华佗再造丸治疗缺血性脑卒中的Meta分析及试验序贯分析

Huatuo Zaizao Pills in the Treatment of Ischemic Stroke:A Meta-analysis and Trial Sequential Analysis

目的:系统评价华佗再造丸治疗缺血性脑卒中的疗效和安全性,旨在为临床治疗用药提供循证参考。方法:检索PubMed、Embase、Cochrane Library、中国知网等数据库,筛选华佗再造丸治疗缺血性脑卒中的临床随机对照试验,文献发表日期限定在从建库开始到2020年12月14日。2名研究者独立进行文献筛选及数据提取。采用Cochrane协作网提供的偏倚风险评估工具评估纳入研究的质量。根据异质性大小选择固定或随机效应模型汇总效应估计值。生成森林图以显示汇总结果,使用TSA0.9软件进行试验序贯分析。结果:共纳入16篇文献,包括1616名受试者,观察组827名,对照组789名。Meta分析结果显示,华佗再造丸组在提高治疗有效率(OR=3.36,95%CI为2.43~4.56,P<0.001)、降低NIHSS评分(MD=-2.72,95%CI为-3.72~-1.73,P<0.001)、提高日常生活能力(MD=8.89,95%CI为4.51~13.26,P<0.001)方面优于对照组;仅6项研究报告了安全性指标,有待更多研究以进一步明确临床用药安全性。TSA结果显示,华佗再造丸组治疗缺血性脑卒中有效率更优的证据确切。结论:当前研究表明华佗再造丸联合基础治疗可显著提高缺血性脑卒中患者的有效率,降低NIHSS评分,提高日常生活能力,但其安全性有待进一步确证。由于本研究纳入的研究方法质量偏低,且样本量小,需进一步进行大规模、高质量的研究验证其疗效和安全性。

Objective:To systematically evaluate the efficacy and safety of Huatuo Zaizao Pills(HZP)in the treatment of ischemic stroke,and to provide a reference for clinical treatment.Methods:PubMed,Embase,Cochrane Library,CNKI and other databases were screened to screen the clinical randomized controlled trials of HZP in the treatment of ischemic stroke.The publication date of the literature was limited to the establishment of the database to December 14,2020.A total of 2 investigators independently screened the literature and extracted data with reference to the inclusion and exclusion criteria.The bias risk assessment tool provided by the Cochrane Collaboration was used to assess the quality of the included studies.According to the size of heterogeneity,we selected fixed or random effect models to summarize effect estimates.We generated a forest map to show the summary results.TSA0.9 was applied in test sequential analysis.Results:A total of 16 studies were included,including 1616 participants,827 in the experimental group,and 789 in the control group.Meta-analysis results showed that the Huatuo Zaizao Pills group improved the total effective rate of treatment[OR=3.36,95%CI(2.43 to 4.56),P<0.001]and reduced the NIHSS[MD=-2.72,95%CI(-3.72 to-1.73),P<0.001],improved daily function and living ability[MD=8.89,95%CI(4.51 to 13.26),P<0.001]better than the control group;only 6 studies have reported safety indicators.More research was needed to further clarify the safety of clinical medication.TSA results showed that the Huatuo Zaizao Pills group had better evidence for the treatment of ischemic stroke.Conclusion:Current research shows that HZP group can significantly improve the total effective rate of patients with ischemic stroke,reduce the stroke scale score,and improve daily functional life ability,but its safety needs to be further determined.Due to the low quality of the research methodology included in this study and the small sample size,further large-scale,high-quality studies are needed to verify its efficacy and safety.