对三抗真菌药物的营销后药监测研究:基于FDA不良事件报告系统数据库的不良事件数据挖掘和分析
Yalan Tian1, Min Jin1, Hong Ning1
1Department of Pharmacy, Mianyang Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Mianyang, China.
Frontiers in pharmacology
|February 7, 2025
概括
这项研究分析了voriconazole,posaconazole和isavuconazole的不良药物事件. 沃里康纳显示眼睛和神经系统疾病的风险更高,在所有三种抗真菌药物中都发现了新的信号.
科学领域:
- 药物监督 药物监督 药物监督
- 药品安全 药品安全
- 临床药理学 临床药理学
背景情况:
- 沃里康纳,波萨康纳和伊萨武康纳是重要的抗真菌剂.
- 了解它们的营销后安全概况对于临床决策至关重要.
研究的目的:
- 分析和比较市场营销后不良药物事件 (ADE) 信号对沃里康纳,波萨康纳和伊萨武康纳.
- 确定安全差异,并为这些醇抗真菌剂的合理临床使用提供见解.
主要方法:
- 使用Open Vigil 2.1工具从FDA FAERS数据库中提取ADE数据 (直到2023年第三季度).
- 对于信号检测,雇员报告几率比率 (ROR) 和比例报告比率 (PRR).
- 使用MedDRA 26.0.0按系统器官类 (SOC) 分类识别的ADE信号.
主要成果:
- 分析了8,898份沃里康纳的ADE报告,1948份波萨康纳和944份伊萨武康纳的ADE报告.
- 确定了607个独特的ADE信号:沃里康纳的402个,波萨康纳的159个和伊萨武康纳的46个.
- 沃里康纳的ADEs经常涉及调查,眼部疾病和神经系统疾病; 波萨康纳涉及调查和一般疾病; 伊萨夫康纳涉及一般疾病和肝胆道疾病.
结论:
- 沃里康纳,波萨康纳和伊萨武康纳共享肝胆道和心脏疾病的潜在风险.
- 沃里康纳对眼睛和神经系统疾病的安全性存在更大的担忧.
- 新的ADE信号包括伏利康纳诱导的拉布多米解,波萨康纳诱导的外周神经病变,以及易萨武康纳诱导的视力障碍和精神混乱,为临床实践提供了信息.
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