季節性およびスティーブンズ・ジョンソン症候群/毒性表皮解剖の傾向,COVID-19 パンデミック前およびその間: 医薬品警戒研究
medRxiv : the preprint server for health sciences
|September 2, 2025
まとめ
FDA有害事象報告システム (FAERS) に報告されているスティーブンズ・ジョンソン症候群/毒性表皮解剖 (SJS/TEN) は,有意な季節的パターンを示さない. これはSJS/TENの安定性を示唆するインフルエンザやRSVのような状態と対照的です.
科学分野:
- 薬用警戒について
- 流行病学
- 公衆衛生
背景:
- 薬剤の副作用の季節的変動は,疾患のメカニズムとリスク軽減にインパクトを与える.
- スティーヴンズ・ジョンソン症候群/毒性表皮解剖 (SJS/TEN) は,季節的影響を伴う重症で生命を脅かす粘膜皮膚反応である.
研究 の 目的:
- 米国食品医薬品局の有害事象報告システム (FAERS) に報告されるSJS/TENの季節的パターンを調査する.
- SJS/TENの季節性およびパンデミックに関連する報告の変化を評価するために,伝統的な季節性分析とタイムシリーズモデリングを使用します.
主な方法:
- 2010年から2019年のFAERS報告書の人口ベースの横断分析.
- クルスカル・ワリステストと季節的傾向分解 (STL) を利用して季節的差異を測定する.
- 予測とパンデミック影響評価のための季節的自動回帰統合移動平均 (SARIMA) モデル.
主要な成果:
- 5,900件のSJS/TEN報告で,季節性強度が低い (0. 163) で,有意な月間または季節性変動は検出されなかった.
- 陽性対照群 (インフルエンザ,RSV,光感受性) は,予期されるような強い季節性を示した.
- SARIMAの予測では,インフルエンザとRSVの減少と対照的に,パンデミック中にSJS/TENの報告がわずかに増加しました.
結論:
- SJS/TENのFAERSへの報告は,インフルエンザとRSVとは異なり,有意な季節性を示さない.
- タイムシリーズの分析は,COVID-19 パンデミック中にSJS/TENの報告の相対的な安定性を確認しました.
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