中医药治疗慢性心力衰竭随机对照试验结局指标的现状分析

Analysis of outcomes in randomized controlled trials of traditional Chinese medicine on chronic heart failure

目的:通过评价目前中医药治疗慢性心力衰竭(CHF)随机对照试验中结局指标的选择现状,为未来相关研究提供依据和基础。方法:检索PubMed、EMbase、Cochrane Library、中国知网数据库、中国生物医学文献服务系统、维普中文科技期刊数据库和万方数据库,搜集中医药治疗CHF的随机对照试验(RCT),检索时限均从建库至2020年3月。由2位评价员独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用定性分析的方法描述纳入研究的结局指标情况。结果:初步检索出15 943篇相关文献,最终纳入67篇文献。67个RCT的结局指标主要分为资源利用、生理和临床、生活影响、不良事件/影响、死亡五大域。结论:中医药治疗CHF的RCT结局指标遴选现状存在较多问题,应该借鉴国际核心指标结局指标集的创建方法,构建符合中医药治疗措施、疗效特色的核心结局指标集。

Objective: To evaluate the outcomes used in randomized controlled trial(RCT) of traditional Chinese medicine(TCM) in the treatment of chronic heart failure(CHF), and to provide a basis for the study of the core outcome set of TCM in the treatment of CHF. Methods: RCT of TCM on the treatment of CHF in the databases of PubMed,EMbase, Cochrane Library, CBM, CNKI, WanFang Data and VIP since inception till March 2020 were searched. Two reviewers independently screened all records, extracted data and evaluated risk of bias of included trials. A qualitative analysis was conducted to describe the outcomes of the included studies. Results: A total of 15 943 related literatures were preliminarily retrieved, and 67 literatures were finally included. A total of 67 RCTs and their outcomes were categorized into 5 categories: Resource utilization indicators, clinical symptoms and signs indicators, quality of life evaluation indicators,adverse reactions and adverse events indicators, and death. Conclusion: Core outcome set for TCM studies on the basis of combining the international standardized core outcome set with the characteristics and laws of diagnosis and treatment of TCM should be established.