疏血通注射液治疗急性脑梗死临床疗效和安全性的系统评价

A system review on efficacy and safety of Shuxuetong Injection in treatment of acute cerebral infarction

目的以银杏叶提取物注射剂为对照药,系统评价疏血通注射液治疗急性脑梗死的临床疗效和安全性。方法检索Pub Med、中国知网(CNKI)、中国生物医学全文数据库(CBM)、维普网(VIP)、万方数据库,收集疏血通注射液对比银杏叶提取物治疗急性脑梗死的随机对照研究(RCTs),检索年限为从建库至2016年7月。由2名研究者独立提取数据、评价质量,并交叉核对,采用Rev Man 5.2软件进行Meta分析。结果纳入11项RCTs,1 338例患者。Meta分析结果显示,疏血通注射液的临床总有效率[RR=1.17,95%CI(1.11,1.23),P<0.01],降低神经功能缺损评分[MD=-4.46,95%CI(-6.07,-3.25),P<0.01]和提高生活能力评分[MD=13.98,95%CI(11.30,16.65),P<0.01]均显著优于银杏叶提取物制剂,两组均未发生严重不良反应。结论现有证据表明疏血通注射液治疗急性脑梗死的临床疗效、改善神经功能缺损和生活能力均优于银杏叶提取物。

Objective Using Ginkgo biloba extract injection as control drug, to systematically review the efficacy and safety of Shuxuetong Injection in the treatment of acute cerebral infarction. Methods Database including PubMed, Medline, CNKI, VIP and WanFang Data were searched to collect randomized controlled trials （RCTs） about Shuxuetong Injection versus G biloba extract injection in the treatment of acute cerebral infarction from database setup time to July of 2016. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. The meta-analysis was conducted by RevMan 5.2 software. Results Total of 11 RCTs, 1 338 patients were included. Meta-analysis showed that Shuxuetong Injection was significantly better than G biloba extract injection in clinical total effective rate [RR = 1.17, 95%CI（1.11, 1.23）, P 〈 0.01], reducing neurological deficit score [MD = -4.46, 95%CI （-6.07, -3.25）, P 〈 0.01] and improving life ability score [MD = 13.98, 95%CI （11.30, 16.65）, P 〈 0.01], there was no serious adverse reaction in both groups. Conclusion Current evidence shows that Shuxuetong Injection is effective and safe in the treatment of acute cerebral infarction better than G biloba extract injection.