对FDA药物不良反应报告的可视化:VisDrugs网络服务器的开发和可用性研究
Renjun Yang1,2, Nuoya Yin1,2, Yang Zhang3
1State Key Laboratory of Environmental Chemistry and Ecotoxicology, Research Center for Eco-Environmental Sciences, Chinese Academy of Sciences, 18 Shuangqing Road, Haidian District, Beijing, 100085, China, 86 01062849096.
JMIR formative research
|July 31, 2025
概括
VisDrugs使用FDA不良事件报告系统 (FAERS) 数据简化了药物不良反应 (ADR) 分析. 该平台提供了对ADR的直观可视化和比较,帮助研究人员和临床医生评估药物安全性.
科学领域:
- 药监和药物安全 药监和药物安全
- 生物信息学和计算生物学
- 医疗信息学 医疗信息学
背景情况:
- 药物不良反应 (ADRs) 在药物安全方面带来了重大挑战.
- 美国食品和药物管理局的不良事件报告系统 (FAERS) 包含了大量的ADR数据,但缺乏用户友好的分析工具.
- 生物信息学专业知识通常需要解释复杂的FAERS数据.
研究的目的:
- 开发VisDrugs,一个基于网络的平台,用于简化从FAERS数据中可视化和比较ADRs.
- 为研究人员和临床医生提供一个直观的工具来评估药物安全性.
- 为了使ADR模式的交互和可解释的图形表示.
主要方法:
- 在ASCII格式中提取了FAERS数据 (2014年第三季度 - 2024年第三季度).
- 处理了大约270万个单药报告,使用R进行统计分析和可视化.
- 开发了一个基于网络的平台,通过使用MedDRA首选术语,通过饼图和林地图 (ROR) 呈现结果.
主要成果:
- VisDrugs成功地可视化了Paxlovid和氧化的不良反应,与现有研究保持一致.
- 鉴定了Paxlovid (COVID-19,失血症) 和氧化 (视网膜毒性,心脏毒性) 的关键副作用.
- 亚组分析显示,根据性别和年龄 (>50岁) 显著的ADR风险差异.
结论:
- "VisDrugs"是有效进行ADR分析和药物安全性评估的宝贵工具.
- 该平台的人口统计分析为ADR变化提供了洞察力.
- 未来的改进将包括更多用于个性化ADR分析的过选项.
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