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失眠症中药新药临床试验疗效评价的几个问题探讨
引用本文:李涛. 失眠症中药新药临床试验疗效评价的几个问题探讨[J]. 中国临床药理学与治疗学, 2006, 11(4): 375-378
作者姓名:李涛
作者单位:中国中医科学院西苑医院神经科,北京,100091
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
文章编号:1009-2501(2006)04-0375-04
收稿时间:2006-02-28
修稿时间:2006-03-07

Some problems on clinical trails evalution of herbs medicine for insomnia
LI Tao. Some problems on clinical trails evalution of herbs medicine for insomnia[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2006, 11(4): 375-378
Authors:LI Tao
Affiliation:Department of Neurology, Xi-yuan Hospital, China Academy of Traditional Chinese Medicine, Beijing 100091, China
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.
Keywords:insomnia   herbs medicine   clinical trails   result evaluation
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