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替奈普酶治疗脑卒中患者的溶栓治疗:系统评价与荟萃分析。

Tenecteplase for thrombolysis in stroke patients: Systematic review with meta-analysis.

机构信息

Department of Internal Medicine, Vila Nova de Gaia Hospital Centre, Portugal.

Department of Internal Medicine, Vila Nova de Gaia Hospital Centre, Portugal.

出版信息

Am J Emerg Med. 2021 Apr;42:31-37. doi: 10.1016/j.ajem.2020.12.026. Epub 2020 Dec 24.

Abstract

INTRODUCTION

Alteplase is an approved treatment for acute ischemic stroke. Tenecteplase is a genetically modified form of alteplase, with lower cost and a more favourable pharmacokinetic profile allowing bolus injection. The aim of this study was to compare both drugs in adult patients with acute ischemic stroke undergoing thrombolysis.

MATERIAL AND METHODS

PubMed and CENTRAL were searched for observational and experimental studies comparing both drugs in the population of interest. Additional studies were sought in clinical trial registries and by means of reference check. The efficacy outcomes of interest were functional status at 3 months, recanalization and early neurological improvement (ENI). The safety outcomes of interest were cerebral haemorrhage (ICH), symptomatic ICH and mortality. The effect measure of interest was the absolute risk difference (ARD). Effect measures for each outcome were pooled across studies using random effect models.

RESULTS

Eight studies were included, involving 2031 patients. Overall, there were no differences in terms of good or excellent functional outcome (ARR = 0.07 and 0.03 respectively, p > 0.05 for both comparisons) but tenecteplase patients showed higher rates of recanalization (ARD = 0.11, 95% CI [0.01;0.20]) and ENI (ARD = 0.10, 95% CI [0.02;0.17]). There were no differences between groups in terms of ICH (ARD = -0.02, 95% CI [-0.06;0.01]), symptomatic ICH (ARD = 0.00, 95% CI [-0.01;0.02]) or death (ARD = 0.00, 95% CI [-0.03;0.03]).

CONCLUSION

Tenecteplase is an alternative to alteplase for stroke thrombolysis, with lower cost and a more favourable pharmacokinetic profile.

摘要

简介

阿替普酶是急性缺血性脑卒中的一种已批准的治疗方法。替奈普酶是阿替普酶的一种基因改良形式,成本更低,药代动力学特征更有利,允许推注给药。本研究旨在比较两种药物在接受溶栓治疗的急性缺血性脑卒中成年患者中的疗效。

材料和方法

在 PubMed 和 CENTRAL 中搜索比较两种药物在目标人群中的观察性和实验性研究。通过临床试验注册处和参考文献检查寻找其他研究。感兴趣的疗效结局是 3 个月时的功能状态、再通和早期神经改善(ENI)。感兴趣的安全性结局是脑出血(ICH)、症状性 ICH 和死亡率。感兴趣的效应测量是绝对风险差异(ARD)。使用随机效应模型汇总研究间各结局的效应测量值。

结果

共纳入 8 项研究,涉及 2031 例患者。总体而言,两种药物在良好或优秀的功能结局方面没有差异(ARR 分别为 0.07 和 0.03,两种比较均 P > 0.05),但替奈普酶组的再通率更高(ARD 为 0.11,95%CI [0.01;0.20])和 ENI(ARD 为 0.10,95%CI [0.02;0.17])。两组在 ICH 方面无差异(ARD 为 -0.02,95%CI [-0.06;0.01])、症状性 ICH(ARD 为 0.00,95%CI [-0.01;0.02])或死亡率(ARD 为 0.00,95%CI [-0.03;0.03])。

结论

替奈普酶是急性缺血性脑卒中溶栓治疗的一种替代药物,成本更低,药代动力学特征更有利。

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