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在患有格雷夫斯病和甲状腺眼病的患者中评估听力功能障碍,不含或含有teprotumumab
Terry J Smith1, Robert J Holt2, Qianhong Fu2
1Department of Ophthalmology and Visual Sciences, W. K. Kellogg Eye Center, and Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI 48105, USA.
The Journal of clinical endocrinology and metabolism
|August 14, 2024
概括
听力问题在格雷夫斯病 (GD) 和甲状腺眼病 (TED) 中很常见. 与单独使用GD/TED相比,TED治疗的Teprotumumab治疗并没有显著增加与听力相关索赔的发生率.
科学领域:
- 眼科医生 眼科 眼科
- 内分泌学 在内分泌学.
- 听力学 听力学是指听力学.
背景情况:
- 甲状腺眼病 (TED),通常与格雷夫斯病 (GD) 相关,显著影响生活质量.
- 原是TED的有效治疗方法,但人们对潜在的听力不良事件 (AE) 提出了担忧.
- 在teprotumumab治疗之前,GD和TED患者的听力功能障碍的背景患病率尚未确立.
研究的目的:
- 量化耳朵相关的诊断代码和GD和TED患者的听力AE.
- 评估在接受teprotumumab的患者中听力AE的发生率和严重程度.
- 为了比较GD/TED患者有和没有teprotumumab治疗的听力问题的患病率.
主要方法:
- 对GD和TED患者的耳朵/迷宫相关ICD-10代码的非识别医疗索赔数据的分析.
- 在teprotumumab的临床试验中评估听力AE发生率和严重程度.
- 格雷夫斯眼科医生生活质量 (GO-QOL) 评分的比较在TED患者中接受了teprotumumab治疗,有和没有听力AEs.
主要成果:
- 与耳朵相关的代码在24%的GD,33%的TED和32%的teprotumumab治疗患者中存在.
- "神经神经听力损失双边"是最常见的代码,影响了7%的GD,11.1%的TED和10.8%的teprotumumab患者.
- 治疗前的耳部代码在17.1%的患者中被发现,治疗后有10.1%的患者出现了新的代码;在teprotumumab试验中观察到类似的比率.
结论:
- 在GD/TED患者中,与听力相关的声称的患病率在teprotumumab治疗前后相似.
- 在这种患者群体中,teprotumumab治疗似乎没有显著增加听力功能障碍的背景率.
- 未来关于teprotumumab听力风险的研究应该包括先验设计,以考虑GD/TED患者现有的听力问题.
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