中药新药临床试验中有关疗效评价若干问题的思考

Several questions about efficacy evaluation of clinical research on new drugs of Chinese materia medica

结合国际新药评价理念发生的巨大变化,分析了目前我国中药新药临床疗效评价的现状,对其中的若干问题进行了探讨,指出中药新药临床疗效评价应根据中药功效主治分类进行评价、突出临床优势、注重个性化疗效特点、疗效评价指标要与时俱进。

Based on the greatly changed notions of the new drug evaluation in the international society,the current situation was analyzed in new clinical efficacy evaluation of traditional Chinese medicine in China and several correlated problems were investigated. New clinical efficacy evaluation of traditional Chinese medicine should base on the classification of the effectiveness and indication, underline the clinical superiority, emphasize the characteristic of individuation efficacy, and the index of the efficacy evaluation should change with the related development.