韩国与佐洛皮相关的自发不良事件报告中的性别差异,2015-2019年
1School of AI Healthcare, College of Integrated Health Science, CHA University, Pocheon, Republic of Korea.
Frontiers in pharmacology
|November 29, 2023
概括
这项研究发现皮不良事件 (AEs) 的性别差异显著. 妇女报告了更多的睡眠障碍,如梦,而男性报告了更多的认知和运动障碍,突出了性别特定安全监测的必要性.
科学领域:
- 药物监督 药物监督 药物监督
- 药品安全 药品安全
- 性别医学性别医学
背景情况:
- 关于Zolpidem的性别特异性药物反应进行了辩论.
- 关于皮不良事件 (AE) 的性别差异的证据有限.
研究的目的:
- 调查与皮相关的副作用的性别差异.
- 分析报告中关于皮副作用的性别风险差异.
主要方法:
- 利用韩国自愿药物不良事件报告系统 (KAERS) 数据 (2015-2019) 的数据挖掘 (2015-2019).
- 在性别子组中计算报告几率比率 (ROR),以确定显著的AE信号差异.
- 使用日志ROR和95%置信区间评估性别特异性报告风险.
主要成果:
- 确定了94个AE信号,其中35个显示出明显的性别差异.
- 女性报告的异常睡眠 (睡梦,异常睡眠) 和心血管疾病风险更高.
- 男人报告了更多的认知障碍 (妄想症,失眠相关) 和运动障碍;梦游症显示了最实质性的性别差异.
结论:
- 对于佐洛皮AEs,存在严重的基于性别的报告差异.
- 妇女对索尔皮德姆诱导的梦游易感性增加.
- 需要进一步的研究,以了解这些性别特异性AE报告模式背后的因素.
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