构建中医药临床疗效评价方法和三结合审评体系的迫切性——对《柳叶刀》发表中风醒脑液治疗急性脑出血临床研究的思考  

The urgency of constructing a method for evaluating the clinical efficacyof traditional Chinese medicine and a three-integrated review system:thoughts on the clinical study of Zhongfeng Xingnao oral prescriptionfor the treatment of acute cerebral hemorrhage published in Lancet

作　　者：许嘉芯 王建新 于宗良 高蕊[2] XU Jia-xin;WANG Jian-xin;YU Zong-liang;GAO Rui(Beijing University of Chinese Medicine,Beijing 100026,China;Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China)

机构地区：[1]北京中医药大学,北京100026 [2]中国中医科学院西苑医院,北京100091

出　　处：《中国新药杂志》2025年第8期785-789,共5页Chinese Journal of New Drugs

基　　金：国家重点研发计划资助项目(2021YFF0901404);中国中医科学院科技创新工程资助项目(CI2021A04701)。

摘　　要：随着研究技术的发展和循证医学领域的进步,大量针对中医药有效性和安全性的高水平随机对照研究得以开展并发表,为中医药循证研究奠定了坚实的基础。近期,Lancet(《柳叶刀》)正刊发表了由复旦大学和广东省中医院研究团队主导的大样本、多中心、随机对照研究CHAIN试验的主要结果。其阴性结论引起了中医药及相关领域研究人员的广泛讨论,本文对该研究及其对中药新药审批的启示进行了探讨。With the development of research technology and the advancement of evidence-based medicine,a large number of high-level randomized controlled studies on the efficacy and safety of traditional Chinese medicine(TCM)have been conducted and published,laying a solid foundation for evidence-based research on TCM.Recently,Lancet published the main results of the CHAIN trial,a large-sample,multi-center,randomized con trolled study led by a research team from Fudan University and Guangdong Provincial Hospital of Traditional Chinese Medicine.Its negative findings have caused extensive discussion among researchers in TCM and related fields.This article provides some thoughts on the study and its implications for the approval of new traditional Chinese medicines.

关 键 词：中风醒脑液 急性脑出血 随机对照研究 三结合审评体系 中医药临床疗效评价 

分 类 号：R95[医药卫生—药学]