银丹心脑通软胶囊辅助治疗急性脑梗死随机对照试验的Meta分析

Meta analysis of the randomized controlled trials on Yindan Xinnaotong soft capsule in adjunctive treatment of acute cerebral infarction

目的评价银丹心脑通软胶囊在辅助治疗急性脑梗死患者中的疗效和安全性。方法计算机检索Cochrane图书馆、Ovid、Pubmed、中国生物医学文献数据库(CBM)、中国知网(CNKI)数据库、维普(VIP)数据库、万方数据库中关于银丹心脑通软胶囊辅助治疗急性脑梗死的随机对照试验(RCT),各数据库检索时间为从2002年1月到2016年5月,由2名研究者根据纳入与排除标准独立筛选文献、提取资料,采用Rev Man 5.3软件进行Meta分析。结果共纳入文献17篇,1 494例患者,其中治疗组729例,对照组665例。Meta分析结果显示,银丹心脑通软胶囊辅助治疗急性脑梗死的总有效率高于常规治疗组[OR=3.23,95%CI(2.22,4.69),P<0.000 01];神经功能缺损程度的美国国立卫生研究所脑卒中评分量表(NIHSS)评分值减少优于常规治疗组[MD=-1.73,95%CI(-2.53,-0.92),P<0.000 1];Barthel指数评分高于常规治疗组[MD=7.93,95%CI(4.32,11.54),P<0.000 1];低密度脂蛋白低于常规治疗组[MD=-0.59,95%CI(-0.34,-0.22),P<0.000 01];纤维蛋白原低于常规治疗组[MD=-0.92,95%CI(-1.40,-0.45),P=0.00 01];不良反应发生率亦低于常规治疗组,但两组比较差异无统计学意义[OR=0.63,95%CI(0.24,1.64),P=0.34]。结论银丹心脑通软胶囊辅助治疗急性脑梗死临床疗效、安全性较好,同时能降低血黏稠度、血脂,但尚需更多设计严谨的高质量随机对照试验加以验证。

Objective To evaluate the effectiveness and safety of Yindan Xinnaotong soft capsule for acute cerebral infarction by sys- tematic review. Methods Randomized controlled trials（RCT） on Yindan Xinnaotong soft capsule in treatment of acute cerebral in- farction were retrieved from electronic databases including Cochrane Database, Ovid, Pubmed, Chinese Biomedical Database, CNKI, VIP, Wanfang Database. For each database retrieval time from January 2002 to May 2016,two reviewers independently screened the eligi- ble studies with confirmation of cross-check. Different opinions were consulted by the third party. Meta analysis was done by Revman 5.3. Results Seventeen original studies met the inclusion criteria,including 1 494 patients. There were 729 patients in treatment group and 665 patients in control group. Meta analysis showed that the total effective rate of Yindan Xinnaotong soft capsule in adjunctive treat- meat of acute cerebral infarction was higher than that of conventional treatment ~ OR = 3.23,95% CI （2.22,4.69）, P 〈 0.000 01 ]. Nation- al institute of health stroke scale（NIHSS） score decrease was more than that of conventional treatment[ MD = - 1.73,95% CI（ - 2.53, - 0.92 ）, P 〈 0. 000 1 ], Barthel index （BI） score was higher [ MD = 7.93,95 % CI （4.32,11.54）, P 〈 0.000 1 ], while low density lipo- protein [ MD = -0.59,95% CI （ -0.34, -0.22） ,P 〈 0.000 01 ] and fibrinogen [ M D = - 0.92,95 % C I （ - 1.40, - 0.45 ） were lower, P = 0. 000 1 ]. Incidence of adverse reactions was lower than in conventional treatment group, but there was no significant statistical difference between two groups[OR =0.63,95% CI（0. 24,1. 64） ,P =0. 341. Conclusion Yindan Xinnaotong soft capsule in ad- junctive treatment of acute cerebral infarction could achieve a better result in clinical curative effect and security. At the same time it can reduce the blood viscosity and blood lipid, but it still needs more rigorous design, high quality randomized controlled trial to verify.