中医古代经典方证据质量评级量表的研制及应用  

Development and Application of the Evidence Quality Rating Scale for Ancient Classical Prescriptions in Traditional Chinese Medicine

作　　者：张居文 刘建平[1] 苏祥飞 魏玮[3] 苏晓兰[3] 冯雪 于凡雅 张煦东 余俊鸿 陈薇[1] ZHANG Juwen;LIU Jianping;SU Xiangfei;WEI Wei;SU Xiaolan;FENG Xue;YU Fanya;ZHANG Xudong;YU Junhong;CHEN Wei(Centre for Evidence-Based Chinese Medicine,Beijing University of Chinese Medicine,Beijing,100029;China Association of Chinese Medicine;Wangjing Hospital,China Academy of Chinese Medical Sciences)

机构地区：[1]北京中医药大学循证医学中心,北京市100029 [2]中华中医药学会 [3]中国中医科学院望京医院

出　　处：《中医杂志》2025年第8期804-810,共7页Journal of Traditional Chinese Medicine

基　　金：国家重点研发计划(2023YFC3503604)。

摘　　要：目的编制以中医古代经典方为评价对象的证据质量评级量表,检验其信度、效度并加以应用,为临床实践指南的制定提供多来源的证据支持。方法通过文献检索,提取并筛选现有文献中的评价维度,然后通过主题分析法归纳总结初始条目。遴选临床医学、医史文献学等领域的专家参与德尔菲问卷调研,进行条目的评价及筛选,开展专家共识会议确定最终纳入的条目。细化条目的评价方法及证据等级的划分方法,形成中医古代经典方证据质量评级量表,并进行信度、效度检验。结果通过文献资料检索、提取、筛选和总结,共形成3个维度和12个初始条目。邀请69名专家对初始条目进行评价,问卷回收率为100%,专家权威系数为0.92,12项条目重要性评分均>4,故予以保留,形成了包含3个维度12个条目的中医古代经典方证据质量评级量表,3个维度分别是古代证据情况、传承情况和现代应用情况,每个维度包含4个评价条目,每个条目满分为5分,根据最终评分划分高、中、低级证据。量表的12个条目水平的内容效度均>0.9,量表平均内容效度指数为0.98,组内相关系数为0.90。结论本研究编制的中医古代经典方证据质量评级量表具有良好的信度和效度,应用过程中具备可操作性,可在中医指南的制定过程中加以运用,更好地辅助临床决策。Objective To develop the Evidence Grading Scale for Ancient classical prescriptions in Traditional Chinese medicine,assess its reliability and validity,and apply it in practice to provide multi-source evidence for clinical practice guidelines development.Methods Literature retrieval was conducted to extract and screen existing evaluation dimensions,then the initial items were summarized using thematic analysis.Experts in the clinical medicine,medical history and literature participated in the Delphi questionnaire survey to evaluate and refine the items.An expert consensus meeting was conducted to finalize the included items,refine the method for items evaluation and evidence grading.The evidence quality rating scale for ancient classical traditional Chinese medicine(TCM)prescriptions was then established and tested for reliability and validity.Results Through literature review,extraction,screening and summarization,a total of 3 dimensions and 12 initial items were formed.Questionnaires were sent to 69 experts to evaluate the initial items,with a questionnaire response rate of 100%and an expert authority coefficient of 0.92.All 12 items were retained for they had importance scores above 4.The Evidence Grading Scale on Ancient classical prescriptions in Traditional Chinese medicine includes 3 dimensions with 12 items.The 3 dimensions includes ancient evidence,inheritance status,and modern application.Each dimension contains 4 items,and each item has a full score of 5 points.The evidence was rated as high-level,moderate-level,and low-level according to the final scores.The content validity index(CVI)of the 12 items was>0.9,the average CVI of the scale was 0.98,and the intraclass correlation coefficient(ICC)was 0.90.Conclusion The Evidence Grading Scale on Ancient classical prescrip⁃tions in Traditional Chinese medicine has good reliability and validity,which is practical for use in the development of TCM clinical guidelines and can better support clinical decision-making.

关 键 词：古代经典方 证据评价 德尔菲法 量表 信度 效度 

分 类 号：R289[医药卫生—方剂学]