在发作后4.5-6小时内治疗中风的丁泰化 (Tenecteplase Plus Butyphthalide):第二阶段研究 (EXIT-BT):
Hui-Sheng Chen1, Ming-Rui Chen2, Yu Cui2
1Department of Neurology, General Hospital of Northern Theater Command, Shenyang, China. chszh@aliyun.com.
Translational stroke research
|January 18, 2024
概括
静脉注射薄膜酶加Dl-3-n-Butylphthalide在4.5小时以上的急性缺血性中风 (AIS) 患者中显示有前途. 这种联合治疗似乎是安全的,并改善了AIS患者早期的神经功能.
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:
- 对于急性缺血性中风 (AIS) 的静脉内血栓溶解通常仅限于发病后4.5小时内.
- 对于延长治疗窗口,通常需要先进的神经成像选择.
研究的目的:
- 在AIS患者中研究静脉注射 tenecteplase (TNK) 与Dl-3-n-Butylphthalide (NBP) 结合的安全性和有效性,呈现在4.5至6小时之间.
- 在这个延长的时间窗口中,评估TNK加NBP与NBP单独对比.
主要方法:
- 一个随机的多中心试验,涉及100名通过非对比CT (NCCT) 诊断的AIS患者.
- 患者被分配给接受静脉TNK (0.25 mg/kg) 加NBP或单独NBP在症状发作后4.5至6小时内.
- 主要终点:有症状的内出血 (symptomatic intracranial hemorrhage,简称SICH);次要终点:优异的功能结果 (修改的兰金度表0-1在90天).
主要成果:
- 症状性内出血 (sICH) 的发病率在各组之间相似 (2.0%在TNK组vs0.0%在对照组).
- 在90天的优秀功能结果中,没有显著差异 (77.6%与69.4%).
- 与对照组相比,TNK组在24小时后的NIHSS得分显著下降,早期神经改善率更高.
结论:
- 静脉TNK与辅助NBP似乎是AIS患者在症状发作后4.5至6小时内选择的安全和可行的治疗选择,由NCCT选择.
- 在这种延长的时间窗口中,这种联合治疗可能会改善AIS患者的早期神经功能.
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