一个针对COVID-19的纳法莫斯塔特随机试验
Susan C Morpeth1,2, Balasubramanian Venkatesh3,4,5, James A Totterdell6
1Department of Microbiology and Infectious Diseases, Middlemore Hospital, Te Whatu Ora Counties Makukau, Auckland, New Zealand.
NEJM evidence
|February 6, 2024
概括
纳法莫斯塔特甲基酸盐在住院COVID-19患者中减少死亡或器官支持的概率为93%. 然而,观察到高胆固醇和出血风险增加,阻止了最终的结论.
科学领域:
- 传染性疾病 传染性疾病
- 药理学 药理学是指药理学的学科.
背景情况:
- 纳法莫斯塔特酸是一种抗病毒抑制TMPRSS2的药物,TMPRSS2是SARS-CoV-2细胞进入的关键酶.
- 严重急性呼吸系统综合征冠状病毒2 (SARS-CoV-2) 导致冠状病毒疾病2019 (COVID-19).
研究的目的:
- 评估纳法莫斯塔特梅西酸盐在COVID-19住院患者的疗效和安全性.
- 为了确定纳法莫斯塔特是否减少死亡率或器官支持的需要.
主要方法:
- 一个开放的,务实的,随机的临床试验,涉及非临床病情的住院COVID-19患者.
- 参与者接受了通常的护理或通常的护理加上纳法莫斯酸.
- 主要终点是28天内死亡或新的通风/血管压力器支持.
主要成果:
- 主要终点发生在5%的接受纳法莫斯塔特治疗的患者中,而在通常治疗组中为11%.
- 纳法莫斯塔特的疗效后期概率为93% (调整后的几率比率<1.0).
- 超血和出血事件在纳法莫斯塔特组中更频繁.
结论:
- 纳法莫斯塔特甲基酸盐表明,在COVID-19患者中减少不良结果的可能性很高.
- 预先规定的停止标准没有得到满足,限制了最终的结论.
- 增加高血和出血的风险需要在使用nafamostat时仔细考虑.
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