建立中西医病证结合、医患共同报告、1+N模式慢性心力衰竭疗效评价体系的思路与方法  

Ideas and Methods of Establishing an Efficacy Evaluation System for Heart Failure:Combining Syndrome in Traditional Chinese and Disease Western Medicine,based on Doctors-patients Shared Reported Outcomes and Using 1+N Model

作　　者：董国菊[1,2] DONG Guoju(Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing,10009l;National Clinical Research Center for Chinese Medicine Cardiology)

机构地区：[1]中国中医科学院西苑医院,北京市100091 [2]国家中医临床心血管病研究中心

出　　处：《中医杂志》2023年第19期1975-1980,共6页Journal of Traditional Chinese Medicine

基　　金：国家自然科学基金(82074423);中国中医科学院科技创新重大攻关项目(CI2021A00903)。

摘　　要：建立符合中医药自身规律的疗效评价体系是中医药发展的关键环节之一,近年来中医药临床疗效评价体系的构建取得了一些进展,但已经形成的评价体系或者共识并没有得到广泛应用,其主要原因与疗效评价缺乏客观化、标准化有关,此外,还与固定的疗效评价体系很难满足不同临床研究目的的需求有关。以心力衰竭(HF)临床疗效评价的发展现状为切入点,探讨以中西医病证结合思想为指导、医患共同报告的临床结局为主体、采用1+N模式构建HF中医临床疗效评价体系的具体方法、优势和难点。建立中西医病证结合的疗效评价体系可以搭建与西医疗效对接的桥梁;医患共同报告的临床结局可以体现中医以人为本的理念和整体观念;构建1+N疗效评价模式,通过固定为“1”的核心指标集满足一般的临床研究需求,搭配不同的“N”的疗效评价指标以满足不同研究目的的临床需求。构建中医HF疗效评价体系的难点在于需要统一HF的证候诊断、规范纳入的HF标准,还要区分证候疗效标准和证候诊断标准的不同。通过构建既符合中医自身特点又体现西医循证理念的1+N模式的HF疗效评价体系,以期为中医临床疗效评价的发展提供思路。Establishing an efficacy evaluation system that conforms to the laws of traditional Chinese medicine(TCM)is one of the keys in the development of TCM.With certain progress in recent years,however,the clinical efficacy evaluation systems or consensus that has been formed are not widely adopted.The main reason is the lack of objectification and standardization of efficacy evaluation,and additionally fixed efficacy evaluation system cannot meet the needs of different clinical research purposes.This paper initially analyzed the development status of clinical efficacy evaluation of heart failure(HF),and then discussed the specific methods,advantages and difficulties in constructing a TCM clinical efficacy evaluation system for HF using the 1+N model,guided by the idea of combining traditional Chinese and western medicine,disease and syndrome,and based on the shared reported clinical outcomes by doctors and patients.Establishing an efficacy evaluation system that combines disease and syndrome can build a bridge to connect TCM with western medicine;the shared reported clinical outcomes by doctors and patients can reflect the people-centered concept and holism concept in TCM;the 1+N efficacy evaluation model can meet the general clinical research need by constructing one core outcome set(“1”),and can match different research purposes by adding numbers of other outcomes(“N”).One difficulty in constructing the TCM efficacy evaluation system for HF is to unify the differentiation standard for TCM syndromes of HF and the standardization to diagnose HF firstly,and then distinguish between syndrome efficacy standards and syndrome diagnostic standards.By constructing a 1+N model-based efficacy evaluation system for HF that not only conforms to the characteristics of TCM itself but also embodies the evidence-based medicine concept in western medicine,it is expected to provide ideas for evaluating clinical efficacy of TCM.

关 键 词：心力衰竭 疗效评价 病证结合 医患共同报告 

分 类 号：R541.6[医药卫生—心血管疾病]