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中国临床药理学与治疗学 ›› 2006, Vol. 11 ›› Issue (4): 375-378.

• 综述 • 上一篇    下一篇

失眠症中药新药临床试验疗效评价的几个问题探讨

李涛   

  1. 中国中医科学院西苑医院神经科, 北京100091
  • 收稿日期:2006-02-28 修回日期:2006-03-07 出版日期:2006-04-26 发布日期:2020-12-08
  • 通讯作者: 李涛, 男, 主任医师, 硕士生导师, 神经科主任, 从事神经系统疾病的中西医结合临床医疗和研究。Tel:010-62875599-6213  E-mail:lt0016@263.net

Some problems on clinical trails evalution of herbs medicine for insomnia

LI Tao   

  1. Department of Neurology, Xi-yuan Hospital, China Academy of Traditional Chinese Medicine, Beijing 100091, China
  • Received:2006-02-28 Revised:2006-03-07 Online:2006-04-26 Published:2020-12-08

摘要: 治疗失眠症的中药新药临床试验, 应当注意药物的安慰剂效应, 考察适应性和停药后的症状变化, 明确治疗定位。推荐采用安慰剂对照, 睡眠日记作为疗效评价的基本依据, 以周作为疗效评价的时间单位, 失眠症状积分为主要疗效指标。

关键词: 失眠症, 中药, 临床试验, 疗效评估

Abstract: The clinical trails of Traditional Chinese Medicine Herbs in treating insomnia need to pay attention to the adaptation and the symptoms change after stopping the herb medicines.It is recomnendated that the placebo control, sleep diary have to be a base for the result evaluation, the week is basic duration of evaluation and the insomnia symptom score is the major index.

Key words: insomnia, herbs medicine, clinical trails, result evaluation

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