中医药治疗缓慢型心律失常随机对照临床试验采用的评价指标及问题分析

Analyses on the outcome measures and its problems used in clinical trials of traditional Chinese medicine for treating bradyarrhythmia

关键词:  中医药  缓慢型心律失常  结局指标  核心指标集  随机对照临床试验

Key words:  traditional Chinese medicine  bradyarrhythmia  outcome  core outcome set  randomized clinical trial

摘要:

[目的] 分析2017—2018年发表的中药治疗缓慢型心律失常随机对照试验的评价指标，为今后中医药治疗缓慢型心律失常核心指标集的构建奠定基础。[方法] 计算机检索中医药临床证据数据库（EVDS）、中国期刊全文数据库（CNKI）、万方、维普、SinoMed、PubMed、Cochrane Library，收集中医药干预的缓慢型心律失常临床随机对照试验（RCT）。检索时间为2017—2018年。由2位作者严格按照纳入与排除标准独立筛选文献、提取资料，如有分歧，经讨论解决。[结果] 最终纳入71篇RCT，共计6 129例患者，65个评价指标。单个研究采用指标数量为1~23个，平均为4.07个。使用频次排前14位的指标依次为：心率变化、临床疗效、不良反应、最慢心率、中医证候积分、中医证候疗效、24 h动态心电图平均心率、最快心率、心电图疗效、24 h动态心电图总心率、24 h动态心电图最慢心率、安全性指标、24 h动态心电图疗效、症状改善疗效。[结论] 当前中药治疗缓慢型心律失常RCT在指标选择、指标参考标准、指标测量时间、测量方法等方面均存在一系列不规范问题，需要构建缓慢型心律失常临床试验核心指标集，为高质量中医药临床研究的设计和开展奠定基础。

Abstract:

[Objective] To analyze the outcome measures used in randomized clinical trials of traditional Chinese medicine(TCM) for treating bradyarrhythmia published from 2017 to 2018,and then provide foundation to summary the data of core outcome set (COS) of TCM about bradyarrhythmia.[Methods] Databases including EVDS,CNKI,WanFang Date,VIP,SinoMed,PubMed and Cochrane Library are retrieved to collect randomized controlled trial (RCT) of TCM for treating bradyarrhythmia from 2017 to 2018. Two reviewers independently screen literature and extract data according to the inclusion and exclusion criteria. Disagreements are resolved by discussion.[Results] The 71 RCT were included,involving 6 129 patients and 65 outcome measures. The number of outcome measures in one of the included RCT varied from 1 to 23 with the average of 4.07. After frequency analysis,the top 14 outcome measures were heart rate,clinical efficacy,adverse events,slowest heart rate,scores of TCM syndrome,efficacy of TCM syndrome,average heart rate of 24 h dynamic ECG,fastest heart rate,efficacy of ECG,total heart rate of 24 h dynamic ECG,slowest heart rate of 24 h dynamic ECG,safety index,efficacy of 24 h dynamic ECG,efficacy of symptom improvement.[Conclusion] There are a series of problems in the randomized controlled trial of TCM for treating bradyarrhythmia,particularly in the issue of outcome selection,outcome reference standards,outcome measurement time and outcome measurement methods. Thus,it is vital to develop COS for treating bradyarrhythmia to improve the quality of clinical researches of TCM.