治疗与预防性抗凝药治疗COVID-19入院患者和D-二次体度升高 (ACTION):一个开放的,多中心的,随机的,受控的试验
Renato D Lopes1, Pedro Gabriel Melo de Barros E Silva2, Remo H M Furtado3
1Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA; Brazilian Clinical Research Institute, São Paulo, Brazil.
Lancet (London, England)
|June 7, 2021
概括
治疗性抗凝血药没有改善住院COVID-19患者的D-二次数升高和出血风险增加的结果. 除非另有说明,否则避免使用治疗剂量的里瓦罗克萨班和类似药物.
科学领域:
- 内部医学
- 心脏病学
- 传染性疾病
背景情况:
- COVID-19 (冠状病毒疾病 2019) 与前血栓状况有关,可能会恶化临床结果.
- 在住院的COVID-19患者中治疗抗凝血剂的有效性尚不清楚.
研究的目的:
- 将治疗与预防性抗凝剂的疗效和安全性比较在住院的COVID-19患者中.
主要方法:
- 一个实用的,开放的,多中心的随机控制试验,涉及615名患有D-二次数升高的住院COVID-19患者.
- 患者被随机分配到治疗抗凝剂 (利瓦洛克萨班或埃诺沙巴林,其次是利瓦洛克萨班) 或预防性抗凝剂 (埃诺沙巴林或未分离的肝素) 中.
- 主要疗效结果是死亡,住院时间或氧气持续时间的等级组合; 主要安全结果是重大或临床相关的非重大出血.
主要成果:
- 与预防性抗凝药相比,治疗性抗凝药没有显著改善主要疗效结果 (胜率为0. 86; p=0. 40).
- 在治疗抗凝组 (8%) 和预防组 (2%) 中,严重或临床相关的非严重出血发生的频率明显高 (RR 3. 64; p=0. 0010).
结论:
- 在患有D-二次数升高的住院COVID-19患者中,住院治疗的抗凝血药物没有改善临床结果.
- 与预防性抗凝剂相比,治疗性抗凝剂显著增加了该患者群的出血风险.
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