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| 基于Meta分析的注射用丹参多酚酸盐治疗急性脑梗死临床评价研究 |
| Meta analysis on Randomized Controlled Trials of Salvianolate Injection in the Treatment of Acute Cerebral Infarction |
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| DOI： |
| 中文关键词: 注射用丹参多酚酸盐 急性脑梗死 Meta分析 |
| 英文关键词:Salvianolate injection Acute cerebral infarction Meta analysis |
| 基金项目:国家自然科学基金课题（编号：81473547、81673829） |
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| 中文摘要: |
| 摘 要 目的：运用Meta分析方法评价注射用丹参多酚酸盐辅助西医常规治疗急性脑梗死的有效性、安全性。方法：计算机检索the Cochrane Library，PubMed、SinoMed、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盐治疗急性脑梗死的随机对照试验文献，检索时限为各数据库建库至2016年8月。采用Cochrane风险评价表评价其研究质量，提取资料通过RevMan 5.3进行Meta分析。结果：共纳入22个随机对照试验，累计2 762名患者。Meta分析结果显示，注射用丹参多酚酸盐辅助西医常规可提高临床疗效总有效率(RR=1.29, 95%CI: 1.21~1.37，P＜0.000 01)和患者日常生活活动能力(MD=8.90, 95%CI:7.03~10.77, P＜0.000 01)，改善神经功能缺损(MD=-3.59, 95%CI:-4.3~-2.87, P＜0.000 01)，改善血液流变学指标，降低患者血清C反应蛋白浓度。有4篇文献明确无不良反应，2篇研究报道了共12例不良反应，其他文献均未对安全性做出说明。结论：注射用丹参多酚酸盐辅助西医常规治疗急性脑梗死具有较好的疗效，值得临床推广，对其安全性尚需进一步探讨。 |
| 英文摘要: |
| ABSTRACT Objective:To evaluate systematically the clinical effectiveness and safety of Salvianolate injection (SI) on acute cerebral infarction (ACI).Methods:Randomized controlled trials regarding ACI treated by SI and routine western medicine were searched in the China National Knowledge Infrastructure Database, China Scienceand Technology Journal Database, Wanfang Database, Chinese Biomedical Literature Database, PubMed and the Cochrane Library up to August, 2016. 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.Results:22 studies involving 2 762 participants were included. Meta analysis, the results of SI group was significantly superior to the routine western medicine group in the total effective rates (RR=1.29，95%CI:1.21-1.37，P＜0.000 01), the activities of daily living (MD=8.90, 95%CI:7.03-10.77，P＜0.000 01), the neurologic impairment (MD=-3.59, 95%CI:-4.31- -2.87，P＜0.000 01). Additionally, SI also can improve the level of hemodynamic indices and reduce the serum levels of C reactive protein. 4 articles cleared that there was no ADRs in the studies, 2 studies reported ADRs. There were 7 cases in the experimental group, and 5 in control group. Conclusion:Comparing with routine western medicine, the combine use of SI was more effective， and it worthwhile for spreading in clinical practice. Drug safety should be confirmed by more well designed and large scale RCTs. |
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