著者

脇坂 真美 宋 一大 田ヶ谷 浩邦 藤田 朋恵 前田 実花 野村 今日子 小林 真美 山本 明子 坂本 泰理 田中 理英子 熊谷 雄治

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.46, no.5, pp.243-248, 2015-09-30 (Released:2016-01-15)

参考文献数

15

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The aim of the present trial was to compare the sedative effects of second generation antihistamines in healthy adult male volunteers. This randomized, double-blind, cross-over clinical trial compared the effects of single doses of olopatadine 5 mg, ketotifen fumarate 1.38 mg, fexofenadine 60 mg, and placebo on psychomotor function in 15 healthy male subjects who gave written informed consent for participation in the study. For each sedative, sleep latency time was measured using the multiple sleep latency test (MSLT); and psychomotor function was measured by thresholds of critical flicker fusion (CFF), the digit symbol substitution test (DSST), and a Straight line Analog Rating Scale (LARS). Measurements were performed before and 2, 5, and 8h after drug administration. The differences between the drugs and placebo were analyzed by repeated analysis of variance (ANOVA) and paired t-tests as appropriate. Intergroup differences in baseline values of all parameters were not significant. Ketotifen induced the shortest sleep latency at 2h (p=0.03 vs. fexofenadine, p=0.03 vs. olopatadine) and 5h (p=0.04 vs. fexofenadine) after administration. Ketotifen also showed the most prolonged recognition (CFF down) at 2h (p<0.001 vs. fexofenadine, p=0.03 vs. olopatadine) and 8h (p=0.01 vs. fexofenadine). Olopatadine showed a more prolonged recognition than fexofenadine at 2h (p=0.03). Ketotifen induced the greatest decline in concentration and cognitive function at 8h (p=0.03) according to DSST. The drugs affected objective psychomotor function without causing subjective symptoms as shown by no significant differences in LARS score. The study indicates that the extent of impaired performance, an important adverse drug reaction, may differ even among second generation antihistamines.

著者

橋本 健太郎 林 敬次 柳 元和 梅田 忠斎 浜 六郎

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.30, no.1, pp.199-200, 1999-01-31 (Released:2010-06-28)

参考文献数

4

著者

吉田 正貴 永田 卓士 桝永 浩一 宮本 豊 工藤 惇三

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.40, no.5, pp.201-206, 2009 (Released:2009-11-25)

参考文献数

17

被引用文献数

1

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Overactive bladder (OAB) syndrome, which is characterized by a complex of storage symptoms (urinary urgency, frequency, nocturia and urgency incontinence) is highly prevalent in the general population; it causes significant distress to patients in terms of their psychosocial and physical functioning. Muscarinic receptors of bladder smooth muscles are involved in both normal and involuntary detrusor contraction (detrusor overactivity). Up-regulation of the muscarinic receptor function may contribute to the pathophysiology of OAB. In addition, several reports have suggested that various stimulations release many substances (ATP, prostaglandins, nitric oxide and acetylcholine) from bladder urothelium, which contribute to the pathophysiology of the increased bladder sensation, OAB symptoms and detrusor overactivity. The bladder urothelium also prossesses the non-neuronal cholinergic system and high density of muscarinic receptors. The roles and functions of the non-neuronal cholinergic system in OAB are currently under evaluation. Furthermore, new action sites of anticholinergic drugs have also been proposed. In this review, in addition to the pathophysiology of detrusor overactivity and OAB, the pharmacotherapy for OAB is discussed.

著者

加藤 正明

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.5, no.2, pp.100-103, 1974-06-30 (Released:2010-06-28)

著者

渡邉 裕司

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.39, no.5, pp.147-150, 2008 (Released:2009-02-05)

参考文献数

9

著者

鈴木 徳治 藤田 正一 古座谷 醇 大木 俊光

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.14, no.3, pp.437-452, 1983-09-30 (Released:2010-06-28)

参考文献数

39

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The usefulness of an approximation formula to calculate the power of analysis of variance for bioequivalence tests in a two-way crossover design was examined by comparison with the power estimated from the upper probability integrals of the noncentral F-distribution. The approximation formula was shown to be useful for the calculation of the power for usual bioequivalence tests . The calculation of the power for bioequivalence tests in a multi-way crossover design was attempted using the approximation formula.Further, data in previously published reports on bioequivalence between drug preparations were reviewed from the standpoint of the power. Only 24 of 86 bioequivalence analyses conducted with 25 different drugs gave a power higher than 80% to detect a 20% difference in bioavailability with α=0.05, and the power of about a half of the analyses was lower than 50%.

著者

田近 奈津子 上野 雄一郎 木下 保子 榊原 千賀 大桃 美穂 羽生 訓子 山本 裕美子 宇田 川崇 山本 亮 木村 弘章

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.35, no.1, pp.176S, 2004-01-31 (Released:2010-06-28)

参考文献数

3

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.50, no.3, pp.125-129, 2019

著者

金城 隆展

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.3, pp.112-114, 2019

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.39, no.3, pp.35S-36S, 2008 (Released:2009-02-04)

参考文献数

3

著者

中村 克徳 横井 毅 中島 美紀 Fred F. Kadlubar 鎌滝 哲也

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.243-244, 1995-03-31 (Released:2010-06-28)

参考文献数

6

著者

井藤 達也 高岡 和夫 竹本 功 秦 温信 井上 勝一 佐々木 健太郎 平野 剛 井関 健 菅原 満 宮崎 勝巳

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.33, no.2, pp.47-52, 2002-03-31 (Released:2010-06-28)

参考文献数

13

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The purpose of this study was to evaluate the distribution of CPT-11 and its active metabolite, SN-38, in pleural and pericardial fluid after intravenous administration.Two patients with lung cancer were treated with intravenous CPT-11 (60 mg/m2) on days 1, 8, and 15. The CPT-11 was detected in the pleural fluid 1.5 hr after the begining of intravenous infusion, and the level reached the maximum 24 hrs later. Similarly, the active metabolite SN-38 was detected in the pleural fluid 1.5 hr after the begining of intravenous infusion, and SN-38 concentration in the pleural fluid was almost as high as that in plasma 24 hrs later. These results suggest that intravenously administered CPT-11 may penetrate the thoracic cavity and may be metabolized to SN-38 there. The proportions of maximum concentrations of CPT-11 and SN-38 in the pleural fluid to the corresponding plasma levels were 20.4% and 28.5%, respectively. In addition, the AUCs of the lactone form SN-38 were much lower than those of the carboxyl form in the pleural fluid.CPT-11, SN-38 and SN-38 glucronide showed similar pharmacokinetics in the pericardium as that in plasma.

著者

柳田 知司

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.6, no.4, pp.347-350, 1975-12-30 (Released:2010-06-28)

参考文献数

3

著者

加藤 英章 桜井 聡 鎌田 知 石井 和広 乃村 昌臣 関野 久之 中道 昇

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.111-112, 1995-03-31 (Released:2010-06-28)

著者

水野 淳宏 植松 俊彦 石川 俊次 吉峯 徳 中島 光好

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.23, no.1, pp.65-66, 1992-03-31 (Released:2010-04-30)

参考文献数

4

著者

天野 敦雄 稲葉 裕明

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.42, no.2, pp.65-66, 2011 (Released:2011-06-30)

参考文献数

6

著者

今村 知世

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.62-67, 2016-03-31 (Released:2016-04-15)

参考文献数

24

被引用文献数

1

著者

津谷 喜一郎

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.40, no.1, pp.7-16, 2009 (Released:2009-03-20)

参考文献数

7

被引用文献数

2 4

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The burden of adverse drug reaction (ADR) is not limited to morbidity and mortality. It also causes healthcare burden as measured by direct cost of hospitalization, etc. as well as economic burden including indirect cost of labor loss and the withdrawal of drugs from the market. It inflicts additional burden on healthcare resources because of litigations that often ensue in cases of serious ADR. Drug withdrawal can be very costly for the companies involved. Since the 2000s, pharmacogenetics has attracted attention as a means of preventing ADRs. The Council for International Organizations of Medical Sciences (CIOMS) published a report on pharmacogenetics in 2005. The Committee to review cases of “Yakugai” hepatitis in Japan and the regulation aimed at preventing its recurrence was established in association with Ministry of Health, Labor and Welfare (MHLW) in May 2008. This paper reviewed the various research on drug withdrawal conducted in the UK and the rest of the world, the US, and Japan. Several litigation cases were introduced. Four preventive measures were discussed, i.e. 1)use of pharmacogenetics in preventing ADRs, 2)use of economic Darwinism by providing longer exclusivity periods to those drugs proven to be safe through long-term clinical trials, etc., 3)use of private or foreign drug review agency as well as margin and insurance systems, and 4)voluntary marketing suspension of drugs with questionable safety profile initiated by pharmaceutical companies.

著者

中野 重行 成尾 鉄朗 渡辺 浩毅 高岡 伸行 大戸 茂弘 小川 暢也 宮内 俊次 三木 吉治

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.21, no.1, pp.197-198, 1990

著者

此村 恵子 金井 紀仁 上田 彩 草間 真紀子 赤沢 学

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.5, pp.189-199, 2016-09-30 (Released:2016-12-16)

参考文献数

18

被引用文献数

1

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Objective: A policy survey regarding the development of hospital formulary and promotion of appropriate drug use in hospital settings was conducted.Methods: We have conducted a similar survey every five years since 2000 to monitor hospital policy changes. This year, we selected 500 hospitals with 200 or more beds from a list of 2,583 national hospitals for 2015. A stratified random sampling method was used to identify 250 hospitals that adopted the diagnosis procedure combination (DPC)-based payment system and those that did not (250 non-DPC hospitals). Questionnaires consisting of eight items were posted to individuals who had primary responsibility of drug management, during a study period from November 2015 to January 2016.Results: A total of 175 responses was returned (overall response rate 35%), with response rates of 42% for DPC hospitals and 28% for non-DPC hospitals (including general and mental hospitals). Inclusion of generic drugs in hospital formulary increased by 10 points from 10% in the 2010 survey. Approximately 85% of the hospitals developed their own formulary lists. According to the responses, the most important factors to select formulary drugs were effectiveness, safety, novelty, quality, formulation, price and cost-effectiveness. This trend was almost the same as that reported in the 2010 survey. Eighty-nine percent of DPC hospitals, 73% of general hospitals, and 45% of mental hospitals had specific criteria to select formulary drugs. Many hospitals reported that generic drugs were added to the formulary immediately after they became available in the market.Conclusion: The results of this survey suggested that many hospitals became more cost-conscious due to social pressure of cutting medical expenditure. The findings that many hospitals already developed formulary lists, had standardized formulary review process, and switched to generic drugs showed increased awareness of appropriate drug choices and uses. However, very few hospitals introduced cost-effectiveness analysis in the review process, and it might take time before this analysis becomes commonly used.