丹参制剂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 Danshen Agents for Acute Ischaemic Stroke

目的:系统评价丹参制剂治疗缺血性中风急性期的疗效及安全性。方法:搜集丹参制剂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、M eta-分析、漏斗图分析、敏感性分析等方法统计相关数据。结果:4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,总有效率比较的合并RR为1.24,99%C I为(1.08,1.42);副作用局部出现点状出血比较合并RR(99%C I)为0.38(0.02,8.26),心慌胸闷发生率比较的合并RR(99%C I)为3.78(0.07,194.99)。结论:M eta-分析结果显示丹参制剂具有改善缺血性中风急性期病人的神经功能缺损状况的趋势,无可靠证据显示该药是否可影响不良事件发生率。由于纳入研究质量普遍较低等因素影响,降低了该系统评价结论的可靠性。要进一步验证其疗效及安全性,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 danshen agents for acute ischaemic stroke. Methods： Randomized controlled trails （RCTs） of danshen agents for acute ischaenfic stroke were identified, eligible studies were included, the methMological quality of inclusive trails was assessed by Jadad scale. Heterogeneity test, Meta - analysis, funnel plot analysis and sensitivity analysis were used to analyse data. Results： Four RCTs were included, with all trails of low methodological quality. Danshen agents vs no - treatment control, Meta - analysis indicated that RR of overall effective rate was 1.24 [ 99% CI （1.08,1.42） ], RR of side - effect was 3.78 （0.07,194.99）. Conclusion .. This systematic review showed that danshen agents perhaps have effective on acute ischaemic stroke, side -effect is unclear. However, the evidence is not strong due to the general low methodological quality. Tn determinately evaluate efficacy and safety of daushen agents for acute ischaemic stroke, more rationally designed and strictly executed RCTs with large samples are necessary.