臨床薬理
Online ISSN : 1882-8272
Print ISSN : 0388-1601
ISSN-L : 0388-1601
37 巻, 5 号
選択された号の論文の11件中1~11を表示しています
  • 第37巻第5号特集/新しい抗うつ薬SSRIの薬物動態, 臨床効果, 副作用
    下田 和孝
    2006 年 37 巻 5 号 p. 253
    発行日: 2006/09/30
    公開日: 2010/06/28
    ジャーナル フリー
  • 上田 幹人, 下田 和孝
    2006 年 37 巻 5 号 p. 255-258
    発行日: 2006/09/30
    公開日: 2010/06/28
    ジャーナル フリー
  • 室井 秀太, 下田 和孝
    2006 年 37 巻 5 号 p. 259-264
    発行日: 2006/09/30
    公開日: 2010/06/28
    ジャーナル フリー
  • 小野 信, 鈴木 雄太郎
    2006 年 37 巻 5 号 p. 265-272
    発行日: 2006/09/30
    公開日: 2010/06/28
    ジャーナル フリー
  • 三浦 淳, 古郡 規雄, 兼子 直
    2006 年 37 巻 5 号 p. 273-277
    発行日: 2006/09/30
    公開日: 2010/06/28
    ジャーナル フリー
  • 吉村 玲児, 中村 純
    2006 年 37 巻 5 号 p. 279-282
    発行日: 2006/09/30
    公開日: 2010/06/28
    ジャーナル フリー
  • 眼球運動速度解析を用いた客観的鎮静作用の検討
    黒沢 顕三, 内田 直樹, 岩瀬 万里子, 保田 国伸, 江花 莉華, 平嶋 勇人, 石垣 征一郎, 松田 和弘, 矢野 怜, 佐久間 大, ...
    2006 年 37 巻 5 号 p. 283-290
    発行日: 2006/09/30
    公開日: 2010/06/28
    ジャーナル フリー
    Drewell ® (diphenhydramine: DPH) is a histamine H1 receptor antagonist and the first OTC sleep aid in Japan. There are few studies which objectively evaluate the sedative effects in elderly subjects. The aim of present study was to evaluate the sedative effects of Drewell ® in healthy elderly and to compare the results with data from young subjects on which we reported previously.
    A placebo controlled, double-blind, crossover clinical pharmacological study was performed. Eight Japanese healthy elderly male volunteers received 2 tablets of Drewell ®, containing 50mg DPH, or matched placebo orally. Plasma levels of DPH after administration were measured hourly up to 4 hours and every 2 hours up to 8 hours. The sedative effects after the dose were measured by using the saccadic eye movement analyzing system for objective assessment and visual analogue scale (VAS) for subjective assessment.
    After Drewell ® administration the saccadic peak velocity (SPV) was decreased and saccade inaccuracy (IAC) was increased compared with placebo. There were no significant differences in saccade latency and VAS. The onset of significant decrease of SPV in elderly was delayed compared to young subjects (90 min in elderly vs 30 min in young) although pharmacokinetic parameters were similar in elderly and young subjects. However, the available data of both pharmacokinetic and pharmacodynamic at the same time point until sedation onset was only 60 min. Therefore further investigation is necessary to precisely determine the differences of onset of the sedative effect up to 90 min after Drewell ® administration.
  • Bone DARPO, Maki ITO
    2006 年 37 巻 5 号 p. 291-304
    発行日: 2006/09/30
    公開日: 2010/06/28
    ジャーナル フリー
    Drug induced QT prolongation and resulting proarrhythmias have caused increasing concern during recent years and led to a number of drug withdrawals from the market, restrictions in the labeling or termination of drugs in development. In May 2005, the 'International Conference on Harmonization....' (ICH) Steering Committee approved two important new guideline documents, which address non-clinical (S7B) and clinical testing (E14) of a new drug's liability to prolong the QT interval. A key feature of the E14 document is the ‘thorough QT study’ and how the results of this study will impact further clinical development of the drug and labeling, if approved. The ‘thorough QT study’ is built on the concept that drugs, which may be proarrhythmic in the targeted patient population can be identified through demonstration of QT prolongation in healthy volunteers exposed to high plasma levels of the drug. Based on experience to-date, this concept retrospectively seems to be correct for all drugs, which have been withdrawn from the market based on proarrhythmic liability. Whether this is also correct for drugs with mild effects on the QT interval irrespective of the underlying mechanism is presently not known. There are large differences in opinion among regulatory authorities in the major regions in regard to the relative importance of non-clinical assays and how to handle the results of the ‘thorough QT study’. These differences have, somewhat contradictory to the ICH concept, not been resolved by the adoption of E14, which handled the differences by the use of a general and less precise language. This commentary describes the content of the E14 document, identifies major areas of controversy between regulators in regard to its interpretation, and how this impacts global drug development.
  • 聖マリアンナ医科大学におけるヒト組織バンク事業に対するアンケート調査
    櫻井 史穂子, 中谷 祥子, 熊井 俊夫, 田中 政巳, 松本 直樹, 大坪 毅人, 小林 真一
    2006 年 37 巻 5 号 p. 305-311
    発行日: 2006/09/30
    公開日: 2010/06/28
    ジャーナル フリー
    The Human Science Research Resources Bank (HSRRB) was established in 2000 by the Japan Health Sciences Foundation as the first human tissue bank of Japan for scientific research. With the aim of collection of human tissue for this bank, St. Marianna University School of Medicine established its own institutional tissue bank system and has been supplying human tissues to HSRRB for four years. To promote this banking system, it is important to inform citizens that the utilization of human tissue in medical research greatly contributes to the progress of medicine and welfare for the public. We attempted to determine the present perceptions and feelings of the patients and family members those who participated in this program, and also of the medical faculty of St. Marianna University by questionnaire.
    Recognition of the human tissue bank was low not only among patients but also among medical staff. On the other hand, the patients and families to whom the coordinator had explained the human tissue bank system well recognized and understood about the program, and they donated their tissue with confidence and full consent.
    To obtain the citizens trust, sufficient disclosure of information of the tissue bank activities and the achievement of research results must be carried out and in order to do so, it will be necessary to increase the staff in this bank, and maintain proper security of donator privacy.
  • 田中 郁子, 大島 久二
    2006 年 37 巻 5 号 p. 313-316
    発行日: 2006/09/30
    公開日: 2010/06/28
    ジャーナル フリー
  • 畑中 薫
    2006 年 37 巻 5 号 p. 317-318
    発行日: 2006/09/30
    公開日: 2010/06/28
    ジャーナル フリー
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