薬物による男性不妊症:FAERSとEudraVigilanceのデータベースを使用した現実世界の研究
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
まとめ
この研究では,ホルモン剤や抗うつ剤を含む,男性不妊の原因となる可能性のある19の高リスク薬が特定されました. 生殖年齢の男性は,不妊カウンセリングを受け,これらの薬を始める前に精子の冷凍保存を検討する必要があります.
科学分野:
- 医薬品警戒と生殖毒理学について
- 薬物安全性およびリスク評価
背景:
- 男性不妊症はますます懸念される問題であり,薬剤の副作用が潜在的な要因である.
- 男性の生殖に毒性をもたらす薬物の体系的な特定は,臨床実務において極めて重要です.
研究 の 目的:
- 男性不妊症や精子異常を引き起こす可能性のある医薬品を体系的に特定する.
- 薬物による男性不妊症に関する臨床実務のためのリスクアラートを提供すること.
主な方法:
- FAERSとEudraVigilanceのデータベース (2002年-2025年) の医薬品監視データを活用した.
- MedDRAを使用して男性の生殖に有害な有害性の不良事件をスクリーニングし,信号検出のためにROR,PRR,IC,EBGMを使用しました.
- クロスデータベースの検証とデチャレンジ/再チャレンジ分析により信頼性が向上します.
主要な成果:
- 1,955件のFAERS症例と1,384件のEudraVigilance症例を分析し,37%が生殖年齢の男性を対象とした.
- ホルモン剤 (フィナステリド,テストステロン),抗新生剤,抗うつ剤を含む19種類の高リスク薬が特定されました.
- フィナステリドは,デチャレンジ/再チャレンジによる強い因果関係を示す証拠を示し,シグナルは尿生殖器系,皮膚科,抗腫瘍性カテゴリーに集中した.
結論:
- ホルモン剤,抗新生剤,抗うつ剤を含む男性不妊症に対する高リスク薬の19種類を特定しました.
- 処方前の受精カウンセリングと生殖年齢の男性に対するリスクの階層化の必要性を強調しています.
- 化学療法前に精子の冷凍保存を推奨し,5α-リドゥクタゼ阻害剤などの特定の薬剤の選択的検討を推奨する.
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