与诺基诺抗生素相关的自杀思想和行为:现实世界的药监测分析
Lijuan Yang1, Congqin Chen1, Lingqing Ding1
1Department of Pharmacy, Xiamen Cardiovascular Hospital of Xiamen University, School of Medicine, Xiamen University, Xiamen, China.
Frontiers in pharmacology
|May 12, 2025
概括
在大型数据库分析中,诺基诺抗生素 (FQs) 没有显示出整体自杀思想和行为风险的增加. 然而,在较年轻的年龄组中观察到略有增加,这需要进一步调查.
科学领域:
- 药物监督 药物监督 药物监督
- 药物不良反应 药物不良反应
- 公共卫生 公共卫生
背景情况:
- 诺基诺 (FQs) 是具有潜在神经精神病学副作用的宽谱抗生素.
- 自杀的想法和行为是严重的不良事件,需要在药物安全监测中仔细监测.
研究的目的:
- 调查诺基诺使用与自杀思想/行为之间的关联.
- 分析来自食品和药物管理局不良事件报告系统 (FAERS) 的数据.
主要方法:
- 利用了FAERS从2004年第一季度到2023年第四季度的数据.
- 使用报告几率比率 (ROR) 和实证贝叶斯几何平均值 (EBGM) 的不成比例分析.
主要成果:
- 报告了737例与FQ相关的自杀想法/行为.
- 没有发现与FQ相关的自杀思想/行为总体不成比例增加 (ROR:0.74).
- 在年龄组<18 (1.51) 和18-24 (2.31) 观察到略高的RORs,但EBGM05s仍然低于2,表明没有显著的安全信号.
结论:
- 目前的FAERS数据并未表明FQs与自杀思想/行为有关的总体安全信号.
- 年轻人群体的风险增加需要进一步调查.
- 需要全面的前性研究来验证这些发现.
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