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与质子抑制剂相关的性功能障碍:来自VigiBase的见解,这是世界卫生组织药监数据库
Salvatore Crisafulli1, Francesco Ciccimarra1, Fabio Scapini1
1Department of Diagnostics and Public Health, University of Verona, P.le L.A. Scuro, 10, 37134, Verona, Italy.
Drug safety
|October 31, 2025
概括
质子抑制剂 (PPI) 的使用可能与性功能障碍有关,包括勃起功能障碍和生殖器不适. 需要进一步的研究来确认这些潜在的安全信号.
科学领域:
- 药物监督 药物监督 药物监督
- 性健康 性的健康
- 胃肠病学 胃肠病学
背景情况:
- 观察性研究和病例报告表明,质子抑制剂 (PPI) 与性功能障碍之间存在联系.
- 这种假设需要进一步调查,因为PPI的广泛使用.
研究的目的:
- 调查PPI使用与性功能障碍发作之间的潜在关联.
- 利用VigiBase,世界卫生组织的全球药物监测数据库,进行全面分析.
主要方法:
- 分析了与PPI (omeprazole,lansoprazole,rabeprazole, pantoprazole,esomeprazole) 相关的性功能障碍的个体病例安全报告.
- 使用不成比例性分析 (报告几率比率与95%CI,调整为多次测试) 来识别安全信号.
- 对18至64岁的患者进行了小组分析,以考虑与年龄相关的影响.
主要成果:
- 鉴定了有关勃起功能障碍的欧梅普拉的不成比例报告 (aROR, 1.76).
- 在女性中发现埃索梅普拉与生殖器不适 (aROR,3.66) 和雌激素缺乏 (aROR,3.80) 的统计学意义上的关联.
- 亚组分析显示,在男性中,奥梅普拉诱导的性欲下降和埃索梅普拉诱导的性质偏高症的潜在信号,在女性中,奥梅普拉诱导的生殖器不适.
结论:
- 该研究表明,潜在的安全信号将PPI使用与勃起功能障碍,生殖器不适以及雌激素缺乏等性功能障碍联系起来.
- 建议进行进一步的观察性研究,以验证和描述这些已识别的安全信号.
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