文献一覧: 臨床薬理 (雑誌)

2 0 0 0 OA Elevated Serum Vancomycin Concentrations After Oral Administration in a Hemodialysis Patient with Pseudomembranous Colitis

著者: Sumio HIRATA Mami MATOBA Satoshi IZUMI Taku FURUKUBO Miyuki OTA Minori FUJITA Senji OKUNO Tomoyuki YAMAKAWA
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.34, no.3, pp.87-90, 2003-05-31 (Released:2010-06-28)
参考文献数: 15
被引用文献数: 4 7

We present a 68-year-old male case, hemodialysis patient (body weight 56.8 kg) with Clostridium difficile (C. difficile) induced pseudomembranous colitis. The colitis was treated with orally administered vancomycin (VCM), 2.0 g/day, for 14 days leading to high serum levels. At this time, the VCM treatment was discontinued following negative stool cultures for C. difficile, and the serum VCM concentration was 58.7 μg/ml, the highest level in oral VCM case reports up to the present. Mean bioavailability was estimated as 16.8% during the VCM administration period in this patient, and it was assumed that the intestinal absorption of VCM was increased with severe colitis. As the serum VCM levels continued to decrease gradually, the symptoms of colitis improved. Nevertheless, the patient's colitis relapsed after oral levofloxacin treatment for bronchitis and high fever, although the serum VCM levels were still far greater than the minimum inhibitory concentration of C. difficile infection.This finding suggests that VCM concentrations may remain insufficient in the colon despite the high serum levels. The high and persistent serum VCM concentrations in this patient may be due to the follow-ing: 1. increased absorption of VCM with severe colitis, 2. decreased excretion with renal impairment leading to VCM serum accumulation, and 3. too high a VCM dosage. We conclude that patients with both renal failure and severe intestinal disease may absorb and accumulate significant amounts of orally administered VCM. Therefore, a high dose oral VCM should be avoided in hemodialysis patients with severe pseudomembranous colitis.

2016-04-06 10:48:01
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2 0 0 0 OA ジェネリック医薬品の科学

著者: 緒方宏泰
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.1, pp.33-35, 2008 (Released:2008-08-29)
参考文献数: 8
被引用文献数: 1 1

2015-11-13 20:45:34
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2 0 0 0 OA 健康成人被験者で高含量の向精神薬の生物学的同等性試験を行うことの妥当性

著者: 松木俊二名取和一小川幸司松井隆松隈京子坂本慶木村美由紀神田英里米納誠伊藤一弥鄭恩希白源正成入江伸
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.4, pp.151-159, 2014-07-31 (Released:2014-08-13)
参考文献数: 24

The aims of the present study were (1) to determine the maximum tolerated doses of quetiapine and pramipexole when given to healthy Japanese male subjects using gradually increasing single doses; (2) to evaluate the feasibility of this exploratory method for further bioequivalence trials; and (3) to conduct bioequivalence trials using doses determined based on prior tolerability trials. For quetiapine, 18 participants received 25 mg in the first stage. In the second stage, participants were divided into three groups of six subjects each and allocated to receive 50 mg, 75 mg or 100 mg depending on the severity of adverse events in the first stage. For pramipexole, 18 participants received 0.125 mg in the first stage, and then received 0.25 mg, 0.375 mg, or 0.5 mg in the second stage in the same manner as quetiapine. In the group receiving 75 mg of quetiapine, three mild adverse events and seven moderate adverse events (including nightmare and syncope) were reported from all six subjects. In the group receiving 0.5 mg of pramipexole, three mild and five moderate adverse events were reported from five subjects. Therefore, we judged that doses equal to or greater than 75 mg of quetiapine and 0.5 mg of pramipexole are not well tolerated by healthy subjects. Based on these results, we conducted two-way crossover bioequivalence clinical trials with brand-name and generic formulations of 25 mg of quetiapine (25 mg tablets or 50% fine granules) and 0.125 mg of pramipexole, in subjects who did not participate in the tolerability studies. By calculating 90% confidence intervals of logarithmic transformed values of Cmax and AUCt, we found that the brand-name and generic formulations were bioequivalent.

2015-07-20 18:40:31
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2 0 0 0 OA 1.日本における動脈硬化性疾患の臨床試験

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.39, no.5, pp.143-146, 2008 (Released:2009-02-05)
参考文献数: 9
被引用文献数: 1 1

1 0 0 0 OA 後発医薬品会社における個別症例安全性報告の因果関係評価基準

著者: 高月公博古川裕之宮本謙一
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.39, no.5, pp.173-179, 2008 (Released:2009-02-05)
参考文献数: 18
被引用文献数: 1 1

The purpose of this study was to determine the items necessary for causality assessment in order to improve the usefulness of the individual case safety report (ICSR) from medical institutions as adverse drug reaction (ADR) information. Thus, we evaluated the standard items for causality assessment by surveying the items used in pharmaceutical manufacturers of generic drugs. The number of respondents was 35, which was 89.7% of the member companies of Japan Generic Pharmaceutical Manufacturers Association. The use of algorithms for causality assessment, terms for causal relation, and criteria for assessing whether or not ADR were varied among the companies. These findings were similar to the previous results in a survey of pharmaceutical companies of original drug. The variety of assessment criteria is inconvenient for reporters to judge and also lowers the validity of judgment. Additionally, it will be inappropriate to assess ADR information all together. And these variations may cause wide differences in the frequency measurement of ADR. Therefore, it is crucial to immediately derive consensus on international assessment criteria for causality assessment.

2023-12-21 08:43:32
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1 0 0 0 OA 小児麻酔前投薬に用いる塩酸クロニジンキャンディーの鎮静効果

著者: 住谷賢治渡邊真知子本間真人馬場泰行猪股伸一豊岡秀訓幸田幸直
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.33, no.1, pp.83S-84S, 2002-01-31 (Released:2010-06-28)
参考文献数: 5

2023-07-24 10:46:40
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1 0 0 0 OA 研究倫理審査の質の向上と効率化について—台湾の取り組みから学ぶ—

著者: 安井涼子山本洋一
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.49, no.2, pp.61-68, 2018-03-31 (Released:2018-04-21)
参考文献数: 13
被引用文献数: 2 1

In Japan, the centralization of institutional review boards (IRBs) has been considered with the objectives to standardize the quality of the review process for multicenter studies and to facilitate efficient and speedy implementation of clinical trials and research. Therefore, we visited some core facilities in Taiwan to observe the IRB meetings for clinical studies, and to exchange ideas with staff of the IRB secretariats. Furthermore, we researched the pioneering review mechanisms for multicenter, sponsor-initiated clinical trials in Taiwan. In Taiwan, the Joint IRB (J-IRB: a type of centralized review system) was established in 1997. This review system contributed to improve the quality of ethical reviews in the country. However, because the J-IRB was not fully government-initiated, many co-operating sites gradually started to conduct their own reviews, and this tendency caused a decline in the efficacy of the J-IRB. Following this, the Taiwanese government enacted a law called the Human Subjects Research Act in 2011. Moreover, the government also started the Central IRB (C-IRB) system in 2013, which is a central-local hybrid type of ethical review system for multicenter clinical trials. The establishment of the C-IRB system increased the number of sponsor-initiated clinical trials. The new Human Subjects Research Act allowed each site to develop appropriate organizational structures, and thus maintained the high quality of clinical studies, regardless of whether they were sponsor-initiated or investigator-initiated studies. Considering the future Japanese goals to conduct ethical reviews and to organize the operational structures of medical facilities, we identified many constructive ideas based on the Taiwanese challenges in past decades.

2023-07-20 22:12:00
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1 0 0 0 OA 4.心房細動治療におけるアップストリームアプローチとダウンストリームアプローチ

著者: 新田順一
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.39, no.5, pp.215-217, 2008 (Released:2009-02-05)
参考文献数: 3

2023-04-17 21:35:21
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1 0 0 0 OA 5 .肺毒性:呼吸器系の薬物有害反応

著者: 原田和博
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.48, no.2, pp.79-83, 2017-03-31 (Released:2017-04-22)
参考文献数: 2

2023-03-25 05:15:54
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1 0 0 0 OA Effect of a Single Glass of Grapefruit Juice on the Apparent Oral Bioavailability of the Dihydropyridine Calcium Channel Antagonist, Azelnidipine, in Healthy Japanese Volunteers

著者: Hayato HIRASHIMA Naoki UCHIDA Ichiro FUKAZAWA Seiichiro ISHIGAKI Eiji UCHIDA Hajime YASUHARA
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.37, no.3, pp.127-133, 2006-05-31 (Released:2010-06-28)
参考文献数: 33
被引用文献数: 2 2

There are many reports on grapefruit juice (GFJ) increasing the apparent oral bioavailability of several clinically important drugs metabolized by the most abundant isoform of cytochrome P450, i. e. CYP 3A4. Azelnidipine (Calblock ®) is a long-lasting 1, 4-dihydropyridine calcium antagonist currently used in the treatment of hypertension in Japan. In a drug interaction study using human liver microsomes, several CYP3A4 inhibitors and substrates inhibited the oxidative metabolism of azelnidipine to the same extent as nifedipine and felodipine. In order to evaluate the possible interaction of azelnidipine with GFJ in humans, a randomized, two-way crossover study was conducted in eight Japanese healthy volunteers.A single oral dose of 8mg azelnidipine was administered orally with either 250mL water or GFJ after overnight fasting. Blood samples were drawn periodically up to 24hours after dosing. Plasma concentrations of azelnidipine were measured by liquid chromatography-tandem mass spectrometry (LC/APCI-MS/MS).Concomitant administration of azelnidipine with GFJ increased the mean Cmax of azelnidipine by 2.5-fold and the AUC by 3.3-fold compared with water; moreover, the time to reach Cmax (tmax) and the mean residence time (MRT) were slightly delayed. No serious adverse events were observed except one subject described mild symptoms of drug-related headache and flushing accompanied with orthostatic hypotension at 4hrs after administration in the GFJ phase.The results demonstrated the pharmacokinetic interaction between azelnidipine and a single glass of GFJ.