尼尔马特里尔维尔/里托纳维尔用于COVID-19的血液透析患者
Jiayue Lu1, Hong Cai1, Yujun Hao2
1Department of Nephrology, Molecular Cell Lab for Kidney Disease, Shanghai Peritoneal Dialysis Research Center, Renji Hospital, Uremia Diagnosis and Treatment Center, Shanghai Jiaotong University, School of Medicine, Shanghai, China.
Frontiers in pharmacology
|May 30, 2023
概括
尼尔马特里尔维尔/里托纳维尔在COVID-19的血液透析患者中显示出潜在的安全问题,近一半的患者经历了不良事件. 该药物并没有显著改善这种人群中的病毒消除时间.
科学领域:
- 药理学 药理学是指药理学的学科.
- 传染性疾病 传染性疾病
- 腎臟病學 (nephrology) 是一種醫學專業.
背景情况:
- 血液透析患者面临严重COVID-19和死亡的风险增加.
- 尼尔马特里尔维尔/里托纳维尔目前不推用于血液透析患者,因为安全性数据不足.
- 了解nirmatrelvir/ritonavir在这个人群中的安全性和有效性至关重要.
研究的目的:
- 评估尼马特里尔维尔/里托纳维尔在轻度COVID-19的血液透析患者的安全性和最低血度 (Cmin).
- 在这个患者群体中评估不同剂量的涅马特里尔维尔/里托纳维尔 (150毫克或300毫克).
- 为了确定尼尔马特里尔维尔/里托纳维尔治疗病毒消除的时间.
主要方法:
- 前性,两步,非随机,开放标签研究设计.
- 参与者接受了涅马特里尔维尔 (每天150毫克或300毫克,血液透析后增加剂量) 和里托纳维尔 (每天两次100毫克) 持续5天.
- 主要结局包括尼马特雷尔维尔Cmin和不良事件 (AE);次要结局是病毒消除时间.
主要成果:
- 在3名 (步骤1) 和7名 (步骤2) 参与者中发生了不良事件;与药物相关的副作用分别发生在2名和6名参与者中.
- 没有报告严重不良事件 (SAEs) 或肝损伤.
- 与对照组相比,涅马特里尔维尔Cmin水平在涅马特里尔维尔/里托纳维尔组显著更高,但病毒消除时间没有显示出统计上的差异.
结论:
- 对于血液透析患者来说,研究的涅马特里尔维尔/里托纳维尔剂量可能过高.
- 虽然一般可以容忍,但近一半的患者经历了与药物相关的不良事件.
- 尼尔马特里尔维尔/里托纳维尔在轻度COVID-19的血液透析患者的病毒消除时间方面没有显著的优势.
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