著者

須藤 将裕

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.52, no.6, pp.175-178, 2021-11-30 (Released:2021-12-15)

著者

浜 六郎 別府 宏圀 坂上 章子 森 久美子 坂口 啓子

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.26, no.1, pp.385-386, 1995-03-31 (Released:2010-06-28)

被引用文献数

1 1

著者

栗山 哲 松本 啓 平尾 磨樹 三穂 乙哉

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.52, no.6, pp.157-164, 2021-11-30 (Released:2021-12-15)

参考文献数

46

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Evidence has emerged as to the cardio-renal protective effect of sodium glucose co-transporter 2 (SGLT2) inhibitors. Recent studies, DAPA‒CKD, DAPA‒HF and EMPEROR-Reduced and EMPEROR-Preserved will extend its clinical indications to heart failure and CKD even in patients without diabetes mellitus. This review anew discusses the presumable pharmacological mode of action with SGLT2 inhibitors in non-diabetics. The putative mechanisms by which SGLT2 inhibitors exert the beneficial effects may be accounted for by salt/water diuresis via SGLT2 and Na/H exchanger 3 inhibition, glucosuria-induced osmotic diuresis, and the subsequent optimization of tubule-glomerular feedback system in the kidney.

著者

川合 眞一 松本 佳純 武永 美津子 金光 敬二 柳川 明 嶋田 甚五郎 水島 裕

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.25, no.1, pp.225-226, 1994

著者

小林 節雄 根本 俊和

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.6, no.1, pp.71-77, 1975

著者

吉村 道博 望月 正武

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.39, no.3, pp.67S-68S, 2008 (Released:2009-02-04)

参考文献数

10

著者

植田 孝子 幸田 隆彦 内田 英二 倉田 知光 高野 裕 渡辺 誠 西村 有希 岩瀬 万里子 青木 康代 安原 一

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.28, no.1, pp.347-348, 1997-03-31

著者

還田 悠平 髙山 茜 成川 衛

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.48, no.1, pp.9-14, 2017

被引用文献数

1

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<p><b>Background</b>: In Japan, delay in marketing approval of new drugs, known as &ldquo;drug lag&rdquo;, was believed to hinder patient access to innovative treatments. The Japanese government took several corrective measures, and the median review time for new drugs was shortened. However, in many cases, new drugs are developed in the United States (US) and European Union (EU) , and these drugs are usually approved first in the US and EU prior to approval in Japan. Increase of drugs approved in Japan before the rest of the world or simultaneous with other countries is expected to further improve patient access to innovative drugs.</p><p><b>Method</b>: For all New Active Substances (NASs)that were approved in Japan between January 2008 and December 2014 , detailed information including the regions where the new drugs were developed and the countries of first global approval were identified. We also collected information about safety concerns that were identified before approval.</p><p><b>Result</b>: Two hundred and thirty-nine NASs obtained Japanese approval during the study period. Of the 239 NASs, 44 (18.4%) were approved in Japan before the rest of the world. Drugs that obtained Japanese approval first in the world were more often developed in Japan from the early stage. Furthermore, the data suggested that these drugs were launched with relatively limited safety information.</p><p></p><b>Conclusion</b>: For better patient access to new drugs, it is important to facilitate early development of new drugs in Japan and at the same time to ensure further strengthening of post-marketing safety measures.

著者

石岡 忠夫 青井 禮子

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.22, no.1, pp.273-274, 1991-03-31 (Released:2010-04-30)

参考文献数

2

著者

宮原 正 下條 貞友 豊原 敬三 今井 健郎 宮島 真之 本田 英比古 亀谷 雅洋 大関 正弘 小勝 順

出版者

The Japanese Society of Clinical Pharmacology and Therapeutics

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.16, no.2, pp.357-365, 1985-06-30 (Released:2011-02-25)

参考文献数

19

被引用文献数

4 4

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A phase I study of EST, a newly synthesized specific thiol protease inhibitor developed as a drug for muscular dystrophy, was performed in healthy adult male volunteers to investigate its safety and pharmacokinetics. EST was administered orally in single doses of 100 mg during fasting, or of 100 mg or 200 mg after a meal. The following results were obtained.The clinical tests and observation of the subjective and objective signs and symptomsfound no change due to EST.EST was detected as E-64-c (effective form of EST) in serum and urine after oral administration. The absorption of EST was slower when administered after a meal than during fasting. The AUC (area under the serum concentration curve) and urinary excretion rate were greater following administration after a meal, which indicates a tendency to better bioavailability of EST.As for the comparison of 100 mg and 200 mg administration after a meal, a distinct dosedependency was observed in the serum concentration and urinary excretion.

著者

安齋 享征 佐藤 哲男

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.41, no.1, pp.59-65, 2009 (Released:2010-04-02)

参考文献数

19

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The sensitivity and detection limit of chemical analysis have improved remarkably since the 1980's, and pharmaceuticals are frequently detected in the environment. Many substances including pharmaceuticals, cosmetics, body care products, disinfectants, fire retardants, industrial additives and gasoline additives have been referred to generally as emerging contaminants. The EU and US have already established regulations concerning environmental risk assessment (ERA) of pharmaceuticals. In Japan, a group closely related to the Ministry of Health, Labour and Welfare has begun to study similar regulations. The adoption of these regulations has been welcome in the EU and US, and ERA guidelines will also be established in Japan in the near future. On the other hand, health professions such as doctors, nurses and pharmacists in Japan appear to be unaware of ERA of pharmaceuticals as emerging contaminants. This article provides a general overview of ERA of pharmaceuticals in the EU and USA, especially targeting health professions in Japan.

著者

河合 昭悦 桑野 友彰 中島 久夫 水野 清史 西本 博之 久保田 信子

出版者

The Japanese Society of Clinical Pharmacology and Therapeutics

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.34, no.4, pp.193-198, 2003-07-31 (Released:2010-06-28)

参考文献数

3

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The major factors that have heretofore prevented an efficient implementation of clinical trials include deviations from the protocol at the investigator's site, defectiveness in filling out the case report forms (CRFs), frequent monitoring and fixing work of patient data by the sponsor, handwritten preparation of various documents, and so on.As an experiment in electronic implementation of an efficient clinical trial utilizing information technology, we formed an electronic data capture (EDC) system that efficiently collects clinical data from the investigator's site, and applied it to a clinical trial. As a result, there was no patient with a GCP violation and thus all were eligible as study subjects and the number of correction log form (CLF) for CRFs was considerably reduced. In addition, it was possible to conduct an efficient clinical trial and shorten the study period by utilizing this EDC system. We discuss the future readiness for clinical trials based on this experience of implementation, as well as the challenges that lie ahead.

著者

片平 洌彦 佐久間 昭 杉沢 秀博

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.18, no.1, pp.135-136, 1987-03-30 (Released:2010-06-28)

参考文献数

16

著者

小林 節雄 根本 俊和

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.6, no.1, pp.71-77, 1975-03-30 (Released:2010-06-28)

参考文献数

33

著者

千葉 寛

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.28, no.1, pp.79-80, 1997-03-31

著者

須永 健一郎 熊谷 雄治 原田 和博 大森 正規 海老原 昭夫 藤村 昭夫

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.27, no.1, pp.37-38, 1996-03-31 (Released:2010-06-28)

参考文献数

1

著者

Tsuyoshi SHIGA Takako KAMIO Kenta UTO Kotaro ARAI

出版者

The Japanese Society of Clinical Pharmacology and Therapeutics

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.52, no.4, pp.101-105, 2021-07-31 (Released:2021-08-18)

参考文献数

18

被引用文献数

1

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Trastuzumab, a humanized monoclonal antibody, is used in the treatment of metastatic breast cancer overexpressing human epidermal growth factor receptor 2 (HER2). Trastuzumab-related cardiotoxicity can usually be reversed by interrupting the use of the drug. We present a 78-year-old woman with metastatic HER2-positive breast cancer whose left ventricular ejection fraction (LVEF) decreased from 56% to 37% within 3 months after starting trastuzumab treatment prior to surgery. She complained of shortness of breath on exertion. Trastuzumab was stopped immediately, and an angiotensin-converting enzyme inhibitor and a beta blocker were started. Her LVEF did not increase 6 months after the cessation of trastuzumab use. Low-dose digoxin (0.0625 mg daily) was added, and the patient's LVEF increased from 35% to 44% one month later. The next month, she was able to undergo mastectomy with axillary lymph node dissection followed by radiation and tamoxifen as adjuvant therapy. She was followed up for 3 years after surgery and experienced no recurrence of breast cancer.Trastuzumab-related cardiotoxicity can usually be reversed by interrupting the use of the drug. Patients with inadequate or nonexistent recovery of LVEF despite cardioprotective therapy cannot undergo standard cancer treatment; this restriction leads to a worsened prognosis. Low-dose digoxin in addition to cardioprotective therapy increased our patient's LVEF to over 40%, allowing her to undergo surgery.

著者

植田 真一郎

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.52, no.3, pp.68-69, 2021

著者

三輪 宜一

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.52, no.3, pp.89-93, 2021

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<p>In recent years, many excellent drugs with few side effects have been introduced into treatment and contribute to improving prognosis, but elderly people often have multiple diseases and take many drugs in combination. As a result, the existence of drug interactions has become more important as a risk factor for the occurrence of adverse drug reactions(ADRs). In Japan as well, the importance of drug interactions has been recognized since the Sorivudine incident in 1993, in which sorivudine, a therapeutic drug for herpes zoster, caused death due to serious myelosuppressive side effects when used in combination with 5-FU anticancer drugs, and cautions have been issued such as the revision of the description procedure in the package insert. In addition, efforts are being made by various parties concerned in the drug development process. In 2018, the Ministry of Health, Labor and Welfare issued the “Guideline on drug interaction for drug development and appropriate provision of information” regarding the method of examining drug interactions and the provision of information.</p><p>On the other hand, looking at the medical field, although some side effects of individual drugs and interactions between the two drugs are described in the package insert, it is impossible to grasp all of them. In addition, even if the drug therapy is recommended in the treatment guidelines for a certain disease, if the drug is complicated with another disease, the drug interaction with the recommended drug for those diseases may become a problem. A meta-analysis of prospective studies on the incidence of drug-induced ADRs in inpatients published by the United States in 1998 estimated that 106,000 people die annually from ADRs. Healthcare professionals are required to work harder than ever to prevent ADRs. Even now, medications are checked by pharmacists, but it is hard to say that they are fully prepared for drug interactions.</p><p>In this session, I would like to describe what can be done and what kind of knowledge should be learned to prevent serious drug interactions. Based on that, I would like to think about what points should be emphasized and dealt with in the actual medical field.</p>

著者

金 美恵子 橋本 健太郎 林 敬次 柳 元和 三田 康子

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.30, no.1, pp.197-198, 1999-01-31 (Released:2010-06-28)