使用FDA不良事件报告系统数据库对与质子抑制剂相关的不良反应进行系统分析
Zhenyu Wang1,2, Jianan Jin3, Guimei Wang1
1Pulmonary and Critical Care Medicine, Regional medical center for National Institute of Respiratory Disease, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, P. R. China.
PloS one
|February 2, 2026
概括
质子抑制剂 (PPI) 与和胃肠道问题,低血和低血有关,特别是在老年人和长期使用时. 仔细监测和避免不必要的处方对于患者安全至关重要.
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:
- 质子抑制剂 (PPI) 被广泛用于与酸有关的条件.
- 了解PPI的不良影响对于安全的临床实践至关重要.
- 美国食品和药物管理局的不良事件报告系统 (FAERS) 数据库为分析药物安全信号提供了宝贵的资源.
研究的目的:
- 综合分析与质子抑制剂 (PPI) 相关的药物不良反应 (ADR).
- 为了确定特定的器官系统和条件最受PPI使用的影响.
- 为了比较不同PPI药物的ADR概况.
主要方法:
- 从2004年第一季度到2024年第四季度利用了FAERS数据库.
- 分析了176,680个与PPI相关的不良事件案例.
- 使用统计方法,包括ROR,PRR,IC025和EBGM来评估ADR信号.
- 根据器官系统类 (SOC) 和首选术语 (PT) 定义的副作用.
主要成果:
- 鉴定了/尿道和胃肠道不良事件的显著增加风险.
- 常见的ADR包括低磁血症,低血症和脏贫血.
- 在早期 (0-30天) 和长期使用 (>6个月) 期间都观察到不良反应.
- 老年患者 (≥65岁) 的风险不成比例.
结论:
- 持续监测对于高风险人群至关重要,包括老年人和功能障碍者.
- 尽量减少长期的PPI使用,避免不必要的处方对于患者的安全至关重要.
- 这些发现指导了临床实践,以更安全的PPI药物管理.
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