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

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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.

著者

中野 重行 菅原 英世 坂本 真佐哉 小関 哲郎 上村 尚人 丹生 聖治 角南 由紀子 松木 俊二 梅月 恵美

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.30, no.1, pp.1-7, 1999-01-31 (Released:2010-06-28)

参考文献数

8

被引用文献数

5 5

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Objectives: A variety of factors influence the incidence of placebo effects . The purpose of this study was to clarify the influence of factors such as the doctor-patient relationship, patient's motivation and expectation for drug therapy on placebo effectsMethods: Data were obtained from two double-blind randomized clinical trials with a placebo control group of 123 patients with psychosomatic disorders. The improvement was assessed by doctors at two weeks after the initiation of treatment. The doctor-patient relationship, patient's motivation and expectation for drug therapy were assessed by doctors at the beginning of clinical trials.Results: The improvement rate in the placebo group was 42.3%, whereas the improvement rate in the diazepam group was 57.6% (p <0.05). In the placebo group, improvement rates were 50.0% in patients with a good doctor-patient relationship, 31.4% in patients with a moderate relationship and 10.0% in patients with a poor relationship (p < 0.05).Improvement rates were 46.1% in patients with a good motiva-tion for drug therapy and 19.0% in patients with poor or lack of motivation (p <0.01).Improvement rates were 36.4% in patients with low expectation for drug therapy, 53.0% in patients with a moderate one, and 7.7% in patients with high expectation (p <0.05).Conclusion: In patients with psychosomatic disorders, factors such as the doctor-patient relationship, patient's motivation and expectation for drug therapy clearly influ-ence the incidence of placebo effects.

著者

松木 俊二 菅原 英世 坂本 真佐哉 田中 雄一郎 楢原 久司 宮川 勇生 中野 重行

出版者

一般社団法人 日本女性心身医学会

雑誌

女性心身医学

巻号頁・発行日

vol.4, no.1, pp.62-68, 1999

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不妊症経過中に発症したうつ病2症例の睡眠障害に対して,腕時計型活動性モニタリング(ACTIWATCH^<[○!R]>)と睡眠チェックリスト,睡眠日記を併用して評価を行った.症例1は27歳主婦.2度の卵管妊娠(両側卵管摘出)の既往あり.2度目の退院後にパニック障害とうつ病を発症した.ACTIWATCH^<[○!R]>は睡眠薬離脱期に2週間装着した.症例2は35歳主婦.両側卵管閉塞による続発性不妊症(体外受精-胚移植による1児あり).ACTIWATCH^<[○!R]>は睡眠薬導入期に4週間装着した.睡眠-覚醒の客観的評価(ACTIWATCH^<[○!R]>)と主観的評価(チェックリスト,日記)は必ずしも符合しなかった.即ち,患者自身が眠っていると感じた時間帯にACTIWATCH^<[○!R]>で評価した身体活動量は増加し,患者自身が眠れないと感じた時間帯にその活動量は低下していた.睡眠障害患者の睡眠の評価には自覚症状のみでなくACTIWATCH^<[○!R]>や睡眠チェックリスト,睡眠日記を用いた客観的指標の有用な場合があることが示唆された.