中成药治疗中风的临床研究及评价(2021—2022年)

Clinical Trials and Evaluation of Chinese Patent Medicine in the Treatment of Stroke(2021—2022)

目的:通过对2021年度发表的中成药治疗中风的临床随机对照试验(RCTs)进行系统的收集、整理、分析和评价,对中成药治疗中风临床证据进行阶段性总结,为后续研究的开展及证据转化应用提供参考。方法:基于中医药循证研究证据库系统(EVDS)中的中成药临床证据数据库收录的文献,补充检索国家知识基础设施数据库(CNKI)、中国生物医学文献数据库(CBM)、中国学术期刊数据库(CSPD)、Cochrane Library、PubMed、EMbase数据库,获取2021年度发表的中成药治疗中风RCTs并进行统计分析。结果:检索得到符合要求的RCTs 147篇,其中样本量≥100例的RCTs 67篇(45.58%);涉及中成药51种,其中口服中成药25种,中药注射剂26种;涉及干预/对照措施16种,其中“中成药+西药+常规治疗”与“西药+常规治疗”比较最多(91篇,61.90%);纳入的147篇RCTs中,仅1篇未报告疗程,63.95%的研究疗程为14 d;研究总体方法学质量仍存在一些问题,尤其是分配隐藏、盲法及其他偏倚等条目低风险率不足5%,此外研究注册和样本量估算等鲜有报告。结论:2021年度发表的中成药治疗中风RCTs在随机方法、分配隐藏、实施偏倚(盲法应用)、其他偏倚4个方面的报告存在明显不足。

Objective:This study collected,collated,analyzed,and evaluated randomized controlled trials(RCTs) of Chinese patent medicine in the treatment of stroke published in 2021 and summarized clinical evidence of Chinese patent medicine in the treatment of stroke at different stages,providing references for follow-up research and evidence transformation and application.Methods:Based on the included literature in the Traditional Chinese Medicine(TCM) Clinical Evidence Database System(EVDS),CNKI,CBM,CSPD,Cochrane Library,PubMed,and EMbase were searched for RCTs of Chinese patent medicine in the treatment of stroke published in 2021,and statistical analysis was conducted.Results:The search yielded eligible RCTs from 147 papers,of which 67(45.58%) were RCTs with a sample size of more than 100 cases.A total of 51 kinds of Chinese patent medicine were involved,including 25 kinds of oral Chinese patent medicine and 26 kinds of TCM injections.A total of 16 intervention/control cases were included in RCTs,and among them,“Chinese patent medicine+Western medicine+conventional treatment” and “Western medicine+conventional treatment” were the most common(91 papers,61.90%).Among the 147 RCTs included,only one did not report a specific course of treatment,and the intervention duration was 14 days in 63.95% of the studies.There were still some problems in the overall methodology quality of research,especially the low risk rate of less than 5% in items including allocation concealment,blindness,and other biases.In addition,research registration and sample size estimation were rarely reported.Conclusion:The reports of RCTs of Chinese patent medicine in the treatment of stroke published in 2021 are significantly insufficient in randomization method,allocation concealment,bias implementation(blind application),and other biases.