循证与实践双重赋能，原研替奈普酶如何重塑溶栓治疗新标准？

*仅供医学专业人士阅读参考

自1995年NINDS研究问世以来，静脉溶栓治疗已成为急性缺血性卒中（AIS）再灌注治疗最主要的手段。其中阿替普酶为主要的溶栓药物，显著改善了AIS患者的预后[1]。替奈普酶作为一种新型纤溶酶原激活物，因其独特的药理学特性及操作简便性，近年来已成为再灌注治疗领域的研究热点，已被视为AIS患者溶栓治疗的新标准。

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医疗卫生专业人士浏览。

参考文献：

[1]董漪,董强.中国卒中临床研究中的溶栓治疗：20年的成就与发展方向[J].中国卒中杂志,2025,20(05):549-554.

[2]国家卫生健康委加强脑卒中防治工作减少百万新发残疾工程专家委员会,吉训明. 《2024年中国脑卒中防治报告》概要[J]. 首都医科大学学报,2025.

[3]王拥军,李子孝,谷鸿秋,等.中国卒中报告2020（中文版）(1)[J].中国卒中杂志,2022,17(05):433-447.

[4]Wang J, Xiao C, Cheng Z, et al. Analysis and prediction of disease burden of stroke and its subtypes in China from 1990 to 2040. Chin Med J (Engl). 2025 Aug 27;138(19):2452–63.

[5]Heeley E, Anderson CS, Huang Y, et al. Role of health insurance in averting economic hardship in families after acute stroke in China. Stroke. 2009 Jun;40(6):2149-56.

[6]Wang Y, Liao X, Zhao X, et al. Using recombinant tissue plasminogen activator to treat acute ischemic stroke in China: analysis of the results from the Chinese National Stroke Registry (CNSR). Stroke. 2011 Jun;42(6):1658-64.

[7]中华医学会神经病学分会,中华医学会神经病学分会脑血管病学组. 中国急性缺血性卒中诊治指南2023[J]. 中华神经科杂志,2024,57(06)：523-559.

[8]Keyt BA, Paoni NF, Refino CJ, et al. A faster-acting and more potent form of tissue plasminogen activator. Proc Natl Acad Sci U S A. 1994 Apr 26;91(9):3670-4.

[9]Zhu A, Rajendram P, Tseng E,et al. Alteplase or tenecteplase for thrombolysis in ischemic stroke: An illustrated review. Res Pract Thromb Haemost. 2022 Sep 20;6(6):e12795.

[10]Tanswell P, Modi N, Combs D,et al. Pharmacokinetics and pharmacodynamics of tenecteplase in fibrinolytic therapy of acute myocardial infarction. Clin Pharmacokinet. 2002;41(15):1229-45.

[11]Menon BK, Buck BH, Singh N, et al. Intravenous tenecteplase compared with alteplase for acute ischaemic stroke in Canada (AcT): a pragmatic, multicentre, open-label, registry-linked, randomised, controlled, non-inferiority trial. Lancet. 2022 Jul 16;400(10347):161-169.

[12]Muir KW, Ford GA, Ford I, et al. Tenecteplase versus alteplase for acute stroke within 4·5 h of onset (ATTEST-2): a randomised, parallel group, open-label trial. Lancet Neurol. 2024 Nov;23(11):1087-1096.

[13]Parsons MW, Yogendrakumar V, Churilov L, et al. 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. Lancet Neurol. 2024 Aug;23(8):775-786.

[14]Palaiodimou L, Katsanos AH, Turc G,et al. Tenecteplase vs Alteplase in Acute Ischemic Stroke Within 4.5 Hours: A Systematic Review and Meta-Analysis of Randomized Trials. Neurology. 2024 Nov 12;103(9):e209903.

[15]Meng X, Li S, Dai H, et al. Tenecteplase vs Alteplase for Patients With Acute Ischemic Stroke: The ORIGINAL Randomized Clinical Trial. JAMA. 2024 Nov 5;332(17):1437-1445.

[16]熊云云,等.卒中:回眸2024[J].中国卒中杂志,2025,20(1):1-19.

[17]Powers WJ, Rabinstein AA, Ackerson T, et al. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019 Dec;50(12):e344-e418.

[18]Alamowitch S, Turc G, Palaiodimou L,et al. European Stroke Organisation (ESO) expedited recommendation on tenecteplase for acute ischaemic stroke. Eur Stroke J. 2023 Mar;8(1):8-54.

[19]中国卒中学会, 《中国卒中学会急性缺血性卒中再灌注治疗指南》编写组, 王拥军. 中国卒中学会急性缺血性卒中再灌注治疗指南2024.中国卒中杂志,2024,19(12):1460-1478.

[20]Skärlund M, Åsberg S, Eriksson M, et al. Tenecteplase compared to alteplase in real-world outcome: A Swedish Stroke Register study. Ups J Med Sci. 2024 Oct 9;129.

[21]Warach SJ, Dula AN, Milling TJ, et al. Prospective Observational Cohort Study of Tenecteplase Versus Alteplase in Routine Clinical Practice. Stroke. 2022 Dec;53(12):3583-3593.

[22]Gao L, Moodie M, Mitchell PJ, et al. Cost-Effectiveness of Tenecteplase Before Thrombectomy for Ischemic Stroke. Stroke. 2020 Dec;51(12):3681-3689.

[23]原研替奈普酶说明书.

审批号：SC-CN-18259，有效期至2026年12月1日

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