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甲状腺眼病治疗teprotumumab的听力学副作用风险:倾向性匹配分析

Jonathan C Markle¹, Anil Johanis², Jacqueline K Shaia^1,3

¹Center for Ophthalmic Bioinformatics, Cleveland Clinic, Cole Eye Institute, Cleveland, OH, USA.

Eye (London, England)

|December 12, 2024

概括

甲状腺眼病 (TED) 的teprotumumab治疗与新的听力症状的风险增加有关,包括听力损失和耳. 这些真实数据证实了关于这种潜在副作用的先前发现.

科学领域:

眼科医生眼科眼科
耳鼻喉科耳鼻喉科耳鼻喉科
药物监督药物监督药物监督

背景情况:

用teprotumumab治疗的甲状腺眼病 (TED) 患者报告有听力症状.
有限的现实世界数据可用于评估这种关联.
泰普穆马布是TED的一种新型生物疗法.

研究的目的:

为了评估与teprotumumab治疗的TED患者的听力症状的真实世界发生率.
为了比较TED患者与没有teprotumumab暴露的听力学结果.

主要方法:

使用TrinetX数据库进行回顾性队列研究.
使用ICD-10和CPT代码识别TED患者.
倾向匹配比较了暴露于teprotumumab和未暴露的TED患者.
听力学结果 (耳,听力损失等) 通过新的ICD-10代码确定.

主要成果:

接受teprotumumab治疗的TED患者患有新的听力症状的风险增加了2.85倍 (RR 2.85 [95% CI 1.94, 4.20]).
在之前有听力障碍的TED患者中,使用teprotumumab显示出增加新听力学测试风险的趋势 (RR 1.90 [0.96, 3.78]).

结论:

这项研究证实,在接受teprotumumab的TED患者中,新的听力学副作用的风险增加.
这些发现支持在接受teprotumumab治疗的患者中监测听力健康的必要性.

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