对COVID-19批准和重新使用的抗病毒药物的比较药监测分析:来自EudraVigilance数据的见解
Paul Andrei Negru1,2, Delia Mirela Tit1,3, Andrei Flavius Radu1,4
1Doctoral School of Biological and Biomedical Sciences, University of Oradea, 410087 Oradea, Romania.
Biomedicines
|June 26, 2025
概括
这项研究使用药监数据比较了COVID-19的抗病毒安全性. 雷梅西维尔 (RDV) 显示出更严重的事件,而涅马特里尔维尔/里托纳维尔 (NTV/r) 有精神和胃肠道问题,指导更安全的药物选择.
科学领域:
- 药理学 药理学是指药理学的学科.
- 药品安全 药品安全
- 现实世界的证据 现实世界的证据
背景情况:
- 由于COVID-19的流行,导致了抗病毒药物的批准/重新使用.
- 这些抗病毒药物的全面安全性需要进行比较.
- 药监数据提供了对现实世界药物性能的见解.
研究的目的:
- 进行对八种COVID-19抗病毒药物的比较药监测分析.
- 通过不成比例性分析识别潜在的安全信号.
- 根据器官系统类别,人口统计和严重程度来比较安全概况.
主要方法:
- 来自EudraVigilance数据库的64,776个个案安全报告 (ICSR) 的分析.
- 根据器官系统类 (SOC) 和严重程度对不良反应的评估.
- 使用报告几率比率 (ROR) 来检测安全信号的不成比例分析.
主要成果:
- 雷梅西维尔 (RDV) 与严重不良事件 (84%) 和肝胆,,心脏疾病中的信号有关.
- 涅马特里尔维尔/里托纳维尔 (NTV/r) 显示出较温和的特征,但对精神病,肠道疾病的RORs是正的.
- 重用抗病毒药物 (利巴维林,洛皮纳维尔/里托纳维尔) 主导了报告;一般,肠道,神经系统疾病是受影响最严重的SOC.
结论:
- 对于COVID-19抗病毒药物,已经确定了不同的药监测概况.
- 雷梅西维尔 (RDV) 和涅马特里尔维尔/里托纳维尔 (NTV/r) 存在不同的安全问题.
- 现实世界的数据分析对于指导抗病毒使用中更安全的治疗决策至关重要.
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