灯盏花制剂治疗缺血性中风急性期随机对照试验的系统评价

目的：系统评价灯盏花制剂治疗缺血性中风急性期的疗效及安全性。方法：搜集灯盏花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、Meta-分析、漏斗图分析、敏感性分析等方法统计相关数据。结果：12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,总有效率比较的合并RR为1.25,99％CI为(1.15,1.37)；不良事件(面色潮红)发生率为0.58％。结论：Meta-分析结果提示灯盏花制剂具有改善缺血性中风急性期病人神经功能缺损状况的趋势,且不良反应少,安全性较高。但由于纳入研究质量普遍较低,存在临床异质性及发表性偏倚可能性较大,以及待评价研究等因素影响,降低了上述结论的可靠性,因此目前证明灯盏花制剂对于缺血性中风急性期的疗效及安全性的证据尚不够充分。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。

A Systematic Review of Brevsicapus Agents for Acute Ischaemic Stroke

Objective: To evaluate efficacy and safety of brevsicapus agents for acute ischaemic stroke. Methods: Randomized controlled trails (RCTs) of brevsicapus agents 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, funnel plot analysis and sensitivity analysis were used to analyse data. Results: 12 RCTs were included, with all trails of low methodological quality. Brevsicapus agents vs no - treatment control, Meta - analysis indicated that RR of overall effective rate was 1.25 [99%CI( 1.15, 1.37) ], rate of side - effect was 0.58%. Conclusion: This systematic review showed that brevsicapus agents perhaps have effective and security on acute is chaemic stroke. However, the evidence was not strong due to the general low methodological quality, it was not enough to evaluate efficacy and safety of brevsicapus agents for acute ischaemie stroke. To determinately evaluate efficacy and safety of brevsicapus agents for acute ischaemic stroke, more rationally designed and strictly executed RCTs with large samples were necessary.