固酶5型抑制剂相关的听力损伤:基于FDA不良事件报告系统的真实世界研究
Xunyan Zhang1, Lu Xia2, Qiang Yang1
1Department of Pharmacy, Suining Central Hospital, No.127, West Desheng Road, Chuanshan District, Suining, 629000, Sichuan, People's Republic of China.
Scientific reports
|April 28, 2024
概括
固酶5型抑制剂 (PDE5I) 可能会造成听力损失的风险,特别是在55岁以上的男性中. 现实世界数据分析表明存在潜在联系,需要持续监测和管理策略.
科学领域:
- 药监和药物安全 药监和药物安全
- 审计健康研究 审计健康研究
- 泌尿病学和雄性病学 泌尿和雄性病学
背景情况:
- 新出现的证据表明,固酶5型抑制剂 (PDE5I) 与听力损伤之间存在联系.
- 要了解这种关联,需要进行全面的现实世界数据分析.
研究的目的:
- 使用FAERS数据库调查与PDE5阻断剂相关的听力损失的发生率和特征.
- 评估与PDE5Is相关的听力损伤不良事件的不成比例性和统计意义.
主要方法:
- 分析了FAERS数据库 (2003年第四季度 - 2023年第二季度) 中四个PDE5Is报告的1,438例听力障碍病例.
- 使用不相称性分析 (ROR,PRR,IC) 和标准化MedDRA查询 (SMQ) 进行听力损伤不良事件.
- 检查了病人的人口统计,地理分布和报告病例的时间趋势.
主要成果:
- 在多个不成比例指标中,在PDE5抑制剂和听力障碍之间发现了统计学上显著的关联.
- 大多数病例涉及55岁以上的男性,大多数报告来自美国.
- 残疾率从8.14%到40%不等,住院率从6.21%到10.24%,干预率从3.31%到9.45%.
结论:
- 这项药监测研究确定了与PDE5Is相关的听力损失的潜在风险.
- 这些发现强调了在使用PDE5抑制剂的患者中持续监测听力不良事件的重要性.
- 在接受PDE5I治疗时,应考虑针对患有听力相关问题的患者采取适当的管理策略.
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