基于终点事件的冠心病心衰中医防治方案循证优化思路和方法

Prevention and Treatment of Traditional Chinese Medicine for Heart Failure Caused by Coronary Heart Disease Based on Endpoint Events: Ideas and Methods of Evidence-Based Optimization

目的:分析目前中医药治疗冠心病心衰临床研究存在的问题,探讨和提出冠心病心衰中医防治方案循证优化的思路和方法。方法:系统检索PubMed、EMBASE、Cochrane Library、CNKI、WanFang、VIP和CBM数据库,筛选中医药治疗冠心病心衰的临床研究,评价研究的风险偏倚和结局指标,与慢性心衰的Cochrane系统综述的结局指标进行比较分析,以发现目前研究存在的问题,并针对问题提出改进方法。结果:纳入32篇中医药治疗冠心病心衰的临床研究,各研究的方法学质量普遍偏低,且研究对病死率、再入院率的终点事件结局报道很少,与Cochrane系统综述所关注的结局指标存在较大差距。在冠心病心衰的中医防治方案中,应加强完善临床研究设计和方法,选择冠心病心衰的终点事件作为研究的主要结局指标。结论:在冠心病心衰中医防治方案循证优化中,提高试验的方法学质量和终点事件结局指标的选择至关重要,更有价值的研究证据才能为冠心病心衰患者提供更佳的治疗方案。

Objective: This paper analyzed the present clinical researches of traditional Chinese medicine(TCM) in the treatment of heart failure caused by coronary heart disease and discusses the ideas and methods of evidence-based optimization. Methods: PubMed, EMBASE, Cochrane Library, CNKI, WanFang, VIP and CBM were searched to screen the clinical studies of TCM for treating heart failure caused by coronary heart disease. The problems and solutions were discussed by evaluating the risk of bias of the studies and analyzing the outcomes compared with the Cochrane systematic reviews of chronic heart failure. Results: A total of 32 clinical researches were included and the methodological quality of the studies was generally low. In addition, few studies assessed the endpoint events, mortality and readmission, as the primary outcomes in their trials, which is significantly different from the outcomes concerned in the Cochrane systematic reviews. Conclusion: It is really critical to improve the methodological quality of the trials and to choose the endpoint events as the primary outcomes in the evidence-based optimization of the prevention and treatment of TCM for heart failure caused by coronary heart disease Chinese medicine.