguchi, Masahiro Kami, Shinichi Matsumoto

Diabetology International　2　(2)　55-64　2011年6月

DOI： 10.1007/s13340-011-0023-1 　

ISSN：2190-1678 2190-1686
Incidence of interstitial lung disease in patients with mesothelioma in the west part of Japan 査読有り

Shuko Nojiri, Kenichi Gemba, Keisuke Aoe, Katsuya Kato, Takuhiro Yamaguchi, Tsugumichi Sato, Kiyoshi Kubota, Takumi Kishimoto

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY　20　(6)　643-652　2011年6月

DOI： 10.1002/pds.2123 　

ISSN：1053-8569
Vitreomacular interface in typical exudative age-related macular degeneration and polypoidal choroidal vasculopathy. 査読有り

Nomura Y, Ueta T, Iriyama A, Inoue Y, Obata R, Tamaki Y, Yamaguchi T, Yanagi Y

Ophthalmology　118　(5)　853-859　2011年5月

DOI： 10.1016/j.ophtha.2010.09.001 　

ISSN：0161-6420

eISSN：1549-4713
Alternative statistical methods for estimating efficacy of interferon beta-1b for multiple sclerosis clinical trials

Makiko N. Mieno, Takuhiro Yamaguchi, Yasuo Ohashi

BMC MEDICAL RESEARCH METHODOLOGY　11　(11)　80-85　2011年5月

DOI： 10.1186/1471-2288-11-80 　

ISSN：1471-2288
Mineral and Bone Disorders Outcomes Study for Japanese Chronic Kidney Disease Stage 5D Patients: Rationale and Study Design

Shunichi Fukuhara, Tadao Akizawa, Masafumi Fukagawa, Yoshihiro Onishi, Takuhiro Yamaguchi, Takeshi Hasegawa, Kiyoshi Kurokawa

THERAPEUTIC APHERESIS AND DIALYSIS　15　(2)　169-175　2011年4月

DOI： 10.1111/j.1744-9987.2010.00906.x 　

ISSN：1744-9979
Clinicopathological features of 171 cases of primary thyroid lymphoma: a long-term study involving 24 553 patients with Hashimoto's disease

Natsuko Watanabe, Jaeduk Y. Noh, Hiroto Narimatsu, Kengo Takeuchi, Takuhiro Yamaguchi, Kaori Kameyama, Kazuhiko Kobayashi, Masahiro Kami, Atsushi Kubo, Yo Kunii, Taeko Shimizu, Koji Mukasa, Fumiko Otsuka, Ayako Miyara, Akinobu Minagawa, Koichi Ito, Kunihiko Ito

BRITISH JOURNAL OF HAEMATOLOGY　153　(2)　236-243　2011年4月

DOI： 10.1111/j.1365-2141.2011.08606.x 　

ISSN：0007-1048
女性のライフステージにおける漢方治療婦人科癌治療患者における漢方治療に対する意識調査と不安状態に関する検討

武田卓, 吉永浩介, 伊藤潔, 築地謙治, 李賓, 山口拓洋, 八重樫伸生

産婦人科漢方研究のあゆみ　(28)　35-39　2011年3月
出版者・発行元：産婦人科漢方研究会
ISSN：0913-865X
Comparison of Allogeneic Hematopoietic Cell Transplantation and Chemotherapy in Elderly Patients with Non-M3 Acute Myelogenous Leukemia in First Complete Remission

Saiko Kurosawa, Takuhiro Yamaguchi, Naoyuki Uchida, Shuichi Miyawaki, Kensuke Usuki, Masato Watanabe, Takuya Yamashita, Heiwa Kanamori, Junji Tomiyama, Yuichiro Nawa, Shingo Yano, Jin Takeuchi, Kazuaki Yakushiji, Fumiaki Sano, Nobuhiko Uoshima, Takahiro Yano, Yasuhito Nannya, Yukiyoshi Moriuchi, Ikuo Miura, Yoichi Takaue, Takahiro Fukuda

BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION　17　(3)　401-411　2011年3月

DOI： 10.1016/j.bbmt.2010.07.013 　

ISSN：1083-8791
Age, gender, will, and use of home-visit nursing care are critical factors in home care for malignant diseases; a retrospective study involving 346 patients in Japan

Yuko Kodama, Tomoko Matsumura, Takuhiro Yamaguchi, Morihito Takita, Shohei Kawagoe, Yukihiro Kimura, Satoshi Hirahara, Hiroshi Suzuki, Hideki Ohta, Shigeru Onozawa, Tadashi Wada, Yukiyasu Nakamura, Kazushi Nakano, Masahiro Kami, Koichiro Yuji

BMC PALLIATIVE CARE　10　17　2011年

DOI： 10.1186/1472-684X-10-17 　

ISSN：1472-684X
Survival and Prognostic Factors in Malignant Pleural Mesothelioma: A Retrospective Study of 314 patients in the West Part of Japan

Shuko Nojiri, Kenichi Gemba, Keisuke Aoe, Katsuya Kato, Takuhiro Yamaguchi, Tsugumichi Sato, Kiyoshi Kubota, Takumi Kishimoto

JAPANESE JOURNAL OF CLINICAL ONCOLOGY　41　(1)　32-39　2011年1月

DOI： 10.1093/jjco/hyq159 　

ISSN：0368-2811
The Impact in Japan of Regulatory Action on Prescribing of Dopamine Receptor Agonists Analysis of a Claims Database between 2005 and 2008

Nobuhiro Ooba, Takuhiro Yamaguchi, Kiyoshi Kubota

DRUG SAFETY　34　(4)　329-338　2011年

ISSN：0114-5916

eISSN：1179-1942
VasquQOL日本語版の信頼性と妥当性の検討

山口拓洋, 宮田哲郎, 市来正隆, 井上芳徳, 小櫃由樹生, 吉川公彦, 杉本郁夫, 中村正人, 南都伸介, 横井宏佳, 飯田修, 駒井宏好, 橋本拓弥

脈管学　51　347-358　2011年
Prognostic factors and outcomes of adult patients with acute myeloid leukemia after first relapse

Saiko Kurosawa, Takuhiro Yamaguchi, Shuichi Miyawaki, Naoyuki Uchida, Toru Sakura, Heiwa Kanamori, Kensuke Usuki, Takuya Yamashita, Yasushi Okoshi, Hirohiko Shibayama, Hirohisa Nakamae, Momoko Mawatari, Kazuo Hatanaka, Kazutaka Sunami, Manabu Shimoyama, Naohito Fujishima, Yoshinobu Maeda, Ikuo Miura, Yoichi Takaue, Takahiro Fukuda

HAEMATOLOGICA-THE HEMATOLOGY JOURNAL　95　(11)　1857-1864　2010年11月

DOI： 10.3324/haematol.2010.027516 　

ISSN：0390-6078
[Evaluation of a program to promote network building between disciplinary agencies and informal community organizations: trial in a community comprehensive support center].

Hiroshi Murayama, Tomoko Kojima, Meiko Tomaru, Harumi Narabu, Reiko Tachibana, Takuhiro Yamaguchi, Sachiyo Murashima

[Nihon koshu eisei zasshi] Japanese journal of public health　57　(10)　909-20　2010年10月

ISSN：0546-1766

詳細を見る詳細を閉じる

OBJECTIVE: To examine the effectiveness of a program promoting network building between disciplinary agencies and informal community organizations (IGOs) comprising community residents, by implemention with staff of a community comprehensive support center (CJCSG). METHODS: The program was implemented for nine staff of a GGSG in Setagaya Ward, Tokyo for a year. For process evaluation, items were assessed concerning the contents of the program such as satisfaction and understandability, participants' goal attainment level at each period of the program, and program satisfaction as a whole. Outcome evaluation included measurement of participants' self-efficacy regarding network building with ICOs before and after the program, using interviews of the members who completed the program. RESULT: Eight out of the nine participants completed the program. All positively evaluated the contents of the program and their own goal attainment at each period of the program. After its completion, they felt highly satisfied. Moreover, there was an improvement in the cognition of the participants, including self-efficacy on network building with IGOs and the atmosphere in the GGSG with regard to network building. CONCLUSION: The efficacy of this program could be confirmed as demonstrated by the staff of the CCSC, although a more detailed assessment of validity and effectiveness will be necessary in the future.
[Program development to promote network building between disciplinary agencies and informal community organizations].

Hiroshi Murayama, Harumi Narabu, Tomoko Kojima, Meiko Tomaru, Reiko Tachibana, Takuhiro Yamaguchi, Sachiyo Murashima

[Nihon koshu eisei zasshi] Japanese journal of public health　57　(10)　900-8　2010年10月

ISSN：0546-1766

詳細を見る詳細を閉じる

OBJECTIVE: To develop a program that promotes network building between disciplinary agencies and informal community organizations (RIO) comprising community residents. METHODS: Questionnaire and interview surveys were conducted for the staff of a community comprehensive support center in order to assess the needs regarding network building with ICOs. Then, a program was developed based on the social cognitive theory. The aim of the program was to raise awareness about network building and to develop necessary skills. RESULTS: The program induded ten sessions, with themes encompassing "reviewing the past activities", "understanding the significance of network building with IGOs", "integrating the aims and visions of staff", and "learning ways to build networks with IGOs". Objectives of each session were set on the basis of the particular theme covered. Participants performed group work during the sessions. CONCLUSION: Establishment and actual implementation of programs in clinical practice could be expected to strengthen networking between disciplinary agencies and ICOs. It is necessary to implement programs and evaluate their effectiveness in the future.
乳がん術前化学療法および内分泌療法の最前線乳がん術前内分泌療法の意義と臨床試験の展望

岩田広治, 柏葉匡寛, 佐治重衡, 遠山竜也, 増田慎三, 平成人, 山本豊, 山口拓洋, 大橋靖雄

日本癌治療学会誌　45　(2)　404-404　2010年9月
出版者・発行元： (一社)日本癌治療学会
ISSN：0021-4671
Randomized, double-blind, placebo-controlled clinical trial of hepatocyte growth factor plasmid for critical limb ischemia 査読有り

H. Shigematsu, K. Yasuda, T. Iwai, T. Sasajima, S. Ishimaru, Y. Ohashi, T. Yamaguchi, T. Ogihara, R. Morishita

Gene Therapy　17　(9)　1152-1161　2010年9月

DOI： 10.1038/gt.2010.51 　

ISSN：0969-7128 1476-5462
Ranibizumab and Stroke

Takashi Ueta, Yasuo Yanagi, Yasuhiro Tamaki, Takuhiro Yamaguchi

OPHTHALMOLOGY　117　(9)　1860-1860　2010年9月

ISSN：0161-6420
The impact of H1N1 influenza A virus pandemic on the blood donations in Hyogo Prefecture, Japan

Masaharu Tsubokura, Haruka Nakada, Tomoko Matsumura, Yuko Kodama, Hiroto Narimatsu, Takuhiro Yamaguchi, Masahiro Kami

TRANSFUSION　50　(8)　1803-1805　2010年8月

DOI： 10.1111/j.1537-2995.2010.02641.x 　

ISSN：0041-1132
Effects of unilateral dysfunction of the inferior vestibular nerve system on postural stability

Chisato Fujimoto, Toshihisa Murofushi, Yasuhiro Chihara, Munetaka Ushio, Takuhiro Yamaguchi, Tatsuya Yamasoba, Shinichi Iwasaki

CLINICAL NEUROPHYSIOLOGY　121　(8)　1279-1284　2010年8月

DOI： 10.1016/j.clinph.2010.02.149 　

ISSN：1388-2457
Interests in beta-cell replacement therapies among Japanese patients with type 1 diabetes

Nobuyo Hatanaka, Morihito Takita, Takuhiro Yamaguchi, Masahiro Kami, Shinichi Matsumoto

Diabetes Research and Clinical Practice　89　(1)　e5-e8　2010年7月

DOI： 10.1016/j.diabres.2010.04.003 　

ISSN：0168-8227
Age-related Changes in Cell Dynamics of the Postnatal Mouse Olfactory Neuroepithelium: Cell Proliferation, Neuronal Differentiation, and Cell Death

Kenji Kondo, Keigo Suzukawa, Takashi Sakamoto, Kenta Watanabe, Kaori Kanaya, Munetaka Ushio, Takuhiro Yamaguchi, Ken-Ichi Nibu, Kimitaka Kaga, Tatsuya Yamasoba

JOURNAL OF COMPARATIVE NEUROLOGY　518　(11)　1962-1975　2010年6月

DOI： 10.1002/cne.22316 　

ISSN：0021-9967
Phase III randomized adjuvant study of tamoxifen alone versus sequential tamoxifen and anastrozole in Japanese postmenopausal women with hormone-responsive breast cancer: N-SAS BC03 study

Tomohiko Aihara, Yuichi Takatsuka, Shozo Ohsumi, Kenjiro Aogi, Yasuo Hozumi, Shigeru Imoto, Hirofumi Mukai, Hiroji Iwata, Toru Watanabe, Chikako Shimizu, Kazuhiko Nakagami, Motoshi Tamura, Toshikazu Ito, Norikazu Masuda, Nobuo Ogino, Kazufumi Hisamatsu, Shoshu Mitsuyama, Hajime Abe, Shiro Tanaka, Takuhiro Yamaguchi, Yasuo Ohashi

BREAST CANCER RESEARCH AND TREATMENT　121　(2)　379-387　2010年6月

DOI： 10.1007/s10549-010-0888-x 　

ISSN：0167-6806
Rationale and design of the Eplerenone combination Versus conventional Agents to Lower blood pressure on Urinary Antialbuminuric Treatment Effect (EVALUATE) trial: a double-blinded randomized placebo-controlled trial to evaluate the antialbuminuric effects of an aldosterone blocker in hypertensive patients with albuminuria

Katsuyuki Ando, Hiroshi Ohtsu, Yoshihiro Arakawa, Kiyoshi Kubota, Takuhiro Yamaguchi, Miki Nagase, Akira Yamada, Toshiro Fujita

HYPERTENSION RESEARCH　33　(6)　616-621　2010年6月

DOI： 10.1038/hr.2010.46 　

ISSN：0916-9636

eISSN：1348-4214
Rationale and design of the Eplerenone combination Versus conventional Agents to Lower blood pressure on Urinary Antialbuminuric Treatment Effect (EVALUATE) trial: a double-blinded randomized placebo-controlled trial to evaluate the antialbuminuric effect 査読有り

Katsuyuki Ando, Hiroshi Ohtsu, Yoshihiro Arakawa, Kiyoshi Kubota, Takuhiro Yamaguchi, Miki Nagase, Akira Yamada, Toshiro Fujita, on behalf of, the, EVALUATE Study Investigators

Hypertens Res　33　(6)　616-621　2010年
A Markov decision analysis of allogeneic hematopoietic cell transplantation versus chemotherapy in patients with acute myeloid leukemia in first remission

Kurosawa S, Yamaguchi T, Miyawaki S, Uchida N, Kanamori H, Usuki K, Yamashita T, Watanabe M, Yakushiji K, Yano S, Nawa Y, Taguchi J, Takeuchi J, Tomiyama J, Nakamura Y, Miura I, Kanda Y, Takaue Y, Fukuda T

Blood　117　(7)　2113-2120　2010年
Background Comparison of Typical Age-related Macular Degeneration and Polypoidal Choroidal Vasculopathy in Japanese Patients

Takashi Ueta, Ryo Obata, Yuji Inoue, Aya Iriyama, Hidenori Takahashi, Takuhiro Yamaguchi, Yasuhiro Tamaki, Yasuo Yanagi

OPHTHALMOLOGY　116　(12)　2400-2406　2009年12月

DOI： 10.1016/j.ophtha.2009.06.013 　

ISSN：0161-6420
Author reply 査読有り

Takashi Ueta, Takuhiro Yamaguchi

Ophthalmology　116　1835　2009年9月

DOI： 10.1016/j.ophtha.2009.04.009 　

ISSN：0161-6420
Survival of Malignant Mesothelioma in a Retrospective Survey in the West Part of Japan 査読有り

Shuko Nojiri, Tsugumichi Sato, Takuhiro Yamaguchi, Kenichi Gemba, Keisuke Aoe, Katsuya Kato, Takumi Kishimoto, Kiyoshi Kubota

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY　18　S38-S39　2009年8月

ISSN：1053-8569
Recovery of Facial Movement and Facial Synkinesis in Bell's Palsy Patients

Kaori Kanaya, Munetaka Ushio, Kenji Kondo, Miho Hagisawa, Keigo Suzukawa, Takuhiro Yamaguchi, Hitoshi Tojima, Mitsuya Suzuki, Tatsuya Yamasoba

OTOLOGY & NEUROTOLOGY　30　(5)　640-644　2009年8月

DOI： 10.1097/MAO.0b013e3181ab31af 　

ISSN：1531-7129
Assessment of diagnostic accuracy of foam posturography for peripheral vestibular disorders: Analysis of parameters related to visual and somatosensory dependence

Chisato Fujimoto, Toshihisa Murofushi, Yasuhiro Chihara, Munetaka Ushio, Keiko Sugasawa, Takuhiro Yamaguchi, Tatsuya Yamasoba, Shinichi Iwasaki

CLINICAL NEUROPHYSIOLOGY　120　(7)　1408-1414　2009年7月

DOI： 10.1016/j.clinph.2009.05.002 　

ISSN：1388-2457

eISSN：1872-8952
Myeloablative unrelated cord blood transplantation for acute leukemia patients between 50 and 55 years of age: single institutional retrospective comparison with patients younger than 50 years of age

Takaaki Konuma, Satoshi Takahashi, Jun Ooi, Akira Tomonari, Nobuhiro Tsukada, Seiko Kato, Aki Sato, Fumihiko Monma, Senji Kasahara, Tokiko Nagamura-Inoue, Kaoru Uchimaru, Tohru Iseki, Arinobu Tojo, Takuhiro Yamaguchi, Shigetaka Asano

ANNALS OF HEMATOLOGY　88　(6)　581-588　2009年6月

DOI： 10.1007/s00277-008-0641-2 　

ISSN：0939-5555

eISSN：1432-0584
The diagnostic value of vestibular-evoked myogenic potential in patients with vestibular schwannoma

Munetaka Ushio, Shinichi Iwasaki, Toshihisa Murofushi, Keiko Sugasawa, Yasuhiro Chihara, Chisato Fujimoto, Masako Nakamura, Takuhiro Yamaguchi, Tatsuya Yamasoba

CLINICAL NEUROPHYSIOLOGY　120　(6)　1149-1153　2009年6月

DOI： 10.1016/j.clinph.2009.01.017 　

ISSN：1388-2457
Cerebrovascular Accidents in Ranibizumab

Takashi Ueta, Yasuo Yanagi, Yasuhiro Tamaki, Takuhiro Yamaguchi

OPHTHALMOLOGY　116　(2)　362-362　2009年2月

ISSN：0161-6420
RESPONSE SHIFT IN A RANDOMIZED CONTROLLED TRIAL OF LOW VISION CARE FOR PATIENTS WITH AGE-RELATED MACULOPATHY 査読有り

K. Shimozuma, T. Yamaguchi, K. Fujita, M. Yuzawa, Y. Suzukamo, N. Takahashi, K. Takahashi, S. Morita, S. Fukuhara

VALUE IN HEALTH　11　(6)　A621-A622　2008年11月

ISSN：1098-3015
Testing of vibratory thresholds as a clinical examination for patients with unsteadiness due to somatosensory disorders

Munetaka Ushio, Toshihisa Murofushi, Yasuhiro Chihara, Shinichi Iwasaki, Takuhiro Yamaguchi, Kimitaka Kaga

GAIT & POSTURE　28　(4)　552-558　2008年11月

DOI： 10.1016/j.gaitpost.2008.03.010 　

ISSN：0966-6362
Chronic graft-versus-host disease following umbilical cord blood transplantation: retrospective survey involving 1072 patients in Japan

Hiroto Narimatsu, Shigesaburo Miyakoshi, Takuhiro Yamaguchi, Masahiro Kami, Tomoko Matsumura, Koichiro Yuji, Naoko Murashige, Eiji Kusumi, Yuko Kodama, Tsunehiko Komatsu, Hisashi Sakamaki, Yasushi Kouzai, Masaya Okada, Yuko Osugi, Ryoji Kobayashi, Masami Inoue, Satoshi Takahashi, Shunro Kai, Koji Kato, Tokiko Inoue-Nagamura, Shuichi Taniguchi, Shunichi Kato

BLOOD　112　(6)　2579-2582　2008年9月

DOI： 10.1182/blood-2007-11-118893 　

ISSN：0006-4971
Chemotherapeutic agents used in patients with malignant mesothelioma and their myelotoxicity: A retrospective survey in the west part of Japan 査読有り

Shuko Nojiri, Tsugumichi Sato, Takuhiro Yamaguchi, Kennichi Gemba, Keisuke Aoe, Katsuya Kato, Takumi Kishimoto, Kiyoshi Kubota

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY　17　S154-S155　2008年8月

ISSN：1053-8569
Phase I trial of r viscumin (INN : aviscumine) given subcutaneously in patients with advanced cancer: A study of the European Organisation for Research and Treatment of Cancer (EORTC protocol number 13001)

Lothar Bergmann, Steiner Aamdal, Sandrine Marreaud, Denis Lacombe, Manfred Herold, Takuhiro Yamaguchi, Karin Wilhelm-Ogunbiyi, Hans Lentzen, Heinz Zwierzina

EUROPEAN JOURNAL OF CANCER　44　(12)　1657-1662　2008年8月

DOI： 10.1016/j.ejca.2008.05.005 　

ISSN：0959-8049

eISSN：1879-0852
加齢黄斑症(ARM)に起因する視力障害を有する高齢者のQOLとロービジョンケアの需要に関する研究ロービジョンケアがQOLとレスポンスシフトに及ぼす影響査読有り

下妻晃二郎, 福原俊一, 湯澤美都子, 藤田京子, 大橋靖雄, 山口拓洋, 鈴鴨よしみ, 高橋寛二, 高橋奈津子

大和証券ヘルス財団研究業績集　31　111-113　2008年3月
Regional differences exist in allogeneic stem cell transplantation rates for acute leukemia

Yuji Miura, Takuhiro Yamaguchi, Takayuki Azuma, Tamae Hamaki, Yuko Kodama, Eiji Kusumi, Tomoko Matsumura, Toshihiko Nakamura, Masahiro Kami, Tsunehiko Komatsu

INTERNATIONAL JOURNAL OF HEMATOLOGY　87　(2)　236-238　2008年3月

DOI： 10.1007/s12185-008-0049-8 　

ISSN：0925-5710
Analyses of risk factors for postoperative airway compromise following arytenoid adduction 査読有り

Takaharu Nito, Munetaka Ushio, Miwako Kimura, Takuhiro Yamaguchi, Niro Tayama

ACTA OTO-LARYNGOLOGICA　128　(12)　1342-1347　2008年

DOI： 10.1080/00016480801958303 　

ISSN：0001-6489
Clinical characteristics and outcomes in patients with t(8;21) acute myeloid leukemia in Japan [3] 査読有り

Narimatsu H, Yokozawa T, Iida H, Tsuzuki M, Hayakawa M, Takeo T, Iino M, Ichihashi T, Kato C, Sawamoto A, Sao H, Yanada M, Emi N, Kiyoi H, Yamaguchi T, Naoe T, Suzuki R, Sugiura I

Leukemia　22　(2)　428-432　2008年

DOI： 10.1038/sj.leu.2404905 　
Meaninglessness in Terminally Ill Cancer Patients: A Randomized Controlled Study

Morita T, Murata H, Kishi E, Miyashita M, Yamaguchi T, Uchitomi Y, on behalf of, the, Japanese Spiritual Care, Task Force

Journal of Pain Symptom Management　37　(4)　649-658　2008年
Analyses of risk factors for postoperative airway compromise following arytenoid adduction

Nito T, Ushio M, Kimura M, Yamaguchi T, Tayama N

Acta Oto-Laryngologica　21　1-6　2008年
Current Status and a Nationwide Challenge to Improve Palliative Care by the Cancer Control Act and the Outreach Palliative Care Trial of Integrated Regional Model (OPTIM) Study

Yamagishi A, Morita T, Miyashita M, Akizuki N, Kizawa Y, Shirahige Y, Akiyama M, Hirai K, Kudo T, Yamaguchi T, Fukushima A, Eguchi K. Palliative, Care in Japan

American Journal of Hospice and Palliative Medicine　44　(12)　1657-1662　2008年
Prediction of the prognosis of Bell's palsy using multivariate analyses

Munetaka Ushio, Kenji Kondo, Naonobu Takeuchi, Hitoshi Tojima, Takuhiro Yamaguchi, Kimitaka Kaga

OTOLOGY & NEUROTOLOGY　29　(1)　69-72　2008年1月

ISSN：1531-7129
Impact of ABO incompatibility on engraftment and transfusion requirement after unrelated cord blood transplantation: a single institute experience in Japan. 国際誌査読有り

Tomonari A, Takahashi S, Ooi J, Tsukada N, Konuma T, Kobayashi T, Sato A, Iseki T, Yamaguchi T, Tojo A, Asano S

Bone marrow transplantation　40　(6)　523-528　2007年9月
出版者・発行元： 6
DOI： 10.1038/sj.bmt.1705765 　

ISSN：0268-3369
Comparative single-institute analysis of cord blood transplantation from unrelated donors with bone marrow or peripheral blood stem-cell transplants from related donors in adult patients with hematologic malignancies after myeloablative conditioning regimen

Satoshi Takahashi, Jun Ooi, Akira Tomonari, Takaaki Konuma, Nobuhiro Tsukada, Maki Oiwa-Monna, Kenji Fukuno, Michihiro Uchiyama, Kashiya Takasugi, Tohru Iseki, Arinobu Tojo, Takuhiro Yamaguchi, Shigetaka Asano

BLOOD　109　(3)　1322-1330　2007年2月

DOI： 10.1182/blood-2006-04-020172 　

ISSN：0006-4971

eISSN：1528-0020
Assessment of the quality of life in patients with age-related macular degeneration 1 year after photodynamic therapy

Tetsuhiro Kyo, Mitsuko Yuzawa, Kasumi Tochigi, Takuhiro Yamaguchi, Kojiro Shimozuma, Shunichi Fukuhara, Yoko Matsumoto

Nippon Ganka Gakkai zasshi　111　(4)　315-321　2007年

ISSN：0029-0203
加齢黄斑症の読書困難に対するロービジョンケア前後のQuality of life評価(会議録).

藤田京子, 湯沢美都子, 山口拓洋, 下妻晃二郎, 柏原康佑, 斉藤真梨, 大橋靖雄, 鈴鴨よしみ, 福原俊一

日本眼科学会雑誌　111　(suppl)　180-180　2007年
Impact of cytomegalovirus serostatus on outcome of unrelated cord blood transplantation for adults: a single-institute experience in Japan

Tomonari A, Takahashi S, Ooi J, Tsukada N, Konuma T, Kato S, Kasahara S, Iseki T, Yamaguchi T, Tojo A, Asano S

European Journal of Haematology　80　(3)　251-257　2007年
加齢黄斑変性患者に対する光線力学療法1年後のquality of life評価

姜哲浩, 湯沢美都子, 栃木香寿美, 山口拓洋, 下妻晃二郎, 福原俊一, 松本容子

日本眼科学会雑誌　111　(4)　315-321　2007年
Predictors of seminal vesicle invasion before radical prostatectomy

Yuzuri Tsurumaki, Kyoichi Tomita, Haruki Kume, Takuhiro Yamaguchi, Teppei Morikawa, Satoru Takahashi, Takumi Takeuchi, Tadaichi Kitamura

INTERNATIONAL JOURNAL OF UROLOGY　13　(12)　1501-1508　2006年12月

DOI： 10.1111/j.1442-2042.2006.01605.x 　

ISSN：0919-8172
Posttransplantation engraftment and safety of cord blood transplantation with grafts containing relatively low cell doses in adults

Satoshi Takahashi, Jun Ooi, Akira Tomonari, Takaaki Konuma, Nobuhiro Tsukada, Arinobu Tojo, Takuhiro Yamaguchi, Shigetaka Asano

INTERNATIONAL JOURNAL OF HEMATOLOGY　84　(4)　359-362　2006年11月

DOI： 10.1532/IJH97.06109 　

ISSN：0925-5710
Usefulness of LigaSure for liver resection: analysis by randomized clinical trial

A Saiura, J Yamamoto, R Koga, Y Sakamoto, N Kokudo, M Seki, T Yamaguchi, T Yamaguchi, T Muto, M Makuuchi

AMERICAN JOURNAL OF SURGERY　192　(1)　41-45　2006年7月

DOI： 10.1016/j.amjsurg.2006.01.025 　

ISSN：0002-9610
The prognostic value of E-cadherin, alpha-, beta-, and gamma-catenin in urothelial cancer of the upper urinary tract

K Kashibuchi, K Tomita, JA Schalken, H Kume, T Yamaguchi, S Muto, S Horie, T Kitamura

EUROPEAN UROLOGY　49　(5)　839-845　2006年5月

DOI： 10.1016/j.eururo.2005.12.023 　

ISSN：0302-2838
Difference of progression to AIDS according to CD4 cell count, plasma HIV RNA level and the use of antiretroviral therapy among HIV patients infected through blood products in Japan

M Kawado, S Hashimoto, T Yamaguchi, S Oka, K Yoshizaki, S Kimura, K Fukutake, S Higasa, T Shirasaka

JOURNAL OF EPIDEMIOLOGY　16　(3)　101-106　2006年5月

ISSN：0917-5040
Assessment of the quality of life of patients with age-related macular degeneration after photodynamic therapy

Tetsuhiro Kyo, Yoko Matsumoto, Kasumi Tochigi, Mitsuko Yuzawa, Takuhiro Yamaguchi, Atsushi Komoto, Kojiro Shimozuma, Shunichi Fukuhara

Nippon Ganka Gakkai zasshi　110　(9)　710-716　2006年

ISSN：0029-0203
Clinical effects of photodynamic therapy with Verteporfin for age-related macular degeneration 1: three-month results

Kasumi Tochigi, Yoko Matsumoto, Tetsuhiro Kyo, Takuhiro Yamaguchi, Atsushi Komoto, Mitsuko Yuzawa, Koujiro Shimotsuma, Shunichi Fukuhara

Nippon Ganka Gakkai zasshi　110　(9)　703-709　2006年

ISSN：0029-0203
加齢黄斑変性患者に対する光線力学療法のquality of life 評価

姜哲浩, 松本容子, 栃木香寿美, 湯沢美都子, 山口拓洋, 広本篤, 下妻晃二郎, 福原俊一

日本眼科学会雑誌　110　(9)　710-716　2006年
加齢黄斑変性に対する光線力学的療法の評価その1：3か月後の臨床所見

栃木香寿美, 松本容子, 姜哲浩, 山口拓洋, 広本篤, 湯沢美都子, 下妻晃二郎, 福原俊一

日本眼科学会雑誌　110　(9)　703-709　2006年
再発事象データの解析

山口拓洋

計量生物学　26　(2)　81-117　2005年12月31日
出版者・発行元： The Biometric Society of Japan
DOI： 10.5691/jjb.26.81 　

ISSN：0918-4430

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Recurrent events data such as epileptic seizures and recurrence of superficial bladder cancer are frequently encountered in medical researches when individuals may experience multiple events of the same type. The analysis of recurrent events is complicated because related recurrent events within a subject are correlated and we need to take into account the dependence of responses from the same subject to draw valid statistical inferences. In principle, statistical strategies are classified into two approaches. The one is we focus on the number of events occurring within defined time intervals and compare / model the event rate (number of events per unit of time). The other is the recurrence times are viewed as multivariate failure times and survival analysis methods are applied. According to this perspective, we review several statistical methods to analyze recurrent events data and illustrate the techniques with real medical applications. We recommend that the choice of the endpoint (effect measure) and the corresponding statistical analysis method should be determined by the study purpose. Robust methods for the assumption of event occurring process should be used especially for analyzing confirmatory studies.
看護系教育課程を持つ大学における疫学・生物統計学教育の実態調査

田中司朗, 山口拓洋, 大橋靖雄

日本公衆衛生雑誌　52　(1)　66-75　2005年
Adjusting for differential proportions of second-line treatment in cancer clinical trials. Part I: Structural nested models and marginal structural models to test and estimate treatment arm effects

T Yamaguchi, Y Ohashi

STATISTICS IN MEDICINE　23　(13)　1991-2003　2004年7月

DOI： 10.1002/sim.1816 　

ISSN：0277-6715
Validity and clinical applicability of the Japanese version of amyotrophic lateral sclerosis: Assessment questionnaire 40 (ALSAQ-40) 査読有り

Takuhiro Yamaguchi, Sadayoshi Ohbu, Mari Saito, Yoichi Ito, Fumio Moriwaka, Kunio Tashiro, Yasuo Ohashi, Shun-Ichi Fukuhara

Brain and Nerve　56　(6)　483-494　2004年6月

ISSN：0006-8969
Comparative analysis of clinical outcomes after allogeneic bone marrow transplantation versus peripheral blood stem cell transplantation from a related donor in Japanese patients

TE Tanimoto, T Yamaguchi, Y Tanaka, A Saito, K Tajima, T Karasuno, M Kasai, K Kishi, T Mori, N Maseki, S Morishima, S Miyakoshi, M Kasai, Y Ohno, SW Kim, A Numata, M Kami, Y Takaue, S Mori, M Harada

BRITISH JOURNAL OF HAEMATOLOGY　125　(4)　480-493　2004年5月

DOI： 10.1111/j.1365-2141.2004.04943.x 　

ISSN：0007-1048
Identification of gene expression profile in tolerizing murine cardiac allograft by costimulatory blockade 査読有り

Yuichi Matsui, Akio Saiura, Yasuhiko Sugawara, Masataka Sata, Katsutoshi Naruse, Hideo Yagita, Takahide Kohro, Chikage Mataki, Akashi Izumi, Takuhiro Yamaguchi, Takashi Minami, Toshiko Sakihama, Sigeo Ihara, Hiroyuki Aburatani, Takao Hamakubo, Tatsuhiko Kodama, Masatoshi Makuuchi

Physiological Genomics　15　199-208　2004年1月

ISSN：1531-2267
Epidemiological characteristics of HIV and AIDS in Japan based on HIV/AIDS Surveillance Data: An International Comparison

Matsuyama Y, Yamaguchi T, Hashimoto S, Kawado M, Ichikawa S, Umeda T, Kihara M

日本エイズ学会誌　6　(3)　184-193　2004年
出版者・発行元： The Japanese Society for AIDS Research
DOI： 10.11391/aidsr1999.6.184 　

ISSN：1344-9478

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Objective: The aim of this study was to compare the annual trends in the reported number of Japanese HIV/AIDS cases, and the distribution of sex, age and route of infection. The increasing trend of reported AIDS cases at the onset of the Japan epidemic was also compared with those of other industrialized countries.<BR>Materials and Methods: HIV/AIDS surveillance data through December 2001 were utilized. As for the comparison of increasing trends at the onset of the epidemic, the Epidemiological Facts Sheets organized by the UNAIDS/WHO (United Nations Programme on AIDS/World Health Organization) were used. Nine industrialized countries, the USA, EU (European Union) (51 countries of the WHO European Region), Canada, Australia, UK, Germany, Italy, Spain, and France were selected for comparisons.<BR>Results: Comparisons of Japanese HIV/AIDS with other industrialized countries revealed that the annual trend in reported cases was still increasing. The proportion of people with HIV aged 40 or above was high, and the proportion of males with HIV infected through heterosexual contact was extremely high. The increasing trend in reported AIDS cases at the onset of the Japan epidemic was extremely slow compared to that in other countries. In particular, there were differences in the number of cases infected through MSM (men who have sex with men), including bisexual contact, and or IDU (injecting drug use).<BR>Conclusion: The epidemiological characteristics of HIV/AIDS in Japan, such as annual trends, and the distribution of sex, age and route of infection were revealed by comparisons with the surveillance data from nine other countries.
ALS特異的QOL尺度ALSAQ-40日本語版－その妥当性と臨床応用にむけて－

山口拓洋, 大生定義, 斎藤真梨, 伊藤陽一, 森若文雄, 田代邦雄, 大橋靖雄, 福原俊一

脳と神経　56　(6)　483-494　2004年
出版者・発行元：医学書院
ISSN：1881-6096
エイズ拠点病院におけるHIV/AIDSの受療者数の推移

川戸美由紀, 橋本修二, 山口拓洋, 松山裕, 中村好一, 木村博和, 市川誠一, 木原正博, 白坂琢磨

日本エイズ学会誌　6　(1)　31-36　2004年
出版者・発行元： The Japanese Society for AIDS Research
DOI： 10.11391/aidsr1999.6.31 　

ISSN：1344-9478

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目的: 全国のブロック拠点病院・拠点病院におけるHIV/AIDS受療者数とその施設間差の推移について検討した。<BR>対象および方法: 全国のブロック拠点病院・拠点病院を対象として2001年および2002年に郵送法の調査を実施し, 各年4月1日現在の, 国籍別, HIV・AIDS別の受療者数 (経過観察中を含む) を調べた。両年とも調査票が回収された施設でのHIV/AIDS受療者数 (血液製剤による感染を除く) について両年を比較した。<BR>結果: 両年とも回収された施設は314 (86%) であった。HIV/AIDS受療者数は2001年に2,976人, 2002年には3,991人であり, 2001年の1.34倍であった。HIV感染者・AIDS患者別ではそれぞれ1.36倍, 1.31倍であり, 日本国籍では1.36倍, 外国国籍では1.21倍であった。東京では1.22倍, 関東・甲信越 (東京を除く) では1.35倍であり, その他の地域ブロックでは1.33倍-1.91倍であった。両年とも受療者数が0人の施設が多く, 一方50人以上の施設もみられた。また, 2001年受療者数が多い施設ほど平均増加受療者数は大きかった。<BR>結論: HIV/AIDS受療者数は2001年から2002年で1.34倍と増加し, その増加程度は国籍や地域ブロックで異なった。受療者数の施設間差は大きく, また拡大傾向であった。
血液製剤によるHIV感染者の調査成績(第一報)CD4値,HIV-RNA量と治療の現状と推移

白阪琢磨, 日笠聡, 岡慎一, 川戸美由紀, 山口拓洋, 吉崎和幸, 木村哲, 福武勝幸, 橋本修二

日本エイズ学会誌　5　(4)　319-319　2003年11月
出版者・発行元： (一社)日本エイズ学会
ISSN：1344-9478
血液製剤によるHIV感染者の調査成績(第2報) AIDS発病とCD4値,HIV-RNA量,抗HIV治療との関連性

川戸美由紀, 橋本修二, 山口拓洋, 岡慎一, 吉崎和幸, 木村哲, 福武勝幸, 日笠聡, 白阪琢磨

日本エイズ学会誌　5　(4)　320-320　2003年11月
出版者・発行元： (一社)日本エイズ学会
ISSN：1344-9478
Identification of gene expression profile in tolerizing murine cardiac allograft by costimulatory blockade

Y Matsui, A Saiura, Y Sugawara, M Sata, K Naruse, H Yagita, T Kohro, C Mataki, A Izumi, T Yamaguchi, T Minami, T Sakihama, S Ihara, H Aburatani, T Hamakubo, T Kodama, M Makuuchi

PHYSIOLOGICAL GENOMICS　15　(3)　199-208　2003年11月

DOI： 10.1152/physiolgenomics.00086.2003 　

ISSN：1094-8341
[Validation of the Japanese version of the Parkinson's Disease Questionnaire].

Junko Kohmoto, Sadayoshi Ohbu, Masanori Nagaoka, Yoshimi Suzukamo, Tameko Kihira, Yoshikuni Mizuno, Yoichi M Ito, M Hith, Takuhiro Yamaguchi, Yasuo Ohashi, Shunichi Fukuhara, Tomoyoshi Kondo

Rinsho shinkeigaku = Clinical neurology　43　(3)　71-6　2003年3月

ISSN：0009-918X

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UNLABELLED: The PDQ-39 (Parkinson's Disease Questionnaire-39) is a specific quality-of-life (QOL) scale for patients with Parkinson's disease (PD). It evaluates the dysfunction of daily living and quality of life. We developed the Japanese-translated version of PDQ-39 and examined the validity of the PDQ-39 in Japanese PD patients. SUBJECTS: A total of 156 patients with PD were studied (age 35-86 years, Hoehn-Yahr stage 1 to 4). None of the patients had dementia. METHODS: Semi-structured interviews were conducted by one trained interviewer. The PDQ-39, SF-36 (36-item short form of the Medical Outcome Study questionnaire), EQ5D (Euro Qol), and NAS-J (Nottingham Adjustment Scale Japanese version) were used for evaluation. The attending physician of each patient rated the patient's condition by using the UPDRS (Unified Parkinson's Disease Rating Scale). RESULTS: Exploratory factor analysis, Cronbach alpha, and construct validity were fair, and there were significant correlations between the results of the PDQ-39 and the corresponding parts of the UPDRS and SF-36, and the Hoehn-Yahr stage, respectively. CONCLUSION: The Japanese version of the PDQ-39 is valuable for evaluating the QOL of Japanese patients with PD. Results of comparison of PDQ-39 with other scales of the QOL such as NAS-J suggest the possibility that acceptance of the disease and feelings of self-achievement improve the QOL of patients with Parkinson's disease.
International Prostate Symptom ScoreとBPH Impact Indexの日本語訳の計量心理学的検討

本間之夫, 塚本泰司, 安田耕作, 大園誠一郎, 吉田正貴, 山口拓洋

日本泌尿器科学会雑誌　94　(5)　560-569　2003年
出版者・発行元：社団法人日本泌尿器科学会
DOI： 10.5980/jpnjurol1989.94.560 　

ISSN：0021-5287

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(目的) International Prostate Symptom Score (IPSS) と BPH Impact Index (BII) の日本語訳の計量心理学的妥当性を検討すること.<br>(方法) IPSSとBIIの日本語質問表について, 103例の前立腺肥大症患者と23例の主観的には無症状の男性より回答を得た. 82例の患者については2週間後に再度調査し, 再現性を検討した. このうち21例の患者では, 更に2週間後に「この1か月」を「この1週間」とした質問紙にも回答を求めた. 反応性を検討するために, 22例の患者で治療後にも再調査した. あわせて, 内的一貫性, 構成的妥当性, 判別的妥当性も検討した.<br>(結果) 再現性は, 全ての項目で重み付きκ係数が0.62以上と, 良好であった. 年齢, 症状重症度, 施設類型, 質問の対象期間が「この1か月」か「この1週間」かで, 再現性は有意な影響を受けなかった. Cronbach's αは0.83以上で, 内的一貫性も高かった. 主成分分析ではIPSSには2つ, BIIでは1つの主成分を検出し, 第一主成分にはどの項目も関与しており, ある程度の一次元性が確認された. ほとんどの項目は他の項目や外的基準 (最大尿流率, 残尿量, 前立腺体積) と有意な相関を示した. 全ての項目でスコアは無症状の男性に比べて患者で明かに高値で, 治療により減少した.<br>(結論) IPSSとBIIの日本語訳は, 日本人において信頼性, 妥当性, 一次元性が示された. これらの日本語訳は原文に相当すると考えられる.
日本人におけるParkinson's Disease Questionnaire-39（PDQ-39）の信頼性評価

河本純子, 大生定義, 長岡正範, 鈴鴨よしみ, 紀平為子, 水野美邦, 伊藤陽一, 山口拓洋, 大橋靖雄, 福原俊一, 近藤智善

臨床神経学　43　71-76　2003年
Protein binding of valproic acid in Japanese pediatric and adult patients with epilepsy

Y Kodama, H Kodama, M Kuranari, K Tsutsumi, S Ono, T Yamaguchi, A Fujimura

AMERICAN JOURNAL OF HEALTH-SYSTEM PHARMACY　59　(9)　835-840　2002年5月

ISSN：1079-2082
A case-control study of risk factors for development of type 2 diabetes: Emphasis on physical activity

Luping Wang, Takuhiro Yamaguchi, Toshiko Yoshimine, Akane Katagiri, Kazuko Shirogane, Yasuo Ohashi

Journal of Epidemiology　12　(6)　424-430　2002年
出版者・発行元： Japan Epidemiology Association
DOI： 10.2188/jea.12.424 　

ISSN：1349-9092 0917-5040
Significance of nocturia in the International Prostate Symptom Score for benign prostatic hyperplasia

Y Homma, T Yamaguchi, Y Kondo, S Horie, S Takahashi, T Kitamura

JOURNAL OF UROLOGY　167　(1)　172-176　2002年1月

ISSN：0022-5347
エイズ治療の拠点病院におけるHIV/AIDSの受療者数

山口拓洋, 橋本修二, 川戸美由紀, 中村好一, 木村博和, 市川誠一, 松山裕, 木原正博, 白阪琢磨

日本エイズ学会誌　4　(3)　91-95　2002年
出版者・発行元： (一社)日本エイズ学会
ISSN：1344-9478
HIV感染者数とAIDS患者数のシステム分析による中長期展望の試み

橋本修二, 福富和夫, 山口拓洋, 松山裕, 中村好一, 木村博和, 市川誠一, 木原正博

日本エイズ学会誌　4　(1)　8-16　2002年
A comparison of gene expression in murine cardiac allografts and isografts by means dna microarray analysis

A Saiura, C Mataki, T Murakami, M Umetani, Y Wada, T Kohro, H Aburatani, Y Harihara, T Hamakubo, T Yamaguchi, G Hasegawa, M Naito, M Makuuchi, T Kodama

TRANSPLANTATION　72　(2)　320-329　2001年7月

ISSN：0041-1337
血液製剤によるHIV感染者のCD4値、HIV-RNA量と抗HIV治療の推移、および、それらの関連

山口拓洋, 橋本修二, 岡慎一, 吉崎和幸, 木村哲, 福武勝幸, 白阪琢磨

日本エイズ学会誌　3　(1)　23-30　2001年
出版者・発行元： The Japanese Society for AIDS Research
DOI： 10.11391/aidsr1999.3.23 　

ISSN：1344-9478

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目的: 血液製剤によるHIV感染者において, CD4値とHIV-RNA量, 抗HIV治療についての推移とそれらの関連性を明らかにする.<br>対象及び方法: 「エイズ発症予防に資するための血液製剤によるHIV感染者の調査研究事業」において, 1993～1998年度に提出されたデータを基礎とした. 1993年度第4期当初の事業対象者417人 (1993年度コホート) について, 1998年度までのAIDS発病状況とCD4値の推移を検討した. 1997年度第1期当初の事業対象者604人 (1997年度コホート) について, CD4値, HIV-RNA量と抗HIV薬の投与状況の推移, および, それらの関連性を分析した.<BR>結果: 1993年度コホートのAIDS発病者数 (死亡を含む) は1993-1996年度の各4半期で平均8.7人を推移していたが, 1997年度以降は平均1.8人とかなり少なかった. CD4値の中央値は, 1993年度第1期の287/μlから1996年度では172-203と低下傾向であったが, 1997年度以降は, 1997年度第1期の206から1998年度第4期の240へと上昇傾向であった. 1997年度コホートのHIV-RNA量については, 1997年度第1期の2,600コピー/mlから1998年度第4期の685へと中央値は低下しており, また, 同時期の抗HIV薬の併用区分については,「RTI1剤」と「RTI2剤」の割合が低下し「RTI2剤+PI1剤」の割合が15.196から36.6%へと上昇していた. さらに, 抗HIV薬の併用区分の変更とCD4値, HIV-RNA量の変化との関連性が示唆された.<BR>結論: 本事業対象者に対する抗HIV治療は「RTI2剤+PI1剤」の割合が上昇しており, CD4値, HIV-RNA量ともに改善傾向が見られ, さらに, これらの関連性が示唆された.
血液製剤によるHIV感染者のCD4値、HIV-RNA量と抗HIV治療の現状

橋本修二, 山口拓洋, 岡慎一, 吉崎和幸, 木村哲, 福武勝幸, 白阪琢磨

日本エイズ学会誌　3　(1)　16-22　2001年
出版者・発行元： The Japanese Society for AIDS Research
DOI： 10.11391/aidsr1999.3.16 　

ISSN：1344-9478

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目的: 血液製剤によるHIV感染者におけるCD4値とHIV-RNA量, 抗HIV治療, および, 服薬と副作用の状況を明らかにすることを目的とした.<BR>対象及び方法: 「エイズ発症予防に資するための血液製剤によるHIV感染者の調査研究事業」に提出された資料に基づいて, 平成11年1-3月の事業対象者658人について, CD4値, HIV-RNA量, 抗HIV薬の投与・服用状況, 副作用, カリニ予防薬と眼底検査の状況を分析した.<BR>結果: CD4値350/μl以上が52%, HIV-RNA量999コピー/ml以下が61%であった. 「RTI2剤+PI1剤」の投与が39%, 抗HIV薬の投与なしが32%であった.CD4値349以下の者は350以上の者に比べて, また, HIV-RNA量999以下の者は1,000以上の者に比べて「RTI2剤+PI1剤」の割合が大きかったが, 「投与なし」や「RTI2剤」もかなり見られた.抗HIV薬の服用状況としては「全部服用」85%であり, 副作用としては下痢14%などであった.「RTI2剤+PI1剤」は他の併用区分と比べて, 服用状況が悪い傾向は見られなかったが, 副作用として下痢が多かった.CD4値199以下の者は200以上の者に比べて, ST合剤の投与が多かったが, その割合はあまり高くなかった.<BR>結論: CD4値とHIV-RNA量は比較的管理されているが, AIDSと合併症の発病予防に向けてさらに改善の余地の可能性が示唆された.
Predictability of conventional tests for the assessment of bladder outlet obstruction in benign prostatic hyperplasia

Yukio Homma, Momokazu Gotoh, Mineo Takei, Kazuki Kawabe, Takuhiro Yamaguchi

International Journal of Urology　5　(1)　61-66　1998年
出版者・発行元： Blackwell Publishing
DOI： 10.1111/j.1442-2042.1998.tb00238.x 　

ISSN：0919-8172
Serum leptin levels are associated with hyperinsulinemia independent of body mass index but not with visceral obesity

H KimMotoyama, T Yamaguchi, T Katakura, M Miura, Y Ohashi, Y Yazaki, T Kadawaki

BIOCHEMICAL AND BIOPHYSICAL RESEARCH COMMUNICATIONS　239　(1)　340-344　1997年10月

ISSN：0006-291X
A Mutation of the β3-Adrenergic Receptor is Associated with Visceral Obesity but Decreased Serum Triglyceride

Kim-Motoyama H, Yasuda K, Yamaguchi T, Yamada N, Ohashi Y

Diabetologia　40　(4)　469-472　1997年4月

ISSN：0012-186X
Estimate criteria for efficacy of treatment in benign prostatic hyperplasia

Yukio Homma, Kazuki Kawabe, Taiji Tsukamoto, Osamu Yamaguchi, Kiyoki Okada, Yoshio Aso, Hiroki Watanabe, Eigoro Okajima, Joichi Kumazawa, Takuhiro Yamaguchi, Yasuo Ohashi

International Journal of Urology　3　(4)　267-273　1996年
出版者・発行元： Blackwell Publishing
DOI： 10.1111/j.1442-2042.1996.tb00532.x 　

ISSN：0919-8172
Estimate criteria for diagnosis and severity in benign prostatic hyperplasia

Yukio Homma, Kazuki Kawabe, Taiji Tsukamoto, Osamu Yamaguchi, Kiyoki Okada, Yoshio Aso, Hiroki Watanabe, Eigoro Okajima, Joichi Kumazawa, Takuhiro Yamaguchi, Yasuo Ohashi

International Journal of Urology　3　(4)　261-266　1996年

ISSN：0919-8172
表在性膀胱がん膀胱内注入療法、国内のメタアナリシス

樋之津史郎, 山口拓洋, 大橋靖雄

腎泌予防医誌　4　66-70　1995年

︎全件表示 ︎最初の5件までを表示

MISC 137

がん患者の術後せん妄に対する個別化医療の開発

貞廣良一, 大渕勝也, 大渕勝也, 杉本昌弘, 杉本昌弘, 山口拓洋, 和田佐保, 和田佐保, 清水研, 松岡弘道, 上園保仁

日本緩和医療薬学会年会プログラム・要旨集　17th　2024年
臨床データマネジャー認定制度の検討状況について

高田宗典, 高田宗典, 倉本宏美, 藤澤健司, 梨本真広, 神田悟志, 宮路天平, 宮路天平, 西基秀, 菅波秀規, 菅波秀規, 山口拓洋, 山口拓洋

薬理と治療　51　(Suppl.1)　2023年

ISSN： 0386-3603
PRO-CTCAE

山口拓洋, 川口崇, 宮路天平

腫瘍内科 = Clinical oncology / 腫瘍内科編集委員会編　30　(3)　318-321　2022年9月
出版者・発行元：科学評論社
ISSN： 1881-6568
持続的鎮静によって患者がコミュニケーションできる機会は失われるか

横道直佑, 山口拓洋, 森田達也, 羽多野裕, 今井堅吾, 木澤義之, 恒藤暁, 志摩泰夫, 升川研人, 宮下光令, 森雅紀

Palliative Care Research　17　(Suppl.)　S.184-S.184　2022年7月
出版者・発行元： (NPO)日本緩和医療学会
eISSN： 1880-5302
医師のPRO調査票とePROに対する認識と日常診療への導入に関する調査

宮路天平, 川口崇, 堀江良樹, 土井綾子, 小倉孝氏, 兼安貴子, 釆野優, 長島文夫, 下妻晃二郎, 下妻晃二郎, 山口拓洋, 中島貴子

日本がんサポーティブケア学会学術集会プログラム・抄録集　7th (Web)　2022年
BALAST:タキサンおよびラムシルマブ併用化学療法を受けた進行胃癌患者の栄養状態に関する観察研究【JST・京大機械翻訳】

川端良平, 川端良平, 水上拓郎, 水上拓郎, 宮路天平, 松島知広, 小倉孝氏, 成田有季哉, 川口崇, 宮垣博道, 伊澤直樹, 原浩樹, 室圭, 山口拓洋, 中島貴子, 中島貴子

日本がんサポーティブケア学会学術集会プログラム・抄録集　7th (Web)　2022年
がんの日常診療におけるePROによる症状モニタリングの有用性の評価および,有害事象とQoLの実態に関するレジストリ研究(RegiPRO study)

堀江良樹, 宮路天平, 土井綾子, 川口崇, 小倉孝氏, 兼安貴子, 長島文夫, 中島貴子, 山口拓洋

日本がんサポーティブケア学会学術集会プログラム・抄録集　7th (Web)　2022年
膵がん患者と腫瘍医の標準治療後の療養の話し合いを促進する統合介入の有効性評価のための無作為化比較試験:J-SUPPORT1704

藤森麻衣子, 佐藤綾子, 奥坂拓志, 山口拓洋, 池田公史, 上野誠, 尾阪将人, 宮路天平, 益子友恵, 岡村優子, 後藤真一, 眞島喜幸, 内富庸介

日本臨床腫瘍学会学術集会(CD-ROM)　19th　2022年
補助化学療法後の乳がん患者を対象とした電子的患者報告アウトカムによる遷延性症状関連有害事象に関する観察研究;ASTRO試験(Trial in Progress)

佐野元彦, 佐野元彦, 原田知彦, 原田知彦, 稲田佑亮, 稲田佑亮, 国吉央城, 国吉央城, 畠山朋樹, 畠山朋樹, 戸塚孝治, 戸塚孝治, 伊藤剛貴, 伊藤剛貴, 川田亮, 川田亮, 森本真宗, 森本真宗, 中野泰寛, 中野泰寛, 川口崇, 宮路天平, 山口拓洋

日本がんサポーティブケア学会学術集会プログラム・抄録集　7th (Web)　2022年
Effect of paracentesis on the survival of patients with terminal cancer and ascites: A propensity score-weighted analysis of the EASED study.

Ken Masuda, Hiroto Ishiki, Naosuke Yokomichi, Takuhiro Yamaguchi, Tetsuya Ito, Hana Takatsu, Koji Amano, Shuji Hiramoto, Takuhiro Yamaguchi, Takashi Kawaguchi, Masanori Mori, Yosuke Matsuda, Takashi Yamaguchi

JOURNAL OF CLINICAL ONCOLOGY　39　(15)　2021年5月

DOI： 10.1200/JCO.2021.39.15_suppl.e24063 　

ISSN： 0732-183X

eISSN： 1527-7755
Effectiveness of a nurse-led, screening-triggered, early specialized palliative care intervention program for patients with advanced lung cancer: A multicenter randomized controlled trial.

Yoshihisa Matsumoto, Ayumi Okizaki, Daisuke Kiuchi, Shigeki Umemura, Takuhiro Yamaguchi, Shunsuke Oyamada, Daisuke Fujisawa, Naoko Kobayashi, Tempei Miyaji, Tomoe Mashiko, Eriko Satomi, Yuko Uehara, Kazuhiro Kosugi, Hiroya Kinoshita, Masanori Mori, Tatsuya Yoshida, Koichi Goto, Yuichiro Ohe, Yosuke Uchitomi, Tatsuya Morita

JOURNAL OF CLINICAL ONCOLOGY　39　(15)　2021年5月

DOI： 10.1200/JCO.2021.39.15_suppl.12097 　

ISSN： 0732-183X

eISSN： 1527-7755
がん患者の周術期精神症状に対する抑肝散の有効性および安全性に関する二重盲検ランダム化比較試験

和田佐保, 和田佐保, 貞廣良一, 松岡豊, 松岡豊, 内富庸介, 内富庸介, 内富庸介, 山口拓洋, 松岡弘道, 清水研

日本サイコオンコロジー学会総会(Web)　34th　2021年
悪性腹水を有する終末期がん患者に対する腹水穿刺が予後に与える影響

増田健, 石木寛人, 横道直佑, 山口拓洋, 伊藤哲也, 鷹津英, 天野晃滋, 平本秀二, 山内敏宏, 川口崇, 森雅紀, 松田洋祐, 山口崇

日本癌治療学会学術集会(Web)　59th　2021年
関連学会の取組と連携したPROガイドラインの作成に関する研究海外のPROGLの検索と日本語版開発

内藤真理子, 兼安貴子, 下妻晃二郎, 鈴鴨よしみ, 宮崎貴久子, 山口拓洋, 川口崇, 中島貴子, 星野絵里, 小嶋智美

関連学会の取組と連携したPROガイドラインの作成令和2年度総括・分担研究報告書(Web)　2021年
同種移植後患者の就労に関する実態調査-慢性GVHD等の自覚症状による仕事・生活への影響度に関する検討-

松浦朋子, 松浦朋子, 黒澤彩子, 黒澤彩子, 山口拓洋, 森文子, 森毅彦, 田中正嗣, 近藤忠一, 坂本周子, 藤井伸治, 一戸辰夫, 奈良美保, 前田智也, 藤澤信, 名和由一郎, 中邑幸伸, 南口仁志, 大西康, 高野久仁子, 高橋都, 福田隆浩

日本造血細胞移植学会総会プログラム・抄録集　43rd　2021年
SPIRIT-PROとCONSORT-PROの解説

宮路天平, 宮路天平, 宮路天平, 川口崇, 川口崇, 川口崇, 木村智美, 山口拓洋, 山口拓洋, 山口拓洋

日本がんサポーティブケア学会学術集会プログラム・抄録集　6th (CD-ROM)　2021年
Advance Directives/Care Planning: Clear, Simple, and Wrong

Keisuke Kaneishi, Kengo Imai, Kazunori Nishimura, Norio Sakurai, Hiroyuki Kohara, Hiroto Ishiki, Yoshiaki Kanai, Shunsuke Oyamada, Takuhiro Yamaguchi, Tatsuya Morita, Satoru Iwase

JOURNAL OF PALLIATIVE MEDICINE　23　(7)　880-881　2020年7月

DOI： 10.1089/jpm.2020.0101 　

ISSN： 1096-6218

eISSN： 1557-7740
A new standard prophylaxis for emesis caused by cisplatin? – Authors' reply

Hironobu Hashimoto, Takuhiro Yamaguchi, Masakazu Abe

The Lancet Oncology　21　(3)　e129　2020年3月1日
出版者・発行元： Lancet Publishing Group
DOI： 10.1016/S1470-2045(20)30100-5 　

ISSN： 1474-5488 1470-2045
がん患者の療養生活の最終段階における体系的な苦痛緩和法の構築に関する研究難治性がん疼痛治療実態調査・予備調査

松本禎久, 上原優子, 加藤雅志, 小杉寿文, 曽根美雪, 中村直樹, 水嶋章郎, 宮下光令, 森田達也, 山口拓洋

がん患者の療養生活の最終段階における体系的な苦痛緩和法の構築に関する研究令和元年度総括・分担研究報告書(Web)　2020年
進行がん患者に対するスクリーニングを組み合わせた看護師主導による治療早期からの専門的緩和ケア介入プログラムの臨床的有用性を検証する無作為化比較試験

沖崎歩, 沖崎歩, 松本禎久, 梅村茂樹, 小林直子, 藤澤大介, 森田達也, 山口拓洋, 森雅紀, 木下寛也, 内富庸介

日本サイコオンコロジー学会総会プログラム・抄録集　33rd (Web)　2020年
がん患者の療養生活の最終段階における体系的な苦痛緩和法の構築に関する研究がん疼痛の治療アルゴリズム構築に関する研究

田上恵太, 宮下光令, 森田達也, 山口拓洋

がん患者の療養生活の最終段階における体系的な苦痛緩和法の構築に関する研究令和元年度総括・分担研究報告書(Web)　2020年
抗がん剤治療中止時の医療従事者によるがん患者の意思決定支援プログラムの開発:教育方法の開発

内富庸介, 宮路天平, 藤森麻衣子, 朴成和, 山口拓洋, 佐藤綾子, 岡村優子, 小田原幸, 梅橋海歩人, 曽我亮, 神野彩香, 畑琴音, 益子友恵, 黒崎美雪

抗がん剤治療中止時の医療従事者によるがん患者の意思決定支援プログラムの開発令和元年度総括・分担研究報告書(Web)　2020年
データマネジメントの教育とキャリアパス

高田宗典, 高田宗典, 宮路天平, 宮路天平, 林行和, 林行和, 山口拓洋, 山口拓洋

薬理と治療　48　(Suppl.2)　2020年

ISSN： 0386-3603
SAQLA study(乳房再建術後のHRQOL・満足度を調査する多施設共同研究)進捗報告:登録患者の背景について

雑賀美帆, 細谷優子, 冨田興一, 倉元有木子, 宇都宮裕己, 相原有望子, 武藤真由, 彦坂信, 宮路天平, 川口崇, 山口拓洋, 渡部聡子, 木股敬裕

日本形成外科学会総会・学術集会プログラム・抄録集　63rd (CD-ROM)　2020年
転倒転落を科学的視点で捉え直す医療機関における入院患者の転倒・転落の実情

山本知孝, 小久江伸介, 小林智明, 本多みち江, 森崎裕, 大野幸子, 宮路天平, 山口拓洋, 河添悦昌, 土井俊祐

医療の質・安全学会誌　14　(Suppl.)　189-189　2019年11月
出版者・発行元： (一社)医療の質・安全学会
ISSN： 1881-3658

eISSN： 1882-3254
医師主導治験におけるラジカル殺菌歯周病治療器の臨床効果の検証無作為化比較試験査読有り

佐々木啓一, 菅野太郎, 中村圭祐, 石山希里香, 山田康友, 白土翠, 庭野吉己, 萱場千恵, 池田浩治, 高木愛理, 山口拓洋

日本歯周病学会会誌　61　(春季特別)　127-127　2019年5月
出版者・発行元： (NPO)日本歯周病学会
ISSN： 0385-0110

eISSN： 1880-408X
ePROを用いた乳房再建多施設前向きコホート研究 SAQLA study

雑賀美帆, 細谷優子, 草野太郎, 倉元有木子, 冨田興一, 相原有希子, 武藤真由, 彦坂信, 宮路天平, 川口崇, 山口拓洋, 渡部聡子, 木股敬裕

日本形成外科学会総会・学術集会プログラム・抄録集　62nd　2019年
化学放射線療法を受ける頭頸部癌患者の放射線皮膚炎に対する基本処置とステロイド外用追加処置に関するランダム化第3相比較試験

石川寛, 横田知哉, 全田貞幹, 山口拓洋, 宮路天平, 益子友恵, 増島広幸, 篠道弘, 石井しのぶ, 中盛祐子, 岡野朋果, 米村雅人, 石木寛人, 内富庸介, 清原祥夫

日本臨床腫瘍薬学会学術大会講演要旨集　2019　2019年
患者報告アウトカム入門

山口拓洋, 川口崇, 宮路天平

日本がんサポーティブケア学会学術集会プログラム・抄録集　4th　2019年
ラムシルマブおよびタキサンの併用化学療法を受ける進行胃がん患者の栄養状態に関する観察コホート研究(Balast試験)(※Tip)

水上拓郎, 宮路天平, 川口崇, 原浩樹, 津田享志, 山口拓洋, 室圭, 中島貴子

日本がんサポーティブケア学会学術集会プログラム・抄録集　4th　2019年
日本がん支持療法研究グループJapan Supportive,Palliative and Psychosocial Oncology Group(J-SUPPORT)の取り組みと実績:2016-2019

華井明子, 全田貞幹, 松岡豊, 山口拓洋, 安部正和, 島津太一, 中谷直樹, 藤森麻衣子, 松本禎久, 宮路天平, 内富庸介

日本がんサポーティブケア学会学術集会プログラム・抄録集　4th　2019年
臨床現場でのデジタルヘルス活用概論(第7回)臨床研究におけるPROおよびmHealthの活用の展望とその課題

宮路天平, 川口崇, 山口拓洋

ミクス = Medical information express : 医薬情報&マーケティング　47　(1)　56-58　2019年1月
出版者・発行元：ミクス
ISSN： 1341-3864
Exploring the association between patient-reported outcomes and patient-generated health data from a wearable device in cancer patients

Tempei Miyaji, Takashi Kawaguchi, Kanako Azuma, Shinya Suzuki, Yoko Sano, Moe Manabe, Ayako Torii, Tadamasa Kamimura, Yuki Ozawa, Takuhiro Yamaguchi

QUALITY OF LIFE RESEARCH　27　S29-S30　2018年10月

ISSN： 0962-9343

eISSN： 1573-2649
Smartphone Problem-Solving Therapy to Reduce Fear of Recurrence Among Breast Cancer Survivors: An Open Single-Arm Pilot Study

Fuminobu Imai, Kanae Momino, Fujika Katsuki, Masaru Horikoshi, Toshi A. Furukawa, Naoto Kondo, Tatsuya Toyama, Takuhiro Yamaguchi, Tatsuo Akechi

PSYCHO-ONCOLOGY　27　146-147　2018年10月

ISSN： 1057-9249

eISSN： 1099-1611
The effect of eye-contact when disclosing prognosis to women with breast cancer: a randomized scripted video-vignette study (J-SUPPORT 1601)

Maiko Fujimori, Masanori Mori, Liesbeth M. van Vliet, Takuhiro Yamaguchi, Chikako Shimizu, Takayuki Kinoshita, Jozien M. Bensing, Eduardo Bruera, Tatsuya Morita, Yosuke Uchitomi

PSYCHO-ONCOLOGY　27　109-109　2018年10月

ISSN： 1057-9249

eISSN： 1099-1611
がん治療中の口腔粘膜炎に対するインドメタシンスプレー製剤の疼痛軽減効果の研究

長岡広香, 百賢二, 濱野淳, 宮路天平, 小山田隼佑, 川口崇, 本間真人, 山口拓洋, 森田達也, 木澤義之

日本癌治療学会学術集会抄録集　56回　P63-2　2018年10月
出版者・発行元： (一社)日本癌治療学会
がん治療中の口腔粘膜炎の疼痛に対するインドメタシンスプレー製剤の有効性に関する無作為化二重盲検プラセボ比較第II相試験

長岡広香, 濱野淳, 百賢二, 宮路天平, 小山田隼佑, 川口崇, 山口拓洋, 森田達也, 木澤義之

Palliative Care Research　13　(Suppl.)　S370-S370　2018年6月
出版者・発行元： (NPO)日本緩和医療学会
eISSN： 1880-5302
A multi-center, randomized, double-blinded, placebo-controlled trial of additive effect of duloxetine for neuropathic cancer pain refractory to opioids and gabapentinoids: JORTC-PAL08 (DIRECT study).

Eriko Satomi, Hiromichi Matsuoka, Satoru Iwase, Tempei Miyaji, Takashi Kawaguchi, Keisuke Ariyoshi, Shunsuke Oyamada, Hideaki Hasuo, Akihiro Tokoro, Toshiaki Shinomiya, Hiroaki Tsukuura, Yoichi Otake, Masatomo Otsuka, Yoshikazu Hasegawa, Yoshihisa Matsumoto, Yuki Kataoka, Hiroyuki Otani, Yasuhiro Kidera, Mayuri Aoyama, Takuhiro Yamaguchi

JOURNAL OF CLINICAL ONCOLOGY　36　(15)　2018年5月

DOI： 10.1200/JCO.2018.36.15_suppl.10102 　

ISSN： 0732-183X

eISSN： 1527-7755
Feasibility trial of collecting patient-generated health data using a wearable device and electronic patient-reported outcomes in cancer patients.

Tempei Miyaji, Takashi Kawaguchi, Kanako Azuma, Shinya Suzuki, Yoko Sano, Moe Akatsu, Ayako Torii, Tadamasa Kamimura, Yuki Ozawa, Akihiko Tsuchida, Daisuke Eriguchi, Mizuha Haraguchi, Makoto Nishino, Yoshiki Tokuda, Yoshiko Nishi, Motohide Nishi, Rintaro Takeya, Yumi Inadome, Tsutomu Yamazaki, Takuhiro Yamaguchi

JOURNAL OF CLINICAL ONCOLOGY　36　(15)　2018年5月

DOI： 10.1200/JCO.2018.36.15_suppl.e18725 　

ISSN： 0732-183X

eISSN： 1527-7755
TransNEOS: Validation of the oncotype DX recurrence score (RS) testing core needle biopsy samples from NEOS as predictor of clinical response to neoadjuvant endocrine therapy for postmenopausal estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer patients

Yutaka Yamamoto, Hiroji Iwata, Norikazu Masuda, Tomomi Fujisawa, Tatsuya Toyama, Masahiro Kashiwaba, Shoichiro Ohtani, Naruto Taira, Takehiko Sakai, Yoshie Hasegawa, Rikiya Nakamura, Hiromitsu Akabane, Yukiko Shibahara, Hiroshi Sasano, Takuhiro Yamaguchi, Kentaro Sakamaki, Calvin Chao, Debbie McCullough, Naoko Sugiyama, Yasuo Ohashi

CANCER RESEARCH　78　(4)　2018年2月

ISSN： 0008-5472

eISSN： 1538-7445
生活の質と症状緩和の質との関係:Personalized Symptom Goalでの検証

田上恵太, 田上恵太, 三浦智史, 三浦智史, 川口崇, 松本禎久, 渡邊有希, 上原優子, 沖崎歩, 増田悠斗, 増田悠斗, 古賀浩子, 山口拓洋, 森田達也

日本サイコオンコロジー学会総会プログラム・抄録集　31st　2018年
Research methodology for supportive care in cancer

Takuhiro Yamaguchi, Tempei Miyaji, Takashi Kawaguchi

CANCER SCIENCE　109　949-949　2018年1月

ISSN： 1349-7006
Patient Reported Outcome(PRO)とPRO-CTCAEについて

山口拓洋, 川口崇, 宮路天平

ファルマシア　54　(3)　231‐235(J‐STAGE)-235　2018年
出版者・発行元：公益社団法人日本薬学会
DOI： 10.14894/faruawpsj.54.3_231 　

ISSN： 0014-8601

詳細を見る詳細を閉じる

近年、がん領域において医療者と患者の症状評価に乖離が見られることなどが明らかになり、患者の健康状態を患者から直接得ることの重要性が指摘されている。患者報告アウトカム (Patient-reported outcome ：PRO) とは、「患者の回答について、臨床医や他の誰の解釈も介さず、患者から直接得られる患者の健康状態に関するすべての報告である」と定義される。本稿では、PROを含む臨床アウトカムの評価に関して説明するとともに、近年開発された、がんの臨床試験における有害事象の報告に用いられる重症度規準NCI-CTCAEのPRO版であるPRO-CTCAEについて情報提供する。
Psychometric validity of the Japanese version of Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Kanako Azuma, Takashi Kawaguchi, Tempei Miyaji, Motohiko Sano, Soan Kim, Yosuke Kawahara, Ayako Torii, Yuri Yamada, Taiki Hirata, Keiichiro Ishibashi, Atsushi Okubo, Ethan Basch, Takuhiro Yamaguchi

QUALITY OF LIFE RESEARCH　26　(1)　100-101　2017年10月

ISSN： 0962-9343

eISSN： 1573-2649
Discordance of adverse event assessment between clinicians and patients using the CTCAE and PRO-CTCAE questionnaires in Japan

Motohiko Sano, Takashi Kawaguchi, Tempei Miyaji, Kanako Azuma, Soan Kim, Yosuke Kawahara, Yoko Sano, Tomohide Shimodaira, Takayuki Seki, Keiichiro Ishibashi, Min KwiSeon, Ethan Basch, Takuhiro Yamaguchi

QUALITY OF LIFE RESEARCH　26　(1)　101-102　2017年10月

ISSN： 0962-9343

eISSN： 1573-2649
担がん患者における腹水濾過濃縮再静注法の有用性および影響の検討

張萌琳, 木内大佑, 西島薫, 宮路天平, 阿出川裕子, 松下弘道, 山口拓洋, 里見絵理子

Palliative Care Research　12　(Suppl.)　S474-S474　2017年6月
出版者・発行元： (NPO)日本緩和医療学会
eISSN： 1880-5302
Effect of nationwide palliative care education program on lung cancer specialists.

Akira Inoue, Takuhiro Yamaguchi, Keiko Tanaka, Akihiro Sakashita, Keisuke Aoe, Kenji Eguchi

JOURNAL OF CLINICAL ONCOLOGY　35　2017年5月

DOI： 10.1200/JCO.2017.35.15_suppl.e21715 　

ISSN： 0732-183X

eISSN： 1527-7755
シスプラチン/パクリタキセル療法による嘔気・嘔吐・食欲不振に対する六君子湯の効果

大西俊介, 渡利英道, 勘野真紀, 大場洋子, 竹内聡, 宮路天平, 小山田隼佑, 野村英司, 加藤秀則, 杉山徹, 浅香正博, 櫻木範明, 山口拓洋, 上園保仁, 岩瀬哲

日本癌治療学会学術集会(Web)　55th　WS5-5　2017年
出版者・発行元： (一社)日本癌治療学会
進行がん患者の呼吸困難に対する送風の効果と三叉神経第2~3枝領域の温度変化について

角甲純, 角甲純, 森田達也, 山口拓洋, 關本翌子, 小林成光, 木下寛也, 小川朝生, 全田貞幹, 内富庸介, 猪口浩伸, 松島英介

日本緩和医療学会学術大会プログラム・抄録集　22nd　S393　2017年
Evaluation of duration of washout period following fan therapy for breathlessness: a methodological pilot study

Kako J, Morita T, Yamaguchi T, Sekimoto A, Kobayashi M, Kinoshita H. Ogawa A, Zenda S, Uchitomi Y, Inoguchi H, Matsushima E

15th World Congress of the European Association for Palliative Care　2017年
総合患者支援情報提供と就労支援乳がん患者におけるInformation needsに関する研究

茂木小百合, 川口崇, 山口拓洋, 東加奈子, 鮎原秀明, 岩瀬哲, エリック・スカイヤー, 恩田健二, 山田公人, 海瀬博史, 松永忠東, 竹内裕紀, 石川孝, 畝崎榮, 明石貴雄

日本癌治療学会学術集会抄録集　54回　MS18-1　2016年10月
出版者・発行元： (一社)日本癌治療学会
総合患者支援情報提供と就労支援乳がん患者におけるControl Preferences Scaleの信頼性および妥当性に関する研究

東加奈子, 川口崇, 山口拓洋, 茂木小百合, 鮎原秀明, 岩瀬哲, エリック・スカイヤー, 恩田健二, 山田公人, 海瀬博史, 松永忠東, 竹内裕紀, 石川孝, 畝崎榮, 明石貴雄

日本癌治療学会学術集会抄録集　54回　MS18-2　2016年10月
出版者・発行元： (一社)日本癌治療学会
Linguistic validation of the Japanese version of the US National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE)

Tempei Miyaji, Yukiko Iioka, Satoru Iwase, Yasushi Goto, Masahiro Tsuboi, Daigo Yamamoto, Hiroki Odagiri, Yu Tsubota, Takashi Kawaguchi, Natsumi Anzai, Sandra A. Mitchell, Ethan Basch, Takuhiro Yamaguchi

QUALITY OF LIFE RESEARCH　25　78-78　2016年10月

ISSN： 0962-9343

eISSN： 1573-2649
傾向スコア法によって調整した最期の療養場所とクオリティ・オブ・ケア,クオリティ・オブ・デスとの関連:J‐HOPE study3

羽多野裕, 羽多野裕, 青山真帆, 山口拓洋, 森田達也, 木澤義之, 恒藤暁, 志真泰夫, 宮下光令

日本緩和医療学会学術大会プログラム・抄録集　21st　(Suppl.)　S319-S319　2016年6月
出版者・発行元： (NPO)日本緩和医療学会
Phase III study of intraperitoneal paclitaxel plus s-1/paclitaxel compared with s-1/cisplatin in gastric cancer patients with peritoneal metastasis: PHOENIX-GC trial

Hironori Ishigami, Yoshiyuki Fujiwara, Ryoji Fukushima, Atsushi Nashimoto, Hiroshi Yabusaki, Haruhiko Imamoto, Motohiro Imano, Yasuhiro Kodera, Yoshikazu Uenosono, Kenji Amagai, Shigenori Kadowaki, Hiroto Miwa, Takuhiro Yamaguchi, Hironori Yamaguchi, Toshiaki Watanabe, Joji Kitayama

JOURNAL OF CLINICAL ONCOLOGY　34　(15)　2016年5月

DOI： 10.1200/JCO.2016.34.15_suppl.4014 　

ISSN： 0732-183X

eISSN： 1527-7755
REASSESSMENT OF RISK FACTORS FOR BIOCHEMICAL RECURRENCE IN D'AMICO INTERMEDIATE-RISK PROSTATE CANCER TREATED BY RADICAL PROSTATECTOMY

Shintaro Narita, Koji Mitsuzuka, Norihiko Tsuchiya, Takuya Koie, Sadafumi Kawamura, Chikara Ohyama, Tatsuo Tochigi, Takuhiro Yamaguchi, Yoichi Arai, Tomonori Habuchi

JOURNAL OF UROLOGY　195　(4)　E712-E713　2016年4月

ISSN： 0022-5347

eISSN： 1527-3792
Nationwide Survey of Aggressive Adult T-Cell Leukemia/Lymphoma to Compare the Clinical Outcome Between Non-Transplanted and Transplanted Patients

Shigeo Fuji, Yoshitaka Inoue, Atae Utsunomiya, Yukiyoshi Moriuchi, Kaoru Uchimaru, Shuichi Hanada, Takashi Miyagi, Jun Taguchi, Ilseung Choi, Eiichi Otsuka, Takeaki Tomoyose, Hisashi Yamamoto, Saiko Kurosawa, Takuhiro Yamaguchi, Takahiro Fukuda

BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION　22　(3)　S39-S39　2016年3月

ISSN： 1083-8791

eISSN： 1523-6536
支持療法研究における臨床アウトカム

山口拓洋, 山口拓洋, 川口崇, 宮路天平

日本臨床腫瘍学会学術集会(CD-ROM)　14th　2016年
HIV感染症患者における意思決定の葛藤と患者背景の関連に関する検討

石田恵美, 川口崇, 竹内裕紀, 畝崎榮, 関根祐介, 東加奈子, 添田博, 明石貴雄, 山口拓洋, 天野景裕, 福武勝幸

東京医科大学雑誌 = The Journal of Tokyo Medical University　73　(4)　422-422　2015年10月30日
出版者・発行元：東京医科大学医学会
ISSN： 0040-8905
乳がん患者の服薬カウンセリングに対する選好傾向

東加奈子, 川口崇, 山口拓洋, 金子亜希子, 北野安紀, 宮松洋信, 茂木小百合, 鮎原秀明, 田中菜央, 岩瀬哲, 山田公人, 松永忠東, 竹内裕紀, 畝崎榮, 明石貴雄

日本癌治療学会学術集会(Web)　53rd　(3)　P3‐3 (WEB ONLY)-448　2015年9月
出版者・発行元： (一社)日本癌治療学会
ISSN： 0021-4671
Development of a Research Network and an Infrastructure for the Nationwide Registry Study in Palliative Care in Japan

Keisuke Ariyoshi, Tempei Miyaji, Isseki Maeda, Satoru Iwase, Takuhiro Yamaguchi

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY　24　455-455　2015年9月

ISSN： 1053-8569

eISSN： 1099-1557
Assessment of cancer-related fatigue, pain, and quality of life in cancer patients after palliative care team referral: A multicenter observational study (JORTC PAL-09).

Satoru Iwase, Takashi Kawaguchi, Tempei Miyaji, Hiroto Ishiki, Keisuke Ariyoshi, Takuhiro Yamaguchi

JOURNAL OF CLINICAL ONCOLOGY　33　(15)　2015年5月

ISSN： 0732-183X

eISSN： 1527-7755
First report of clinicopathological analysis in neoadjuvant treatment phase in NEOS: A randomized study of adjuvant endocrine therapy with or without chemotherapy for postmenopausal breast cancer patients who responded to neoadjuvant letrozole

Takehiko Sakai, Hiroji Iwata, Yoshie Hasegawa, Rikiya Nakamura, Hiromitsu Akabane, Shoichiro Ohtani, Masahiro Kashiwaba, Naruto Taira, Tatsuya Toyama, Yutaka Yamamoto, Tomomi Fujisawa, Norikazu Masuda, Takuhiro Yamaguchi, Hirofumi Mukai, Yasuo Ohashi

CANCER RESEARCH　75　2015年5月

ISSN： 0008-5472

eISSN： 1538-7445
米国における医療大麻のコンパッショネート・ユース制度の歴史

宮路天平, 山口拓洋, 山口拓洋, 津谷喜一郎

日本薬史学会年会講演要旨集　2015　2015年
Decision Analysis of Allogeneic Hematopoietic Stem Cell Transplantation Versus Chemotherapy in Cytogenetically Standard-Risk Acute Myeloid Leukemia in First Complete Remission: The Impact of FLT3-ITD Profile

Saiko Kurosawa, Hiroki Yamaguchi, Takuhiro Yamaguchi, Keiko Fukunaga, Shunsuke Yui, Heiwa Kanamori, Kensuke Usuki, Nobuhiko Uoshima, Masamitsu Yanada, Katsuhiro Shono, Toshimitsu Ueki, Ishikazu Mizuno, Shingo Yano, Jin Takeuchi, Junya Kanda, Hiroshi Okamura, Kinuko Tajima, Yoshihiro Inamoto, Koiti Inokuchi, Takahiro Fukuda

BLOOD　124　(21)　2014年12月

ISSN： 0006-4971

eISSN： 1528-0020
Patient preference trial comparing capecitabine and S-1 in metastatic breast cancer patients.

Daigo Yamamoto, Satoru Iwase, Takuhiro Yamaguchi, Yu Tsubota, Takashi Kawaguchi, Hiroki Odagiri, Keisuke Ariyoshi, Kaoru Kitamura

JOURNAL OF CLINICAL ONCOLOGY　32　(15)　2014年5月

ISSN： 0732-183X

eISSN： 1527-7755
Voriconazole Vs. Itraconazole for Antifungal Prophylaxis in Patients with GVHD: A Randomized Trial

Yoshiki Hayashi, Yoshinobu Kanda, Hirohisa Nakamae, Heiwa Kanamori, Kazuteru Ohashi, Michihiro Hidaka, Shingo Yano, Kazuo Hatanaka, Akio Kohno, Yukiyoshi Moriuchi, Hiroatsu Ago, Takuya Yamashita, Tohru Takata, Minoru Yoshida, Masayuki Hino, Takuhiro Yamaguchi, Takahiro Fukuda

BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION　20　(2)　S91-S91　2014年2月

ISSN： 1083-8791

eISSN： 1523-6536
臨床抗HIV療法 ART開始患者の葛藤に対する服薬説明の有用性「意思決定の葛藤尺度(Decisional Conflict Scale)日本語版」を用いた解析

関根祐介, 東加奈子, 添田博, 川口崇, 中原紀子, 山口拓洋, 竹内裕紀, 畝崎榮, 天野景裕, 福武勝幸, 明石貴雄

日本エイズ学会誌　15　(4)　378-378　2013年11月
出版者・発行元： (一社)日本エイズ学会
ISSN： 1344-9478
Cytomegalovirus Reactivation After Allogeneic Stem Cell Transplantation Is Associated With a Reduced Risk Of Relapse In Patients With Acute Myeloid Leukemia: The Japan Society For Hematopoietic Cell Transplantation (JSHCT) Transplantation-Related Complication Working Group

Katsuto Takenaka, Tetsuya Nishida, Yuki Asano-Mori, Kumi Oshima, Gaku Oshikawa, Koichi Miyamura, Tetsuya Eto, Hirohisa Nakamae, Hisashi Sakamaki, Yasuo Morishima, Ritsuro Suzuki, Takuhiro Yamaguchi, Takahiro Fukuda

BLOOD　122　(21)　2013年11月

ISSN： 0006-4971

eISSN： 1528-0020
Randomized study of capecitabine versus S-1 in women with metastatic or recurrent breast cancer: Japan Breast Cancer Research Network (JBCRN) 05 trial.

Daigo Yamamoto, Satoru Iwase, Chizuko Yamamoto, Yu Taubota, Takuhiro Yamaguchi

JOURNAL OF CLINICAL ONCOLOGY　31　(15)　2013年5月

ISSN： 0732-183X

eISSN： 1527-7755
A new equation to predict glomerular filtration rate one year after radical nephrectomy in Japanese patients.

Shuichi Shimada, Hideo Saito, Akihiro Ito, Naomasa Ioritani, Sadafumi Kawamura, Tatsuo Tochigi, Takuhiro Yamaguchi, Yoichi Arai

JOURNAL OF CLINICAL ONCOLOGY　31　(15)　2013年5月

ISSN： 0732-183X

eISSN： 1527-7755
Potential risk of residential asbestos exposure: Japanese general screening study for asbestos-related diseases (JGSARD)

Nobuhiko Seki, Takuhiro Yamaguchi, Kenji Eguchi, Masahiro Kaneko, Masahiko Kusumoto

JOURNAL OF CLINICAL ONCOLOGY　31　(15)　2013年5月

ISSN： 0732-183X

eISSN： 1527-7755
無作為化クロスオーバー試験による進行期がん患者の倦怠感に対するリフレクソロジーの有効性の検討

宮内貴子, 宮下光令, 山口拓洋

がん看護　18　(3)　395-400　2013年3月20日
出版者・発行元：南江堂
ISSN： 1342-0569
Effect of related donor availability on outcome of AML in the context of related and unrelated hematopoietic cell transplantation

Yanada M, Kurosawa S, Yamaguchi T, Uchida N, Miyawaki S, Kanamori H, Usuki K, Kobayashi T, Watanabe M, Nagafuji K, Yano S, Nawa Y, Tomiyama J, Tashiro H, Nakamura Y, Fujisawa S, Kimura F, Emi N, Miura I, Fukuda T

Bone Marrow Transplant　48　(3)　390-395　2013年3月

DOI： 10.1038/bmt.2012.159 　
Impact of body mass index on clinicopathologic outcome and biochemical recurrence after radical prostatectomy in 1,257 Japanese patients with prostate cancer

Shintaro Narita, Koji Mitsuzuka, Takahiro Yoneyama, Sadafumi Kawamura, Yoichi Arai, Chikara Ohyama, Tatsuo Tochigi, Takuhiro Yamaguchi, Tomonori Habuchi

JOURNAL OF CLINICAL ONCOLOGY　31　(6)　2013年2月

ISSN： 0732-183X

eISSN： 1527-7755
mFOLFIRI+BV併用療法とIRIS+BV併用療法の安全性確認試験(T-CORE0702)

加藤俊介, 石岡千加史, 安藤秀明, 蒲生真紀夫, 山口拓洋, 村川康子, 下平秀樹, 高橋信, 森隆弘, 吉岡孝志

東北医学雑誌　124　(2)　216-216　2012年12月
出版者・発行元：東北医学会
ISSN： 0040-8700
PROSPECTIVE TRIAL OF CETUXIMAB PLUS IRINOTECAN FOR OXALIPLATIN AND IRINOTECAN-BASED CHEMOTHERAPY-REFRACTORY PATIENTS ADVANCED AND/OR METASTATIC COLORECTAL CANCER, EVALUATION OF THE EFFICACY AND SAFETY BASED ON MUTATION STATUS OF THE EGFR RELATED GENES

H. Shimodaira, H. Soeda, M. Gamoh, H. Andoh, T. Yamaguchi, M. Watanabe, H. Ishobe, T. Sudo, S. Kato, C. Ishioka

ANNALS OF ONCOLOGY　23　119-119　2012年10月

ISSN： 0923-7534
Comparative Safety of Statins in Japanese Patients: A Short-Term Prospective Case-Cohort Study (Japan Statin Study, JSS)

Shigeru Kageyama, Masaki Kitamura, Akira Kokan, Kiyoshi Kubota, Hideaki Kurata, Kenichi Matsui, Nobuhiro Ooba, Takao Orii, Tsugumichi Sato, Yoshihiro Shimodozono, Emiko Shina, Yukari Yaju, Takuhiro Yamaguchi, Hiroshi Yoshida

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY　21　270-270　2012年8月

ISSN： 1053-8569
地域緩和ケア介入研究<OPTIM study>が明らかにしたこと明日への示唆 OPTIM-studyがわが国の緩和ケアの研究方法論にもたらすもの

宮下光令, 五十嵐歩, 佐藤一樹, 花田芙蓉子, 五十嵐美幸, 山口拓洋

日本緩和医療学会学術大会プログラム・抄録集　17回　173-173　2012年6月
出版者・発行元： (NPO)日本緩和医療学会
CONSISTENT USE OF CINACALCET IMPROVES CLINICAL OUTCOMES IN JAPANESE HAEMODIALYSIS PATIENTS WITH SECONDARY HYPERPARATHYROIDISM: MARGINAL STRUCTURAL ANALYSES FROM THE MINERAL AND BONE DISORDER OUTCOMES STUDY FOR JAPANESE CKD STAGE 5D PATIENTS (MBD-5D)

Tadao Akizawa, Tadao Akizawa, Tadao Akizawa, Noriaki Kurita, Masahide Mizobuchi, Masafumi Fukagawa, Yoshihiro Onishi, Takuhiro Yamaguchi, Takeshi Hasegawa, Shingo Fukuma, Kiyoshi Kurokawa, Shunichi Fukuhara

NEPHROLOGY DIALYSIS TRANSPLANTATION　27　498-498　2012年5月

ISSN： 0931-0509

eISSN： 1460-2385
Potential risk of asbestos exposure among Japanese general population: Japanese general screening study for asbestos-related diseases (JGSARD)

Nobuhiko Seki, Takuhiro Yamaguchi, Kenji Eguchi, Masahiro Kaneko, Masahiko Kusumoto

JOURNAL OF CLINICAL ONCOLOGY　30　(15)　2012年5月

ISSN： 0732-183X

eISSN： 1527-7755
ANCA関連腎炎の寛解導入療法におけるシクロフォスファミドの効果

土屋善慎, 岩渕將, 中屋来哉, 柴垣有吾, 山口拓洋, 福原俊一, 大江祐治, 八幡真弓, 相馬淳, 佐藤壽伸, 田熊淑男

日本腎臓学会誌　54　(3)　218-218　2012年4月
出版者・発行元： (一社)日本腎臓学会
ISSN： 0385-2385
An Interim Efficacy Analysis of Neoadjuvant Letrozole in the New Primary Endocrine-Therapy Origination Study (NEOS/N-SAS BC06): A Randomized Study of Adjuvant Endocrine Therapy with or without Chemotherapy for Postmenopausal Breast Cancer Patients Who Responded to Neoadjuvant Letrozole.

H. Iwata, T. Yamaguchi, N. Masuda, T. Toyama, M. Kashiwaba, Y. Yamamoto, N. Taira, S. Saji, Y. Ohashi

CANCER RESEARCH　71　2011年12月

DOI： 10.1158/0008-5472.SABCS11-P3-15-01 　

ISSN： 0008-5472

eISSN： 1538-7445
Matched HLA Haplotype Contributes to Reduce Sever Acute GVHD with Conserving GVL Effect in HLA-Mismatched Cord Blood Transplantation

Satoshi Takahashi, Jun Ooi, Seiko Kato, Toshiro Kawakita, Arinobu Tojo, Yasuhiro Ebihara, Shinji Mochizuki, Shohei Yamamoto, Kohichiro Tsuji, Takuhiro Yamaguchi, Satoko Morishima, Yasuo Morishima, Shigetaka Asano

BLOOD　118　(21)　1771-1771　2011年11月

ISSN： 0006-4971

eISSN： 1528-0020
mFOLFIRI+bevacizumab併用療法とIRIS+bevacizumab併用療法の安全性確認試験

安藤秀明, 加藤俊介, 蒲生真樹夫, 山口拓洋, 酒寄真人, 佐々木優香, 森隆弘, 大堀久詔, 吉岡孝志, 石岡千加史

日本癌治療学会誌　46　(2)　480-480　2011年9月
出版者・発行元： (一社)日本癌治療学会
ISSN： 0021-4671
JAPANESE GENERAL SCREENING STUDY FOR ASBESTOS-RELATED DISEASES (JG SARD): RESULTS OF BASELINE SCREENING

Nobuhiko Seki, Takuhiro Yamaguchi, Kenji Eguchi, Masahiro Kaneko

JOURNAL OF THORACIC ONCOLOGY　6　(6)　S1392-S1393　2011年6月

ISSN： 1556-0864
A randomized pilot study comparing safety and efficacy of irinotecan plus S-1 plus bevacizumab (IRIS plus BV) and modified FOLFIRI plus BV (mFOLFIRI plus BV) in patients (pts) with metastatic colorectal cancer (mCRC): The result of efficacy report of T-CORE0702.

H. Andoh, S. Kato, M. Gamoh, T. Yamaguchi, M. Sakayori, Y. Sasaki, T. Mori, H. Ohori, T. Yoshioka, C. Ishioka

JOURNAL OF CLINICAL ONCOLOGY　29　(15)　2011年5月

ISSN： 0732-183X

eISSN： 1527-7755
IMPACT OF REDUCTION IN GVHD-RELATED MORTALITY FOR RECENT IMPROVEMENT OF NON-RELAPSE MORTALITY AFTER ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANTATION

S. Kurosawa, K. Yakushijin, T. Yamaguchi, Y. Atsuta, T. Nagamura-Inoue, H. Akiyama, S. Taniguchi, K. Miyamura, S. Takahashi, T. Eto, Y. Morishima, H. Sakamaki, T. Fukuda

BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION　17　(2)　S288-S289　2011年2月

ISSN： 1083-8791
Phase II trial of cetuximab plus irinotecan for FOLFOX and FOLFIRI-refractory patients with EGFR-positive advanced and/or metastatic colorectal cancer: Evaluation of the efficacy and safety based on KRAS mutation status (T-CORE0801)

H. Shimodaira, H. Soeda, M. Gamoh, H. Andoh, T. Yamaguchi, M. Watanabe, H. Isobe, T. Sudo, S. Kato, C. Ishioka

JOURNAL OF CLINICAL ONCOLOGY　29　(4)　2011年2月

ISSN： 0732-183X

eISSN： 1527-7755
MYELOABLATIVE UNRELATED CORD BLOOD TRANSPLANTATION FROM GRAFTS WITH THREE HLA ANTIGEN MISMATCHES RESULTED IN SUPERIOR OUTCOMES FOR PATIENTS WITH DE NOVO ACUTE LEUKEMIAS

N. Tsukada, S. Takahashi, J. Ooi, S. Kato, T. Kawakita, F. Nagamura, T. Yamaguchi, A. Tojo, S. Asano

BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION　17　(2)　S337-S337　2011年2月

ISSN： 1083-8791
A randomized pilot study comparing safety and efficacy of irinotecan plus S-1 (IRIS) plus bevacizumab (BV) and modified (m) FOLFIRI plus BV in patients (pts) with metastatic colorectal cancer (mCRC): First report of T-CORE0702.

S. Kato, H. Andoh, M. Gamoh, T. Yamaguchi, Y. Murakawa, Y. Sasaki, S. Takahashi, H. Shimodaira, T. Yoshioka, C. Ishioka

JOURNAL OF CLINICAL ONCOLOGY　29　(4)　2011年2月

ISSN： 0732-183X

eISSN： 1527-7755
本邦における同種移植後非再発死亡割合と死因の年次推移:50歳以上の検討

黒澤彩子, 薬師神公和, 山口拓洋, 熱田由子, 長村登紀子, 秋山秀樹, 谷口修一, 宮村耕一, 高橋聡, 衛藤徹也, 森島泰雄, 坂巻壽, 福田隆浩

日本造血細胞移植学会総会プログラム・抄録集　33rd　228　2011年
本邦における同種移植後非再発死亡割合と死因の年次推移:49歳以下成人での検討

薬師神公和, 黒澤彩子, 山口拓洋, 熱田由子, 長村登紀子, 秋山秀樹, 谷口修一, 宮村耕一, 高橋聡, 衛藤徹也, 森島泰雄, 坂巻壽, 福田隆浩

日本造血細胞移植学会総会プログラム・抄録集　33rd　310　2011年
Changes In Incidence and Causes of Non-Relapse Mortality (NRM) After Allogeneic Hematopoietic Cell Transplantation (allo-HCT): Are Transplants Improving?

Saiko Kurosawa, Kimikazu Yakushijin, Takuhiro Yamaguchi, Yoshiko Atsuta, Tokiko Nagamura-Inoue, Hideki Akiyama, Shuichi Taniguchi, Koichi Miyamura, Satoshi Takahashi, Tetsuya Eto, Yasuo Morishima, Hisashi Sakamaki, Takahiro Fukuda

BLOOD　116　(21)　397-397　2010年11月

ISSN： 0006-4971
地域専門機関とインフォーマル組織間のネットワーク構築促進プログラムの評価地域包括支援センターにおける試行

村山洋史, 兒島智子, 戸丸明子, 奈良部晴美, 立花鈴子, 山口拓洋, 村嶋幸代

日本公衆衛生雑誌　57　(10)　909-920　2010年10月
出版者・発行元：日本公衆衛生学会
DOI： 10.11236/jph.57.10_909 　

ISSN： 0546-1766
Japan Statin Study (JSS), a Prospective Case-Cohort Study for Monitoring Multiple Adverse Events: Rationale, Design and Characteristics of Study Subjects

Shigeru Kageyama, Masaki Kitamura, Akira Kokan, Kiyoshi Kubota, Kenichi Matsui, Nobuhiro Ooba, Takao Orii, Tsugumichi Sato, Yoshihiro Shimodozono, Hiromi Uehara, Mitsunori Yagame, Yukari Yaju, Takuhiro Yamaguchi

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY　19　S169-S169　2010年8月

ISSN： 1053-8569

eISSN： 1099-1557
The Impact of Regulatory Action on ECG Monitoring in Patients with Dopamine Agonists in Japan: Analysis of Claims Database

Nobuhiro Ooba, Takuhiro Yamaguchi, Kiyoshi Kubota

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY　19　S49-S49　2010年8月

ISSN： 1053-8569

eISSN： 1099-1557
透析MBDアウトカム研究(MBD‐5D)~背景と研究デザイン~

長谷川毅, 福原俊一, 深川雅史, 秋澤忠男, 大西良浩, 山口拓洋, 黒川清

日本透析医学会雑誌　43　(Supplement 1)　389　2010年5月18日

ISSN： 1340-3451
External review of the revised version (2009) of the clinical practice guidelines for hepatocellular carcinoma

Takuhiro Yamaguchi, Masumi Kadoya, Namiki Izumi, Toshiharu Yamaguchi, Shoji Kubo, Kentaro Sugano

Acta Hepatologica Japonica　51　(10)　591-598　2010年

DOI： 10.2957/kanzo.51.591 　

ISSN： 0451-4203
実現・持続可能性ある臨床研究フェローシップ構築研究臨床研究デザイン遠隔学習プログラム:Bコース

草場鉄周, 次橋幸男, 山口拓洋, 佐久嶋研, 柴垣有吾, 竹上未紗, 野口善令, 長谷川毅, 山本洋介, 中村文明, 福森則男, 横山葉子, 福原俊一

実現・持続可能性ある臨床研究フェローシップ構築研究平成21年度総括・分担研究報告書　27-65　2010年
Comparison of Allogeneic Hematopoietic Cell Transplantation and Chemotherapy as Post-Remission Strategy in Elderly Patients with Non-M3 AML in CR1: Retrospective Analysis with 1036 Patients

Saiko Kurosawa, Takuhiro Yamaguchi, Naoyuki Uchida, Toru Sakura, Kensuke Usuki, Masato Watanabe, Takuya Yamashita, Heiwa Kanamori, Junji Tomiyama, Yuichiro Nawa, Shingo Yano, Jin Takeuchi, Kazuaki Yakushiji, Fumiaki Sano, Nobuhiko Uoshima, Yasuhito Nannya, Yoshiyuki Moriuchi, Yoichi Takaue, Takahiro Fukuda

BLOOD　114　(22)　218-218　2009年11月

ISSN： 0006-4971
The Impact of HLA Haplotype Matching for Mismatched Cord Blood Transplantation.

Satoshi Takahashi, Jun Ooi, Nobuhiro Tsukada, Seiko Kato, Aki Sato, Toshiro Kawakita, Yasuyuki Nagata, Maki Monna-Ooiwa, Arinobu Tojo, Takuhiro Yamaguchi, Satoko Morishima, Yasuo Morishima, Shigetaka Asano

BLOOD　114　(22)　496-496　2009年11月

ISSN： 0006-4971
A Markov Decision Analysis of Post-Remission Strategies in 2029 Patients with AML in First Remission (CR1): Should We Perform Allogeneic Hematopoietic Cell Transplantation in CR1?

Saiko Kurosawa, Takuhiro Yamaguchi, Naoyuki Uchida, Shuichi Miyawaki, Heiwa Kanamori, Kensuke Usuki, Takuya Yamashita, Masato Watanabe, Kazuaki Yakushiji, Shingo Yano, Yuichiro Nawa, Jun Taguchi, Jin Takeuchi, Yoko Nakamura, Yasuhito Nannya, Yasushi Okoshi, Yoshinobu Kanda, Ikuo Miura, Yoichi Takaue, Takahiro Fukuda

BLOOD　114　(22)　899-899　2009年11月

ISSN： 0006-4971
抗甲状腺薬による汎血球減少症の発症頻度と予後について

渡邊奈津子, 成松宏人, 吉村弘, 山口拓洋, 上昌広, 伊藤公一, 伊藤國彦

臨床血液　50　(9)　964-964　2009年9月30日
出版者・発行元： (一社)日本血液学会-東京事務局
ISSN： 0485-1439

eISSN： 1882-0824
癌患者における各種愁訴対策としての漢方治療癌治療患者における漢方治療に対する現状と意識調査

武田卓, 吉永浩介, 伊藤潔, 山口拓洋, 八重樫伸生

日本癌治療学会誌　44　(2)　322-322　2009年9月
出版者・発行元： (一社)日本癌治療学会
ISSN： 0021-4671
Cerebrovascular Accidents and Ranibizumab Reply

Takashi Ueta, Takuhiro Yamaguchi

OPHTHALMOLOGY　116　(9)　1835-1835　2009年9月

ISSN： 0161-6420
婦人科癌治療患者における漢方治療・代替医療の現状と意識調査

武田卓, 吉永浩介, 伊藤潔, 山口拓洋, 八重樫伸生

日本婦人科腫瘍学会雑誌　27　(3)　302-302　2009年6月
出版者・発行元： (公社)日本婦人科腫瘍学会
ISSN： 1347-8559
Contact Lens Wear Is Associated with Decrease of Meibomian Glands

Reiko Arita, Kouzo Itoh, Kenji Inoue, Aya Kuchiba, Takuhiro Yamaguchi, Shiro Amano

OPHTHALMOLOGY　116　(3)　379-384　2009年3月

DOI： 10.1016/j.ophtha.2008.10.012 　

ISSN： 0161-6420
網膜脈絡膜・視神経萎縮症に関する調査研究 13.加齢黄斑変性におけるranibizumab硝子体内投与後の脳血管障害のリスク

上田高志, 柳靖雄, 玉置泰裕, 山口拓洋, 新家眞

網膜脈絡膜・視神経萎縮症に関する研究平成20年度総括・分担研究報告書 (3年計画の1年目)　2009年
甲状腺原発悪性リンパ腫171例の臨床像と橋本病における発症率の検討

渡邊奈津子, 吉村弘, 成松宏人, 竹内賢吾, 山口拓洋, 小林一彦, 上昌広, 伊藤公一, 伊藤國彦

日本臨床腫瘍学会学術集会プログラム・抄録集　7th　2009年
Contribution of HLA Incompatibility on Clinical Outcomes of CBT in Patients with MDS Including Secondary ANM in Japan: Multivariate Analysis Using Competing Risk Regression Model

Satoshi Takahashi, Takuhiro Yamaguchi, Maki Monna-Ooiwa, Shuichi Taniguchi, Hisashi Sakamaki, Takeshi Morii, Yoshihisa Nagatoshi, Nobuyuki Aotsuka, Shunichi Kato, Minoko Takanashi, Tokiko Nagamura, Hiroshi Azuma, Shunro Kai, Koji Kato, Shigetaka Asano

BLOOD　112　(11)　1033-1033　2008年11月

ISSN： 0006-4971
A Randomized Trial Comparing Individualized Vs. Non-Individualized Treatment for Elderly Acute Myeloid Leukemia: JALSG GML200 Study

Atsushi Wakita, Shigeki Ohtake, Satoru Takada, Fumiharu Yagasaki, Hirokau Komatsu, Yasushi Miyazaki, Koumei Kubo, Yukihiko Kimura, Akihiro Takeshita, Yoko Adachi, Hitoshi Kiyoi, Takuhiro Yamaguchi, Minoru Yoshida, Kaunori Ohnishi, Shuichi Miyawaki, Tomoki Naoe, Ryuzo Ueda, Ryuzo Ohno

BLOOD　112　(11)　1017-1017　2008年11月

ISSN： 0006-4971
Palliative Care in Japan: Current Status and a Nationwide Challenge to Improve Palliative Care by the Cancer Control Act and the Outreach Palliative Care Trial of Integrated Regional Model (OPTIM) Study

Akemi Yamagishi, Tatsuya Morita, Mitsunori Miyashita, Nobuya Akizuki, Yoshiyuki Kizawa, Yutaka Shirahige, Miki Akiyama, Kei Hirai, Tadashi Kudo, Takuhiro Yamaguchi, Asuka Fukushima, Kenji Eguchi

AMERICAN JOURNAL OF HOSPICE & PALLIATIVE MEDICINE　25　(5)　412-418　2008年10月

DOI： 10.1177/1049909108318568 　

ISSN： 1049-9091
A randomized, double-blind, placebo-controlled phase II dose-finding study of the novel anti-muscarinic agent imidafenacin in Japanese patients with overactive bladder

Yukio Homma, Takuhiro Yamaguchi, Osamu Yamaguchi

INTERNATIONAL JOURNAL OF UROLOGY　15　(9)　809-815　2008年9月

DOI： 10.1111/j.1442-2042.2008.02104.x 　

ISSN： 0919-8172
Phase I trial of r viscumin (INN : aviscumine) given subcutaneously in patients with advanced cancer: A study of the European Organisation for Research and Treatment of Cancer (EORTC protocol number 13001)

Lothar Bergmann, Steiner Aamdal, Sandrine Marreaud, Denis Lacombe, Manfred Herold, Takuhiro Yamaguchi, Karin Wilhelm-Ogunbiyi, Hans Lentzen, Heinz Zwierzina

EUROPEAN JOURNAL OF CANCER　44　(12)　1657-1662　2008年8月

DOI： 10.1016/j.ejca.2008.05.005 　

ISSN： 0959-8049

eISSN： 1879-0852
Estimation of the marginal survival time in the presence of dependent competing risks using inverse probability of censoring weighted (IPCW) methods

Yutaka Matsuyama, Takuhiro Yamaguchi

PHARMACEUTICAL STATISTICS　7　(3)　202-214　2008年7月

DOI： 10.1002/pst.290 　

ISSN： 1539-1604
Liver transection using the LigaSure sealing system

A. Saiura, J. Yamamoto, R. Koga, M. Seki, T. Yamaguchi

HPB　10　(4)　239-243　2008年
出版者・発行元： Taylor and Francis Ltd.
DOI： 10.1080/13651820802167714 　

ISSN： 1477-2574 1365-182X
Acute graft-versus-host disease following umbilical cord blood transplantation: Retrospective survey involving 2015 Japanese patients

Shigesaburo Miyakoshi, Takuhiro Yamaguchi, Masahiro Kami, Tomoko Matsumura, Koichiro Yuji, Hiroto Narimatsu, Eiji Kusumi, Hisashi Sakamaki, Yasushi Kouzai, Masaya Okada, Yuko Osugi, Ryuji Kobayashi, Masami Inoue, Satoshi Takahashi, Makoto Murata, Shunro Kai, Koji Kato, Tokiko Nagamura, Shuichi Taniguchi, Shunichi K. Kato

BLOOD　110　(11)　324A-324A　2007年11月

DOI： 10.1182/blood.V110.11.1070.1070 　

ISSN： 0006-4971
The comparative analysis of bone marrow transplantation and cord blood transplantation from unrelated donors in patients with myelodysplastic syndrome in Japan

Satoshi Takahashi, Takuhiro Yamaguchi, Jun Ooi, Akira Tomonari, Nobuhiro Tsukada, Takaaki Konuma, Tokiko Nagamura, Shunichi Kato, Takakazu Kawase, Yasuo Morishima, Shigetaka Asano

BLOOD　110　(11)　599A-599A　2007年11月

ISSN： 0006-4971
Unrelated cord blood transplantation using myeloablative regimen for acute leukemia patients aged between 50 and 55 years: Single institutional retrospective comparison with patients less than 50 years of age

Takaaki Konuma, Satoshi Takahashi, Jun Ooi, Akira Tomonari, Nobuhiro Tsukada, Seiko Kato, Maki Oiwa-Monna, Kaoru Uchimaru, Arinobu Tajo, Takuhiro Yamaguchi, Shigetaka Asano

BLOOD　110　(11)　599A-599A　2007年11月

ISSN： 0006-4971
Unrelated cord blood transplanation for malignant lymphoma: A retrospective study from the Japan Cord Blood Bank Network (JCBNW)

Morihito Takita, Koichiro Yuji, Takuhiro Yamaguchi, Tomoko Matsumura, Masahiro Kami, Hisashi Sakamaki, Yasushi Kouzai, Masaya Okada, Yuko Osugi, Ryuji Kobayashi, Masami Inoue, Satoshi Takahashi, Makoto Murata, Shunro Kai, Koji Kato, Tokiko Nagamura, Shuichi Taniguchi, Shunichi Kato

BLOOD　110　(11)　603A-603A　2007年11月

ISSN： 0006-4971
本邦における臍帯血移植後graft‐versus‐host diseaseについて

宮腰重三郎, 山口拓洋, 上昌広, 松村有子, 湯地晃一郎, 成松宏人, 滝田盛仁, 久住英二, 坂巻壽, 香西康司, 岡田昌也, 大杉夕子, 小林良二, 井上雅美, 高橋聡, 谷口修一, 加藤俊一

臨床血液　48　(9)　900　2007年9月30日

ISSN： 0485-1439
Tacrolimus as prophylaxis for acute graft-versus-host disease in reduced intensity cord blood transplantation for adult patients with advanced Hematologic diseases

Shigesaburo Miyakoshi, Masahiro Kami, Tetsuya Tanimoto, Takuhiro Yamaguchi, Hiroto Narimatsu, Eiji Kusumi, Tomoko Matsumura, Shinsuke Takagi, Dalsuke Kato, Yukiko Kishi, Naoko Murashige, Koichiro Yuji, Naoyuki Uchida, Kazuhiro Masuoka, Atsushi Wake, Shuichi Taniguchi

TRANSPLANTATION　84　(3)　316-322　2007年8月

DOI： 10.1097/01.tp.0000269796.23593.16 　

ISSN： 0041-1337
Comparative single-institute analysis of cord blood transplantation from unrelated donors with bone marrow or peripheral blood stem cell transplantation from related donors in adult patients with hematological malignancies after myeloablative condition・・・

Takahashi S, Ooi J, Tomonari A, Konuma T, Tsukada N, Oiwa-Monna M, Fukuno K, Uchiyama M, Takasugi K, Iseki T, Tojo A, Yamaguchi T, Asano S

Blood　109　(3)　1322-1330　2007年2月

DOI： 10.1182/blood-2006-04-020172 　

ISSN： 0006-4971

eISSN： 1528-0020
Case-control study on the association of upper gastrointestinal bleeding and nonsteroidal anti-inflammatory drugs in Japan

Choitsu Sakamoto, Kentaro Sugano, Shinichi Ota, Nobuhiro Sakaki, Shin'ichi Takahashi, Yukio Yoshida, Taku Tsukui, Hiroyuki Osawa, Yukihiro Sakurai, Junji Yoshino, Yuji Mizokami, Tetsuya Mine, Tetsuo Arakawa, Hajime Kuwayama, Katsunori Saigenji, Koji Yakabi, Tsutomu Chiba, Tooru Shimosegawa, Jane E. Sheehan, Susana Perez-Gutthann, Takuhiro Yamaguchi, David W. Kaufman, Tsugumichi Sato, Kiyoshi Kubota, Akira Terano

EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY　62　(9)　765-772　2006年9月

DOI： 10.1007/s00228-006-0171-6 　

ISSN： 0031-6970

eISSN： 1432-1041
Phase I and pharmacokinetic study of halofuginone, an oral quinazolinone derivative in patients with advanced solid tumours

M. J. A. de Jonge, H. Dumez, J. Verweij, S. Yarkoni, D. Snyder, D. Lacombe, S. Marreaud, T. Yamaguchi, C. J. A. Punt, A. van Oosterom

EUROPEAN JOURNAL OF CANCER　42　(12)　1768-1774　2006年8月

DOI： 10.1016/j.ejca.2005.12.027 　

ISSN： 0959-8049
Clinical outcomes of cord blood transplantation from unrelated donors comparable with marrow or blood transplantation from related donors in adults: A single institute analysis.

S Takahashi, J Ooi, A Tomonari, T Konuma, K Fukuno, N Tsukada, M Monna-Ooiwa, T Yamaguchi, A Tojo, S Asano

BLOOD　106　(11)　93A-93A　2005年11月

ISSN： 0006-4971
Overlap coefficient for assessing the similarity of pharmacokinetic data between ethnically different populations

S Mizuno, T Yamaguchi, A Fukushima, Y Matsuyama, Y Ohashi

CLINICAL TRIALS　2　(2)　174-181　2005年

DOI： 10.1191/1740774505cn077oa 　

ISSN： 1740-7745
Single-institute comparative analysis of unrelated bone marrow transplantation and cord blood transplantation for adult patients with hematologic malignancies

S Takahashi, T Iseki, J Ooi, A Tomonari, K Takasugi, Y Shimohakamada, T Yamada, K Uchimaru, A Tojo, N Shirafuji, H Kodo, K Tani, T Takahashi, T Yamaguchi, S Asano

BLOOD　104　(12)　3813-3820　2004年12月

DOI： 10.1182/blood-2004-03-1001 　

ISSN： 0006-4971
Adjusting for differential proportions of second-line treatment in cancer clinical trials. Part II: An application in a clinical trial of unresectable non-small-cell lung cancer

T Yamaguchi, Y Ohashi

STATISTICS IN MEDICINE　23　(13)　2005-2022　2004年7月

DOI： 10.1002/sim.1817 　

ISSN： 0277-6715
Adjusting for differential proportions of second-line treatment in cancer clinical trials. Part I: Structural nested models and marginal structural models to test and estimate treatment arm effects

T Yamaguchi, Y Ohashi

STATISTICS IN MEDICINE　23　(13)　1991-2003　2004年7月

DOI： 10.1002/sim.1816 　

ISSN： 0277-6715
Single institutional analysis of unrelated donor transplants in adults recipients using umbilical-cord blood compared with bone marrow.

S Takahashi, J Ooi, A Tomonari, K Takasugi, Y Shimohakamada, T Yamada, T Iseki, K Uchimaru, A Tojo, H Kodo, T Yamaguchi, S Asano

BLOOD　102　(11)　479A-479A　2003年11月

ISSN： 0006-4971
A comparison of error detection rates between the reading aloud method and the double data entry method

M Kawado, S Hinotsu, Y Matsuyama, T Yamaguchi, S Hashimoto, Y Ohashi

CONTROLLED CLINICAL TRIALS　24　(5)　560-569　2003年10月

DOI： 10.1016/S0197-2456(03)00089-8 　

ISSN： 0197-2456
Analysis of time to event data with dependent competing risks: Estimation of the marginal survival time using Inverse Probability of Censoring Weighted (IPCW) methods

Y Matsuyama, T Yamaguchi

CONTROLLED CLINICAL TRIALS　24　56S-56S　2003年6月

ISSN： 0197-2456
Proportional hazards models with random effects to examine centre effects in multicentre cancer clinical trials

T Yamaguchi, Y Ohashi, Y Matsuyama

STATISTICAL METHODS IN MEDICAL RESEARCH　11　(3)　221-236　2002年6月

DOI： 10.1191/0962280202sm284ra 　

ISSN： 0962-2802
Physical condition and activity of daily living among HIV patients infected through blood products in Japan

Takuhiro Yamaguchi, Shuji Hashimoto, Shin-Ichi Oka, Kazuyuki Yoshizaki, Satoshi Kimura, Katsuyuki Fukutake, Takuma Shirasaka

Journal of Epidemiology　12　(5)　383-393　2002年
出版者・発行元： Japan Epidemiology Association
DOI： 10.2188/jea.12.383 　

ISSN： 1349-9092 0917-5040
Investigating centre effects in a multi-centre clinical trial of superficial bladder cancer

T Yamaguchi, Y Ohashi

STATISTICS IN MEDICINE　18　(15)　1961-1971　1999年8月

DOI： 10.1002/(SICI)1097-0258(19990815)18:15<1961::AID-SIM170>3.0.CO;2-3 　

ISSN： 0277-6715

︎全件表示 ︎最初の5件までを表示

講演・口頭発表等 5

Patient reported outcomes (PRO) results for prophylactic effect of dexamethasone on regorafenib-related fatigue and/or malaise: a randomized, placebo-controlled, double-blind clinical study in patients with unresectable metastatic colorectal cancer: KSCC1

Shimokawa Mototsugu, Oki Eiji, Yamaguchi Takuhiro, Tanioka Hiroaki, Miyamoto Yuji, Tsuji Akihito

JOURNAL OF CLINICAL ONCOLOGY　2018年5月20日
21-8-O18-07 服薬カウンセリングに対する支払意思に関する研究(がん薬物療法(その他),口頭発表,一般演題,医療薬学の進歩と未来-次の四半世紀に向けて-)

東加奈子, 山田公人, 松永忠東, 竹内裕紀, 畝崎榮, 明石貴雄, 川口崇, 山口拓洋, 佐野陽子, 下平智秀, 鳥居綾子, 鮎原秀明, 山田裕理, 岩瀬哲

日本医療薬学会年会講演要旨集　2015年
患者自己評価式有害事象評価(PRO-CTCAE)日本語版の予備的調査

高津優人, 橋本浩伸, 矢内貴子, 久保晶子, 岩佐悟, 本間義崇, 高島淳生, 加藤健, 濱口哲弥, 山田康秀, 安西奈津美, 川口崇, 山口拓洋, 島田安博, 林憲一

日本癌治療学会誌　2013年9月
P1-125 抗がん剤治療を受けるがん患者が抱える葛藤に薬剤師の服薬説明が与える影響(がん薬物療法(服薬指導・情報提供),ポスター,一般演題,岐路に立つ医療～千年紀の目覚め～よみがえれ!ニッポン!薬の改革は我らが手で!)

東加奈子, 明石貴雄, 川口崇, 鮎原秀明, 江田理子, 大西正美, 山口拓洋, 濃沼政美, 竹内裕紀, 畝崎榮

日本医療薬学会年会講演要旨集　2012年
P1-126 『意思決定の葛藤尺度(DCS)』日本語版作成とその信頼性および妥当性の検討(がん薬物療法(服薬指導・情報提供),ポスター,一般演題,岐路に立つ医療～千年紀の目覚め～よみがえれ!ニッポン!薬の改革は我らが手で!)

佐野陽子, 畝崎榮, 明石貴雄, 添田博, 濱田泰子, 東加奈子, 川口崇, 山口拓洋, 恩田健二, エリックスカイヤー, 竹内裕紀

日本医療薬学会年会講演要旨集　2012年

共同研究・競争的資金等の研究課題 21

アドバンス・ケア・プランニングを始める時期が客観的にわかる方法の開発と効果の検証

浜野淳, 香川璃奈, 讃岐勝, 山口拓洋, 森田達也, 竹内文乃, 平塚裕介

2022年4月1日～ 2026年3月31日
患者報告型アウトカムの臨床活用の有効性を検証するクラスター・ランダム化比較試験

宮下光令, 田村恵子, 青山真帆, 堀江良樹, 山口拓洋, 森田達也

2021年4月1日～ 2025年3月31日

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海外では患者報告型アウトカム（PRO: Patient Reported Outcome）の日常的な臨床活用の有効性が検証されているが、わが国ではPROの日常的な臨床活用は普及していない。本研究では緩和ケア病棟・ホスピス住宅・外来化学療法の3つの臨床セッティングにおいて、それぞれ独立したStepped-Wedgeクラスター・ランダム化比較試験を実施し、日常的にPROを臨床活用することの有効性の検証を行う予定である。 2021年度は当初の予定では緩和ケア病棟・ホスピス住宅においてパイロット調査を行い、本調査の方法の計画を確定させる予定であった。それぞれ患者報告型アウトカムはIPOS（Integrated Palliative Care Outcome Scale）を使用し、評価項目としてEORTC-QLQ-C15PALおよび患者とスタッフのコミュニケーションを測定する尺度を利用する予定である。パイロット調査対象施設に訪問し、現場スタッフとの議論によって調査計画を確定し、研究倫理審査の承認が得られた。しかし、COVID-19によりパイロットを予定していたホスピス住宅に外部の研究者が入ることが困難になり、また、パイロットを予定していた緩和ケア病棟はCOVID-19により病棟閉鎖になったため、パイロット試験を行うことができなかった。すでにパイロット調査の準備はできているため、次年度に研究者が施設に入ることが可能になり次第、パイロット調査を実施する予定である。研究全体の進捗もCOVID-19の感染流行状況次第ではあるものの、1~2年遅れる見込みである。
専門家レベルの緩和ケアAIプログラムの開発と検証～終末期の苦痛を一掃する

森雅紀, 山口崇, 田村恵子, 山口拓洋, 木澤義之, 宮下光令, 田上恵太

2020年7月30日～ 2025年3月31日

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超高齢多死社会を迎えた日本では、緩和ケアを全国に普及させる画期的な手段の開発が求められる。本研究では、多くの終末期患者の苦痛を緩和するAIプログラムを開発する。令和3年度までは、最近のAI研究に関する文献・書籍をレビューし、AI研究に関わる医療者・研究者と情報共有を行うことで、緩和ケアへのAIの活用に関する現状把握を行ってきた。緩和ケア専門家の推奨は多岐にわたるが、そのようなAIプログラムの開発や類する研究は先例がないことを確認した。したがって、大規模にデータを取得するに先立ち、対象となる苦痛を絞り、想定したデータ構造から解析が可能か、臨床的に意味のある結果が抽出できるかを検討するパイロットが必要であることを確認した。国内外において特に終末期に頻度が高く、十分な緩和が得られていない苦痛として、痛みと呼吸困難を主な対象とすることを検討した。令和3年度は、痛みに対する専門的緩和ケアのデータをAI開発のパイロットとして取得した。多施設の緩和ケアチーム・緩和ケア病棟で痛みに対して専門的な治療を行った424人の患者を対象に計1498日分のデータを収集した。入力用のデータとして、登録時情報から得られる変数（74種類）と毎日記載の調査票から得られる変数（AIデータ含め35種類）を用いた。出力用のデータとして行うべき緩和ケアの推奨リストを取得した（16種類）。ランダムフォレスト、勾配ブースティング回帰木、ロジスティック回帰による多クラス分類、ニューラルネットワークの手法を用いて、インプットからアウトプットの予測精度を確認した。その結果、各出力データの出現頻度は概ね低く手法を問わず予測精度は大差ないこと、その中でも頻度が比較的高い項目が本試験での出力データの候補になるという見通しをつけた（定時オピオイドの増量、オピオイドの変更、非オピオイドの使用、鎮痛補助薬の使用など）。
苦痛緩和のための鎮静と安楽死との違いを明確にする鎮静の定義に関する実証研究

今井堅吾, 山口拓洋, 川口崇

2019年4月1日～ 2023年3月31日

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終末期に苦痛緩和のために行われる鎮静では、標準化された鎮静薬の投与方法がないことや、鎮静の定義が意識を低下させるという意図を含んでいるためにあいまいで、何が鎮静かについて解釈がバラバラで安楽死との違いが明確でない。これを解決するために、再現可能な投与プロトコル(薬剤投与方法の手順)により鎮静を新たに定義することで安楽死との違いを明確化することに取り組んだ。 2018年度までに単施設（聖隷三方原病院）で実施されてきた鎮静薬の投与プロトコルを各施設での実践状況と照らし合わせて差異を検証した。各施設で実施可能となるように鎮静薬の投与量、評価・増量間隔、早送り間隔などに修正を加えた。苦痛に合わせて鎮静薬を増量する調節型鎮静プロトコルと、最初から深昏睡になるまで鎮静薬を投与し維持する持続的深い鎮静プロトコルを作成した。調節型鎮静プロトコルは、なるべく意識が保たれるようにしながら苦痛緩和が可能であるが、迅速な苦痛緩和が難しい可能性がある。一方持続的深い鎮静プロトコルは、迅速に苦痛緩和が出来るがコミュニケーションが直ちに困難になる。患者の状態により相応なプロトコルを選択することとした。各施設において投与プロトコルを用いてパイロット試験を行った。試験での問題点を抽出し、更に修正して最終的な投与プロトコルを作成した。プロトコルによる鎮静を行い、苦痛、意識、有害事象/生命予後を前向きに評価していく。それにより、安楽死との違いを明確にする鎮静の定義が確立できる。更に、各投与プロトコルで定義された鎮静は、治療内容と結果が明らかな、再現可能な標準治療となる。今後、標準治療と新たな投与プロトコルの比較試験を行うことで、更に治療成績の良い投与プロトコルの開発につながる。
行動経済学を取り入れたアドバンスケアプランニングの効果に関する検証試験

木澤義之, 竹之内沙弥香, 山口拓洋, 森田達也, 余谷暢之

2019年4月1日～ 2023年3月31日

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将来の意思決定能力の低下に備えて、患者がその家族や医療専門職と、医療やケアの目標や、価値観、具体的な治療、療養の場所等の希望について話し合うプロセスは、アドバンス・ケア・プランニング(ACP)と呼ばれる。我が国においてもその重要性は認識されているものの、臨床におけるACPの実践には数々の障壁があることが報告されている。そこで本研究では、ハーバード大学で開発され、その効果が実証されているSICP（Serious Illness Care Program）に行動経済学的知見を加えてモディファイして用いる。本年度は、進行がん患者を対象に、医師と看護師が協働してACP支援する「日本型ACP支援モデル」をつくりその実施性を評価した。具体的には、進行がん患者のACP支援に携わる京都大学医学部附属病院の医師及び看護師を対象に、「日本型ACP支援モデル」を用いたACP支援方法を教育し、研究対象者への介入の質を担保する方策について、研究協力者と検討を重ねた。また、研究計画に即した実施手順書を作成し、手順書に基づき臨床現場における本研究の実施可能性を再確認した。さらに、症例登録センターにおける症例登録手順について、登録責任者およびスタッフと協議しその内容を踏まえ、COVID-19感染拡大の状況に応じて、本研究の調査対象者の紹介を依頼する医療機関の診療科に所属する医師と密に連携し、調査対象者の登録を開始した。同時に、介入群に登録された調査対象者に精神機能障害が疑われる場合の対応手順について、研究分担医師及び研究分担看護師、精神医学の専門家を含む共同研究者等と検討した。
アドバンス・ケア・プランニングを始める時期が客観的にわかる方法の開発と効果の検証

浜野淳, 香川璃奈, 讃岐勝, 山口拓洋, 竹内文乃, 宮下光令, 森田達也

2019年4月1日～ 2023年3月31日

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本研究は、進行がん患者に対してACPを開始する適切なタイミングが判断できる予後予測指標の開発と効果の検証を行う。本研究の研究課題は以下の3つである。①血液検査データのみを用いて、進行がん患者の生命予後30日・60日・90日を高い精度で予測する指標を開発・検証する。（すでに申請者らが実施可能であるFractional polynomial modelという方法を用いる）②実際に、開発された指標で予測された個々の患者の生存確率が自動的に電子カルテに表示されるシステムを用いた場合の、臨床的な効果（例：ACP実施率）を検証する。③同じ手法を用いて心不全患者において、客観的に予後が予測できる指標を開発する。 2020年度は、①血液検査データのみを用いて、進行がん患者の生命予後30日・60日・90日を高い精度で予測する指標を開発・検証するという研究課題について、約2000人の進行がん患者のデータをFractional polynomial modelで解析した。その結果、申請者らが以前に異なるデータベースを用いて開発・検証した時と同等の精度を持つ生命予後予測モデルを開発することができた。この結果、血液検査データのみを用いて、精度の高い生命予後予測モデルを開発する手法が確立したと考えられた。また、この手法を用いることによって、生命予後だけでなく、身体機能予後の予測も可能になると考えられた。よって、2021年度は、実臨床における臨床的な効果を測定する方法の開発・検証、心不全患者など進行がん患者以外の患者において、精度の高い予後予測モデル開発の検証、そして、発展的に身体機能予後の予測方法について検証していく。
がん患者の不安、抑うつに対するスマートフォン精神療法の有効性：無作為割付比較試験

明智龍男, 山口拓洋, 内富庸介, 古川壽亮

提供機関：Japan Society for the Promotion of Science

制度名：Grants-in-Aid for Scientific Research

研究種目：Grant-in-Aid for Scientific Research (B)

研究機関：Nagoya City University

2019年4月1日～ 2023年3月31日

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がんはわが国の死因の第一位であり、年間100万人以上が罹患する最大の健康問題である。その致死性のため、患者の30-40％に不安、抑うつがみられる。がん患者の不安、抑うつに対しては薬物療法と認知行動療法を代表とする精神療法双方の有用性が示されているが、患者の大多数は精神療法を好む。一方、莫大な患者数に対し治療者の不足のため、適切な精神療法はほとんど提供されていない。以上のような背景を受け、本研究では、情報通信技術を駆使した革新的な臨床試験体制を構築するとともに、広くがん患者の不安、抑うつに対するこれらアプリの有効性を無作為化比較試験で検証することを目的とする。 2021年度までに以下を実施した。スマートフォンを用いた問題解決療法の治療プログラム（「解決アプリ」）および行動活性化に基づく治療プログラム（「元気アプリ」）を開発し、本研究に即した形に改良した。我々が他の研究で開発した臨床試験システムをもとに（特願2019-017498）、対象者の募集、説明と同意、評価項目の入力等のほぼすべての研究プロセスをインターネットをはじめとした情報通信技術を介して行う臨床試験体制（Decentralized Clinical Trial）を本研究に即した形で構築した。2020年度はシステムのチェックのための予備試験を行った後に臨床試験を開始した。当初はエントリーが少なく研究進捗が遅れたため、乳がんのハイボリュームセンター、乳がんクリニックに依頼し、研究計画を倫理審査委員会の承認を得て、担当医から対象となる患者に直接本研究参加の推奨をしていただくこととして飛躍的に参加者が増加した。結果的に2021年度までに200名以上の参加を得た。
がんサバイバーに対する「安全・安心ケアネット」の構築

小松浩子, 小松康宏, 中澤仁, 矢ヶ崎香, 山口拓洋, 住谷昌彦, 辻哲也, 武林亨, 神田清子

提供機関：Japan Society for the Promotion of Science

制度名：Grants-in-Aid for Scientific Research

研究種目：Grant-in-Aid for Scientific Research (A)

2016年4月1日～ 2021年3月31日

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本研究の目的は、がんサバイバーの健康や生活に重大な影響をもたらす神経系合併症および皮膚侵害性合併症に焦点をあてた「がん安全・安心ケア」を標準化し、効率的にケアを波及するためのケアネットワークを構築することにあった。転倒予防を目的とした安全・安心ケアモジュールは、①アンメットニーズを引き出すための工夫、②リスク認知による健康行動の形成、③自己効力感の促進の3要素で構成された。患者の生活に密着した予防的な転倒予防ケアモジュールシステムとして、モバイル・ウェアラブル端末に着目し、末梢神経障害による患者の日常的な転倒状況を実社会環境で測定・分析できる「FD-AWARE」システムを構築した。
高齢者の終末期の緩和できない苦痛と尊厳死・安楽死の希望に関する国際共同研究

恒藤暁, 森田達也, 木澤義之, 山口拓洋

提供機関：Japan Society for the Promotion of Science

制度名：Grants-in-Aid for Scientific Research

研究種目：Grant-in-Aid for Scientific Research (B)

研究機関：Kyoto University

2016年7月19日～ 2020年3月31日

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日本の緩和ケア病棟20施設の971名を対象とし、希死念慮の頻度と理由を調査した。希死念慮は18％（95％C.I., 16-20）、積極的安楽死の要求がその46％（38-53）であった。死を望む理由は、自分で自分のことができない（45％）、楽しみになることがない（28％）など精神的な理由が多かった。身体的苦痛では、倦怠感（２３％）、呼吸困難（21％）、疼痛（12％）が挙げられた。クラスター分析と質的研究の結果、死を望む患者は４群（自分のことが自分でできず迷惑をかけているのがつらい、楽しみに感じることがない、呼吸困難か疼痛、著明な倦怠感）に分けられた。日本、台湾、韓国のいずれも同様であった。
日本人独自のノモグラムによる腎腫瘍に対する標準的治療法の確立

齋藤英郎, 荒井陽一, 山口拓洋, 伊藤明宏, 山田成幸

提供機関：Japan Society for the Promotion of Science

制度名：Grants-in-Aid for Scientific Research

研究種目：Grant-in-Aid for Scientific Research (C)

研究機関：Tohoku University

2014年4月1日～ 2017年3月31日

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泌尿器腹腔鏡技術認定医が所属し、十分に腹腔鏡下腎部分切除術を行っている本邦の施設を対象に、1,375例を検討し、周術期成績が良好であること。組織型については、女性・小径で良性の割合が高くなっていた。年齢・BMI・性別・腫瘍径が統計学的に有意な因子として残り、多変量解析による良性確率予測式を作成した。また、東北大学関連施設のコホートを用い、術後一年目での腎機能を予測する予測式を作成した。この予測式は、部分切除術やサーベイランスの治療オプションの選択という、臨床における重要な判断に参考になるものとしてInvestigative and Clinical Urologyにアクセプトされた。
先端医療技術の開発における臨床試験の計画と統計解析に関する研究

松井茂之, 江口真透, 手良向聡, 松浦正明, 森田智視, 山口拓洋, 藤澤洋徳, 大門貴志, 寒水孝司, 川口淳, 伊藤陽一, 山中竹春, 平川晃弘, 野間久史

提供機関：Japan Society for the Promotion of Science

制度名：Grants-in-Aid for Scientific Research

研究種目：Grant-in-Aid for Scientific Research (A)

2012年4月1日～ 2016年3月31日

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再生医療、個別化医療などの先端医療技術の開発における臨床試験の計画や統計解析の方法に関する研究を行った。1) オミクスデータを用いた予後・治療効果予測マーカーの解析、2) 早期臨床試験の計画と解析（用量反応関係、患者集団の探索）、3) 検証的臨床試験の計画と解析（治療効果の検定と不偏推定）に分けて、新しい統計的方法の開発を行った。個別化医療の臨床試験に関する成果は洋書として出版した。これは、個別化医療の臨床試験の計画とデータ解析に関する統計的方法を包括的にまとめたものであり、世界的にみても初めての試みである。
外来化学療法におけるオンコロジーエマージェンシーの安全ケア質保証統合システム開発

小松浩子, 矢ヶ崎香, 山口拓洋, 東尚弘, 内布敦子, 荒尾春惠, 鈴木志津枝, 渡邊知映, 吉村公雄, 飯野京子

提供機関：Japan Society for the Promotion of Science

制度名：Grants-in-Aid for Scientific Research

研究種目：Grant-in-Aid for Scientific Research (A)

研究機関：Keio University

2011年4月1日～ 2016年3月31日

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本研究では、外来がん化学療法看護におけるoncology emergencyの安全性改善をめざす＜ケア質保証統合システム＞を開発した。＜ケア質保証統合システム＞として、①ケアの質指標（QI) の開発、②静脈ラインあるいはポートからの抗がん剤安全投与ガイドラインの作成と公開、および③[理解の再確認]、[意向の表出と選択]、[相談]の要素で構成した「経口抗がん剤のアドヒアランス促進服薬自己管理支援プログラム」を開発した。エビデンスレベルの高い成果を得るために服薬自己管理支援プログラムを用いた無作為化比較試験を実施した。
ＰＲＯ－ＣＴＣＡＥ日本語版の開発と普及に関する研究

山口拓洋, 岩瀬哲, 後藤悌, 山本大悟, 小田桐弘毅, 坪井正博, 川口崇

提供機関：Japan Society for the Promotion of Science

制度名：Grants-in-Aid for Scientific Research

研究種目：Grant-in-Aid for Scientific Research (C)

研究機関：Tohoku University

2012年4月1日～ 2015年3月31日

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PRO-CTCAE 日本語訳東北大学/東京大学/JCOG版について、平成23年度から実施したがん患者へのインタビュー調査の結果をまとめ、言語的妥当性、原版との文化的・意味論的同等性、言語的流暢性を評価した。JCOG1018試験で使用する9項目（下痢、活力低下、手足症候群、吐き気、手足の痺れ等）のfeasibility studyの結果から本尺度は臨床試験において測定可能と確認した。計量心理学特性は米国で既に検討がなされている為、欧米の先行研究結果と大きな差異がない事の確認を目的とするバリデーション研究を計画し、タブレット入力が可能となるようなプラットフォームの開発も同時に進め、登録中である。
がん臨床研究における多変量生存時間データの解析

山口拓洋

2005年～ 2007年

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平成17,18年度に引き続き、がん臨床試験における多変量生存時間データの解析方法について、実データへの適用を考慮いつつ検討した。・クラスターデータの解析昨年度の胃がんの手術療法に関する多施設臨床試験データの解析に加えて、同じく胃がんの化学療法に関する多施設臨床試験データを用いて、施設間差の検討を行った。Frailtyモデルのパラメータ推定にはWinBUGSを用いた。ペナルティー付き尤度に基づく方法などと比して、ベイズ流のアプローチを用いることで安定した結果が得られ、推定の性能も良好であった。・多段階遷移データ及び競合危険データの解析血液がんにおける移植療法のデータを中心に検討した。多段階遷移データに関して、GVL効果を検討するために提案されている複数の統計モデルについて比較を行った。通常用いられている、GVHDの発症を時間依存性変数として考慮したCox回帰モデルの適用には限界があると考えられたが、一方で、他の因果モデルの適用についても既存のデータを生状況が直感的に理解できるようなグラフ表示方法について検討した。また、Cumulative Incidence及び対応する回帰手法である競合危険回帰について、どのような状況において用いることが適当であるか実データに基づき検討した。競合危険回帰については、利用可能な統計パッケージについて調査した。
乳がん補助化学療法後の認知機能障害のポジトロン断層法(FDG-PET)による測定

大橋靖雄, 山口拓洋, 大津洋, 中村祐, 田代学

提供機関：Japan Society for the Promotion of Science

制度名：Grants-in-Aid for Scientific Research

研究種目：Grant-in-Aid for Scientific Research (C)

研究機関：The University of Tokyo

2005年～ 2006年

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本研究の目的は、補助化学療法を受けた乳がん患者の認知機能を測定し認知機能障害の経時変化の分析、特に、機能生理検査(18F-FDG-PET)により、患者の認知機能障害が脳神経組織の活動性の低下を伴うものであるかを検討することにある。本研究の実施に先立ち、詳細な研究プロトコルおよび調査票を作成し、(財)パブリックヘルスリサーチセンターの倫理審査委員会および、協力依頼を承諾した日大板橋病院、三井記念病院の倫理審査委員会で、PET検査対象者のデータの守秘、PET検査の侵襲性と対象者の利益に関しての審査を受け、研究が承認された。協力医療機関にて、手術可能な女性原発乳がんで、術前補助的化学療法を受療する患者の登録を平成18年度前半に開始した。補助的化学療法開始前の時点、終了時点より1ヵ月後の2点で測定を行う。各測定点では、1.問診による包括的医療情報、2.月経状況、3.血液・尿検査、4.一般的健康状態(ECOG-PSR)、5.有害事象(CTC)などの臨床情報に加え、1.神経心理学的認知機能(WAIS-R)、2.抑鬱状態・気分障害(POMS)、3.健康関連QOL (EORTC QLQ C-30)を、調査員の前で患者本人が回答、記入する。その後、東京大学医学部附属病院に患者を移送し、PETによる脳機能・形態の撮影を行い、所見を分析する。 WAIS-Rの学習効果を確認し、測定結果を調整するために、乳がん患者への検査と平行して、健常者5名の同年代の女性に対して、本研究計画と同様の2回の認知機能測定を実施している。協力医療機関及び東京大学医学部附属病院より研究事務局に検査結果を収集し総合分析を行う。諸機関の調整と研究の流れの整備ができ、対象者の登録を開始したものの、期間中に充分な対象者が確保できなかったため、科学研究費補助金の支給期間終了後も引き続き研究を継続する。
医学情報管理学競争的資金
医学研究方法論競争的資金
医学統計学競争的資金
Information Management 競争的資金
Clinical and Epidemiological Research Methodology 競争的資金
Biostatistics 競争的資金

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