张强 王志飞 谢雁鸣 黎元元 王连心 刘峘 耿洪娇 崔鑫 刘福梅 孙春全 魏瑞丽 张利丹

摘要 药品临床综合评价为药品上市后临床定位、资源配置、医保与基药准入等工作提供了有效的依据。中成药临床综合评价除了满足一般药品综合评价6个维度外，还应考虑中医药特色。目前对于中成药临床综合评价研究的具体实施环节和评价方法比较模糊，因此制定中成药临床综合评价技术规范迫在眉睫。起草组遵循《中国药品综合评价指南参考大纲（第二版）》以及《药品临床综合评价管理指南（2021年版试行）》等文件的相关法规要求，经过文献复习和专家讨论论证，结合多项中成药临床综合评价研究的实践经验，制定了中成药临床综合评价技术规范。本规范包括了中成药临床综合评价的临床定位、资料获取、质量控制、评价内容与方式、各维度的评价技术方法等方面，为中成药开展临床综合评价工作提供方法学指导，使评价过程及结果更加科学合理。

关键词 中成药;临床综合评价;技术规范;中医药特色;临床定位;临床价值

Abstract The comprehensive clinical evaluation of drugs provides an effective basis for the clinical positioning，resource allocation，medical insurance and access of basic drugs.In addition to meeting the six dimensions of general drug comprehensive evaluation，the clinical comprehensive evaluation of Chinese patent medicine should also consider the characteristics of traditional Chinese medicine.At present，the specific implementation links and evaluation methods of clinical comprehensive evaluation of Chinese patent medicine are relatively vague，so it is urgent to formulate the technical specification of clinical comprehensive evaluation of Chinese patent medicine.The drafting group has formulated the technical specifications for clinical comprehensive evaluation of Chinese patent medicines in accordance with the relevant regulatory requirements of the reference outline of the guidelines for comprehensive evaluation of Chinese medicines （Second Edition） and the guidelines for the management of clinical comprehensive evaluation of drugs （trial version in 2021），after literature review，expert discussion and demonstration，and in combination with the practical experience of a number of clinical comprehensive evaluation studies of Chinese patent medicines.This specification covers the clinical positioning，data acquisition，quality control，evaluation contents and methods，evaluation technology and methods of various dimensions of the clinical comprehensive evaluation of Chinese patent medicines，so as to provide methodological guidance for the clinical comprehensive evaluation of Chinese patent medicines and make the evaluation process and results more scientific and reasonable.

Keywords Chinese patent medicine; Comprehensive clinical evaluation; Technical specifications; Characteristics of traditional Chinese medicine; Clinical positioning; Clinical value

中圖分类号：R288;R289.9文献标识码：Adoi：10.3969/j.issn.1673-7202.2021.22.024

药品临床综合评价是药品上市后研究的重要内容，也是提升卫生健康资源配置效率、优化药品使用结构、完善国家药物政策的重要途径。药品临床综合评价是评价主体运用多种评价方法和工具对药品开展的多维度、多层次的综合研判，其的核心内容是临床证据和临床价值评估。目前现有的中成药临床综合评价研究质量参差不齐，核心要素不明显，技术层面较弱化，难以体现其临床价值[1-2]。……