药物诱导的男性不孕症:使用FAERS和EudraVigilance数据库的现实研究
Zhuozhi Gong1, Jing He2, Qiujian Feng1
1Department of Andrology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, China.
Frontiers in pharmacology
|February 16, 2026
概括
这项研究确定了19种高风险药物,包括荷尔蒙药物和抗抑郁药,可能导致男性不孕. 在开始服用这些药物之前,生育年龄的男性应该接受生育咨询,并考虑冷保存精子.
科学领域:
- 药物监测和生殖毒理学
- 药物安全和风险评估
背景情况:
- 男性不孕症是一个日益关注的问题,药物的副作用是潜在的促成因素.
- 系统地识别导致男性生殖毒性的药物对于临床实践至关重要.
研究的目的:
- 系统地识别可能导致男性不孕或精子异常的药物.
- 为临床实践提供有关药物诱导的男性不孕症的风险警报.
主要方法:
- 利用了来自FAERS和EudraVigilance数据库的药监数据 (2002-2025年).
- 使用MedDRA选男性生殖毒性的不良事件,使用ROR,PRR,IC和EBGM进行信号检测.
- 通过交叉数据库验证和脱挑战/重新挑战分析提高可靠性.
主要成果:
- 分析了1,955个FAERS病例和1,384个EudraVigilance病例,其中37%涉及生殖年龄的男性.
- 确定了19种高风险药物,包括荷尔蒙药物 (芬胺,丸素),抗新生素和抗抑郁药.
- 费纳斯特通过déchallenge/rechallenge显示出强有力的因果证据;信号集中在生殖尿路,皮肤和抗类别.
结论:
- 确定了19种男性不孕症的高风险药物,包括荷尔蒙药物,抗质药和抗抑郁药.
- 强调需要在处方前进行生育咨询,并对生育年龄的男性进行风险分层.
- 建议在化疗前冷保存精子,并选择性考虑某些药物,如5α-减少酶抑制剂.
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