重组组织型纤溶酶原激活物静脉溶栓治疗超时间窗急性缺血性卒中的Meta分析  

Efficacy and safety of rt-PA intravenous thrombolysis for treating acute ischemic stroke beyond the therapeutic window:a Meta-analysis

作　　者：朱丽娜[1] 陈邓[1] 陈涛[1] 林燕[1] 徐达[1] 刘凌[1] 

机构地区：[1]四川大学华西医院神经内科,成都610041

出　　处：《中国现代神经疾病杂志》2016年第2期64-70,共7页Chinese Journal of Contemporary Neurology and Neurosurgery

摘　　要：目的 系统评价超时间窗（4.50-6.00 h）的急性缺血性卒中患者行重组组织型纤溶酶原激活物（rt-PA）静脉溶栓治疗的有效性和安全性。方法 分别以缺血性卒中/脑梗死/脑梗塞、溶栓治疗、延长时间窗,以及acute ischemic stroke、thrombolytic therapy、beyond 4.5 hours等中英文词组为检索词,计算机检索1980年1月-2015年8月美国国立医学图书馆生物医学信息检索系统、Cochrane图书馆、中国知网中国知识基础设施工程、万方数据库等收录的rt-PA静脉溶栓治疗超时间窗（4.50-6.00 h）急性缺血性卒中随机对照临床试验;Jadad量表和Rev Man 5.3统计软件进行文献质量评价和Meta分析。结果 共获得681篇文献,经剔除重复和不符合纳入标准者,最终纳入3项随机对照临床试验计2033例急性缺血性卒中（发病〈6 h）患者（rt-PA静脉溶栓组1029例、安慰剂组1004例）。Meta分析显示：rt-PA静脉溶栓与安慰剂对改善患者神经功能（RR=1.070,95%CI：0.940-1.220;P=0.310）和日常生活活动能力（RR=1.040,95%CI：0.940-1.160;P=0.430）、降低病死率（RR=1.260,95%CI：0.990-1.610;P=0.060）差异无统计学意义,但rt-PA静脉溶栓组患者脑出血发生率高于安慰剂组（RR=1.550,95%CI：1.030-2.340;P=0.030）。结论 rt-PA静脉溶栓治疗超时间窗（4.50-6.00 h）急性缺血性卒中无明显疗效且可能增加脑出血风险,高质量证据尚待大样本多中心随机对照临床试验加以验证。Objective To evaluate the efficacy and safety of thrombolytic therapy with recombinant tissue- type plasminogen activator （rt- PA） in the treatment of acute ischemic stroke with broadened therapeutic window （4.50-6.00 h）. Methods Online databases, such as PubMed, Cochrane Library, China National Knowledge Infrastructure （CNKI）, Wanfang data were searched from January 1980 to August 2015 with key words： acute ischemic stroke, thrombolytic therapy, beyond 4.5 hours. The included studies were evaluated according to Jadad Scale, and Meta-analysis was performed by using RevMan 5.3 software. Results There were 681 relevant records through preliminary searching, and 3 randomized controlled trials （RCTs） were finally included, involving 2033 patients with acute ischemic stroke （1029 patients in rt- PA thrombolytic therapy and 1004 patients in placebo therapy）, who were treated within 6 h from the onset of symptoms. Results of Meta-analysis showed there were no statistical differences between rt-PA group and placebo group on modified Rankin Scale （mRS） score （RR = 1.070, 95%CI： 0.940-1.220; P = 0.310）, Barthel Index （BI） score （RR = 1.040, 95%CI： 0.940-1.160; P = 0.430） and mortality （RR = 1.260, 95%Ch 0.990-1.610; P = 0.060）. However, the incidence of intraeerebral hemorrhage （ICH） in rt-PA group was significantly higher than that in placebo group （RR = 1.550, 95% CI： 1.030-2.340; P = 0.030）. Conclusions Thrombolytic therapy with rt-PA in broadened therapeutic window （4.50-6.00 h） is not effective for treating acute ischemic stroke, and the risk of ICH is increased with rt- PA treatment. However, this conclusion still needs to be verified with more high-quality, multi-center, large-sample RCTs.

关 键 词：脑缺血 组织型纤溶酶原激活物 META分析 

分 类 号：R743.3[医药卫生—神经病学与精神病学]