女人的第二代抗精神病药物相关严重不良事件:对国家药物流行病学数据库的分析
Kenneth L McCall1, Emily E Leppien1, Brian J Piper
1From the Department of Pharmacy Practice, Binghamton University School of Pharmacy & Pharmaceutical Sciences, Johnson City, NY.
Journal of clinical psychopharmacology
|February 27, 2025
概括
服用第二代抗精神病药物 (SGA) 的女性患上Torsades de pointes (TdP) 的几率更高,这是一种危险的心律. 这项研究发现女性的TdP结果更差,突出了在SGA使用中需要性别特定的安全研究.
科学领域:
- 药物监督 药物监督 药物监督
- 临床药理学 临床药理学
- 基于性别的医学
背景情况:
- 第二代抗精神病药物 (SGA) 被广泛使用,但临床试验数据往往低于女性.
- 这种差异引发了人们对SGA安全概况在性别上普遍性的担忧.
研究的目的:
- 调查六种常见SGA的不良事件报告中的基于性别的差异.
- 为了评估特定不良事件的风险,包括Torsades de pointes (TdP),神经乱性恶性综合征 (NMS),晚期动症 (TD),农细胞病 (AG) 和脑血管不良事件 (CVAE) 在女性与男性相比.
主要方法:
- 对2019年1月1日至2024年7月8日美国不良事件报告系统的分析.
- 包括阿里皮普拉,克洛扎,奥兰扎,奎蒂亚,瑞斯和齐普拉西的数据.
- 计算报告5个关键不良事件的概率比率 (ROR),将女性与男性进行比较,并检查TdP相关的结果.
主要成果:
- 该研究分析了87,356份报告,女性占队列的48.7%.
- 与男性相比,女性的Torsades de pointes (TdP) (ROR = 5.55) 的几率明显更高.
- 此外,女性与TdP相关的住院或死亡几率增加 (ROR = 3.09).
结论:
- 研究结果表明,使用SGA的女性中,TdP的风险可能更高,TdP相关的结果更严重.
- 这些结果强调了将性别视为SGA药物监测中的生物变量的重要性.
- 需要进一步的研究来验证这些初步发现,并为临床实践提供信息.
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