基于Meta分析的红花注射剂治疗急性脑梗死临床评价研究

Meta-analysis of Safflower Injection in Treatment with Acute Cerebral Infarction

目的:系统评价红花注射剂联合西医常规治疗急性脑梗死的临床疗效及安全性。方法:系统检索Embase、PubMed、the Cochrane Library、中国期刊全文数据库(CNKI)、中文科技期刊全文数据库(VIP)、中国生物医学文献数据库(Sino Med)、万方数据库1979~2016年文献,全面搜集红花注射剂联合西医常规治疗急性脑梗死的随机对照试验,对纳入文献进行质量评价,提取资料并通过RevMan 5.3软件进行数据分析。结果:共纳入10篇文献,累计897例受试者。Meta分析结果显示:在常规用药的基础上,联合使用红花注射剂,可提高临床总有效率(RR=1.19,95%CI:1.08~1.32,P<0.000 7)。此外,血栓通注射剂还可降低血液流变学指标等,但不能明显改善神经功能缺损评分。结论:在西医常规治疗的基础上联合使用红花注射剂对急性脑梗死有较好的疗效,其安全性仍需进一步探讨,但本研究结论还需要进一步大样本严格的随机对照试验来证实。

Objective：To systematically evaluate the clinical efficacy and safety of Safflower injection combined with conventional therapy in the treatment with acute cerebral infarction （ACI）. Methods：According to literature databases, we conducted a thorough and systematic retrieval of randomized controlled trials （RCTs） which regarding Safflower injection for treating ACI. The Cochrane Risk of Bias Assessment Table was used to evaluate the methodological quality of the RCTs and then the data were extracted and Meta-analysed by RevMan5.3 software. Results： A total of 10 RCTs with 897 participants were included. In the Meta-analysis, the combining use of Safflower injection and conventional therapy in the treatment with ACI can achieve a higher total effective rate （RR = 1. 19, 95% CI： 1.08-1.32, P 〈 0. 000 7）. Furthermore, Safflower injection can can improve hemorheologic parameters. And there was no major or serious adverse drug event. Conclusion：Safflower injection combined with conventional therapy had good therapeutic effect on acute cerebral infarction（ ACI）, its safety should be further studied. While our study still needed to be proved by more rigorously designed randomized controlled trials （RCT）.