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替奈普酶与阿替普酶治疗急性缺血性脑卒中患者的比较:一项随机对照试验的荟萃分析。

Tenecteplase versus alteplase for patients with acute ischemic stroke: a meta-analysis of randomized controlled trials.

机构信息

Department of Cardiac Surgery, The General Hospital of Northern Theater Command, Shenyang, Liaoning 110000, China.

Department of Nursing, Xinqiao Hospital, Chongqing 400037, China.

出版信息

Aging (Albany NY). 2023 Dec 26;15(24):14889-14899. doi: 10.18632/aging.205315.

DOI:10.18632/aging.205315
PMID:38149983
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10781500/
Abstract

Tenecteplase (TNK), a newer fibrinolytic agent with greater fibrin specificity and longer half-life than alteplase, may has practical advantages over alteplase in acute ischemic stroke (AIS) thrombolysis. We aimed to perform a systematic review and meta-analysis of randomized controlled trials (RCTs) to compare different doses of TNK (0.1, 0.25, 0.4 mg/kg) and alteplase in acute ischemic stroke patients. We systematically searched PubMed, Embase and https://clinicaltrials.gov/ for RCTs comparing TNK with alteplase in this population eligible for thrombolysis. The Cochrane Risk of Bias Tool was used to assess study quality. Random-effects or fixed-effects meta-analysis models were used for evaluating all outcomes. Total 10 RCTs with 5097 patients were included. Compared with alteplase, TNK at doses of 0.25 mg/kg may associated with the greatest odds to achieve 90-day excellent independence (mRS score ≤1), but there were no significant differences between other doses of TNK (0.1 mg/kg and 0.4 mg/kg) and alteplase. Among secondary outcomes, no significant differences were found in functional outcome (mRS score ≤2) and mortality at 90 days between any dose of TNK and alteplase. Compared with alteplase, TNK was effective at doses of 0.1 mg/kg and 0.25 mg/kg without increased risk of symptomatic intracerebral hemorrhage (sICH), but patients treated with TNK 0.4 mg/kg showed increased odds of sICH. In conclusion, compared with alteplase, intravenous thrombolysis with TNK at dose of 0.25 mg/kg has a better efficacy and similar safety profile and is a reasonable option for patients with AIS.

摘要

替奈普酶(TNK)是一种新型纤维蛋白溶解剂,与阿替普酶相比,其纤维蛋白特异性更强,半衰期更长,在急性缺血性脑卒中(AIS)溶栓治疗中可能具有实际优势。我们旨在对随机对照试验(RCT)进行系统评价和荟萃分析,以比较不同剂量的 TNK(0.1、0.25、0.4mg/kg)与阿替普酶在急性缺血性脑卒中患者中的疗效。我们系统地检索了 PubMed、Embase 和 https://clinicaltrials.gov/,以寻找适合溶栓治疗的该人群中 TNK 与阿替普酶比较的 RCT。使用 Cochrane 偏倚风险工具评估研究质量。使用随机效应或固定效应荟萃分析模型评估所有结局。共纳入 10 项 RCT,共计 5097 例患者。与阿替普酶相比,TNK 0.25mg/kg 剂量可能与 90 天实现良好独立性(mRS 评分≤1)的最大几率相关,但其他剂量的 TNK(0.1mg/kg 和 0.4mg/kg)与阿替普酶之间无显著差异。在次要结局中,任何剂量的 TNK 与阿替普酶在 90 天的功能结局(mRS 评分≤2)和死亡率方面均无显著差异。与阿替普酶相比,TNK 在 0.1mg/kg 和 0.25mg/kg 剂量下有效且不会增加症状性颅内出血(sICH)的风险,但接受 TNK 0.4mg/kg 治疗的患者 sICH 风险增加。总之,与阿替普酶相比,0.25mg/kg 剂量的静脉溶栓治疗 TNK 具有更好的疗效和相似的安全性,是 AIS 患者的合理选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6943/10781500/130c4aa9671d/aging-15-205315-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6943/10781500/130c4aa9671d/aging-15-205315-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6943/10781500/130c4aa9671d/aging-15-205315-g001.jpg

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本文引用的文献

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Symptomatic Intracranial Hemorrhage With Tenecteplase vs Alteplase in Patients With Acute Ischemic Stroke: The Comparative Effectiveness of Routine Tenecteplase vs Alteplase in Acute Ischemic Stroke (CERTAIN) Collaboration.症状性颅内出血与替奈普酶和阿替普酶治疗急性缺血性脑卒中:急性缺血性脑卒中常规替奈普酶与阿替普酶的比较效果(CERTAIN)协作组。
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Tenecteplase versus alteplase in acute ischaemic cerebrovascular events (TRACE-2): a phase 3, multicentre, open-label, randomised controlled, non-inferiority trial.替奈普酶与阿替普酶治疗急性缺血性脑血管事件的疗效对比(TRACE-2):一项3期、多中心、开放标签、随机对照、非劣效性试验
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不同剂量的各种静脉溶栓药物治疗急性缺血性卒中(AIS)的疗效和安全性:一项系统评价和网状Meta分析
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Tenecteplase versus alteplase for the management of acute ischaemic stroke in Norway (NOR-TEST 2, part A): a phase 3, randomised, open-label, blinded endpoint, non-inferiority trial.替奈普酶与阿替普酶治疗挪威急性缺血性卒中(NOR-TEST 2,A部分):一项3期随机开放标签盲终点非劣效性试验
Lancet Neurol. 2022 Jun;21(6):511-519. doi: 10.1016/S1474-4422(22)00124-7. Epub 2022 May 4.
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Stroke Vasc Neurol. 2022 Feb;7(1):47-53. doi: 10.1136/svn-2021-000978. Epub 2021 Aug 24.
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European Stroke Organisation (ESO) guidelines on intravenous thrombolysis for acute ischaemic stroke.欧洲卒中组织(ESO)急性缺血性卒中静脉溶栓指南。
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