中成药治疗心律失常的临床研究及评价

Clinical trials and evaluation of Chinese patent medicine for arrhythmia

关键词:  中成药  心律失常  随机对照试验  循证医学

Key words:  Chinese patent medicine  arrhythmia  randomized controlled trial  evidence-based medicine

摘要:

[目的] 对中成药治疗心律失常的临床随机对照试验（RCT）进行系统收集、分析与评价，总结证据全貌，为后续临床研究开展、指南及政策制定提供参考。[方法] 基于中医药循证研究证据库系统（EVDS）中成药临床证据数据库，并补充检索PubMed、Web of Science数据库，检索时间为建库至2020年12月31日，纳入中成药治疗心律失常的RCT，对其研究特征、方法学质量进行分析与评价。[结果] 纳入中成药治疗心律失常RCTs 1 934篇。共涉及中成药100种，其中口服药82种，注射液18种。64.89%的RCT观察周期为15~30 d；38.00%的RCT样本量＞100例；纳入RCT共涉及65种干预/对照设计，中成药+西药vs西药的方式应用最多，占27.25%。评价指标方面，症状/体征指标（3 106次）和理化检测指标（2 616次）应用最多。方法学方面，中、英文RCT的方法学质量差距大，近4年RCT的方法学质量没有明显提高。[结论] 治疗心律失常的中成药品种较多，以口服为主；但相关RCT存在研究规模小、临床价值定位不清晰、研究设计不能体现中成药价值、测量指标不科学、测量方法不规范等问题；未来研究应重视并解决以上问题，提高研究的质量和价值，增强研究的真实性，提高证据的可靠性和外推性。

Abstract:

[Objective] This study reviewed the clinical randomized controlled trials (RCTs) of Chinese patent medicine for arrhythmia to provide references for clinical research,guideline development,and policy formulation.[Methods] EVDS,PubMeb,Web of Science were searched for RCTs of Chinese patent medicine for arrhythmia from database inception to December 31,2020.[Results] A total of 1 934 RCTs were included,involving 100 Chinese patent medicines,including 82 oral medicines and 18 injections.Treatment course of 64.89% RCTs were 15 to 30 d;38.00% of RCTs had a sample size of more than 100 cases;65 types of interventions/controls were involved in the RCTs,with Chinese patent medicine+Western medicine vs.western medicine as the top one used (27.25%).In outcomes,symptoms/signs (3 106) and physicochemical detection (2 616) were the most frequently applied.High difference were in the methodological quality between Chinese RCTs and English RCTs.RCTs'methodological quality were not improve in near 4 years.[Conclusion] Many deficiencies in the RCTs of Chinese patent medicine for arrhythmia,such as small study size,not clear clinical value proposition,study design that fails to reflect the value of Chinese patent medicine,unscientific outcomes,unreasonable measured methods.Future studies should give priority to above problem and solve them,improving the quality and value of studies and enhancing the reliability and extrapolation of evidence.