多中心随机试验评估了在COVID-19 ARDS中透气多纳斯阿尔法的疗效和安全性
Charles Gregoire1, Lucas Di Meglio2,3, Chloé Le Cossec4
1Intensive Care Department, Rothschild Foundation Hospital, 25-29 Rue Manin, 75019, Paris, France. charles.gregoire@gmail.com.
Scientific reports
|October 22, 2025
概括
透气多纳α没有改善COVID-19患者的急性呼吸系统应急综合征 (ARDS) 严重程度或临床结果. 该药物耐受性良好,但生物可用性问题可能会限制其在ARDS治疗中的有效性.
科学领域:
- 肺部病理学 肺部病理学
- 关键护理医学 关键护理医学
- 药理学 药理学是指药理学的学科.
背景情况:
- 中性粒细胞外细胞陷 (NETs) 导致COVID-19 ARDS中的炎症和损伤.
- 阿尔法多纳是一种DNAase,可能会减少NET并改善肺功能.
- 在COVID-19中高死亡率ARDS需要有效的治疗.
研究的目的:
- 评估气溶液多尔纳斯阿尔法在改善ARDS严重程度的有效性,在直管COVID-19患者.
- 评估dornase alfa对死亡率,无呼吸器日和其他临床结果的影响.
- 为了研究药物的生物可用性和对NET标记物的影响.
主要方法:
- 多中心,随机对照试验,比较标准护理 (SOC) 与SOC加气溶液多纳α.
- 主要终点:使用柏林标准,在第7天ARDS严重程度的改善.
- 二级终点:28天死亡率,无呼吸器/ICU日,NET标志物和DNAse活动.
主要成果:
- 在第7天,dornase alfa和SOC组之间在ARDS严重性改善方面没有显著差异 (18%对29%).
- 在28天死亡率或无呼吸器/无ICU天没有显著差异.
- 透气多纳α没有显著降低NET标记物或增强DNAase活性,这表明生物可用性受限.
结论:
- 与SOC相比,在COVID-19 ARDS患者中,空气注射的多纳α没有改善临床结果.
- 药物耐受性良好,但喷雾剂的使用可能会损害生物可用性.
- 需要进一步研究替代性输送方法或特定的患者亚组.
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