与COVID-19抗病毒药物相关的不良事件:基于FDA不良事件报告系统 (FAERS) 的分析
Muhammad Ikhwan Syahmi Mohamad Radzuan1, Mahmathi Karuppannan1
1Department of Pharmacy Practice and Clinical Pharmacy, Faculty of Pharmacy, Universiti Teknologi MARA (UiTM) Selangor Branch, 42300 Bandar Puncak Alam, Selangor, Malaysia.
像Paxlovid,Molnupiravir和Remdesivir这样的COVID-19抗病毒药物有相关的不良药物反应 (ADR). 仔细监测和个性化治疗对于管理患者这些风险至关重要.
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:
- 由于COVID-19的流行,需要快速开发抗病毒疗法,包括尼尔马特里尔维尔/里托纳维尔 (帕克斯洛维德),莫尔努皮拉维尔和雷姆德西维尔.
- 虽然有效,但这些抗病毒药物与有关药物不良反应 (ADRs) 的担忧有关.
研究的目的:
- 综合评估与关键COVID-19抗病毒药物相关的不良药物反应 (ADR).
- 使用FDA的不良事件报告系统 (FAERS) 数据库来分析ADR.
主要方法:
- 从2022年1月到2023年5月为Paxlovid,Molnupiravir和Remdesivir提取和分类的ADR报告.
- 计算报告几率比 (ROR) 来确定抗病毒药物与特定副作用之间的关联.
- 根据严重程度,反应类型和人口统计学变量分析了ADR.
主要成果:
- 帕克斯洛维德 (Paxlovid) 显示与疾病复发和失灵症相关; 莫尔努皮拉维尔 (Molnupiravir) 与胃肠道和皮肤反应相关; 雷梅西维尔 (Remdesivir) 与肝脏和脏功能障碍相关.
- 在女性中,Paxlovid和Molnupiravir的ADR更频繁,在男性中,Remdesivir更频繁.
- 帕克斯洛维德和雷梅西维尔的不良反应在成年人 (18-64岁) 中很常见,而莫尔努皮拉维尔的不良反应在老年人 (65-85岁) 中更普遍.
结论:
- 强调需要持续监测和管理与COVID-19抗病毒治疗相关的ADRs.
- 强调根据个别患者的病史和先前存在的疾病来定制抗病毒治疗的重要性.
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