确保盲法实施的中药安慰剂制备和评价关键问题  

Key issues in preparation and evaluation of traditional Chinese medicine placebo to ensure blinded implementation

作　　者：张三妹 吴梅 吴飞[1] 王优杰[1] 胡佳亮[1] 林晓[1] 冯怡[1] ZHANG San-mei;WU Mei;WU Fei;WANG You-jie;HU Jia-liang;LIN Xiao;FENG Yi(Engineering Research Center of Modern Preparation Technology of Traditional Chinese Medicine,Ministry of Education,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)

机构地区：[1]上海中医药大学中药现代制剂技术教育部工程研究中心,上海201203

出　　处：《中草药》2022年第21期6919-6930,共12页Chinese Traditional and Herbal Drugs

基　　金：上海市卫健委科研基金资助项目(201940296)。

摘　　要：近年来,随着安慰剂作为优先考虑的中药临床评价的对照方式,对中药安慰剂的制作水平和评价技术要求也逐步提高。作为一种模拟制剂,中药安慰剂与受试制剂的相似性直接影响了临床盲法的实施效果,需要确保其无药效的适用性才能准确评估受试制剂的真实药效;作为一种临床应用的制剂,对中药安慰剂的安全性、可控性也有要求。目前很多临床试验中安慰剂的应用已经无法保证临床试验的盲法实施,因此对中药安慰剂的质量控制水平尚待进一步提升。通过分析近10年来相关临床研究中安慰剂的研究状况,结合研究实践,对中药安慰剂制备和评价的一系列关键问题进行探讨,为中药安慰剂的研究水平提升和法规制定提供参考。In recent years,as a priority control method for clinical evaluation of traditional Chinese medicine(TCM),the production and evaluation technology of TCM placebo have achieved accelerated improvements.As a simulated preparation,the similarity of placebo and the test preparation affects the implementation of clinical blindness,and it is necessary to ensure its applicability without efficacy in order to accurately evaluate the real efficacy of the test preparation.Meanwhile,the safety and controllability of placebo are the basic principles that a clinical formulation should follow.At present,the application of placebo in many clinical trials cannot guarantee the blinded implementation of the trial,so the quality control level of TCM placebo needs to be further improved.From the perspective of blind clinical trials,a series of key issues in the preparation and evaluation of TCM placebo in the context of research practice were discussed by analyzing the research status of placebo in relevant clinical studies in recent 10 years,providing reference for the improvement of the research level of TCM placebo and the formulation of laws and regulations.

关 键 词：中药安慰剂 盲法 关键质量属性 安全性 适用性 相似性 可控性 

分 类 号：R994.1[医药卫生—毒理学]