冠心病稳定性心绞痛中医辨治方案的循证优化设计与思考

Evidence-based Optimization Design and Thinking on TCM Syndrome Differentiation and Treatment Protocol of Stable Angina

目的:通过规范的循证设计、测量和评价方法,加强稳定性心绞痛痰瘀互结证中医辨治与疗效之间的因果联系,从而完善中医临床证据,提高证据水平。方法:在顶层母方案设计框架下,面向中医早期干预稳定性心绞痛适宜人群疗效优势的研究目的,采用多中心实用性随机对照试验方法,采取优效性设计,在受试者选择、干预措施制定、指标体系构建、样本量估算、安全性观察、质量控制等方面,细化临床试验的设计要点。结果:以国家重点研发计划项目课题一"稳定性心绞痛痰瘀互结证中医辨治方案循证优化研究"为例,完善循证医学与中医辨治结合的临床研究设计。结论:实用性RCT设计可更充分体现中医辨治特色,中医药循证设计可为提升证据质量提供方法学支持。

Objectives: To strengthen the causal link between TCM syndrome differentiation and curative effect of stableangina through standardized evidence-based design, measurement and evaluation methods, so as to improve the clinicalevidence of TCM. Methods: Under the framework of the top-level parental design, this study aims at the research purposeof early intervention of TCM in patients with stable angina, and adopts a multicenter practical randomized controlled trial.This study adopts superior design and refines the design points of clinical trials in terms of subject selection, interventionsetting, index system construction, sample size estimation, safety observation, and quality control. Results: The nationalkey research and development plan project,'Study on Evidence-based Optimization of TCM Syndrome and TreatmentProtocol of Stable Angina Pectoris and Cross-Boundary Syndrome'indicated that the clinical research design ofevidence-based medicine and TCM differentiation and treatment was improved. Conclusions: The practical RCT designcan fully reflect the characteristics of TCM differentiation and treatment. The evidence-based design of TCM can providemethodological support for improving the quality of evidence.