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基于Meta分析的丹红注射液与复方丹参注射液治疗急性脑梗死对比性评价研究
Meta analysis of Danhong Injection versus Compound Salvia Miltiorrhizae Injection in the Treatment of Acute Cerebral Infarction
  
DOI:
中文关键词:  丹红注射液  复方丹参注射液  急性脑梗死  Meta分析
英文关键词:Danhong injection  Compound salvia miltiorrhizae 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 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分析方法评价丹红注射液与复方丹参注射液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、Embase、SinoMed、中国知网、维普期刊数据库和万方数据库有关丹红注射液和复方丹参注射液治疗急性脑梗死的随机对照临床试验,检索时限为各数据库建库至2016年10月。采用Cochrane系统评价员手册5.1.0版RCT偏倚风险评估工具对纳入研究进行偏倚风险评价。通过Stata 13.1软件对提取数据进行Meta分析。结果:最终共纳入18个随机对照试验,累计1 986名患者。Meta分析结果显示,相较于复方丹参注射液,丹红注射液辅助西医常规可提高临床总有效率(RR=1.22,95%CI:1.17~1.27,P<0.01)、改善神经功能缺损(MD=-3.75,95%CI:-5.03~-2.46, P<0.01)、改善血液流变学指标,而在降低死亡率方面,尚无明显差异。有7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,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,对于急性脑梗死患者,丹红注射液辅助西医常规在提高临床总有效率、改善神经功能缺损、改善血液流变学指标等方面优于复方丹参注射液,安全性尚需要更多高质量的研究予以证实。
英文摘要:
      ABSTRACT Objective:To evaluate systematically the effectiveness and safety of Danhong injection (DH) versus compound salvia miltiorrhizae injection (CSM) in treating patients with acute cerebral infarction (ACI). Methods: Randomized controlled trials regarding ACI treated by DH and CSM were searched in the China National Knowledge Infrastructure Database, China Science and Technology Journal Database, Wanfang Database, Chinese Biomedical Literature Database, PubMed and the 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:18 studies involving 1 986 participants were included. The results of Meta analysis showed DH group was significantly superior to CSM group in the total effective rates(RR=1.22, 95%CI:1.17-1.27, P<0.01), the neurologic impairment (MD=-3.75, 95%CI:-5.03 -2.46, P<0.01). There was no obvious difference in reducing mortality. Additionally, DH also can improve the level of hemodynamic indices. 7 articles cleared that there was no ADRs in the studies, 2 studies reported 7 ADRs. Conclusion: Current evidence suggested that DH injection combined with conventional therapy was superior to compound salvia miltiorrhizae injection for acute cerebral infarction. However, safety still needed to be verified further by more large scale and well designed RCTs.
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