安慰剂对中药新药临床试验的影响及相关建议  

Influence of placebo on clinical trials of new traditional Chinese medicine and relevant suggestions

作　　者：史万忠[1] 元唯安[1] SHI Wanzhong;YUAN Weian(Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)

机构地区：[1]上海中医药大学附属曙光医院,上海201203

出　　处：《药物评价研究》2022年第5期817-821,共5页Drug Evaluation Research

基　　金：国家自然科学基金资助项目(81403414);上海市“科技创新行动计划”生物医药科技支撑专项(20S21902100、22S21900700);上海市慢性筋骨病临床医学研究中心项目(20MC1920600);上海市卫计委“杏林新星”项目(ZYSNXD011-RC-XLXX-20130049);上海市卫健委临床研究专项(201940063);上海市教委资助项目(A1-U21-205-0103);上海申康医院发展中心临床三年行动计划项目(SHDC2020CR1051B);上海市级医院医企协同临床试验管理项目(20CR4003B)。

摘　　要：由于方法学和中药新药临床特点,中药安慰剂在临床研究使用较为广泛。中药安慰剂质量和模拟效果,影响整个中药新药临床研究的质量和有效性评价的客观性与准确性。从中药安慰剂制作的技术难度,与受试药物相似性,客观化、规范化模拟效果评价,服用依从性等方面探讨目前中药新药临床试验中安慰剂的主要问题。在此基础上,提出了加强安慰剂制作技术和可用原辅料研究;出台安慰剂模拟效果评估指导原则,引导研发企业加强相关研究;增加客观性评价指标设置,提高临床研究结果 的可信度;根据不同研究阶段、剂型和给药方式,通过流程设计和管理,弥补中药安慰剂模拟效果不佳等缺陷的建议和思考。Due to the methodology and clinical characteristics of traditional Chinese medicine(TCM), TCM placebo is widely used in clinical research. The quality and simulation effect of TCM placebo affect the quality of the whole clinical research of new TCM and the objectivity and correctness of effectiveness evaluation. This article discusses the main problems of placebo in the clinical trials of new drug of TCM from the aspects of technical difficulty in the preparation of TCM placebo, similarity with the tested drug,objective and standardized simulation effect evaluation, medication compliance and so on. On this basis, it is proposed to strengthen the research on the preparation technology and available raw and auxiliary materials of placebo. Issue guidelines for placebo simulation effect evaluation to guide research and development enterprises to strengthen relevant research. Increase the setting of objective evaluation indexes and improve the reliability of clinical research results. Make up for the poor simulation effect of TCM placebo according to different research stages, dosage forms and administration methods with process design and management.

关 键 词：中药新药 临床试验 安慰剂 有效性评价 

分 类 号：R944.5[医药卫生—药剂学]