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在4. 5至24小时内治疗急性缺血性中风的Alteplase:HOPE随机临床试验
Ying Zhou1,2, Yaode He1,2, Bruce C V Campbell3
1Department of Neurology, the Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, China.
JAMA
|August 7, 2025
概括
在缺血性中风后4. 5至24小时内静脉注射阿尔特,可挽救脑组织的患者的功能独立性得到改善. 这种治疗增加了症状性内出血的风险,但没有影响死亡率.
科学领域:
- 神经学
- 紧急医疗
- 放射学
背景情况:
- 静脉注射血栓缓解剂对超过4. 5小时的缺血性中风的疗效和安全性尚未得到充分证实.
- 识别可挽救脑组织的患者对于延长治疗窗口至关重要.
研究的目的:
- 在急性缺血性中风患者中评估静脉注射Alteplase的安全性和有效性,这些患者在中风发病后4. 5至24小时内可以恢复大脑组织.
- 评估结果不论大血管封闭或计划内血管血栓切除.
主要方法:
- 一个随机的,开放的,盲目的终点试验,涉及中国26个中风中心的372名患者.
- 患者接受了静脉输入的高血 (0. 9 mg/ kg) 或标准的医疗治疗.
- 输血成像发现可挽救的大脑组织;符合条件包括4. 5至24小时的中风发作窗口和没有初步的血栓切除计划.
主要成果:
- 40% 的接受阿尔特普拉斯治疗的患者获得了功能独立 (Rankin 修改分数0- 1 在90天后),而接受标准治疗的患者为26% (调整后风险比,1. 52;P=. 004).
- 症状性内出血发生在3. 8%的阿尔特群中,而对照组为0. 51% (调整后风险比,7. 34;P=. 01).
- 在90天后所有原因的死亡率在两组之间相似 (两组均为11%).
结论:
- 在缺血性中风发作后4. 5至24小时内静脉注射阿尔特,对已发现可挽救的大脑组织的患者提供功能性益处.
- 这种治疗与症状性内出血的风险增加有关.
- 这些发现支持在选择的中风患者中扩大使用alteplase,超出传统的4. 5小时窗口.
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