生脉注射液治疗缺血性中风急性期随机对照试验的系统评价

目的:系统评价生脉注射液治疗缺血性中风急性期的疗效及安全性。方法:搜集生脉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,统计方法应用异质性检验、M eta-分析等。结果:2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。M eta-分析结果显示,纳入研究间具有同质性,总有效率相对危险度(RR值)及99%的可信区间(C I值)为1.24(1.06,1.45),不良反应(面部潮红)RR(99%C I)为9.00(0.20,406.10)。结论:临床总有效率比较的合并效应量分析提示生脉注射液具有改善缺血性中风急性期患者神经功能缺损状况的趋势。但由于纳入研究质量较低等因素影响,降低了该系统评价结论的可靠性。要进一步验证生脉注射液治疗缺血性中风急性期的疗效及安全生,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。

A Systematic Review of Shengmai Injection for Acute Ischaemic Stroke

Objective:To evaluate efficacy and safety of shengmai injection for acute ischaemic stroke.Methods:Randomized controlled trails(RCTs) of shengmai injection for acute ischaemic stroke were identified,eligible studies were included,the methodological quality of inclusive trails was assessed by Jadad scale.Heterogeneity test,Mete-analysis,funnel plot analysis and sensitivity analysis were used to analyse date.Results:Two RCTs were included,with all trails of low methodological quality.Shengmai injection vs no-treatment control,Meta-analysis indicated that tests for heterogeneity P>0.05,RR of overall effective rate was 1.24(1.06,1.45),side effect rate is 9.00(0.20,406.10).Conclusion:This systematic review showed that shengmai injection is effective and safe for acute ischaemic stroke.However,the evidence is not strong due to the general low methodological quality.To determinately evaluate efficacy and safety of shengmai injection for acute ischaemic stroke,more rationally designed and strictly executed RCTs with large samples are necessary.