中药临床试验中阳性对照药选择的新思路  

A new idea of the positive control medicine in the clinical trial of traditional Chinese medicine

作　　者：向楠[1] 邓阿黎[1] 李晓东[1] 周亚娜[1] 

机构地区：[1]湖北省中医院国家药物临床试验机构

出　　处：《中国临床药理学与治疗学》2007年第12期1395-1397,共3页Chinese Journal of Clinical Pharmacology and Therapeutics

摘　　要：中药新药临床试验中,由于中医药诊疗体系的自身特点及特殊性,阳性对照药的选择常存在一些问题,严重影响试验药物的有效性评价。"复合对照"这一思路的提出,为今后的中药新药临床试验阳性对照药的选择提供了选择面很广的新方法,在探索中药有效性评价方面具有现实意义。In the clinical trial of new traditional Chinese medicine, because of the special characteristics and particularity in the diagnosis and treatment system of TCM, the choice of the positive control medicine always face some problems. Which affects the validity of clinical drug evaluation seriously. We present a new concept of ＂composite control＂. The new concept provides new ways, which is widely used in the choice of the positive control medicine in the clinical trial of TCM. It has realistic significance to research the validity of clinical drug evaluation.

关 键 词：中药新药 临床试验 阳性对照药 选择 复合对照 

分 类 号：R969[医药卫生—药理学]