[Fortelyzin用于急性缺血性中风治疗:一个开放的,前性,非干预性,观察性研究 FORPI注册]
N A Shamalov1,2, M Yu Martynov1,2, E I Gusev1,2
1Federal Center for Brain and Neurotechnology, Moscow, Russia.
Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova
|January 12, 2026
概括
福特利津在急性缺血性中风 (AIS) 患者中显示出安全性和有效性,症状性脑内出血率低,功能性结局良好. 这支持在4.5小时内更广泛地使用Fortelyzin治疗AIS.
科学领域:
- 神经学 神经学
- 心血管医学 心血管医学
- 药理学 药理学是指药理学的学科.
背景情况:
- 急性缺血性中风 (AIS) 需要及时干预.
- 静脉内血栓溶解是AIS的关键治疗方法.
- 福特利津是一种用于AIS管理的血栓溶解剂.
研究的目的:
- 在现实临床环境中评估Fortelyzin在AIS患者的安全性和有效性.
- 评估症状性脑内出血 (ICH) 和功能独立等结果.
- 将发现与现有的临床试验数据进行比较.
主要方法:
- 未来的,观察性的,开放标签的FORPI注册表.
- 在2021年3月至2024年10月期间注册了17636名AIS患者,他们接受了Fortelyzin治疗.
- 收集了关于人口统计,中风严重程度 (NIHSS),治疗时间,安全性 (ICH,死亡率) 和疗效 (mRS) 的数据.
主要成果:
- 症状性ICH的比率为2% (ECASS III) 和2% (SITS-MOST). 这两种情况的比率相对较高.
- 90天后所有原因的死亡率为9%.
- 61%的患者在90天后实现了功能独立 (mRS 0-2).
结论:
- 用Fortelyzin进行静脉血栓溶解在4.5小时内在常规实践中对AIS是安全有效的.
- 安全性和有效性概况与之前的临床试验结果一致.
- 这些发现鼓励Fortelyzin在符合条件的AIS患者中得到更广泛的应用.
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