布雷克萨诺龙的营销后安全概况:基于FDA不良事件报告系统 (FAERS) 的药监测分析
Meilian Zhang1, Wenhuo Xie2, Jianbin Li2
1Department of Ultrasound, Fujian Maternity and Child Health Hospital, College of Clinical Medicine for Obstetrics & Gynecology and Pediatrics, Fujian Medical University, Fuzhou, China.
Archives of women's mental health
|October 13, 2023
概括
布雷克萨诺 (Zulresso®) 用于产后抑郁症显示出高频率的精神和神经系统不良药物反应. 需要进一步的研究来澄清这些安全信号.
科学领域:
- 药物监督 药物监督 药物监督
- 神经科学是一个神经科学.
- 精神病学是一个精神病学.
背景情况:
- 布雷克萨诺龙 (Zulresso®) 已被批准用于产后抑郁症 (PPD).
- 关于布雷克萨诺龙的不良药物反应 (ADRs) 的数据有限.
研究的目的:
- 为了探索布雷克萨诺龙的营销后安全概况.
- 调查与布雷克萨诺隆治疗PPD相关的副作用.
主要方法:
- 使用FDA不良事件报告系统 (FAERS) 进行病例/非病例药监测研究.
- 不成比例性分析 (报告几率比率,信息组件),将布雷克萨诺隆与所有药物和SSRI进行比较.
- 对围产期抑郁症子组的敏感性分析.
主要成果:
- 267个布雷克萨诺龙病例被确定;97.38%的可疑药物报告.
- 精神病和神经系统的不良反应显示出显著的报告风险.
- 在11.61%的患者中报告了严重的结局.
结论:
- 布雷克萨诺的使用与精神和神经系统ADR的高频率有关.
- 这些安全信号需要通过前性研究紧急澄清.
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