天麻素注射液治疗急性脑梗死有效性和安全性的Meta分析

Efficacy and safety of Tianmasu injection in treatment of acute cerebral infarction:a meta analysis

目的系统评价天麻素注射液治疗急性脑梗死的有效性和安全性。方法计算机检索PubMed、Web of Science、Insitnte for Scientific Information、Cochrane、Embase、中国学术期刊网络出版总库、万方期刊数据库、中文科技期刊全文数据库以及中国生物医学文献等数据库,收集天麻素注射液治疗急性脑梗死的随机对照试验,检索时间为各数据库建库至2017年11月,采用Cochrane提供的偏倚风险评价工具对纳入研究进行质量评价,并使用RevMan 5. 3软件进行统计分析。结果共纳入12项研究,累计受试者1 062例。Meta分析结果显示,在西医常规治疗的基础上,联用天麻素注射液可明显提高急性脑梗死的临床疗效(比值比=1.22,95%置信区间:1.05～1.41,P=0.008),天麻素注射液可有效降低神经功能损伤程度(均数差=-1.86,95%置信区间:-2.40～-1.33,P<0.000 01),同时还能提高患者日常生活活动能力,显著改善患者血液流变学指标,降低患者血脂含量,且不良反应较低。结论与常规西医疗法相比,天麻素注射液治疗急性脑梗死具有较好的临床效果,对于安全性,尚需要更多高质量的研究予以证实。

Objective To evaluate the efficacy and safety of Tianmasu injection in the treatment of acute cerebral infarction. Methods Randomized controlled trials（RCTs） of Tianmasu injection treating acute cerebral infarction published before November 2017 were retrieved from PubMed, Web of Science, Institute for Scientific Information, Cochrane, Embase, China National Knowledge Infrastructure, Wanfang Data, Chinese Sci-tech Periodical Full-text Database and Chinese Biomedical Database. Cochrane risk assessment tool was used for quality assessment of RCTs. RevMan 5.3 software was used for meta analysis.ResultsTwelve RCTs with 1 062 patients were included. Meta analysis showed that the combined use of Tianmasu injection and western medicine treating acute cerebral infarction can improve the total effective rate（odds ratio=1.22, 95% confidence interval： 1.05-1.41, P=0.008） and reduce neurologic injury（mean difference=-1.86, 95% confidence interval： -2.40 to -1.33, P〈0.000 01）; it can also improve the activity of daily living, improve hemorheology and reduce blood lipid level with few adverse reactions. Conclusion Tianmasu injection combined with western medicine has good effectiveness and safety in the treatment of cerebral infarction.