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中国患者急性缺血性卒中替奈普酶与阿替普酶的对比:ORIGINAL研究方案
Xia Meng1,2, Shuya Li1,2, Hongguo Dai3
1Department of Neurology and Department of Clinical Trial Center Beijing Tiantan Hospital, Capital Medical University Beijing China.
Stroke (Hoboken, N.J.)
|January 26, 2026
まとめ
替奈普酶治疗中国患者急性缺血性卒中的疗效不劣于阿替普酶。本研究支持替奈普酶作为症状发作后4.5小时内一种安全有效的溶栓选择。
科学分野:
- 神经病学; 心血管医学; 药理学
背景:
- 替奈普酶是一种新型溶栓药物,是阿替普酶的生物工程变体。; 急性缺血性卒中治疗需要及时有效的溶栓治疗。
研究 の 目的:
- 评估替奈普酶与标准治疗(阿替普酶)在中国急性缺血性卒中患者中的疗效和安全性。; 旨在证明替奈普酶在症状发作后4.5小时内达到良好功能结局方面不劣于阿替普酶。
主な方法:
- 一项多中心、随机(1:1)、主动对照的III期研究。; 在中国招募了适合在4.5小时内接受溶栓治疗的急性缺血性卒中成人患者。; 主要终点:90天时改良Rankin量表评分为0或1;次要终点:功能结局和安全性事件,包括症状性脑内出血和全因死亡。
主要な成果:
- 本研究旨在证明替奈普酶(0.25 mg/kg)与阿替普酶(0.9 mg/kg)的疗效不劣于后者。; 主要安全性终点包括90天时的症状性脑内出血、全因死亡和严重残疾(mRS 5-6)。
結論:
- 本研究预计将支持替奈普酶在急性缺血性卒中患者中疗效不劣于阿替普酶。; 结果预计将支持替奈普酶在中国作为急性缺血性卒中治疗的新适应症。
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