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基于Meta分析的丹参酮ⅡA磺酸钠注射液治疗急性脑梗死临床评价研究
Meta analysis on Randomized Controlled Trials of Tanshinone ⅡA Sulfonate Injection of Treatment for Acute Cerebral Infarction
  
DOI:
中文关键词:  丹参酮ⅡA磺酸钠注射液  急性脑梗死  Meta分析
英文关键词:Tanshinone ⅡA sulfonate injection  Acute cerebral infarction  Meta analysis
基金项目:国家自然科学基金项目(编号:81473547、81673829)
作者单位
刘施吴嘉瑞段笑娇张丹张晓朦张冰 ①北京中医药大学中药学院(北京 100102) 
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中文摘要:
      摘 要 目的:采用Meta分析方法评价丹参酮ⅡA磺酸钠注射液治疗急性脑梗死的有效性及安全性。方法:计算机检索the Cochrane library、PubMed、Embase、SinoMed、中国知网、维普期刊数据库和万方数据库有关丹参酮 ⅡA磺酸钠注射液治疗急性脑梗死的随机对照试验,检索时限为各数据库建库至2016年10月。采用Cochrane风险评价表进行偏倚风险评价,提取资料通过Stata 13.1进行Meta分析。结果:最终共纳入13个随机对照试验,累计1 273名患者。Meta分析结果显示,对比西医常规治疗,丹参酮 ⅡA磺酸钠注射液辅助西医常规治疗急性脑梗死可提高临床总有效率(RR=1.22,95%CI:1.16~1.28,P<0.01),改善神经功能缺损(MD=-5.08,95%CI:-7.40~-2.77,P<0.01),降低炎性指标。在减少恶化情况方面,差异无统计学意义。有7篇文献明确无不良反应,2篇研究报道了共11例不良反应,其他文献均未对安全性做出说明,无严重不良反应。敏感性分析显示结果稳定性较好。结论:现有证据表明,丹参酮 ⅡA磺酸钠注射液治疗急性脑梗死在临床疗效、神经功能缺损改善及炎性指标减少等方面比单用西医常规疗效较好。但基于现有研究缺陷,所获得的支持证据强度有待提高,尚需要更多设计严谨、随访时间更长的临床研究予以证实。
英文摘要:
      ABSTRACT Objective:To systematically evaluate the effectiveness and safety of Tanshinone ⅡA sulfonate injection in treating patients with acute cerebral infarction (ACI). Methods: Randomized controlled trials regarding ACI treated by Tanshinone ⅡA were searched in the China National Knowledge Infrastructure Database, China Science and Technology Journal Database, Wanfang Database, Chinese Biomedical Literature Database, PubMed and Cochrane Library up to October, 2016. Two reviewers independently retrieved RCTs and extracted information. The Cochrane risk of bias method was used to assess the quality of included studies, and Meta analysis was conducted with Stata 13.1 software.Results:13 studies involving 1 273 participants were included. In the Meta analysis, Tanshinone ⅡA injection combined with western medicine was significantly superior to the routine western medicine group in the total effective rates (RR=1.22, 95%CI:1.16-1.28, P<0.01), the neurologic impairment (MD=-5.08, 95%CI:-7.40-2.77, P<0.01), There was no obvious difference in reducing the worsening situation. Additionally, DH also can reduce inflammatory indexes. There were 7 studies without obvious adverse reactions. 2 studies reported 11 ADRs.Conclusion:Comparing with routine western medicine, Tanshinone ⅡA sulfonate injection combined with routine western medicine is more effective in improving the total effective rates and the neurologic impairment. But based on the limitations of the study, more high quality trials with longer following up are necessary for further evidence.
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