与佐皮克隆和埃索皮克隆相关的自杀不良事件:基于FAERS,JADER和CVARD的药监测分析
Yinpeng Xu1, Fang Li1, Mei Zhang2
1Department of Pharmacy, Ninth People's Hospital of Zhengzhou, Zhengzhou, Henan, China.
PloS one
|January 8, 2026
概括
自杀不良事件,包括企图和想法,与佐皮克隆和埃索皮克隆有关. 男性患者和早期使用药物 (0-180天) 显示风险增加,需要进一步的临床试验.
科学领域:
- 药监和药物安全 药监和药物安全
- 临床药理学 临床药理学
- 精神病学是一个精神病学.
背景情况:
- 与自杀相关的不良事件是索皮克隆和埃斯索皮克隆的一个重大问题.
- 这项研究旨在评估与这些药物相关的自杀事件风险.
研究的目的:
- 评估佐皮克隆/埃佐皮克隆使用与自杀相关不良事件之间的关联.
- 确定使用这些药物的患者自杀事件的风险因素和时间模式.
主要方法:
- 使用了来自FAERS,JADER和CVARD数据库 (2004-2024) 的数据.
- 采用了统计方法,包括报告几率比率 (ROR),比例报告比率 (PRR) 和信息组件 (IC).
- 在FAERS数据上进行多变量后勤回归和生存分析.
主要成果:
- 确定了361起与自杀有关的事件,自杀企图是一个一致的积极信号.
- 男人显示自杀的风险增加 (OR:14.70).
- 大多数事件发生在0-180天内;50%导致死亡. 报告的剂量往往超过了最大推剂量.
结论:
- 这些发现证实了现有的关于与佐皮克隆和埃索皮克隆相关的自杀风险的报告.
- 需要进一步的临床试验来彻底调查这些自杀风险.
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