基于中药新药临床试验中药安慰剂的使用探讨

Discussion on Usage of TCM Placebo Based on Clinical Trials of New Drugs in TCM

中药新药临床试验探索性研究中的安慰剂应用不容忽视。基于安慰剂本身的特殊性,临床试验实际操作过程中的利与弊并存,导致目前面临严重的困境与挑战。如何正确应用安慰剂以最大程度上真实反映中药的疗效和安全性,同时在临床试验过程中哪些主要环节值得关注,都是目前值得思考与分析的问题。

The application of placebo in the exploratory research of the clinical trials of new drugs in TCM can not be ignored.Based on the particularity of the placebo itself,the advantages and disadvantages of the clinical trials are coexisting in the actual operation process,which leads to the serious difficulties and challenges.How to correctly apply the placebo can truly reflect the efficacy and safety of TCM.At the same time,the main links in the clinical trials are worthy of attention.These are all problems worthy of consideration and analysis at present.