川芎嗪注射液治疗缺血性中风急性期随机对照实验的系统评价

目的系统评价川芎嗪注射液治疗缺血性中风急性期的临床疗效及安全性。方法搜集川芎嗪注射液治疗缺血性中风急性期随机对照实验文献,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、M eta-分析、敏感性分析等方法统计相关数据。结果有4项符合纳入标准,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,与空白对照组比较,总有效率RR合并=1.45,其99%可信区间为(1.24,1.70);神经功能缺损评分比较的WMD合并=-4.98,99%C I为(-8.21,-1.74)。敏感性分析显示M eta-分析结果稳定、可靠。结论系统评价结果显示川芎嗪注射液治疗缺血性中风急性期有效;无相关报道,故安全性尚不明确。由于纳入研究质量普遍低,降低了系统评价结论的可靠性。要进一步验证川芎嗪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实验。

A Systematic Review of Ligustrazine Injection for Acute Ischaemic Stroke

ObjectiveTo evaluate efficacy and safety of Ligustrazine Injection for acute ischaemic stroke.MethodsRandomized controlled trails(RCTs) of Ligustrazine Injection for acute ischaemic stroke were identified,eligible studies were included, the methodological quality of inclusive trails was assessed by Jadad scale.Heterogeneity test,Meta-analysis and sensitivity analysis were used to analyse data.ResultsFour RCTs were included,with all trails of low methodological quality.Ligustrazine injection vs no-treatment control,Meta-analysis indicated that relative risk of overall effective rate was 1.45[99%CI(1.24,1.70)],weighted mean difference of improving neurological impairment was-4.98[99%CI(-8.21,-1.74)].Sensitivity analysis indicated that result of Meta-analysis was credible.ConclusionThis systematic review showed that Ligustrazine Injection is effective for acute ischaemic stroke;safety is unclear.However,the evidence is not strong due to the general low methodological quality.To determinately evaluate efficacy and safety of Ligustrazine Injection for acute ischaemic stroke,more rationally designed and strictly executed RCTs with large samples are necessary.