甲状腺眼病中与teprotumumab相关的不良事件:一个多中心研究
Shreya A Shah1, Linus Amarikwa1, Connie M Sears1
1Department of Ophthalmology, Byers Eye Institute, Stanford University School of Medicine, Palo Alto, California.
Ophthalmology
|October 18, 2023
概括
甲状腺眼病 (TED) 的teprotumumab治疗通常会导致不良事件 (AE),其中大多数是轻微的和可逆的. 然而,可能会发生严重的副作用,需要对患者进行仔细的监测和管理.
科学领域:
- 眼科医生 眼科 眼科
- 内分泌学 在内分泌学.
- 类风湿病学 类风湿病学
背景情况:
- 甲状腺眼睛疾病 (TED) 是一种使人虚弱的自身免疫性疾病,影响眼球轨道.
- 德鲁马布是一种类似胰岛素的生长因子1受体 (IGF-1R) 抑制剂,用于治疗TED.
- 了解teprotumumab的安全概况对于临床决策至关重要.
研究的目的:
- 评估TED患者与teprotumumab治疗相关的不良事件 (AEs) 的发生率,持续时间,可逆性和严重程度.
- 评估副作用对治疗延续和患者结果的影响.
主要方法:
- 进行了一项多中心,回顾性,观察性队列研究.
- 包括131名TED患者,他们接受了至少4次teprotumumab输注.
- 收集和分析了不良事件数据,包括发病,严重程度,持续时间和可逆性.
主要成果:
- 在81.7%的患者中发生了不良事件,平均每患者发生4次不良事件. 大多数副作用是轻微的 (74.0%) 和可逆的 (平均持续时间17.6周).
- 肌肉骨 (58.0%),胃肠道 (38.2%) 和皮肤 (38.2%) 的副作用最常见. 严重的副作用发生在8.4%的患者中.
- 观察到质 (77%),临床活性评分 (CAS) 和双眼视的显著改善. 12.2%的患者因AEs而停止治疗.
结论:
- 德鲁马布与高AEs发病率有关,主要是轻微和可逆的.
- 医生必须向患者提供有关AE风险的建议,适当查,并密切监测AE管理.
- 虽然通常是安全的,但可能会发生严重的副作用,可能导致治疗中止.
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