替奈普酶治疗急性缺血性脑卒中疗效及安全性的Meta分析  

Efficacy and safety of tenecteplase in the treatment of acute ischemic stroke:a meta-analysis

作　　者：凤心雨 王敏[2] 郭文军 李云涛[2] FENG Xinyu;WANG Min;GUO Wenjun;LI Yuntao(Dept.of Neurology,the Second Affiliated Hospital of Nanjing Medical University,Nanjing 210011,China;Dept.of General Practice,the Second Affiliated Hospital of Nanjing Medical University,Nanjing 210011,China)

机构地区：[1]南京医科大学第二附属医院神经内科,南京210011 [2]南京医科大学第二附属医院全科医学,南京210011

出　　处：《中国药房》2023年第9期1119-1125,共7页China Pharmacy

基　　金：江苏省卫生健康委科研项目(No.M2022045)。

摘　　要：目的系统评价替奈普酶用于治疗急性缺血性脑卒中(AIS)的疗效和安全性,为临床合理选择静脉溶栓药物提供循证依据。方法计算机检索PubMed、Embase、the Cochrane Library、Web of Science、Sinomed、中国知网、万方数据库和维普网,收集替奈普酶对比阿替普酶(对照)治疗AIS疗效与安全性的随机对照试验,检索时限均为建库起至2022年6月。由2位评价员独立筛选文献,从文献中提取资料并评价纳入研究的偏倚风险,采用Stata 15软件对数据进行Meta分析。结果最终纳入8篇文献,共计2129例患者。Meta分析结果显示,0.25 mg/kg(中剂量)替奈普酶组患者早期神经功能改善率[OR(95%CI)=2.44(1.09,5.46),P=0.030]、神经功能恢复良好率(静脉溶栓治疗90 d后改良Rankin量表评分0~2分)[OR(95%CI)=1.54(1.00,2.36),P=0.048]高于阿替普酶组。其余结局指标(包括再通率、再灌注病变百分比、神经功能恢复优异率、出血发生率、症状性颅内出血发生率及90 d内全因死亡率)方面,替奈普酶组与阿替普酶组比较,差异均无统计学意义(P>0.05)。结论与阿替普酶相比,中剂量替奈普酶在早期神经功能改善及神经功能恢复方面有一定优势,且未增加不良事件发生率。OBJECTIVE To systematically evaluate the efficacy and safety of intravenous bolus of tenecteplase in the treatment of acute ischemic stroke(AIS),in order to provide evidence-based support for the clinic’s choice of intravenous thrombolytic drugs.METHODS Randomized controlled trials(RCTs)about the efficacy and safety of tenecteplase versus alteplase(control)in the treatment of AIS were collected from PubMed,Embase,the Cochrane Library,Web of Science,Sinomed,CNKI,Wanfang Data,and VIP during the inception to June 2022.Two evaluators independently screened the literature,extracted data from the literature,assessed the bias risk of included study,and then conduct meta-analysis by using Stata 15 software.RESULTS A total of 8 literature were included,involving 2129 patients.Meta-analysis results showed that the early improvement rate of neurological function[OR(95%CI)=2.44(1.09,5.46),P=0.030]and the good rate of neurological function recovery(modified Rankin scale score 0-2 after 90 days of intravenous thrombolysis treatment)[OR(95%CI)=1.54(1.00,2.36),P=0.048]were higher in 0.25 mg/kg tenecteplase group(medium dose)than alteplase group.According to meta-analysis of other outcome indicators(including recanalization rate,percentage of reperfusion lesions,excellent rate of neurological function recovery,the incidence rate of bleeding,the incidence rate of symptomatic intraventricular hemorrhage and all-cause mortality rate within 90 d),the tenecteplase group had no statistically significant difference with alteplase group(P>0.05).CONCLUSIONS Compared with alteplase,medium dose of tenecteplase has some advantages in terms of early neurological function improvement and neurological function recovery,and it does not increase the risk of adverse events.

关 键 词：急性缺血性脑卒中 替奈普酶 阿替普酶 有效性 安全性 META分析 

分 类 号：R972.6[医药卫生—药品] R743.32[医药卫生—药学]