中药安慰剂质量评价思考

Thinking on quality evaluation for traditional Chinese medicine placebo

为探讨中药安慰剂质量的评价方法,检索近10年发表的中药安慰剂制备及质量评价相关文献,对目前安慰剂制备和质量评价方法进行总结分析,在此基础上提出了一些思考。质量评价方法有内在指标成分测定和外观评价(人工打分法和电子仿生测评法)等,但尚无统一标准,多数研究报告内容不详。因此,制定科学、规范的质量评价标准,从中药安慰剂质量评价的客观指标、主观使用感受等方面综合评价安慰剂质量,对安慰剂的真实作用和临床试验的可靠性都有重要意义。

To explore the methods of quality evaluation for traditional Chinese medicine(TCM) placebo, we systematically analyzed the current preparation and quality evaluation of TCM placebo by searching interrelated literatures that had been published in recent 10 years. These literatures reported that the quality evaluation methods included internal composition determination and appearance evaluation(artificial scoring method and electronic bionic assessment method), but there was lack of unified standard, and most of research reports were not complete. Therefore, only a scientific and normative quality evaluation standard for TCM placebo can be developed that will comprehensively evaluate the quality of TCM placebo from the views of objective indexes and subjective feelings, the TCM placebo will exert actual effects and improve the reliability of the clinical trials.