基于Meta分析的葛根素注射剂辅助治疗脑梗死临床评价研究

Meta-analysis on Randomized Controlled Trials of Purearin Injection for Treating Cerebral Infarction

目的:采用Meta分析方法评价葛根素注射剂辅助西医常规治疗脑梗死的有效性及安全性。方法:计算机检索the Cochrane Library、PubMed、Embase、SinoMed、中国期刊全文数据库(CNKI)、中文科技期刊全文数据库(VIP)、万方数据库中有关葛根素注射剂治疗脑梗死的随机对照试验(RCTs),文献检索年限为各数据库建库至2016年10月22日。采用Cochrane风险评估表评价其偏倚风险,提取资料并通过Rev Man 5.3软件进行数据分析。结果:共纳入18个RCTs,累计1 624名患者。Meta分析结果显示,在西医常规治疗的基础上,联用葛根素注射剂可提高脑梗死患者的临床总有效率(RR=1.21,95%CI:1.15~1.26,P<0.000 01)。此外,联用葛根素注射剂也可改善神经功能缺损情况(MD=-5.03,95%CI:-6.88^-3.17,P<0.000 01),影响血液流变学指标等。纳入研究中2个RCTs明确记录未发生明显不良反应,5个RCTs发生了26例不良反应。结论:葛根素射剂辅助西医常规治疗脑梗死具有较好的疗效,但其安全性需进一步探讨。

Objective：To evaluate systematically the clinical effectiveness and safety of Purearin injection in treatment of Cerebral Infarction（CI）. Methods：Randomized controlled trials（RCTs） regarding CI treated by Purearin injection and conventional therapy in the China National Knowledge Infrastructure Database, China Scienceand Technology Journal Data- base, Wanfang Database, Chinese Biomedical Literature Database, PubMed and the Cochrane Library up to 22nd October, 2016. Two reviewers independently retrieved RCTs and extracted information. The Coehrane Hsk of bias method was used to assess the quality of included studies, and a Meta-analysis was conducted with ReMan 5.3 software. Results： A total of 18 RCTs involving 1 624 participants were included, 824 cases in Purearin injection group and 800 cases in the routine western medicine group. In Meta-analysis, the results of Purearin injection group was significantly superior to the routine western medicine group in the total effective rates（RR = 1.21,95% CI： 1.15-1.26, P 〈0.000 O1 ）. And Purearin injec- tion could have effects on neurologic impairment（MD = -5.03, 95% CI： -6.88-3. 17, P 〈0.000 01 ）, hemorheologi- cal parameters and other outcomes. Two articles cleared that there was no ADRs in the studies, 5 studies reported 26 cases of ADRs. Conclusion： Purearin injection combined with conventional therapy has good therapeutic effect on CI, while its safety still needs to be further investigated.