痰瘀辨治顽固性高血压真实世界的因果推断方法研究

项目名称： 痰瘀辨治顽固性高血压真实世界的因果推断方法研究

项目编号： No.81202846

项目类型： 青年科学基金项目

立项/批准年度： 2013

项目学科： 医学八处

项目作者： 宇文亚

作者单位： 中国中医科学院中医临床基础医学研究所

项目金额： 23万元

中文摘要： 临床疗效评价实际上是干预措施与临床结局之间是否具有因果关系的研究。辨证论治在真实临床环境下的疗效优势是客观存在的事实，但由于缺乏科学的疗效评价方法，使其疗效很难得到国际医学界的认可。据此，本项目以顽固性高血压（Resistant Hypertension,RH）为范例，在明确痰瘀辨治有效性的基础上，开展真实世界研究（Real-world study,RWS）中因果推断的方法研究。首先，引入虚拟量，用数学公式精确定义痰瘀辨治RH疗效评价中因果关系的科学内涵；其次，针对RWS中数据的多态性，通过可比较性准则和倾向性评分法识别和处理混杂因素，筛选出两组同质人群；然后，构建虚拟事实因果模型，利用同质人群估算虚拟量，计算痰瘀辨治的总体因果作用ACE；最后，对虚拟事实因果模型进行RWS临床验证，初步研究出真实临床环境下，辨证论治与临床结局间因果推断方法的关键技术及适用范围。

中文关键词： 顽固性高血压；因果推断；倾向性评分；痰瘀辨治；真实世界研究

英文摘要： The research of clinical effectiveness assessment is to explore the causal relationship between treatment and outcome. The survivability and vitality of traditional Chinese medicine (TCM) lies in the syndrome differentiation and treatment.However,duing to the absence of inference methods of causal relationship between the syndrome differentiation and treatment and the clinical results under real-world study (RWS),the therapeutic effectiveness of TCM is hard to be recognized by the international medical community.Accordingly, based on the effectiveness of tan-yu treatment, the research takes the Resistant Hypertension (RH) as example to study the causal inference methods under real world. Fisrtly,potential counterfactual result is introduced to define scientific connotation of causal relationship in the tan-yu treatment of RH.Secondly,duing to the polymorphism of RWS data,the comparable criterion and the tendency scoring method are utilized respectively to recognize and settle the confounding factors and to achieve the homogeneity of two-group clinical trials.Thirdly,based on the priciple of counterfactual model,counterfactual results are estimated for the homogeneous trials,and the average causal effect (ACE) is computed for the tan-yu treatment of RH. Lastly,the counterfactual model of RWS should be verified cl

英文关键词： resistant hypertension；causal inference；tendency score method；tan-yu treatment；real-world study