基于结局指标重要性和中医药代表性构建中医临床疗效评价指标体系  

Construction of evaluation index system of TCM clinical efficacy based on importance of outcome assessment and representativeness of TCM treatment

作　　者：于长禾[1] 张英 万颖 陈千吉 翁志文[1] 孙亚男[3] YU Chang-he;ZHANG Ying;WAN Ying;CHEN Qian-ji;WENG Zhi-wen;SUN Ya-nan(Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,China;The First Medical College of Beijing University of Chinese Medicine,Beijing 100700,China;Traditional Chinese Medicine Department,Xuanwu Hospital,Capital Medical University,Beijing 100053,China)

机构地区：[1]北京中医药大学东直门医院,北京100700 [2]北京中医药大学第一临床医学院,北京100700 [3]首都医科大学宣武医院中医科,北京100053

出　　处：《中华中医药杂志》2021年第3期1238-1243,共6页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家自然科学基金青年科学基金项目(No.81803956)。

摘　　要：中医临床疗效评价指标体系的建立是中医药现代化研究领域的关键问题。结局指标作为疗效评价指标体系的基础单元,首先必须满足作为一种结局评判尺度的基本功能,其次才是体现中医的特色性、代表性。所谓的中医、西医的结局指标差异源于中国与国外人群对健康状态的认知等文化差异,而非中医与西医干预措施的本身。因此,西医的某些结局指标同样适用于评价中医药疗法的特色:除此之外,证候疗效是中医的特色结局指标,指通过辨证论治、针对证候进行疾病防治所产生的效果,通过患者结局报告、健康相关生活质量量表及医生结局报告等指标构建体现辨证论治效果的特色结局指标集。中医疗效评价指标体系的层次结构上,既往研究关注中医、西医的差异进而区分结局指标归属问题,本研究则根据结局指标重要性和反映中医药特色代表性方面,提出新观点:中医疗效评价指标体系由患者健康状态相关的核心结局指标集和干预措施相关的特色结局指标集构成。前者针对特定健康领域的所有临床研究中应当报告的最小集合,包括所有的干预措施;后者针对具有代表性干预措施类别的特色指标集合。It is the primary issue of modern traditional Chinese medicine(TCM) to construct the evaluation index system of TCM clinical efficacy. The outcome assessment, as basic unit in TCM evaluation index system of clinical efficacy, must meet demands of being a good scale for outcome assessment, and then can be regarded as specific and representative outcomes for TCM treatment. The true difference of outcomes between TCM and modern medicine is the cultural difference among the patients who will be assessed by such outcomes, but not treatments themselves. Therefore, many outcomes, that assess modern medicine treatment, also evaluate TCM treatment. Besides, the effect of TCM pattern differentiation is the main and TCM specific outcome, and it means the effect of all treatments that apply TCM pattern differentiation for diseases. Such effect can be collected by patient reported outcomes, clinician reported outcomes and health related quality of life scales, and be described as the outcome in TCM specific outcome sets. Apart from the former categories of outcome index in the outcome assessment system by TCM and modern medicine, we emphasize the outcome relating to importance to patients and representativeness of TCM treatment for the new categories for the system. We propose the establishment of a new system which consists of core outcome sets related to participants(Participant-related COS, Pa-COS) and specific outcome sets related to interventions(Intervention-related specific outcome sets, In-SOS), especially for TCM. The former sets focus on that the minimum set of outcomes should be reported in all trials, but the latter ones on that the outcomes representing specific treatment, eg. TCM, can be reported as primary outcome in the trials with the such treatment.

关 键 词：结局评价 心理测量学 证候疗效 医患共建 文化差异 中医临床疗效评价指标体系 核心结局指标集 特色结局指标集 

分 类 号：R242[医药卫生—中医临床基础]