参麦注射液治疗缺血性中风急性期随机对照试验的系统评价

A Systematic Review of Shenmai Injection for treating acute ischaemic stroke

目的:系统评价参麦注射液治疗缺血性中风急性期的疗效及安全性。方法:搜集参麦注射液治疗缺血性中风急性期随机对照试验文献,筛选合格研究,应用Jadad评分法进行质量评价,运用异质性检验、Meta-分析、漏斗图分析、敏感性分析等方法统计相关数据。结果:6项研究符合纳入标准,Jadad评分显示所有研究得分均低于3分,属低质量文献。Meta-分析结果显示,与空白对照组比较,总有效率的RR合并=1.20,99%CI为(1.09,1.33),神经功能缺损评分的WMD合并=-5.98,99%CI为(-8.68,-3.28),治疗后12周Barthel氏指数的WMD=11.58,99%CI为(-15.52,38.68)。结论:系统评价结果显示参麦注射液治疗缺血性中风急性期有效;无相关报道,故安全性及长期疗效尚不明确。由于纳入研究质量普遍较低、存在发表性偏倚的可能等因素影响,降低了系统评价结论的可靠性。要进一步验证参麦注射液治疗缺血性中风急性期的疗效及安全性,尚需进行设计合理、执行严格、多中心大样本且随访时间足够的随机对照试验。

Objective:To evaluate efficacy and safety of Shenmai Injection for treating acute ischaemic stroke.Methods:Randomized controlled trails(RCTs)of Shenmai Injection for treating acute ischaemc stroke were searched and selected.Their quality was assessed by Jadad scale and the data were analysed.Heterogeneity test,Meta-analysis,funnel plot analysis and sensitivity analysis.Results:Six RCTs were up to the entering standard,the scores of all trails were below 3 to below quality by Jadad.Meta-analysis indicated that relative risk of overall effective rate was 1.2099%CI(1.09,1.33),weighted mean difference of improving neurological impairment was -5.9899%CI(-8.68,-3.28),weighted mean difference of Barthel Index was 11.58 99%CI(-15.52,38.68).Conclusion:This systematic review showed that Shenmai Injection is effective for acute ischaemic stroke;safety and effect for long term are not clear.However,the evidence is not strong due to the general low methodological quality.To further determinate the efficacy and safety of Shenmai Injection for acute ischaemic stroke,more rationally designed and strictly executed RCTs with large samples are necessary.