使用食品和药物管理局的不良事件报告系统,全面检测妄相关药物的信号
Masakazu Hatano1, Rintaro Sogawa2, Kenji Shin3
1Department of Pharmacotherapeutics and Informatics, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.
General hospital psychiatry
|June 28, 2024
概括
许多药物,包括二类药物和阿片类药物,与妄想有关. 这项研究证实,这些药物类别是独立的风险因素,加强了与药物相关的痴呆症的证据.
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
- 药品安全 药品安全
背景情况:
- 妄想是一种严重的疾病,通常与药物有关,但有力的证据有限.
- 鉴于多药性,确定导致妄想的特定药物具有挑战性.
研究的目的:
- 综合评估与妄想相关的药物的安全信号.
- 评估各种药物类别对引起妄想的独立风险.
主要方法:
- 使用日本制药信息中心处理的食品和药物管理局不良事件报告系统 (JAPIC AERS).
- 采用多变量逻辑回归来调整包括年龄,性别,适应症和黑激素受体激动剂使用在内的共变量.
- 分析了22种药物类别与妄想的关联,计算了调整后的报告几率比率 (ROR).
主要成果:
- 包括数据排除后的7,527,568名患者.
- 在对共变量进行调整后,在17种药物类别中确定了显著的妄想信号.
- 关键发现包括二类药物 (aROR=1.76),阿片类药物 (aROR=4.42) 和三环抗抑郁药 (aROR=2.44).
结论:
- 证实了多种药物类别,特别是类药物和阿片类药物,是 Delirium 的独立风险因素.
- 这项研究提供了强有力的证据,支持各种药物与 Delirium 的发展之间的关联.
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