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在发作4.5-24小时内治疗急性缺血性中风的静脉注射 Tenecteplase (ROSE-TNK):第二阶段,随机,多中心研究

Lu Wang¹, Ying-Jie Dai¹, Yu Cui¹

¹Department of Neurology, General Hospital of Northern Theater Command, Shenyang, China.

Journal of stroke

|August 23, 2023

概括

静脉注射的薄膜酶 (TNK) 显示了急性缺血性中风 (AIS) 患者在症状出现后长达24小时的潜在安全性和可行性. 这项试点研究在优秀的功能结果中没有发现显著差异,但注意到TNK的早期神经改善.

科学领域:

神经学神经学
紧急医疗紧急医疗
放射学放射学是一门学科.

背景情况:

在4.5小时以上的急性缺血性中风 (AIS) 中,静脉注射薄膜酶 (TNK) 的有效性尚未得到充分证实.
像DWI-FLAIR不匹配等先进的成像技术有助于在延长治疗窗口的患者选择.

研究的目的:

为了评估静脉TNK在AIS患者的疗效和安全性,在发病后4.5至24小时之间呈现.
为了确定TNK对特定AIS群体的功能结果和安全终点的影响.

主要方法:

一项试点,随机化,多中心试验,涉及80名有DWI-FLAIR不匹配的AIS患者.
随机分配患者接受静脉TNK (0.25 mg/kg) 或在发病后4.5-24小时内接受标准治疗.
主要终点:90天的优异功能结果 (mRS 0-1);主要安全终点:症状性内出血 (sICH).

主要成果:

在TNK和对照组之间90天后在优异的功能性结果 (mRS 0-1) 中没有显著差异 (52.5%与50.0%,P=0.82).
TNK组显著显示出更早的神经改善 (11对3,P=0.03).
没有出现症状的内出血 (sICH);7.5%的TNK患者经历了无症状的内出血.

结论:

在4.5-24小时内静脉TNK给药可能是安全的和可行的AIS患者与DWI-FLAIR不匹配.
需要进一步的研究来证实在这个延长的时间窗口中的有效性.

关键词:

急性缺血性中风是一次急性缺血性中风.临床试验临床试验是指临床试验的临床试验.神经成像的选择选择.太尼克特代替了太尼克特.血栓溶解是一种血栓溶解.

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