临床荟萃

• 荟萃分析 • 上一篇    下一篇

重组组织型纤溶酶原激活物对急性轻型脑梗死的治疗效果及安全性的Meta分析

  

  1. 1.上海市杨浦区控江医院 神经内科,上海 200093;2.同济大学附属杨浦医院 上海市杨浦区中心医院 
    a.中心实验室; b.科研管理部,上海 200090
  • 出版日期:2017-12-05 发布日期:2017-12-14
  • 通讯作者: 通信作者:嵇承栋,Email: 15800397667@163.com
  • 基金资助:
    上海市科委软科学重点项目“Mini-卫生技术评估在医疗机构循证卫生决策中的应用研究”(16692107000),上海市卫计委
    项目“专利信息分析法在医疗机构卫生技术评估中的应用研究”(201540112),上海市卫计委项目“医疗机构Mini卫生技术评估应用及推
    广模式的研究”(201640066),上海市卫计委项目“基于医疗机构的技术预见体系构建与实证研究”(20174Y0009)

Efficacy and safety of thrombolysis with recombinant tissue plasminogen activator for patients with acute mild ischemic infarction

  1. 1. Department of Neurology, Shanghai Kongjiang Hospital, Shanghai 200093, China;
    2a.Laboratory of Clinical Research;  b.Department of Researh Management, Yangpu Hospital,
    Tongji University, Shanghai 200090, China
  • Online:2017-12-05 Published:2017-12-14
  • Contact: Corresponding author: Ji Chengdong, Email: 15800397667@163.com

摘要: 目的  系统评价重组组织型纤溶酶原激活物(recombinant tissue plasminogen activator, rtPA)对急性轻型缺血性脑梗死进行溶栓治疗的有效性及安全性。方法  电子检索Pubmed,Cochrane Central,Embase,中国生物医学文献数据库(Sinomed),万方,维普、知网(CNKI)数据库,按Cochrane系统评价方法对纳入的文献进行质量评价和资料提取。统计学分析采用 RevMan5.3软件。结果  共纳入5个随机对照研究(RCT),4 401例急性轻型缺血性脑梗死患者,rtPA组在4.5小时内行rtPA溶栓治疗,no rtPA组为对照组,采用常规抗血小板治疗或不进行溶栓治疗。Meta分析主要结局指标结果显示,rtPA组与no rtPA组相比,90天改良Rankin(modified Rankin scale, mRS)为0~1的总体效应(OR=0.80,95%CI=0.61~1.06,P>0.05)。对次要结局指标进行meta分析显示,rtPA组的出血转归(hemorrhagic transformation, HT)发生率是对照组的14.09倍(OR=14.09,95%CI=5.32~37.31,P<0.01);比较rtPA组与no rtPA组的死亡率(OR=0.66,95%CI=0.27~1.64,P>0.05),提示rtPA组的死亡率与对照组的死亡率差异无统计学意义。主要和次要结局指标均不存在明显异质性。结论  美国国立卫生院卒中量表评分(NIHSS)≤5分的急性轻型脑梗死患者在4.5小时内使用rtPA进行溶栓治疗与对照组治疗效果相似;rtPA组与no rtPA组的死亡率差异无统计学意义,但rtPA可能使HT发生率升高。

关键词: 组织型, 纤溶酶原激活物, 脑梗塞, 血栓溶解疗法, meta分析

Abstract: Objective  To evaluate the efficacy and safety of thrombolysis with recombinant tissue plasminogen activator (rtPA) for patients with acute mild ischemic infarction. Methods  PubMed, Cochrane Central Register of Controlled Trials, Embase, Ovid, Sinomed, Wanfang Data, VIP and Chinese National Knowledge Infrastructure (CNKI) databases were searched from inception to 31st April, 2017 to comprehensively collect randomized controlled trials (RCTs) of rtPA for acute mild ischemic infarction. The relevant data were extracted by two reviewers independently. The methodological quality of the included RCTs  were assessed according to the Cochrane Handbook. Then, metaanalysis was performed by RevMan5.3 software. Pooled effect sizes were calculated using the fixed effects model when  I2<50%,P>0.1, otherwise the random effects model were applied. Mean difference (MD) and 95% confidence interval (CI) were applied on the measurement data and Odds risk (OR) and CI on the enumeration data. Five RCTs involving 3 070 patients met the inclusion criteria. Results  A total of 5 RCTs involving 4 401 patients were finally included. Trial group were given rtPA while no rtPA groups, i.e., control group, were given the standard antiplatelet therapy or other therapies. The results of metaanalysis showed that more patients in the rtPA groups had mRS scores of 0 to 1 than no rtPA groups did  at 90 days after thrombolytic therapy (OR=0.80,95%CI=0.611.06,P>0.05). As to safety, rtPA group did not show a notable change of incidence of death compared with no rtPA groups after thrombolysis (OR=0.66,95%CI0.271.64,P>0.05). However, hemorrhagic transformation (HT) rates between two groups showed significance (OR=14.09,95%CI=5.3237.31,P<0.01). Conclusion  Multiple evidence suggests that rtPA group had similar outcomes as patients receiving the standard antiplate therapy and as not receiving thrombolysis. In addition, rtPA had hemorrhagic tendency for thrombolysis purpose in patients with acute mild ischemic infarction.

Key words: tissue plasminogen activator; , brain infarction, thrombolytic therapy, metaanalysis