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在中国急性缺血性中风中使用 Tenecteplase 血栓溶解疗法:现实世界,多中心,回顾性,受控研究
Ye Liu1,2, Guozhi Lu3, Dan Li3
1Department of Neurology, National Center for Neurological Disorders, Huashan Hospital, Fudan University, Shanghai, China.
Stroke and vascular neurology
|November 13, 2024
概括
在中国,特内克 (TNK) 与阿尔特 (Alteplase) 在急性缺血性中风 (AIS) 中同样安全,没有增加症状性内出血的风险. 在90天后,TNK可能会提供更好的早期神经改善和功能结果.
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:
- 与alteplase相比,Tenecteplase (TNK) 在中风血栓溶解方面提供了后勤优势,因为它只能一次注射.
- 关于TNK在中国急性缺血性中风 (AIS) 患者的安全性和有效性的现实数据有限.
研究的目的:
- 在中国的AIS患者中研究TNK与阿尔特相比的真实世界的安全性和有效性.
- 评估结果,包括症状性内出血 (sICH),神经改善和功能恢复.
主要方法:
- 在18个中国中风中心对AIS患者接受TNK或阿尔特等在发病后4.5小时内 (2019年3月至2023年10月) 的回顾性研究.
- 倾向性得分匹配 (PSM) 用于创建1:1匹配的TNK和高高治疗患者队列.
- 主要结局:72小时内患病率. 二次结局:对瘤出血,任何内出血,出血,死亡率,NIHSS,早期神经改善,以及90天后修改的兰金度量表 (mRS).
主要成果:
- 在PSM之后,1113名TNK患者与1113名阿尔特血患者进行了匹配. 在sICH率 (1.8%对1.98%,p=0.864) 中没有显著差异.
- 在TNK组中,任何内出血的发生率较低 (OR:0.51,95%CI:0.31-0.86,p=0.012).
- 在24小时后,TNK与较高的早期神经改善有关 (OR: 1.76,p=0.000),90天的mRS更好 (OR: 0.67,p=0.000),mRS 0-1 (OR: 1.27,p=0.012) 和mRS 0-2 (OR: 1.41,p=0.001) 的比例更高.
结论:
- 基酶 (TNK) 血栓溶解与中国AIS患者的症状性内出血风险增加无关.
- 与alteplase相比,TNK可能会导致更好的早期神经改善和更好的90天功能结果.
- 现实世界的证据支持TNK作为中国AIS血栓溶解的安全有效替代品.
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