系统循证医学:推动中医药疗效研究的新方向  

Systems evidence-based medicine(sysEBM):a new model toward the studies on effects of traditional Chinese medicine interventions

作　　者：谭婧[1,2,3] 王雯 李玲[1,2,3] 刘青松 梅凡[1,2,3] 王子晨 陈晨 秦璇 丁玲 王礼群[4] 刘佳利 罗小超 刘学红 何逸飞 王文玲 任燕 赖钦淮 熊益权 姚明宏 徐嘉悦[1,2,3] 姚于勤 陈素君 蒋静文 陈雏 郜洁 金钊 孙鑫 TAN Jing;WANG Wen;LI Ling;LIU Qingsong;MEI Fan;WANG Zichen;CHEN Chen;QIN Xuan;DING Ling;WANG Liqun;LIU Jiali;LUO Xiaochao;LIU Xuehong;HE Yifei;WANG Wenling;REN Yan;LAI Qinhuai;XIONG Yiquan;YAO Minghong;XU Jiayue;YAO Yuqin;CHEN Sujun;JIANG Jingwen;CHEN Chu;GAO Jie;JIN Zhao;SUN Xin(Chinese Evidence-Based Medicine Center/Chinese Cochrane Center,West China Hospital,Sichuan University,Chengdu 610041,P.R.China;Sichuan Center for Real World Data Innovation,Chengdu 610041,P.R.China;Sichuan Center for Evidence-Based Chinese Medicine,Chengdu 610041,P.R.China;West China School of Public Health and West China Fourth Hospital,Sichuan University,Chengdu 610041,P.R.China;Sichuan Academy of Chinese Medicine Sciences,Chengdu 610041,P.R.China;The First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510405,P.R.China;Chengdu University of Traditional Chinese Medicine,Chengdu 611137,P.R.China)

机构地区：[1]四川大学华西医院中国循证医学中心,成都610041 [2]四川省真实世界数据技术创新中心,成都610041 [3]四川省循证中药学研究中心,成都610041 [4]四川大学华西公共卫生学院/华西第四医院,成都610041 [5]四川省中医药科学院,成都610041 [6]广州中医药大学第一附属医院,广州510405 [7]成都中医药大学,成都611137

出　　处：《中国循证医学杂志》2025年第2期125-133,共9页Chinese Journal of Evidence-based Medicine

基　　金：国家自然科学基金项目(编号:82225049);四川省中央引导地方科技发展专项(编号:2022ZYD0127);中央级公益性科研院所基本科研业务费专项(编号:2020YJSZX-3);四川省中医药管理局中医药科研专项重点项目(编号:2024zd023)。

摘　　要：中医药是中华民族的瑰宝,疗效是中医药生存发展的根基,确保有效是中医药传承创新的核心命题。然而,中医药体系的高度复杂性导致其疗效在研发与应用中常偏离预期(即“疗效脱靶”),是中医药面临的关键挑战。笔者团队基于前期工作提出了面向中医药复杂干预的创新思路(“系统循证医学”)。其核心思想是:针对中医药“疗效生成”和“疗效测量”问题,融合临床与非临床药效评价手段,构建“疗效靶标识别-疗效作用发现-疗效精准验证”的系统化中医药疗效评价路径,确保中医药疗效呈现,实现中医药“疗效精准打靶”。进一步整合药学、信息、生物技术,多维度解析中医药的靶标网络和作用机理,为阐释中医药防治疾病的科学原理提供基础支撑。在此基础上,笔者团队融合真实世界数据大队列、临床试验、证据合成与快速推荐方法,以及信息技术、生物医药技术,构建了中医药干预(如针灸、已上市中药)的系统循证模型(6R模型),并在孕产、重症、骨关节疾病等领域进行了应用。Traditional Chinese medicine(TCM)is a treasure of the Chinese nation.Presence of clinical effects represents a fundamental issue for TCM development.Nevertheless,the complexities of TCM interventions often result in presented effects deviating from expected ones,a phenomenon so called as"effect off-target";this issue has become a major challenge for the development and use of TCM interventions.In continuing efforts,we have proposed an innovative evidence-based medicine model for studying the effects of TCM interventions,termed"systems evidence-based medicine(sysEBM)".Essentially,the sysEBM model integrates clinical and non-clinical evaluation to develop a systematic pathway for studying effects of TCM interventions,and the methodological steps typically include the development of PICO framework for a putative effect,exploration of the effect and confirmation of the effect by using animal models,observational studies and clinical trials.As an additional step,multidisciplinary technologies including pharmaceutical,pharmacological,information and biological technologies will be used to provide multidimensional analyses of potential action networks and mechanisms of TCM interventions.Building on this concept,we have developed a sysEBM model("6R"model)for acupuncture and marketed Chinese patent medicines by integrating real-world evidence,clinical trials,evidence syntheses,and rapid recommendation methodologies,as well as information technology and biomedical technologies.We also applied this model for developing TCM interventions for maternal health,critical care,and knee osteoarthritis.

关 键 词：中医药 复杂干预 疗效脱靶 多学科整合 系统循证医学 

分 类 号：R28[医药卫生—中药学]