从“累加证候改善-疾病改善”探讨适应中医临床实践指南证据体的疗效评价指标  

Exploration on the efficacy evaluation indicators of evidence adapted to traditional Chinese medicine clinical practice guidelines from‘improvement of cumulative syndrome-improvement of disease’

作　　者：高胤桐 董兴鲁[1,2,3,4] 王悦 李晶娅 张根明 GAO Yin-tong;DONG Xing-lu;WANG Yue;LI Jing-ya;ZHANG Gen-ming(The First Clinical Medical College of Beijing University of Chinese Medicine,Beijing 100700,China;Dongzhimen Hospital,Bejing University of Chinese Medicine,Beijing 100700,China;Institute of Chinese Encephalopathy,Bejing University of Chinese Medicine,Beijing 100700,China;Chinese Medicine Key Research Room of Brain Disorders Syndrome and Treatment of the National Administration of Traditional ChineseMedicine,Beijing 100700,China)

机构地区：[1]北京中医药大学第一临床医学院,北京100700 [2]北京中医药大学东直门医院,北京100700 [3]北京中医药大学中医脑病研究院,北京100700 [4]国家中医药管理局脑病中医证治重点研究室,北京100700

出　　处：《中华中医药杂志》2022年第11期6561-6565,共5页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家重点研发计划(No.2019YFC1712003)。

摘　　要：中医临床实践指南的推荐意见,应遵循中医辨病、辨证论治思想。中医临床试验作为形成推荐意见的证据体,其结局评价指标也应具备相应特征。因此,中医特色疗效评价指标的构建应基于辨病、辨证两个层面,以适应中医的干预特色。现有中医疗效评价工具,基本反映了“辨病层面”的疗效评价特点,但在证候层面尚未达成统一认识。这使相关中医临床试验的结局评价,过于依赖现代生物医学指标,或因证候层面疗效评价指标的主观性而产生一定偏倚,从而影响了中医临床实践指南的证据质量。完善“证候改善-疾病改善”相关性的论证,探寻累加证候改善与疾病主症改善的关系,根据不同疾病探索出对应的“证候疗效单元”及“证候疗效单位”,有助于丰富中医阶段性疗效评价指标,完善中医证据体系的构建,为中医临床实践指南提供适用性更强的证据体。The thought of disease differentiation and syndrome differentiation should be followed when the recommendations of the traditonal Chinese medicine(TCM)clinical practice guidelines are produced.Clinical trials of TCM as the evidence body to form recommendations,the outcome evaluation index should also have corresponding characteristics.Therefore,the evaluation index of TCM characteristic curative effect should be constructed based on disease differentiation and syndrome differentiation to adapt to the intervention characteristics of TCM.Existing TCM efficacy evaluation tools basically reflect the characteristics of efficacy evaluation at the symptom level,but there is no unified understanding at the syndrome level.As a result,TCM clinical trials rely heavily on modern medical indicators,or there is a certain bias due to the subjectivity of the efficacy evaluation indicators at the syndrome level,which ultimately affects the quality of evidence in TCM clinical practice guidelines.To improve the correlation between syndrome improvement and disease improvement,explore the relationship between the improvement of accumulated syndromes and the improvement of main disease symptoms,and explore the corresponding‘syndrome curative effect unit’and‘syndrome efficacy unit’according to different diseases,which will be helpful to enrich the evaluation indicators of TCM phased efficacy,improve the construction of TCM evidence system,and provide more applicable evidence body for TCM clinical practice guidelines.

关 键 词：证候 中医疗效评价 中医特色随机对照试验 中医临床实践指南 证据体 证候疗效单元 证候疗效单位 评价指标 

分 类 号：R2-03[医药卫生—中医学]