以患者为中心研究模式与适应性设计在中医药临床研究中的实践  

Patient-centered research strategy and adaptive design in clinical research of traditional Chinese medicine

作　　者：李牧之 王思村 党海霞[2] 刘骏[1] 王忠[1] 于亚南[1] LI Muzhi;WANG Sicun;DANG Haixia;LIU Jun;WANG Zhong;YU Ya'nan(Institute of Clinical Basic Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Experimental Research Center,China Academy of Chinese Medical Sciences,Beijing 100700,China)

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700 [2]中国中医科学院中医药发展研究中心,北京100700

出　　处：《世界临床药物》2024年第12期1213-1218,共6页World Clinical Drug

基　　金：国家自然科学基金项目(82105052);中国中医科学院科技创新工程项目(CI2021A04707);中国中医科学院基本科研业务费优秀青年科技人才(创新类)培养专项(ZZ13-YQ-076)。

摘　　要：中医药理论重整体,更关注“病的人”,即“以患者为中心的诊疗模式”。新版《药品注册管理办法》指出,中药的疗效评价应当选择与中药临床定位相适应、能够体现其作用特点和优势的疗效指标。与此同时,在现代评价体系的不断推动下,临床研究方法不断革新,更快速、更灵活的临床研究设计贯穿药品全生命周期,以求在合理使用的基础上提高研究效率。该文以地奥心血康胶囊治疗慢性稳定型心绞痛(stable angina pectoris)临床研究为例,介绍该研究以患者为中心的临床研究模式与适应性设计相结合的实践探索,为中医药疗效评价提供有益借鉴。The holistic concept of traditional Chinese medicine(TCM)pays more attention to the''sick person'',that is''patient-centered diagnosis and treatment strategies''.The most recent iteration of the Measures for the Administration of Drug Registration points out that the therapeutic evaluation of TCM should select the indicators that align with the clinical principles and showcase its unique functional characteristics and advantages.At the same time,under the continuous promotion of modern evaluation systems,there has been a notable increase in innovative clinical trial methods of TCM.There is a growing trend towards utilizing more flexible and expedited clinical trial designs throughout the drug product lifecycle to enhance efficiency of the trials based on rational utilization.This paper took the clinical research of Di'ao Xinxuekang capsule in the treatment of chronic stable angina pectoris as an example,introducing the practical exploration of combining patient-centered clinical research approach with adaptive design,providing useful reference for the evaluation of TCM efficacy.

关 键 词：以患者为中心 适应性设计 中医药临床研究模式 地奥心血康胶囊 心绞痛 

分 类 号：R972[医药卫生—药品] R-3[医药卫生—药学]