药物诱导的上部胃肠道出血:一个现实世界的药监测研究
Bojing Wang1, Xiaohong Wang2, Shiqi Li1
1Department of Gastroenterology, the Affiliated Hospital of Southwest Medical University, Luzhou, China.
PloS one
|February 23, 2026
概括
这项研究分析了药物安全数据,以确定上部胃肠道出血 (UGIB) 的风险. 在主要数据库中,阿司匹林,里瓦罗克萨班和华法林是与UGIB相关的顶级药物之一.
科学领域:
- 药物监督和药物安全研究
- 在药物不良反应监测中,现实世界的证据.
- 药物的定量风险评估 药物的定量风险评估
背景情况:
- 药物诱导的上部胃肠道出血 (UGIB) 是一个需要警监测的重大不良事件.
- 在现实世界中,药物监管对于了解药物安全性和预防潜在风险至关重要.
- 现有研究强调需要加强药物安全监督.
研究的目的:
- 为了对药物诱导的UGIB进行现实世界的药监测研究.
- 识别和评估与UGIB相关的经常报告的药物的风险概况.
- 为改善临床药物安全决策提供证据.
主要方法:
- 利用了来自食品和药物管理局不良事件报告系统 (FAERS) 和日本不良药事件报告 (JADER) 数据库 (2004-2024) 的数据.
- 应用了四种信号检测方法:报告概率比率,比例报告比率,实证贝叶斯几何平均值和贝叶斯信心传播神经网络.
- 专注于前50名药物,报告的UGIB频率较高.
主要成果:
- 分析了62,941份UGIB报告 (57,414份来自FAERS,5,527份来自JADER).
- 阿司匹林在两个数据库中都显示出高频率和信号强度.
- 里瓦罗克萨班,华法林和普拉达克萨在FAERS中是最高风险的药物;克洛皮多格雷尔,洛克索芬,阿皮克萨班和贝瓦齐祖马布在JADER中,其中一些药物表现出极高的信号值.
结论:
- 对FAERS和JADER的综合分析确定了与UGIB风险相关的常见和数据库特定药物.
- 对高频报告药物进行了系统的定量风险评估.
- 这些发现提高了对药物风险概况的理解,并为临床药物安全提供了关键证据.
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