通过FAERS的Nirmatrelvir/Ritonavir对不良药物事件信号的数据挖掘
Ji Sun1,2, Xuanyu Deng1,2, Juanjuan Huang1,2
1The Affiliated Changsha Hospital of Xiangya School of Medicine, Central South University, Changsha, China.
PloS one
|December 31, 2024
概括
用于COVID-19的尼尔马特里尔维尔/里托纳维尔显示出已知的副作用,如腹和腹. 在现实世界的数据中发现了新的潜在不良药物事件,包括白的便和黄色的皮肤.
科学领域:
- 药物监督 药物监督 药物监督
- 传染性疾病 传染性疾病
- 药品安全 药品安全
背景情况:
- 尼尔马特里尔维尔/里托纳维尔是一种有效的COVID-19抗病毒药物,但其药物安全性需要进一步调查.
- 现有的关于尼尔马特里尔维尔/里托纳维尔不良反应的研究是有限的,需要对现实世界的数据进行分析.
研究的目的:
- 使用FDA不良事件报告系统 (FAERS) 数据库识别和分析与尼马特里尔维尔/里托纳维尔相关的不良反应信号.
- 为在COVID-19治疗中安全合理使用尼尔马特里尔维尔/里托纳维尔提供基础.
主要方法:
- 利用FAERS数据库,分析了所有COVID-19紧急使用授权 (EUA) 产品的不良药物事件 (ADE) 报告,直到2023年第三季度.
- 采用报告几率比率 (ROR) 方法来检测重大不良事件信号.
- 集中分析了35,250份关于Nirmatrelvir/Ritonavir是主要可疑药物的ADE报告.
主要成果:
- 观察到高信号强度的疾病 (ROR = 72.98),腹 (ROR = 3.03),和头痛 (ROR = 1.25),与已知的副作用一致.
- 确定了新的潜在不良反应,包括浅色便 (ROR = 45.53),色素 (ROR = 3.07),皮肤黄色 (ROR = 3.62) 和舌头涂层 (ROR = 35.55).
- 这些发现补充了药物说明书中未列出的已知ADEs.
结论:
- 该研究确定了尼尔马特里尔维尔/里托纳维尔的显著不良反应信号,包括以前未经记录的事件.
- 这些发现凸显了临床关注尼尔马特里尔维尔/里托纳维尔潜在不良药物事件 (ADEs) 的重要性.
- 这项研究为临床实践中尼尔马特里尔维尔/里托纳维尔的安全有效应用提供了理论基础.
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