基于循证医学原则的中医干预类临床证据分级系统的构建  

Construction of Clinical Evidence Grading System of TCM Intervention Based on Evidence-based Medicine Principles

作　　者：刘少南[1,2] 郭新峰 吴大嵘[1,2] Anthony Lin Zhang Charlie Changli Xue[3] 温泽淮 LIU Shao-nan;GUO Xin-feng;WU Da-rong;Anthony Lin Zhang;Charlie Changli Xue;WEN Ze-huai(Second Affiliated Hospital,Guangzhou University of Chinese Medicine/Guangdong Provincial Hospital of Chinese Medicine,Guangzhou,510120;State Key Laboratory of Dampness Syndrome of Chinese Medicine,Second Affiliated Hospital,Guangzhou University of Chinese Medicine,Guangzhou,510120;School of Health and Biomedical Sciences,RMIT University,Melbourne,Australia,3083;Science and Technology Innovation Center,Guangzhou University of Chinese Medicine,Guangzhou,510405)

机构地区：[1]广州中医药大学第二附属医院/广东省中医院,广州510120 [2]省部共建中医湿证国家重点实验室(广州中医药大学第二附属医院),广州510120 [3]School of Health and Biomedical Sciences(RMIT University,Melbourne,3083),Australia [4]广州中医药大学科技创新中心,广州510405

出　　处：《中国中西医结合杂志》2023年第8期911-915,共5页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：广东省中医院中医药科学技术研究专项(No.YN2019QL16);2021年广东省科技厅“海外名师”项目(No.粤科智字[2022]6号)。

摘　　要：基于证据推荐等级的评估、制订与评价(GRADE)系统构建符合中医药临床实践特点的中医干预类临床证据分级系统。通过文献调研和核心小组讨论,中医干预类临床证据包括中医古籍、名医经验及现代临床研究证据,采用德尔菲法专家调查,确定该证据分级系统的范围、评价条目及具体的分级水平。其中,中医古籍干预类证据评价因素包括古籍医案的来源、诊疗内容完整性及古籍的传承性三方面;名医经验证据的评价因素包括名医资质、内容完整性、经验传承性三方面;评价条目采用权重赋分,将古籍及名医经验的证据均分为高、中、低3个等级。中医干预类临床证据分级水平与现代临床研究的GRADE分级一致,分为高、中、低、极低4个水平,旨在为中医临床实践和未来的研究提供参考。构建的中医干预类临床证据分级系统既遵从循证医学原则,又体现中医药临床证据特点,期望能更加全面、客观地评估支撑中医药临床实践的多来源证据。To develop a clinical evidence grading system for Chinese medicine(CM)interventions based on the Grading of Recommendations Assessment,Development and Evaluation(GRADE)system.The CM clinical evidence grading system was the outcome of systematic review and syntheses of inputs from classical literature,famous doctors'experience and modern clinical evidence according to the literature review and group discussion.Through literature research and core group discussion,clinical evidence of traditional Chinese medicine intervention includes ancient books of CM,famous doctors'experience,and modern clinical research evidence.Delphi method was used to determine the scope,evaluation items and specific grading level of the evidence grading system.Among them,the evaluation factors for intervention evidence in CM ancient books included the source of ancient medical records,the completeness of diagnosis and treatment contents,and the inheritance of ancient books.The evaluation factors of famous doctors'experience included qualification of famous doctors,content integrity,and inheritance of experiences.The evaluation items are weighted,the evidence of ancient books and famous doctors'experiences were leveled as high,moderate,and low.The clinical evidence grading level of CM intervention was consistent with the GRADE grading of modern clinical research,divided into four levels:high,moderate,low,and very low,aiming to provide reference for clinical practice and future research of CM.The constructed clinical evidence grading system of CM intervention not only followed the principles of evidence-based medicine,but also reflected the characteristics of clinical evidence of CM.It was expected to more comprehensively and objectively evaluate the multi-source evidence supporting clinical practice of CM.

关 键 词：中医学 干预类临床证据 古籍 名医经验 证据推荐等级的评估、制订与评价系统 

分 类 号：R2-03[医药卫生—中医学]