一个新型的自充气球用于治疗耐火良性食道狭窄症:一个前性,单臂,多中心研究
Longsong Li1, Ning Xu1, Pengju Wang1
1Department of Gastroenterology, The First Medical Center of Chinese PLA General Hospital, Beijing.
新的自助式充气气球 (SHIB) 对耐火良性食道狭窄症 (BESs) 显示出有前途,改善生活质量. 狭窄的原因和治疗持续时间会影响复发风险.
科学领域:
- 胃肠病学 胃肠病学
- 医疗器械 医疗器械
- 手术创新 在外科创新.
背景情况:
- 耐火良性食道收缩 (BESs) 存在重大治疗挑战.
- 目前用于BES的治疗方法往往是漫长的,并产生不理想的结果.
- 为了解决这些局限性,开发了一种新型的自助式充气气球 (SHIB).
研究的目的:
- 评估自助式充气气球 (SHIB) 治疗耐火良性食道狭窄症 (BESs) 的疗效和安全性.
主要方法:
- 一项前性多中心研究招募了2019年1月至2022年3月期间接受SHIB治疗的耐火性BES患者.
- 主要终点是SHIB移除后12个月的临床成功.
- 二级终点包括SHIB持续时间,体重指数 (BMI) 和与健康有关的生活质量 (HRQoL) 变化.
主要成果:
- 临床成功率为51.2%,内镜组的成功率更高 (63.3%).
- 在使用SHIB期间,所有患者都经历了食障碍的改善;48.8%的患者出现了复发,但狭窄的长度下降,无干预间隔增加.
- 与基线相比,平均BMI和HRQoL在治疗后显著改善.
结论:
- SHIB证明了对各种病因的耐火性BES的高疗效和安全性,特别是在内镜切除后.
- 缩病因和SHIB佩戴时间是复发性缩的独立预测因素.
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