尤瑞克林联合阿替普酶治疗急性缺血性卒中有效性及安全性的Meta分析

Efficacy and safety of human urinary kallidinogenase combined with alteplase for acute ischemic stroke: a systematic review and meta-analysis

目的 系统评价尤瑞克林(HUK)联合阿替普酶(rt-PA)治疗急性缺血性卒中(AIS)的有效性及安全性。方法 检索PubMed,Web of Science,Embase,The Cochrane Library,中国生物医学文献数据库、万方数据库、维普中文科技期刊全文数据库、中国期刊全文数据库,检索时间为2015年4月至2021年1月。筛选有关尤瑞克林联合阿替普酶治疗AIS的随机对照试验(RCT)文献。由两名研究人员对纳入的临床研究独立进行数据提取和质量评价,采用RevMan5.3软件进行Meta分析。结果 共纳入7项RCT文献共602例AIS患者,均为中文文献。Meta分析结果显示,与阿替普酶比较,尤瑞克林联合阿替普酶治疗的总有效率明显提高(RR=1.23,95%CI:1.15~1.32,P<0.000 01),患者神经功能缺损程度显著改善(MD=-2.43,95%CI:-2.70~-2.16,P<0.000 01),Barthel指数显著提高(MD=17.41,95%CI:13.19~21.63,P<0.000 01),而不良事件的发生率比较差异无统计学意义(RR=0.73,95%CI:0.42~1.24,P=0.24)。结论 现有证据表明,与单独使用阿替普酶相比,尤瑞克林联合阿替普酶可提高疗效,减少神经功能缺损程度,且不增加不良反应。但受纳入研究质量限制,上述结论需要更多大规模、高质量的随机对照试验来加以验证。

Objective To systematically evaluate the efficacy and safety of human urinary kallidinogenasen(HUK) combined with alteplase(rt-PA) in the treatment of acute ischemic stroke(AIS). Methods PubMed, Web of Science, Embase, The Cochrane Library, Chinese Biomedical Literature Database, Wanfang database, VIP Chinese Scientific Journals Full-text Database, China Academic Journals Full-text Database were retrieved from April 2015 to January2021 to screen literature on randomized controlled trials(RCT) of HUK combined with rt-PA in the treatment of AIS. Two researchers independently extracted data and evaluated the quality of the included clinical studies. Meta-analysis was performed using RevMan5.3 software. Results A total of 7 RCTs(602 AIS patients) were included, which were all Chinese. According to meta-analysis, compared with rt-PA, the effective rate of HUK combined with rt-PA was significantly improved(RR=1.23, 95%CI: 1.15 to 1.32, P<0.000 01);the neurological deficits of AIS patients was significantly improved(MD=-2.43, 95%CI:-2.70 to-2.16, P<0.000 01);Barthel Index was significantly increased(MD=17.41, 95%CI:13.19 to 21.63, P<0.000 01);there was no significant difference in the incidence of adverse events(RR=0.73, 95%CI: 0.42to 1.24, P=0.24). Conclusion Available evidence suggests that, compared with rt-PA alone, HUK in combination with rt-PA improves the efficacy and reduces the neurological deficits without incurring any added adverse events. More large-scale and high-quality RCTs are warranted to confirm these results, due to the limited quality of the included study.