急性缺血性卒中标准时间窗内新型静脉溶栓药物临床研究及展望

doi:10.3969/j.issn.1673-5765.2026.01.002

中国卒中杂志 ›› 2026, Vol. 21 ›› Issue (1): 24-29.DOI: 10.3969/j.issn.1673-5765.2026.01.002

急性缺血性卒中标准时间窗内新型静脉溶栓药物临床研究及展望

何丹丹^1，2，许淑红¹，李姝雅^1，3，4

1北京 100070 首都医科大学附属北京天坛医院临床试验中心
2北京 100070 首都医科大学临床流行病学与临床试验学系
3北京 100070 首都医科大学附属北京天坛医院神经系统疾病国家临床医学研究中心
4北京 100070 首都医科大学附属北京天坛医院神经病学中心

收稿日期:2025-10-12 修回日期:2026-01-06 接受日期:2026-01-13 出版日期:2026-01-20 发布日期:2026-01-20
通讯作者: 李姝雅 shuyali85@163.com
基金资助:
国家自然科学基金青年科学基金项目（B类）（82522025）

Clinical Research and Prospects of Novel Intravenous Thrombolytic Agents for Acute Ischemic Stroke within the Standard Time Window

HE Dandan^1,2, XU Shuhong¹, LI Shuya^1,3,4

1 Department of Clinical Trial Center, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China
2 Department of Clinical Epidemiology and Clinical Trial, Capital Medical University, Beijing 100070, China
3 China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China
4 Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China

Received:2025-10-12 Revised:2026-01-06 Accepted:2026-01-13 Online:2026-01-20 Published:2026-01-20
Contact: LI Shuya, E-mail: shuyali85@163.com

摘要/Abstract

摘要： 再灌注治疗是改善急性缺血性卒中患者预后的核心手段。近三十年来，阿替普酶在静脉溶栓治疗领域长期占据主导地位，但其临床应用仍面临全球药物供应短缺、操作流程烦琐及出血风险相对较高等现实挑战，这制约了其临床应用的普及性。替奈普酶、瑞替普酶及尿激酶原等新型静脉溶栓药物在前期探索性研究中已初步展现出良好的溶栓潜力；近期完成的多项确证性临床研究进一步证实，这些新型静脉溶栓药物在疗效与安全性方面均不劣于阿替普酶。本文系统梳理了上述新型静脉溶栓药物的分子结构、药理学特性及重要临床研究数据，深入剖析了不同药物的临床应用特点，并探讨了在多药选择背景下静脉溶栓治疗面临的新机遇与挑战，旨在提升急性缺血性卒中静脉溶栓治疗的可及性与规范性，优化医疗服务质量，推动急性缺血性卒中静脉溶栓治疗迈入新阶段。

关键词: 急性缺血性卒中; 静脉溶栓; 瑞替普酶; 替奈普酶; 尿激酶原

Abstract: Reperfusion therapy is the cornerstone intervention for improving the prognosis of patients with acute ischemic stroke. Over the past three decades, alteplase has maintained a dominant position in the field of intravenous thrombolysis. However, its clinical applications are confronted with numerous practical challenges, including global supply shortages, cumbersome clinical administration protocols, and a relatively elevated risk of hemorrhage, all of which limit the widespread implementation of this therapeutic approach. Novel intravenous thrombolytic agents, including tenecteplase, reteplase, and prourokinase, have shown promising thrombolytic potential in preliminary exploratory studies. Recent confirmatory clinical trials have further demonstrated that these new intravenous thrombolytic agents exhibit non-inferior efficacy and safety profiles compared to alteplase. This review systematically summarizes the molecular structures, pharmacological properties, and key clinical trial data of these novel thrombolytic agents, provides an in-depth analysis of the clinical application characteristics of different agents, and discusses the emerging opportunities and challenges facing intravenous thrombolysis in the context of multiple therapeutic options. It aims to enhance the accessibility and standardization of intravenous thrombolysis for acute ischemic stroke, optimize the quality of medical services, and facilitate the advancement of intravenous thrombolysis for acute ischemic stroke into a new phase.

Key words: Acute ischemic stroke; Intravenous thrombolysis; Reteplase; Tenecteplase; Prourokinase

中图分类号:

何丹丹, 许淑红, 李姝雅. 急性缺血性卒中标准时间窗内新型静脉溶栓药物临床研究及展望[J]. 中国卒中杂志, 2026, 21(1): 24-29.

HE Dandan, XU Shuhong, LI Shuya. Clinical Research and Prospects of Novel Intravenous Thrombolytic Agents for Acute Ischemic Stroke within the Standard Time Window[J]. Chinese Journal of Stroke, 2026, 21(1): 24-29.

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急性缺血性卒中标准时间窗内新型静脉溶栓药物临床研究及展望

Clinical Research and Prospects of Novel Intravenous Thrombolytic Agents for Acute Ischemic Stroke within the Standard Time Window

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