一个生物与耳部的后果:听力损失和teprotumumab使用FDA不良事件报告系统的分析
Pauline P Huynh1, Elias Saba1, Alexander Rivero1
1Department of Head & Neck Surgery, Kaiser Permanente Oakland Medical Center.
概括
用于甲状腺眼睛疾病的teprotumumab与耳学不良反应的显著风险有关,特别是听力损失. 老年患者面临更高的风险,强调了治疗期间需要进行听力测量评估的必要性.
科学领域:
- 眼科医生 眼科 眼科
- 药物监督 药物监督 药物监督
- 耳鼻喉科 耳鼻喉科 耳鼻喉科
背景情况:
- 德图穆马布是一种新型生物药物,用于治疗活跃的甲状腺眼病.
- 耳腔学不良反应 (OAR) 是teprotumumab治疗的一个潜在问题.
研究的目的:
- 用药监督数据评估与teprotumumab相关的OARs,包括听力损失 (OARs-HL) 的发生率和风险.
- 为了确定患者的因素,如年龄,这可能会预测OARs和OARs-HL.
主要方法:
- 从2020Q1到2023Q1对食品和药物管理局不良事件报告系统 (FAERS) 数据库的回顾性审查.
- 分析患者人口统计和报告的OAR,包括OAR-HL.
- 后勤回归和不成比例分析 (OpenVigil) 以评估风险和预测因素.
主要成果:
- 报告了2,109例与teprotumumab相关的不良反应病例,其中296例 (14.05%) 被归类为OAR.
- 在7.06%的病例中报告了OARs-HL,在9.20%的病例中报告了其他OARs.
- 不成比例性分析显示,OARs-HL的报告几率比率 (ROR) 显著增加 (44.33;p < 0.001). 年龄是一个显著的预测因素 (ORR为OARs-HL的1.04;p<0.01),50岁和65岁以上的患者的风险增加.
结论:
- 采用teprotumumab治疗与OAR风险增加有关,尤其是听力损失.
- 患者年龄的增加是OARs发展的重要风险因素.
- 对于接受teprotumumab的患者,特别是老年人,建议进行听力计咨询和评估.
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