注射用丹参多酚酸盐治疗缺血性脑卒中疗效与安全性的系统评价

Effectiveness and Safety of Salvianolate Injection on Acute Cerebral Infarction

摘要:

目的: 系统评价注射用丹参多酚酸盐治疗缺血性脑卒中的疗效与安全性。方法: 计算机检索PubMed,Cochrane 图书馆,CBM,CNKI 和WanFang Data,查找丹参多酚酸盐治疗缺血性脑卒中的随机对照试验,检索时限均从1994年1月至2014年4月。由2名研究者按照纳入与排除标准独立进行文献筛选、资料提取和质量评价后,采用RevMan 5.2软件进行Meta分析。结果: 纳入12个RCT,共1 574例患者。Meta分析结果显示,丹参多酚酸盐治疗组, 6项研究的有效率[OR=2.78,95%CI(1.87,4.12),P<0.000 01],5项研究的NIHSS评分[OR=-2.05,95%CI(-2.51,-1.59),P<0.000 01],以及对多项血管内皮细胞参数的影响优于常规治疗对照组。在安全性评价方面,尚未见丹参多酚酸盐的毒副反应报告。结论: 本系统评价结果显示,与常规治疗相比,注射用丹参多酚酸盐有更好的治愈率,且能提高血管内皮细胞保护功能,改善血液流变学。但由于纳入文献数量较少,质量较低,当前证据尚不能确定完全适用于临床,但其疗效优势值得进一步研究,特别需要高质量的多中心大样本随机双盲对照试验来验证。

Abstract:

Objective: To evaluate the effectiveness and safety of salvianolate injection (SI) on acute cerebral infarction (ACI) versus conventional treatment (CT). Method: Systematic literature searches were performed in PubMed, Cochrane Library, CBM, CNKI and WanFang datbase from Jan 1994 to Apr 2014.Randomized controlled trials (RCTs) on SI treating ACI were enrolled. Two reviewers screened articles according to the inclusion and exclusion criteria, extracted data and assessed the quality of the included studies independently. The Meta-analysis was performed using RevMan 5.2. Result: A total of 12 RCTs involving 1 574 patients were included. The results of Meta-analysis demonstrated that SI had higher curative rate [OR=2.78,95%CI(1.87, 4.12), P<0.000 01] on 6 RCTs, improvement evaluation of NIHSS [OR=-2.05, 95%CI (-2.51,-1.59), P<0.000 01] on 5 RCTs, and amendment many endothelia parameters as compared with the CT group. No severe adverse reactions after SI treatment were reported. Conclusion: Current evidence shows SI may be superior to CT in treating ACI patients in recovery rate, vascular endothelial cell protection and improvement hemorheology index. However, due to lack of enough high-quality studies, SI has to be further studied by conducting more strictly-designed, multicenter, large-scale and double-blind RCTs.