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Tenecteplase for Acute Ischemic Stroke Thrombolysis: Practical Considerations and Real-World Implementation.替奈普酶用于急性缺血性脑卒中溶栓治疗:实际考量与现实应用
Neurol Clin Pract. 2024 Feb;14(1):e200221. doi: 10.1212/CPJ.0000000000200221. Epub 2024 Jan 11.
2
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。
JAMA Neurol. 2023 Jul 1;80(7):732-738. doi: 10.1001/jamaneurol.2023.1449.
3
Tenecteplase in acute ischemic stroke: Review of the literature and expert consensus from the French Neurovascular Society.替奈普酶用于急性缺血性卒中:法国神经血管学会的文献综述与专家共识
Rev Neurol (Paris). 2023 Mar;179(3):150-160. doi: 10.1016/j.neurol.2022.08.005. Epub 2022 Nov 8.
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Tenecteplase vs Alteplase for Patients With Acute Ischemic Stroke: The ORIGINAL Randomized Clinical Trial.替奈普酶与阿替普酶治疗急性缺血性卒中患者:ORIGINAL随机临床试验
JAMA. 2024 Nov 5;332(17):1437-1445. doi: 10.1001/jama.2024.14721.
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Comparing Tenecteplase and Alteplase for Acute Ischemic Stroke.比较替奈普酶和阿替普酶治疗急性缺血性卒中的疗效
J Neurosci Nurs. 2025 Jun 1;57(3):127-131. doi: 10.1097/JNN.0000000000000821. Epub 2025 Feb 12.
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Cost-effectiveness of tenecteplase versus alteplase for acute ischemic stroke.替奈普酶与阿替普酶治疗急性缺血性脑卒中的成本效果分析。
Eur Stroke J. 2023 Sep;8(3):638-646. doi: 10.1177/23969873231174943. Epub 2023 May 19.
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Evaluation of Door-to-Needle Times Between Alteplase and Tenecteplase for Acute Ischemic Stroke at Two Academic Medical Centers.两家学术医疗中心对急性缺血性卒中患者使用阿替普酶和替奈普酶的门到针时间评估
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Innov Pharm. 2024 Mar 18;15(1). doi: 10.24926/iip.v15i1.5801. eCollection 2024.
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Should we switch to tenecteplase for all ischemic strokes? Evidence and logistics.对于所有缺血性中风患者,我们都应该改用替奈普酶吗?证据与后勤考量。
Int J Stroke. 2025 Mar;20(3):261-267. doi: 10.1177/17474930241307098. Epub 2025 Jan 6.
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A practice game changer: Impact of tenecteplase for acute ischemic stroke in a multicenter quality improvement project.一种改变实践的方法:在一项多中心质量改进项目中替奈普酶对急性缺血性卒中的影响
Am J Health Syst Pharm. 2022 Apr 19;79(9):e149-e153. doi: 10.1093/ajhp/zxab482.

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Tenecteplase in acute ischemic stroke: a new era in thrombolysis.替奈普酶用于急性缺血性卒中:溶栓治疗的新时代。
Arq Neuropsiquiatr. 2025 May;83(5):1-11. doi: 10.1055/s-0045-1808088. Epub 2025 Jun 1.
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Assessment of clot-lysing and membrane-stabilizing capacity of ascorbic acid: approach with molecular docking.抗坏血酸的溶栓和膜稳定能力评估:分子对接方法
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Bibliometric analysis of the usage of tenecteplase for stroke.替奈普酶用于中风治疗的文献计量分析
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Successful use of intra venous tenecteplase for acute ischemic stroke in pregnancy.静脉注射替奈普酶成功用于妊娠期急性缺血性卒中。
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本文引用的文献

1
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。
JAMA Neurol. 2023 Jul 1;80(7):732-738. doi: 10.1001/jamaneurol.2023.1449.
2
European Stroke Organisation (ESO) expedited recommendation on tenecteplase for acute ischaemic stroke.欧洲卒中组织(ESO)发布了关于替奈普酶治疗急性缺血性卒中的加速推荐。
Eur Stroke J. 2023 Mar;8(1):8-54. doi: 10.1177/23969873221150022. Epub 2023 Feb 2.
3
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
Lancet. 2023 Feb 25;401(10377):645-654. doi: 10.1016/S0140-6736(22)02600-9. Epub 2023 Feb 9.
4
Safety and efficacy of tenecteplase in patients with wake-up stroke assessed by non-contrast CT (TWIST): a multicentre, open-label, randomised controlled trial.非对比 CT 评估的觉醒型卒中患者使用替奈普酶的安全性和有效性(TWIST):一项多中心、开放标签、随机对照试验。
Lancet Neurol. 2023 Feb;22(2):117-126. doi: 10.1016/S1474-4422(22)00484-7. Epub 2022 Dec 19.
5
Outcomes with IV tenecteplase and IV alteplase for acute ischemic stroke with or without thrombectomy in real-world settings in the United States.在美国现实环境中,静脉注射替奈普酶和静脉注射阿替普酶用于急性缺血性卒中(无论是否进行血栓切除术)的疗效。
J Stroke Cerebrovasc Dis. 2023 Feb;32(2):106898. doi: 10.1016/j.jstrokecerebrovasdis.2022.106898. Epub 2022 Dec 6.
6
Treatment times, functional outcome, and hemorrhage rates after switching to tenecteplase for stroke thrombolysis: Insights from the TETRIS registry.转为使用替奈普酶进行中风溶栓后的治疗时间、功能结局及出血率:来自TETRIS注册研究的见解
Eur Stroke J. 2022 Dec;7(4):358-364. doi: 10.1177/23969873221113729. Epub 2022 Jul 21.
7
Prospective Observational Cohort Study of Tenecteplase Versus Alteplase in Routine Clinical Practice.前瞻性观察性队列研究:替奈普酶与阿替普酶在常规临床实践中的比较。
Stroke. 2022 Dec;53(12):3583-3593. doi: 10.1161/STROKEAHA.122.038950. Epub 2022 Sep 23.
8
Intravenous tenecteplase compared with alteplase for acute ischaemic stroke in Canada (AcT): a pragmatic, multicentre, open-label, registry-linked, randomised, controlled, non-inferiority trial.加拿大急性缺血性脑卒中静脉内替奈普酶与阿替普酶比较(AcT):一项实用的、多中心、开放标签、与登记系统相关联、随机化、对照、非劣效性试验。
Lancet. 2022 Jul 16;400(10347):161-169. doi: 10.1016/S0140-6736(22)01054-6. Epub 2022 Jun 29.
9
Comparison of tenecteplase with alteplase for the early treatment of ischaemic stroke in the Melbourne Mobile Stroke Unit (TASTE-A): a phase 2, randomised, open-label trial.替奈普酶与阿替普酶用于墨尔本移动卒中单元早期治疗缺血性卒中的比较(TASTE-A):一项2期随机开放标签试验
Lancet Neurol. 2022 Jun;21(6):520-527. doi: 10.1016/S1474-4422(22)00171-5. Epub 2022 May 4.
10
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.

替奈普酶用于急性缺血性脑卒中溶栓治疗:实际考量与现实应用

Tenecteplase for Acute Ischemic Stroke Thrombolysis: Practical Considerations and Real-World Implementation.

作者信息

Streib Christopher

机构信息

University of Minnesota, Minneapolis.

出版信息

Neurol Clin Pract. 2024 Feb;14(1):e200221. doi: 10.1212/CPJ.0000000000200221. Epub 2024 Jan 11.

DOI:10.1212/CPJ.0000000000200221
PMID:38223783
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10786601/
Abstract

The only FDA-approved medical treatment for acute ischemic stroke (AIS) is alteplase (commonly referred to as "tPA"). The utilization of a newer fibrinolytic agent, tenecteplase, in routine stroke care is increasing because of recent clinical trial findings, streamlined clinical workflows, and cost-effectiveness. The stroke community is monitoring this development with considerable interest and special attention to the following questions: (1) Does the current evidence support superiority or noninferiority of tenecteplase compared with standard-of-care alteplase? (2) What are the ramifications of off-label treatment with tenecteplase? (3) And what are the real-world considerations when transitioning from alteplase to tenecteplase for AIS thrombolysis? This commentary provides a practical synthesis of the current evidence and discusses our institutional experience with tenecteplase including treatment considerations, off-label use, patient consent, stroke center accreditation, and cost savings. Necessary "Code Stroke" workflow changes to ensure a safe transition from alteplase to tenecteplase are detailed.

摘要

美国食品药品监督管理局(FDA)批准的唯一用于急性缺血性卒中(AIS)的药物是阿替普酶(通常称为“tPA”)。由于近期的临床试验结果、简化的临床工作流程以及成本效益,新型纤溶药物替奈普酶在常规卒中治疗中的应用正在增加。卒中领域正密切关注这一进展,并特别关注以下问题:(1)目前的证据是否支持替奈普酶相对于标准治疗药物阿替普酶具有优越性或非劣效性?(2)替奈普酶的超说明书用药有哪些影响?(3)从阿替普酶转换为替奈普酶进行AIS溶栓时,实际应用中需要考虑哪些因素?本述评对当前证据进行了实用的综合分析,并讨论了我们机构使用替奈普酶的经验,包括治疗注意事项、超说明书用药、患者知情同意、卒中中心认证以及成本节约。详细介绍了必要的“卒中急救”工作流程变更,以确保从阿替普酶安全转换为替奈普酶。