丹塞引发的失明:一个药监数据库研究的药物监控研究
R Barus1, C Potey2, S Gautier2
1Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital, Toulouse, France.
Expert opinion on drug safety
|October 18, 2023
概括
一种抗药物Ondansetron很少与失明有关. 这项研究发现,与其他抗药物相比,丹塞会增加与失明相关的药物不良反应的风险.
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
- 眼科医生 眼科 眼科
背景情况:
- 丹塞是一种抗药物 (AED),用于控制恶心和吐.
- 在产品信息中指出了一种罕见的暂时失明风险,特别是在静脉注射和化疗时.
- 这项研究旨在更好地描述与丹塞使用相关的失明.
研究的目的:
- 分析与丹塞相关的与失明相关的药物不良反应 (ADRs) 的发生率和特征.
- 为了比较报告的风险与失明相关的ADRs对ondansetron与其他AEDs.
主要方法:
- 使用VigiBase®数据进行了描述性和案例/非案例分析.
- 与失明相关的不良反应 (无毛病,无毛病,失明) 被确定为病例.
- 使用报告几率比率 (ROR) 的不成比例分析评估了报告风险.
主要成果:
- 在136,315例AED报告的副作用中,有136例与失明有关,其中44例 (32.4%) 涉及丹塞.
- 大多数与丹塞相关的失明不良反应发生在使用的第一天;72%的患者康复.
- 与其他AED相比,Ondansetron显示与失明相关的ADR报告风险显著增加 (ROR = 4.00,p < 0.001).
结论:
- 失明是一种罕见的不良药物反应,与静脉注射和口服丹塞有关.
- 与其他抗emetic药物相比,使用Ondansetron与较高的失明风险相关.
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