不同剂量替奈普酶治疗急性缺血性卒中疗效性和安全性的贝叶斯网状Meta分析

Bayesian network Meta-analysis of efficacy and safety of different doses of tenecteplase in the treatment of acute ischemic stroke

目的:对已发表的随机对照试验进行网状Meta分析,比较不同剂量替奈普酶和阿替普酶治疗急性缺血性脑卒中(acute ischemic stroke,AIS)的有效性和安全性。方法:计算机检索中国期刊全文数据库(CNKI)、维普数据库(VIP)、万方数据库和PubMed,Cochrane Library,Embase,Web of Science数据库自建库至2023年7月替奈普酶治疗AIS的随机对照研究。由2位研究员独立筛选文献、提取资料并用Cochrane评价工具对文献质量进行评价,采用RevMan 5.3,Rstudio,Stata 17软件进行Meta分析。结果:共纳入12项随机对照试验,共5352例患者,替奈普酶组2916例(54.48%),阿替普组2436例(45.52%)。直接Meta分析结果显示,0.25 mg·kg^(-1)替奈普酶在血管再通[比值比(odds ratio,OR)=3.27,95%CI=(1.66~6.41),P=0.0006]及3个月后优秀功能结局[OR=1.18,95%CI=(1.03~1.35),P=0.02]方面疗效显著;0.4 mg·kg^(-1)替奈普酶可增加症状性颅内出血[OR=2.23,95%CI=(1.04~4.80),P=0.04],网状Meta分析结果也显示0.4 mg·kg^(-1)替奈普酶与症状性颅内出血[OR=2.7,95%CI=(1.2~7.6)]显著相关。结论:与0.9 mg·kg^(-1)阿替普酶相比,0.25 mg·kg^(-1)替奈普酶能提供更多获益,0.4 mg·kg^(-1)替奈普酶可增加症状性颅内出血风险,为替奈普酶治疗AIS提供了可靠证据,但仍需要更多高质量随机对照试验加以验证。

Objective:To compare the efficacy and safety of different doses of tenecteplase vs alteplase for the treatment of acute ischemic stroke(AIS)through a network Meta-analysis of all published randomized controlled trials(RCTs).Methods:RCTs about the efficacy and safety of tenecteplase in the treatment of AIS were collected from CNKI,VIP,Wanfang Data,PubMed,Cochrane Library,Embase and Web of Science from the inception to July 2023.Two evaluators independently screened the literature,extracted data from the literature,evaluated the literature with Cochrane evaluation tool,and then conducted Meta-analysis by using RevMan 5.3,Rstudio and Stata 17 software.Results:A total of 5352 patients were enrolled in 12 RCTs,including 2916 patients in tenecteplase group(54.48%)and 2436 patients in ateplase group(45.52%).Direct Meta-analysis showed that 0.25 mg·kg^(-1)tenecteplase was effective in recanalization[OR=3.27,95%CI=(1.66~6.41),P=0.0006]and excellent functional outcome after 3 months[OR=1.18,95%CI=(1.03~1.35),P=0.02];0.4 mg·kg^(-1)tenecteplase could increase symptomatic intracranial hemorrhage[OR=2.23,95%CI=(1.04~4.80),P=0.04];the network Meta-analysis also showed that 0.4 mg·kg^(-1)tenecteplase was significantly associated with the incidence of symptomatic intracranial[OR=2.7,95%CI=(1.2~7.6)].Conclusion:Compared with 0.9 mg·kg^(-1)alteplase,0.25 mg·kg^(-1)tenecteplase can provide more benefits,while 0.4 mg·kg^(-1)tenecteplase can increase the risk of symptomatic intracranial hemorrhage.This analysis provides reliable evidence for the treatment of AIS,but high-quality RCTs are needed to validate the findings.