基于Meta分析的注射用丹参多酚酸治疗急性脑梗死临床评价

Meta-analysis on Randomized Controlled Trials of Salvianolate Injection for Treatment of Acute Cerebral Infarction

目的:系统评价注射用丹参多酚酸辅助西医常规治疗急性脑梗死有效性、安全性,及对急性脑梗死患者运动和认知功能的影响。方法:计算机检索Cochrane library,Pubmed,Embase,中国生物医学文献数据库,中国知网,维普期刊数据库和万方数据库有关注射用丹参多酚酸治疗不稳定型心绞痛的随机对照临床试验文献,采用Cochrane风险评价表评价其研究质量,提取资料通过Rev Man 5.3进行Meta分析。结果:共纳入7个随机对照试验,累计622名患者。Meta分析显示注射用丹参多酚酸辅助西医常规治疗急性脑梗死具有很好的疗效,能促进神经功能恢复[MD=-2.56,95%CI(-3.19,-1.93),P<0.000 01],降低残疾程度[MD=-0.54,95%CI(-0.89,-0.19),P<0.000 01],提高患者日常生活能力[MD=9.90,95%CI(7.21,12.59),P<0.000 01],改善患者的认知学习能力,提高生活质量,还能显著提高临床疗效总有效率,降低C反应蛋白。有1篇文献明确无不良反应,2篇研究报道了共7例不良反应,其他文献均未对安全性做出说明。结论:急性脑梗死患者使用注射用丹参多酚酸治疗,能够明显提高临床疗效,有效促进神经功能恢复,提高日常生活行为能力,并显著改善卒中后认知功能,值得临床推广。因安全性尚不能得到确切的结论,安全性有待扩大临床试验样本量进一步研究。

Objective： To systematically evaluate the clinical effectiveness and safety of salvianolate injection （SI） in treating acute cerebral infarction （ACI）. Method： Randomized controlled trials regarding ACI treated by SI and routine western medicine were searched in the China National Knowledge Infrastructure database, China Science and Technology Journal database, Wanfang database, Chinese Biomedical Literature database, PubMed and Coehrane library. Two reviewers independently retrieved randomized controlled trials （RCTs） and collected information. The Cochrane risk of bias method was used to assess the quality of included studies, and a Meta-analysis was conducted with Review Manager 5.3 software. Result： A total of 7 studies involving 622 participants were included. The pooled results showed that SI group was significantly superior to the routine western medicine group in alleviating neurologie impairment [ MD = - 2.56, 95% CI （ - 3.19, - 1.93 ） , P 〈 0.00001], improving the activities of daily living [MD= -0.54, 95 %CI （ -0.89, -0.19）, P〈0.00001], reducing the degree of disability [MD = 9.90, 95% CI （7.21, 12.59）, P 〈 0. 000 01], improving cognitive function and quality of life of the acute cerebral infarction patients. Additionally, SI can alsoimprove the total effective rates and reduce the serum levels of C reactive protein. Among them, one article made clear that there was no adverse drug reactions （ADRs） in the studies, 2 studies reported 7 ADRs. All of the other literatures did not define the safety. Conclusion： Compared with routine western medicine, the combined use of SI and routine western medicine was more effective, and worth promotionin clinical practice. However, the safety has been defined and shall be further studied with a bigger clinical trial sample size.