著者
後藤 伸之 月岡 理絵 八田 壽夫 政田 幹夫 北澤 式文
出版者
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.2, pp.465-468, 1996-06-30 (Released:2010-06-28)
参考文献数
9

We performed a pharmacoepidemiological study on triazolam dependence with typical doses in out-patients of Fukui Medical School Hospital. We investigated the prescriptions (duration of treatment and total dose prescribed) for patients administered triazolam.The patients were classified according to the prescription pattern of this drug, Group 1: patients who had been prescribed triazolam daily, Group 2: those who had been allowed to take triazolam when they cannot sleep.Approximately 40% of all the patients had been prescribed triazolam for 8 months or longer, and were judged to be normal dose dependence. The prevalence of this dependence was apparently higher in group 1 than in group 2.
著者
上野 光一
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.37, no.3, pp.165-169, 2006-05-31 (Released:2010-06-28)
参考文献数
12
著者
栗原 千絵子
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.45, no.2, pp.41-51, 2014-03-31 (Released:2014-04-16)
参考文献数
64

The latest revision of the Declaration of Helsinki was adopted by the World Medical Association (WMA) in October 2013. The year 2014 is the 50th anniversary since the first adoption of the Declaration in 1964, which was based on strong reflection over the unethical human experimentation conducted by doctors during World War II. Subsequently, the WMA has continuously elaborated the Declaration with the goal to prevent abuse of human dignity, and to guide physicians worldwide toward the conduct of ethically and scientifically sound research involving human subjects, to adhere to their duty of working for the patients' best interest.The most remarkable points discussed toward this 2013 revision are: (1) adding subheadings; (2) creating a provision to assure compensation and treatment for subjects harmed as a result of research; (3) clarifying the provisions of comparators e.g., placebo; (4) clarifying the provisions of protecting vulnerable populations and post-study arrangement; (5) adding the concept of biobank in the provision of research using human material and/or data; (6) strengthening the function of research ethics committees; (7) expanding the range of research to be registered in public database; and (8) clarifying the provision of the use of unproven intervention.There remain pros and cons of the principles in the revised Declaration; however, it is important to understand the historical background and continuing debates regarding the Declaration as a "living document". In this paper, the author describes such discussions that are believed to promote profound understanding of this document, which are necessary for the research communities in the world to conduct ethically and scientifically sound research involving human subjects.
著者
熊谷 雄治 田中 理英子 宋 一大 坂本 泰理
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.47, no.2, pp.31-37, 2016-03-31 (Released:2016-04-15)
参考文献数
9
被引用文献数
2 6

Background: Acetaminophen is widely used for pain relief, but is known to cause liver injury in cases of overdose. Previously, the maximum dose in Japan was 1500 mg/day, which was much lower than those in other countries. In 2011, the approved maximum dose was changed to 4000 mg/day in Japan, raising concerns over the safety of its use in Japanese patients. Therefore, we performed an epidemiological study to examine the safety of acetaminophen. In this study, we analyzed the data from a special drug use surveillance on elevation of liver function tests in Japanese patients, to assess drug-induced liver injury (DILI) of high-dose acetaminophen.Methods: Patients who were treated with a high dose (2400 to 4000 mg/day) of acetaminophen for 4 to 24 weeks were included. Data were collected from the hospital medical information systems of 87 hospitals, from which consecutive eligible patients between January 2011 and April 2013 were identified. An abnormal liver function test (LFT) was defined as elevated alanine transaminase (ALT) level greater than 3 times the upper limit of the normal range. The prevalence of abnormal LFT was calculated, and correlation with background factors was analyzed using logistic regression.Results: A total of 703 cases that met the inclusion criteria were analyzed. Abnormal LFT findings were observed in 22 cases (3.1%), and causality with acetaminophen could not be ruled out in 7 cases (1.0%). A logistic regression analysis showed that abnormal LFT findings correlated significantly with the presence of concomitant disease, a history of allergic disease, the duration of treatment, and on-demand use.Conclusion: The prevalence of elevated ALT level among Japanese patients treated with acetaminophen was almost identical to that reported in other countries. However, a significant relationship between abnormal LFT and some clinical factors including the duration of treatment was found. However, this study had a limitation of inadequate patient population, suggesting a need to collect data continuously in Japan.
著者
安部 順子 山田 康一 吉井 直子 柴多 渉 大島 一浩 掛屋 弘
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.51, no.6, pp.325-330, 2020-11-30 (Released:2021-01-21)
参考文献数
19

40 歳代の女性.慢性腎臓病(CKD)にて維持血液透析を週 3 回施行中で,内シャント閉塞のため人工血管植え込みあり.今回,同部位の人工血管感染からのメチシリン耐性黄色ブドウ球菌(MRSA)菌血症,化膿性椎間板炎および両側腸腰筋膿瘍の診断にて入院となり,ダプトマイシン(DAP)1 回 6 mg/kg を週 3 回透析後に開始したが,週末は「サンフォード感染症治療ガイド」に基づき 1.5 倍に増量投与した.約 7 週間後,炎症反応は正常化し,画像所見上膿瘍も消失.DAP の週明けのトラフ濃度(Cmin)は 24.3 μg/mL 以下で,クレアチンキナーゼ(CK)値はほぼ正常範囲内で推移し,その他の副作用もなかった.本症例について,DAP の血中濃度 7 点からのシミュレーションにより,週 3 回の血液透析患者に対する週末の投与方法について薬物動態学的に検討した結果,有効性,安全性,耐性菌誘導の抑制の観点から,週末は 1.5 倍量 1 回の投与方法が最適であることが予測できた.
著者
大谷 浩一
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.44, no.3, pp.286-290, 2013-05-31 (Released:2013-06-21)
参考文献数
5
著者
後藤 伸之 白波瀬 正樹 八田 寿夫 政田 幹夫 李 鍾大 坪川 明義 清水 寛正 上田 孝典 中村 徹 北澤 式文
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.27, no.4, pp.725-730, 1996-12-31 (Released:2010-06-28)
参考文献数
7
被引用文献数
2 2

We performed a pharmacoepidemiological study on the effect of different types of questionnaires on coughing and the prevalence of this symptom in out-patients taking angiotensin converting enzyme inhibitors (ACEI) in Fukui Medical School Hospital.The following three types of quentionnaires were prepared:Type 1 ; Questionnaire asking whether the patient has a cough or no after implying that ACEI might cause this symptom.Type 2 ; Questionnaire on the general adverse effects of ACEI, including coughing.Type 3 ; Questionnaire on the general adverse effects of ACEI other than coughing.All questionnaires included a blank space in which the patients were asked to write any adverse effects. The patients were randomly divided into three groups. Each group was given one of the three questionnaires. In the type 3 questionnaire, no patient com-plained of coughing. The prevalence of cough was higher in type 1 questionnaire than in type 2 quetionnaire patients. These results indicate that the prevalence of adverse effects varies greatly depending the type of questions in the questionnaire.
著者
前田 章太郎 東郷 香苗 石黒 武蔵 井上 貴之 坂本 武彦 菅野 公寿 近藤 充弘
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.50, no.4, pp.167-175, 2019-07-31 (Released:2019-08-24)
参考文献数
33

Background: The use of big data/real-world data (BD/RWD) is expected to be a new option for evidence generation in drug development. Pharmaceutical companies are considered to be a group of key drivers to promote widespread use of BD/RWD in Japan. However, little is reported about the current status of the use of BD/RWD for drug development in Japan.Objective: This study was conducted to reveal the current usage of BD/RWD by pharmaceutical companies in Japan and their current organization structure, with the aim to gain insight on the challenges and future perspective of BD/RWD in Japan.Methods: A questionnaire survey was conducted on 66 pharmaceutical companies affiliated with Japan Pharmaceutical Manufacturers Association from 16 to 31 October 2018. The survey consisted of two parts: Questionnaire 1 investigated the current usage of BD/RWD in drug development in Japan, and Questionnaire 2 investigated the current organization structure.Results: Of 52 companies that responded to Questionnaire 1, 30 companies (57.7%) were currently using BD/RWD for drug development in Japan for various purposes, 29 of which (96.7%) planned to continue using BD/RWD. Of 28 companies that responded to Questionnaire 2 and currently using BD/RWD, 9 companies (32.1%) had established divisions or organizations for internal management of BD/RWD, and 14 companies (50.0%) had standard operation procedures or guidance for handling legal and regulatory aspects associated with the use of BD/RWD for drug development in Japan.Conclusion: BD/RWD is currently used for various purposes in drug development in Japan. However, the proportion of companies currently using BD/RWD for drug development is limited to approximately 50%. Proactive involvement of pharmaceutical companies toward the use of BD/RWD for drug development in Japan together with further industry-government-academia harmonization for environment improvement are awaited.
著者
兼子 幸一
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.48, no.2, pp.84-90, 2017-03-31 (Released:2017-04-22)
参考文献数
7
著者
Hiroshi YAMADA Takashi DAIMON Katsuhiko MATSUDA Masayuki YOSHIDA Norikata TAKUMA Yukihiko HARA
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.38, no.5, pp.323-330, 2007-09-30 (Released:2008-10-31)
参考文献数
30
被引用文献数
11 13

Experimental studies have revealed that tea catechins prevent influenza virus infection ; however, the clinical effects have been inconclusive. At the onset of the influenza season, a randomized, double-blind, placebo-controlled study was conducted from December 2005 to March 2006 in Japan. A total of 404 healthy volunteers, 20-65 years of age, were enrolled and randomly assigned to two groups : the catechin group gargling with tea catechin extract solution (approximately 400 μg/mL catechins) or the placebo group gargling without tea catechin extracts. In both groups, gargling was performed three times daily for 90 days. All participants were inoculated with the influenza vaccine before participating in the study. The primary outcome measure was the incidence rate of influenza infection during the study identified by a rapid assay for influenza virus antigens. On an intention to treat basis, 195 participants in the catechin group and 200 in the placebo group who started the intervention were included in the analysis. Of the participants, 6 (1.5%) were infected with influenza. The incidence rate of influenza infection in the catechin group (1.0%, 2 participants) was half that in the control group (2.0%, 4 participants), but not significant between the two groups. We could not find significant effects of gargling with tea catechin on prevention of influenza in the healthy adults inoculated with the influenza vaccine of the 2005-2006 season. However, the effects in more susceptible groups, i.e., those not vaccinated against the influenza virus, children, elderly or immunosuppressed people remain inconclusive.
著者
小林 司
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.3, no.4, pp.351-356, 1972-12-30 (Released:2010-06-28)
参考文献数
8
著者
相澤 保代 清水 晶子
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.34, no.1, pp.223S-224S, 2003-01-31 (Released:2010-06-28)
参考文献数
1
被引用文献数
1 1