*僅供醫學專業人士閱讀參考
本期要點:
●靜脈溶栓是治療急性缺血性卒中(AIS)的金標準,但治療所帶來的出血風險等安全性問題仍是臨床上值得關注的問題。因此,加強對新型溶栓藥物安全性的了解和監測至關重要,并且是提高溶栓治療獲益的關鍵環節。
●替奈普酶作為新型溶栓藥物,依據指南推薦可作為阿替普酶的替代方案應用于AIS4.5小時時間窗內的靜脈溶栓治療。
●本期內容對臨床研究以及真實世界研究(包括GWTG-Stroke所收集的最新數據分析)中原研替奈普酶治療發病4.5小時內AIS的安全性數據進行梳理,以供讀者參考。
*以下內容僅供在中國大陸執業的
醫療衛生專業人士瀏覽。
參考文獻:
[1]Tanswell P, et al. Pharmacokinetics and pharmacodynamics of tenecteplase in fibrinolytic therapy of acute myocardial infarction. Clin Pharmacokinet. 2002;41(15):1229-1245.
[2]Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT-2) Investigators, et al. Single-bolus tenecteplase compared with front-loaded alteplase in acute myocardial infarction: the ASSENT-2 double-blind randomised trial. Lancet. 1999;354(9180):716-722.
[3]中國醫師協會神經內科醫師分會腦血管病專家組. 急性缺血性卒中替奈普酶靜脈溶栓治療中國專家共識. 中國神經精神疾病雜志,2022,48(11):641-651.
[4]Menon BK, 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;400(10347):161-169.
[5]Muir KW, 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;23(11):1087-1096.
[6]Parsons MW, 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;23(8):775-786.
[7]Meng X, et al. Tenecteplase vs Alteplase for Patients With Acute Ischemic Stroke: The ORIGINAL Randomized Clinical Trial. JAMA. 2024;332(17):1437-1445.
[8]Palaiodimou L, et al. Tenecteplase vs Alteplase in Acute Ischemic Stroke Within 4.5 Hours: A Systematic Review and Meta-Analysis of Randomized Trials. Neurology. 2024;103(9):e209903.
[9]Warach SJ, et al. 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. JAMA Neurol. 2023;80(7):732-738.
[10]Rousseau JF, et al. Short-Term Safety and Effectiveness for Tenecteplase and Alteplase in Acute Ischemic Stroke. JAMA Netw Open. 2025;8(3):e250548.
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審批編號:SC-CN-16772 有效期至2026年5月27日
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