与尤斯塔希管气球扩张相关的不良事件和后续管理
Sarah Jeoung1, Li-Xing Man2, Alexander K Mandych2
1University of Rochester School of Medicine and Dentistry University of Rochester Rochester New York USA.
OTO open
|August 11, 2023
概括
皮下肺是尤斯塔基管气球扩张后最常见的不良事件. 这项研究分析了FDA的数据,强调了对潜在并发症的进一步研究和改善患者咨询的需要.
科学领域:
- 耳鼻喉科 耳鼻喉科 耳鼻喉科
- 最少侵入性的手术
- 医疗器械安全 医疗器械安全
背景情况:
- 持续的欧斯塔基管功能障碍往往是通过微创性欧斯塔基管气球扩张来治疗的.
- 美国食品和药物管理局 (FDA) 已批准三家制造商的设备用于此程序.
- 关于与欧斯塔基管气球扩张相关的不良事件及其管理的数据有限.
研究的目的:
- 分析在欧斯塔基管气球扩张后报告给FDAMAUDE数据库的不良事件.
- 确定不良事件的类型和频率及其后续管理.
- 评估特定制造商是否与更高的不良事件发生率有关.
主要方法:
- 采用了一个案例系列设计.
- 数据从FDA制造商和用户设施设备体验 (MAUDE) 数据库中提取.
- 从2000年1月到2022年7月的报告被分析为不良事件和管理策略.
主要成果:
- 总共有13个不良事件被确定.
- 皮下肺是最常见的不良事件 (n=8),其次是的尤斯塔希管 (n=2),血管剖析 (n=1),鼻粘膜 (n=1),耳 (n=1).
- 大多数皮下肺的患者接受了抗生素和住院治疗;一个患有动脉剖析的患者在支架放置后康复. 可获得的术前信息有限,两名患者的康复不完全.
结论:
- 皮下肺是与欧斯塔基管气球扩张相关的最常见的不良事件.
- 对潜在的不良事件进行进一步的调查是必要的,以提供全面的患者咨询.
- 没有任何一家制造商与报告的不良事件有不成比例的关联.
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