アダプトジェニックおよび免疫調節作用を有する天然製品の安全性
Chen Jia Wen Liang1, Herman J Woerdenbag2, Corine Ekhart3
1Pharmacy Master Programme, School of Science and Engineering, University of Groningen, Antonius Deusinglaan 1, 9713 AV Groningen, The Netherlands.
Pharmaceuticals (Basel, Switzerland)
|August 28, 2025
まとめ
適応性および免疫調節性天然製品の安全性は十分に理解されていません. 重篤な有害事象は稀だが報告され,よりよい研究と警告の必要性を強調した.
科学分野:
- 医薬品の監視と天然製品の研究
- 統合医療と補足医療の安全性
背景:
- 適応性および免疫調節性天然製品は,ユーラシアの伝統医学で広く使用されています.
- 安全性プロファイル,特に有害事象 (AEs) と重篤な有害事象 (SAEs) は十分に理解されていません.
- 薬草,真菌,動物由来物質などです.
研究 の 目的:
- 適応性および免疫調節性天然製品の安全性を評価する.
- ヒトの研究のスケーピングレビューとWHO-UMC VigiBase 個々の症例安全性報告 (ICSRs) の分析を用いた.
主な方法:
- PRISMA-ScRのガイドラインに従ってPubMed (1980-2024) のスコーピングレビューを実施しました.
- ランダム化/非ランダム化試験および安全性に関する症例報告が含まれています.
- VigiBaseから49の天然製品に関する45,042のICSRを分析し,製品タイプ,AE,および人口統計によって分類しました.
主要な成果:
- 単一成分製品に関する臨床試験285件,ケーススタディ119件,複数成分製品に関する臨床試験54件,ケーススタディ21件を特定した.
- 胃腸,皮膚,肝臓,心血管,免疫による
- 致死者を含め,単一成分ICSRの15. 8%が有害事象であったが,因果関係は不明であった.
結論:
- 安全性プロフィールの包括的な概要は,製品組成の変動と標準化の欠如を明らかにします.
- 研究における不完全な報告と,医薬品監視データベースにおける不十分な報告は,正確なリスク評価を妨げています.
- 消費者の保護には,さらに質の高い研究,医薬品の監視の改善,そして明確な安全性警告が不可欠です.
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