中医杂志2026，Vol.67Issue(4)：416-424,9.DOI:10.13288/j.11-2166/r.2026.04.013
基于COSMIN指南对中医证候疗效评价量表的系统评价
A Systematic Review of Traditional Chinese Medicine Syndrome Efficacy Evaluation Scales Based on the COSMIN Guidelines
摘要
Abstract
Objective To systematically evaluate the methodological quality and measurement properties of traditional Chinese medicine(TCM)syndrome efficacy evaluation scales,and to provide evidence-based references for selecting high-quality assessment tools in TCM clinical practice.Methods China National Knowledge Infrastruc-ture(CNKI),Wanfang Data,VIP Database,Chinese Biomedical Literature Database(CBM),PubMed,the Cochrane Library,Embase,and Web of Science were searched from inception to April 2,2025,for studies evaluating the mea-surement properties of TCM syndrome efficacy evaluation scales.Data were extracted,and the methodological quality and measurement properties of the included scales were assessed according to the consensus-based standards for the selection of health measurement instruments(COSMIN).Recommendation levels were formulated based on the grading of evidence.Results A total of 46 studies were included,involving 22 generic syndrome efficacy evaluation scales and 24 disease-specific syndrome efficacy evaluation scales.None of the scales reported cross-cultural validity or measurement error.According to the recommendation grades,2 scales met Grade A recommendations and are sug-gested for clinical use;38 scales were classified as Grade B,indicating potential applicability but requiring further validation;and 6 scales were classified as Grade C,suggesting the need for further refinement.Conclusion Existing TCM syndrome efficacy evaluation scales exhibit substantial variability in methodological quality,incomplete report-ing of measurement properties,and insufficient attention to scale revision.Future efforts should emphasize standardized design in the development of TCM syndrome scales,strengthen validation procedures for key measurement properties,and prioritize dynamic revision of scales,thereby providing high-quality tools to support the precise evaluation of syn-drome efficacy.关键词
中医证候/疗效评价/量表/测量学特性/COSMIN指南/系统评价Key words
traditional Chinese medicine syndromes/efficacy evaluation/scales/measurement properties/consensus-based standards for the selection of health measurement instruments guidelines/systematic review引用本文复制引用
苏凯林,冯贞贞,王佳佳,王露,赵贵香,李建生..基于COSMIN指南对中医证候疗效评价量表的系统评价[J].中医杂志,2026,67(4):416-424,9.基金项目
国家重点研发计划中医药现代化重点专项(2024YFC3505302) （2024YFC3505302）
河南省国家中医药传承创新中心科研专项(2023ZXZX1126) （2023ZXZX1126）
河南省"双一流"创建科学研究专项(HSRP-DFCTCM-2023-3-01,HSRP-DFCTCM-2023-4-09) （HSRP-DFCTCM-2023-3-01,HSRP-DFCTCM-2023-4-09）
