重组组织型纤溶酶原激活剂静脉溶栓治疗急性缺血性脑卒中疗效及安全性的Meta分析

Efficacy and Safety of Recombinant Tissue-type Plasminogen Activator for Acute Ischemic Stroke:A Meta-analysis

目的系统评价重组组织型纤溶酶原激活剂（rt-PA）静脉溶栓治疗急性缺血性脑卒中的疗效及安全性。方法计算机检索The Cochrane Library（2013年第3期）、PubMed、CNKI、SCI、EMBase数据库、Medline及万方全文数据库,收集rt-PA或安慰剂治疗急性缺血性脑卒中的随机对照试验,检索时间为1995年1月—2013年6月。2名评价者按照纳入与排除标准选择试验、提取资料和评价质量后,采用RevMan 5.0软件进行Meta分析。结果纳入7个随机对照试验,包含6 548例患者。Meta分析结果显示：rt-PA组治疗急性缺血性脑卒中的3～6个月有利神经评分〔改良Rankin（mRS）评分0～1分、牛津残障评分（OHS）0～1分〕发生率高于对照组〔RR=1.22,95%CI（1.10,1.35）,P〈0.05〕;rt-PA组0～3.0 h时间窗〔RR=1.53,95%CI（1.32,1.78）,P〈0.05〕、3.1～4.5 h时间窗〔RR=1.13,95%CI（1.02,1.25）,P=0.02〕有利神经评分发生率均高于对照组,4.6～6.0 h时间窗rt-PA组与对照组有利神经评分发生率比较差异无统计学意义（P〉0.05）。rt-PA组症状性颅内出血发生率高于对照组〔RR=3.94,95%CI（2.31,6.70）,P〈0.05〕,但两组的3～6个月总体病死率比较差异无统计学意义（P〉0.05）。结论 rt-PA组急性缺血性脑卒中患者有利神经评分发生率较对照组高,在0～4.5 h时间窗内溶栓治疗的有利神经评分发生率高于对照组,但在4.6～6.0 h时间窗,两组的有利神经评分发生率无差别。rt-PA组较对照组溶栓后症状性颅内出血发生率更高,两组的3～6个月总体病死率无差异。

Objective To systematically study the efficacy and safety of recombinant tissue -type plasminogen activa- tor （rt -PA） in the treatment of acute ischemic stroke. Methods The Cochrane Library （The 3rd issue in 2013）, PubMed, CNKI, SCI, EMbase database, Medline and Wanfang Database were retrieved by computer to collect randomized or non - randomized controlled trials of rt - PA or placebo treating acute ischemic stroke. The retrieving time was from January 1995 to June ：2013. According to inclusion and exclusion criteria, two evaluators extracted information and assessed the quality, and then con- ducted Meta analysis by using RevMan 5.0. Results 7 randomized controlled trials （RCTs） including 6 548 patients were in- cluded. Meta analysis showed that the incidence of favorable neurological score of rt - PA group in the treatment of patients with acute ischemic stroke between three to six month （ mRS 0 - 1, OHS 0 - 1 ） was significantly higher than the control group [ RR = 1.22, 95% CI （ 1.10, 1.35 ） , P 〈 0. 051- The incidence of favorable neurological score of rt - PA group in 0 - 3.0 h time window [RR：l.53, 95%CI （1.32, 1.78）, P〈0.05], 3.1-4.5 h time window [RR=1. 13, 95%CI （1.02, 1.25）, P = 0.02 ] was significantly higher than the control group. But in 4. 6 - 6. 0 h time window, the rt - PA group and the control group showed no statistically significant difference （ P 〉 0. 05 ）. The incidence of intracranial hemorrhage in the rt - PA group was significantly higher than the control group [ RR = 3.94, 95 % CI （2. 31, 6. 70）, P 〈 0. 05 ], but the mortality rate of three to six month between the two groups showed no statistically significant difference （P 〉 0. 05 ）. Conclusion The rt - PA group has better favorable neurological score than the control group in the treatment of acute ischemic stroke, especially in the 0 - 4. 5 h time window, but the two groups showed no statistically significant difference in 4. 6 - 6. 0 h time window. The rt - PA has a higher incidence of intracranial bleeding rate than the control group, but the two groups showed no difference in overall mortality rate from three to six months.