薬理と治療

創刊以来約40年にわたり幅広い購読層から信頼されてきた医薬原著論文投稿誌。読者対象は各科臨床医,薬剤師,医薬品開発担当者・研究者。
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扉・目次
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TOPIC 第21回CRCと臨床試験のあり方を考える会議 2021 in 横浜
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- シンポジウム5/CRC が直面する特定臨床研究への支援における課題共有と対策
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臨床研究中核病院における特定臨床研究に対する研究支援の現状と取り組み
50, 7(2022);View Description
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臨床研究法等の施行により,臨床研究の実施には臨床研究に関する知識と高度なスキルが要求され,治験に近い実施体制と品質管理が求められつつある。北海道大学病院(以下,当院)は,臨床中核病院としてプロモーションユニット(以下,当ユニット)内にARO 機能を整備しており,CRC,データマネージャー,モニター,生物統計家,知財担当者,プロジェクトマネージャーなど臨床研究専門職がおのおの専門性を発揮し,基礎・非臨床開発から臨床開発まで幅広い研究支援を行っている1~5()図1)。当ユニットの支援体制と,特定臨床研究に対する研究支援に関する課題について紹介する。 -
発展途上のARO における特定臨床研究支援の現状と課題
50, 7(2022);View Description
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佐賀大学医学部附属病院(以下,当院)は,高度急性期医療と地域医療の最後の砦を担う病床数604床の佐賀県唯一の大学病院である。当院の臨床研究センター(以下,センター)は,臨床研究法の施行に対応して特定臨床研究の管理体制を強化するとともに,法規制に伴う研究者支援を目的としたARO機能の拡充にも対応してきた。本シンポジウムでは,「臨床研究中核病院ではない」規模のARO における課題や対策を紹介し,臨床研究コーディネーター(CRC: Clinical ResearchCoordinator)に期待する役割についても再考する。 -
CRB 事務局の立場からの特定臨床研究の審査
50, 7(2022);View Description
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臨床研究法では,臨床研究審査委員会(以下,CRB)に関連した手続きが煩雑であり,研究事務局などの支援体制のない研究においては,研究者が大変な労力を費やしている。CRB 事務局は,法に沿った手続きについて研究者を支援しているが,研究の実施状況については定期報告やモニタリング報告書で把握するしかなく,CRB事務局ができることには限界がある。そのため,より良い研究を実施するためにも,CRCと連携した支援体制について考えてみたい。 -
臨床研究分担施設における特定臨床研究支援の現状と課題─SMO の立場から─
50, 7(2022);View Description
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臨床研究の意義は,国としても10 年以上前から繰り返し指摘され,医薬品産業ビジョンをはじめ多くの政策が展開されている。同時に「治験は制度から整備されてきたが,臨床研究が適切に実施できる体制は整備されていない」などと,臨床研究基盤の脆弱さも指摘されてきた(図1)。そのなかで,臨床研究に関する社会問題を契機に臨床研究法が成立し,臨床研究中核病院が医療法に規定された。これに伴い,わが国の臨床研究のあり方は大きく変化した。今回は本シンポジウムを機に,臨床研究分担施設を支援する立場から,特定臨床研究支援における課題を振り返り,今後の展望を含め再考した。
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ORIGINAL ARTICLES
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臨床試験の結果報告に関する臨床試験登録レジストリとCONSORT 2010声明の比較
50, 7(2022);View Description
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Objectives This study aims to compare the CONSORT 2010 statement (CONSORT statement), which is a standard for reporting interventional trials, with the WHO-Trial Registration Data Set (TRDS) version1.3.1 and clinical trial registries, as well as to clarify the current status of foreign and domestic registries on elements for reporting results. Methods We compared topics of the results and discussion in the CONSORT statement with those in TRDS and the following clinical trial registries in this study: ClinicalTrials.gov, EU Clinical Trial Registry (EUCTR), Japan Pharmaceutical Information Center Clinical Trials Information (JapicCTI), Japan Medical Association Center for Clinical Trials, Clinical Trials Registry (JMACCT CTR), University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR), and Japan Registry of Clinical Trial (jRCT). Results The TRDS contained items related to all the results topic of the CONSORT statement except for the topic of “Number analyzed” but did not contain items related to discussion topics. ClinicalTrials.gov and EUCTR implemented all of items related to the results topic and topic of “Limitations” in the discussion. All items related to the results topic were included in JapicCTI, JMACCT CTR, UMIN-CTR, and jRCT, except for “Number analyzed.” For the “Outcome and estimation” topic, information on the “Number analyzed” topic was deemed to be available. Furthermore, JMACCT had items for three discussion related topics, whereas the other three registries had no items. Conclusions It was discovered that the reporting of trial results in domestic and international clinical trial registries permits the registration of clinical research results following the CONSORT statement. (Jpn Pharmacol Ther 2022;50:1177-85) -
短期食餌制限が高血圧性臓器障害発症に及ぼす影響
50, 7(2022);View Description
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Objectives In this study, we examined the beneficial effects of short-term food restriction on hypertensive end-organ damage and life span in stroke-prone spontaneously hypertensive rats (SHRSP). Methods Experiment 1: Male 10week-old SHRSP were fed 70% of the diet of the control group for 2 weeks and then were returned to free intake of food. At 30 weeks of age the survival and incidence of stroke were compared. Experiment 2: Male 14week-old SHRSPs were fed 70% of the diet of the control group for 2 weeks. At 18 weeks of age when body weight recovered in the food restriction group, adipocytokine levels in serum and adipocyte, and mRNA expression of SIRT1, AMPK and GLUT2 in liver were compared. Results Experiment 1: At 30 weeks of age, the survival rate was higher, and incidence of stroke was lower in the food restricted group as compared to those in the Control group. Experiment 2: At 18 weeks of age, serum leptin levels and the expression of mRNA in adipose tissue were higher in the food restricted SHRSP than in the Control. Furthermore, the mRNA expression of SIRT1, AMPK and GLUT2 in liver were upregulated in the food restricted SHRSP. Conclusions It was shown that short-term food restriction has beneficial effects for prevention of hypertensive organ damage even in lean models. This may be due to improvement of vascular function, and energy metabolism based on the activation of AMPK in the liver, owing to upregulation of leptin in adipose tissue. (Jpn Pharmacol Ther 2022;50:1187‒94) -
納豆菌および納豆表皮の免疫賦活効果
50, 7(2022);View Description
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Background and purpose Natto was made from soybeans fermented with Bacillus subtilis (natto)and B. subtilis(natto)ware present on the surface of natto. Natto and B. subtilis(natto) were known as probiotics, but the immunostimulatory function was not well known. We examined the immunostimulatory effect of B. subtilis(natto)and natto epidermis. Methods We measured the IFN-γ production levels of mouse spleen cells stimulated with B. subtilis(natto)and natto epidermis in vitro. Mice were orally administered with Natto epidermis for 7 days and the spleen cells were collected and used for the measurement of NK activity and IFN-γ production. Results IFN-γ production from mouse spleen cells significantly increased after stimulation with B. subtilis(natto). This effect was stronger in the vegetative cell than in the spore. Although there was no immunostimulatory effect on boiled beans, natto and natto epidermis induced IFN-γ production, and natto epidermis was more effective. The NK activity in mice administered with natto epidermis was higher than that in control mice. Conclusion These results indicated that B. subtilis(natto)and natto epidermis exert immunostimulatory effects, especially activation of innate immunity. (Jpn Pharmacol Ther 2022;50:1195‒9) -
Bacillus subtilis subsp. natto QOL(QOL納豆菌®)含有食品摂取による睡眠の質の改善効果―無作為化二重盲検プラセボ対照並行群間比較試験―
50, 7(2022);View Description
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Objectives Bacillus subtilis subsp. natto QOL(QOL Bacillus natto)is suggested to improve quality of sleep. This study aims to evaluate the efficacy of a supplement product containing QOL Bacillus natto on the sleep quality. Methods A randomized, double-blind, placebo-controlled, parallel-group study was conducted in 60 participants(Age 20-64, Pittsburgh Sleep Quality Index≧6). Participants were randomly assigned to receive either the test product containing QOL Bacillus natto or placebo daily for 8 weeks. Participants were evaluated using OSA sleep inventory for middle age and aged(OSA-MA), Athens Insomnia Scale, Pittsburg Sleep Quality Index, s-IgA secretion rate, blood stress marker, Profile of Mood States 2nd Edition, Visual Analogue Scale questionnaire on fatigue feeling and concentration tests such as Uchida-Kraepelin test(UK-Test). Results Sleeping on rising score of OSA-MA was significantly improved in the test group compared with the placebo group at week 8. The amount of change in DHEA-S, a blood stress marker, was significantly increased in the placebo group. In the UK-Test, the agitation rate was significantly improved in the placebo group at first half and in the test group at last half. Conclusions The result suggested that QOL Bacilus natto ingestion improves quality of sleep and reduces stress feeling in daily life. (UMIN ID: UMIN000044803)(Jpn Pharmacol Ther 2022;50:1201‒12)
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