基于FDA的不良事件报告系统和VigiAccess数据库,对与环酸盐相关的不良事件的现实研究
Xiaona Jia1, Lei Liu1, Pan Wang1
1Department of Pharmacy, Civil Aviation General Hospital, Beijing, China.
PloS one
|October 10, 2025
概括
这项研究调查了与环环酸盐 (SZC) 相关的不良药物事件 (ADEs),用于治疗高血症. 确定了新的安全信号,包括心脏和胃肠道问题,提供了关键的临床见解.
科学领域:
- 药物监督 药物监督 药物监督
- 临床安全研究 临床安全研究
- 药物监管科学 药物监管科学
背景情况:
- 氧化环酸盐 (SZC) 用于治疗高血症.
- 对SZC的真实安全数据对于临床实践至关重要.
- 了解与SZC相关的不良药物事件 (ADEs) 是非常重要的.
研究的目的:
- 调查与SZC相关的ADE的频率,类型和信号.
- 确定SZC在现实使用中的潜在安全问题.
- 为临床医生提供SZC的最新安全信息.
主要方法:
- 使用FAERS和VigiAccess数据库进行ADE报告.
- 使用OpenVigil 2.1来从FAERS (2004-2024) 中提取数据.
- 应用MedDRA (版本27.0) 用于ADE标准化和分类.
- 用ROR和PRR方法进行信号检测和分析.
主要成果:
- 确定了SZC的1384 (FAERS) 和1518 (VigiAccess) 的ADE报告.
- 顶级系统器官类 (SOCs) 包括一般性疾病,胃肠道和调查.
- 确定了药物说明书中没有的新型ADE信号,如心力衰竭,大肠,肠道穿孔和高血症.
- 检测到异常血,血增加和血增加的显著积极信号.
结论:
- 已确认与SZC相关的常见ADEs.
- 发现了需要临床关注的新型安全信号.
- 结果为SZC临床使用提供了有价值的安全参考数据.
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