替奈普酶与阿替普酶治疗急性缺血性卒中的疗效比较：随机试验的系统评价与荟萃分析

Tenecteplase vs. alteplase for treatment of acute ischemic stroke: A systematic review and meta-analysis of randomized trials.

作者信息

Kobeissi Hassan, Ghozy Sherief, Turfe Bilal, Bilgin Cem, Kadirvel Ramanathan, Kallmes David F, Brinjikji Waleed, Rabinstein Alejandro A

机构信息

Department of Radiology, Mayo Clinic, Rochester, MN, United States.

School of Medicine, Ross University, Bridgetown, Barbados.

出版信息

Front Neurol. 2023 Jan 23;14:1102463. doi: 10.3389/fneur.2023.1102463. eCollection 2023.

BACKGROUND AND OBJECTIVES

Several randomized controlled trials (RCTs) have compared tenecteplase to alteplase for treatment of acute ischemic stroke (AIS). Yet, there is no meta-analysis that includes the latest published RCTs of 2022. We sought to compare the safety and efficacy of tenecteplase vs. alteplase for the treatment of AIS through a meta-analysis of all published RCTs.

METHODS

A systematic literature review of the English language literature was conducted using PubMed, Web of Science, Scopus, and Embase. We included RCTs that focused on patients with AIS treated with tenecteplase and alteplase. Multiple reviewers screened through potential studies to identify the final papers included in our analysis. Following PRISMA guidelines, multiple authors extracted data to ensure accuracy. Data were pooled using a random-effects model.

RESULTS

Nine trials, with 3,706 patients, compared outcomes of patients treated with tenecteplase and alteplase for AIS. Both treatments resulted in comparable rates of modified Rankin Scale (mRS) 0-1 at 90 days (RR = 1.03; 95% CI = 0.97-1.10; -value = 0.359) and mRS 0-2 at 90 days (RR = 1.03; 95% CI = 0.87-1.22; -value = 0.749). There was no heterogeneity among included studies regarding mRS 0-1 rates (I = 26%; -value = 0.211); however, there was significant heterogeneity in mRS 0-2 rates (I = 71%; -value = 0.002). Similarly, rates of mortality (RR = 0.97; 95% CI = 0.81-1.16; -value = 0.746) and symptomatic intracranial hemorrhage (sICH) rates (RR = 1.10; 95% CI = 0.75-1.61; -value = 0.622) were comparable in both treatment groups. There was no significant heterogeneity among included studies in either mortality (I = 30%; -value = 0.181) or sICH (I = 0%; -value = 0.734) rates. Further analysis comparing dosing of tenecteplase (0.1, 0.25, 0.32, and 0.4 mg/kg) yielded no significant differences for any of the endpoints (mRS 0-1, mRS 0-2, sICH, and mortality) compared to alteplase.

DISCUSSION

Based on available evidence from completed RCTs, tenecteplase has proven similar safety and efficacy to alteplase for treatment of AIS.

背景与目的

多项随机对照试验（RCT）比较了替奈普酶与阿替普酶治疗急性缺血性卒中（AIS）的效果。然而，尚无纳入2022年最新发表的RCT的荟萃分析。我们试图通过对所有已发表的RCT进行荟萃分析，比较替奈普酶与阿替普酶治疗AIS的安全性和有效性。

方法

使用PubMed、科学网、Scopus和Embase对英文文献进行系统的文献综述。我们纳入了聚焦于接受替奈普酶和阿替普酶治疗的AIS患者的RCT。多名审阅者筛选潜在研究，以确定纳入我们分析的最终论文。按照PRISMA指南，多名作者提取数据以确保准确性。使用随机效应模型汇总数据。

结果

9项试验共3706例患者，比较了接受替奈普酶和阿替普酶治疗AIS的患者的结局。两种治疗在90天时改良Rankin量表（mRS）评分为0 - 1的比例（RR = 1.03；95% CI = 0.97 - 1.10；P值 = 0.359）和90天时mRS评分为0 - 2的比例（RR = 1.03；95% CI = 0.87 - 1.22；P值 = 0.749）相当。纳入研究中关于mRS 0 - 1比例不存在异质性（I² = 26%；P值 = 0.211）；然而，mRS 0 - 2比例存在显著异质性（I² = 71%；P值 = 0.002）。同样，两个治疗组的死亡率（RR = 0.97；95% CI = 0.81 - 1.16；P值 = 0.746）和症状性颅内出血（sICH）发生率（RR = 1.10；95% CI = 0.75 - 1.61；P值 = 0.622）相当。纳入研究在死亡率（I² = 30%；P值 = 0.181）或sICH发生率（I² = 0%；P值 = 0.734）方面均无显著异质性。与阿替普酶相比，进一步分析比较替奈普酶的剂量（0.1、0.25、0.32和0.4 mg/kg）在任何终点（mRS 0 - 1、mRS 0 - 2、sICH和死亡率）上均无显著差异。