全国多中心研究与穿透性囊相关的不良事件:关于适当使用穿透性囊的额外调查研究
Teppei Omori1, Naoki Ohmiya2, Kenji Watanabe3
1Institute of Gastroenterology, Tokyo Women's Medical University, Tokyo, Japan.
Journal of gastroenterology and hepatology
|October 16, 2023
概括
没有标签的PillCam通透性囊 (PC) 是安全有效的防止小肠囊内镜 (CE) 保留. 包括囊阻塞和涂层残留在内的不良事件是罕见的,可以管理的.
科学领域:
- 胃肠病学 胃肠病学
- 医疗器械 医疗器械
- 内镜检查是指内镜检查.
背景情况:
- 没有标签的PillCam通透性囊 (PC) 在2012年在日本推出,以防止小肠囊内镜 (CE) 保留.
- 进行了一项多中心研究,以评估与无标签PC相关的不良事件 (AE).
研究的目的:
- 为了确定无标签PC相关不良事件的发生率和特征.
- 评估无标签PC在防止CE保留方面的安全性和有效性.
主要方法:
- 对1096名患者进行了回顾性调查 (第一队列),并对1482名患者进行了额外的调查 (第二队列).
- 关于PC相关AE的临床特征的数据是在2012年6月至2014年12月期间收集的.
主要成果:
- 在2578名患者中,61人 (2.37%) 经历了74次AEs.
- 最常见的副作用包括残留的烯涂层 (0.97%),PC诱导的小肠阻塞 (0.89%) 和CE保留 (0.39%).
- 克罗恩氏病与涂层残留有关;缺乏经验的医生和先前的腹痛史与阻塞有关.
结论:
- 没有标签的PC是防止CE保留的安全有效工具.
- 准确的PC定位和腹痛史的检查前查对于患者的安全至关重要.
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