具有适应性和免疫调节作用的天然产品的安全考虑
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
概括
适应性和免疫调节性天然产品的安全性尚不清楚. 严重不良事件 (SAE) 很少发生,但报告,强调需要更好的研究和警告.
科学领域:
- 药监和天然产品研究
- 整合和补充医学安全性
背景情况:
- 适应性和免疫调节性天然产品在欧亚传统医学中广泛使用.
- 安全性概况,特别是不良事件和严重不良事件的了解不足.
- 这包括草药,真菌和来自动物的物质.
研究的目的:
- 评估适应性和免疫调节性天然产品的安全性.
- 使用人类研究的范围审查和WHO-UMC VigiBase个体病例安全报告 (ICSR) 的分析.
主要方法:
- 根据PRISMA-ScR指南进行了PubMed (1980-2024) 的范围审查.
- 包括针对安全结果的随机/非随机试验和病例报告.
- 从VigiBase分析了49种天然产品的45 042个ICSR,按产品类型,AE和人口统计分类.
主要成果:
- 确定了51种天然产品;285个单成分产品的临床试验和119个案例研究;多成分产品的54个试验和21个案例研究.
- 常见的副作用:胃肠道,皮肤,肝脏,心血管和免疫.
- 不良反应很少发生,但针对特定产品报告;其中15. 8%的单一成分ICSR是不良反应,包括死亡,但因果关系尚不清楚.
结论:
- 对安全性概况的全面概述显示了产品成分的变化和缺乏标准化.
- 研究报告不完整,药物监督数据库报告不足,阻碍了准确的风险评估.
- 进一步进行高质量的研究,改善药物监测和明确的安全警告对于消费者保护至关重要.
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