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替奈普酶用于急性缺血性卒中:溶栓治疗的新时代。

Tenecteplase in acute ischemic stroke: a new era in thrombolysis.

作者信息

Silva Gisele Sampaio, Rocha Eva, Pontes-Neto Octávio Marques, Martins Sheila Ouriques

机构信息

Universidade Federal de São Paulo, Escola Paulista de Medicina, Departamento de Neurologia e Neurocirurgia, São Paulo SP, Brazil.

Hospital Israelita Albert Einstein, Centro de Ensino e Pesquisa, São Paulo SP, Brazil.

出版信息

Arq Neuropsiquiatr. 2025 May;83(5):1-11. doi: 10.1055/s-0045-1808088. Epub 2025 Jun 1.

DOI:10.1055/s-0045-1808088
PMID:40451189
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12127046/
Abstract

Tenecteplase (TNK) is a genetically engineered variant of alteplase, showing promise for acute ischemic stroke treatment. With a longer half-life and higher fibrin specificity, TNK enables more targeted and efficient clot dissolution. Clinical trials demonstrate potential advantages, including improved reperfusion rates and functional outcomes with lower systemic bleeding. Though not officially approved for this purpose by all regulatory agencies, TNK is used off-label and in acute stroke guidelines due to its ease of administration and effectiveness. The 0.25 mg/kg dosage within 4.5 hours of symptom onset was shown to be consistently effective and safe. Further trials are expected to identify patient subgroups that benefit most from TNK treatment. The present narrative review assesses the existing literature and evidence regarding the use of tenecteplase for the treatment of acute ischemic stroke.

摘要

替奈普酶(TNK)是阿替普酶的基因工程变体,在急性缺血性中风治疗方面显示出前景。TNK具有更长的半衰期和更高的纤维蛋白特异性,能够实现更有针对性和高效的血栓溶解。临床试验证明了其潜在优势,包括更高的再灌注率和功能结局,同时全身出血风险更低。尽管并非所有监管机构都正式批准将其用于此目的,但由于其易于给药和有效性,TNK被用于非适应症用药并被纳入急性中风指南。症状发作后4.5小时内使用0.25mg/kg的剂量已被证明始终有效且安全。预计进一步的试验将确定最能从TNK治疗中获益的患者亚组。本叙述性综述评估了关于使用替奈普酶治疗急性缺血性中风的现有文献和证据。

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本文引用的文献

1
Tenecteplase for Ischemic Stroke at 4.5 to 24 Hours without Thrombectomy.替奈普酶治疗发病 4.5 至 24 小时内的缺血性脑卒中且未进行取栓治疗。
N Engl J Med. 2024 Jul 18;391(3):203-212. doi: 10.1056/NEJMoa2402980. Epub 2024 Jun 14.
2
Tenecteplase versus alteplase for thrombolysis in patients selected by use of perfusion imaging within 4·5 h of onset of ischaemic stroke (TASTE): a multicentre, randomised, controlled, phase 3 non-inferiority trial.替奈普酶与阿替普酶用于缺血性脑卒中发病 4.5 h 内采用灌注成像选择的患者溶栓治疗(TASTE):一项多中心、随机、对照、3 期非劣效性试验。
Lancet Neurol. 2024 Aug;23(8):775-786. doi: 10.1016/S1474-4422(24)00206-0. Epub 2024 Jun 13.
3
15th World Stroke Congress, 10-12 October 2023, Toronto, Canada.第15届世界卒中大会,2023年10月10日至12日,加拿大多伦多
Int J Stroke. 2023 Oct;18(3_suppl):3-420. doi: 10.1177/17474930231192010.
4
Comprehensive Review of Tenecteplase for Thrombolysis in Acute Ischemic Stroke.替奈普酶在急性缺血性脑卒中溶栓治疗中的全面综述。
J Am Heart Assoc. 2024 May 7;13(9):e031692. doi: 10.1161/JAHA.123.031692. Epub 2024 Apr 30.
5
Developing Systems of Care for Stroke in Resource-limited Settings.在资源有限的环境下开发卒中护理体系。
Semin Neurol. 2024 Apr;44(2):119-129. doi: 10.1055/s-0044-1782617. Epub 2024 Mar 21.
6
Advances in neurovascular research: Scientific highlights from the 2024 international stroke conference.
J Stroke Cerebrovasc Dis. 2024 May;33(5):107671. doi: 10.1016/j.jstrokecerebrovasdis.2024.107671. Epub 2024 Mar 4.
7
Tenecteplase for Stroke at 4.5 to 24 Hours with Perfusion-Imaging Selection.发病 4.5 至 24 小时的脑卒中患者采用灌注成像选择使用替奈普酶溶栓治疗。
N Engl J Med. 2024 Feb 22;390(8):701-711. doi: 10.1056/NEJMoa2310392. Epub 2024 Feb 8.
8
Tenecteplase thrombolysis for stroke up to 24 hours after onset with perfusion imaging selection: the umbrella phase IIa CHABLIS-T randomised clinical trial.基于灌注成像选择的发病后 24 小时内的急性缺血性脑卒中患者使用替奈普酶溶栓治疗:伞状 CHABLIS-T Ⅱa 期随机临床试验。
Stroke Vasc Neurol. 2024 Nov 5;9(5):551-559. doi: 10.1136/svn-2023-002820.
9
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Neurol Clin Pract. 2024 Feb;14(1):e200221. doi: 10.1212/CPJ.0000000000200221. Epub 2024 Jan 11.
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International Section for Early Career and Training Stroke Beyond Borders: Building Strategies to Improve Stroke Care Worldwide.国际早期职业与培训分会 超越国界的卒中:构建全球改善卒中护理的策略
Stroke. 2023 Aug;54(8):e399-e402. doi: 10.1161/STROKEAHA.122.038459. Epub 2023 Jun 2.