上食道关节辅助装置的随机对照试验在喉回流病中的喉回流病
Rena Yadlapati1, Lorijane Robles1, Mary K Clarke1
1Division of Gastroenterology & Hepatology, University of California San Diego.
概括
在一项随机试验中,上食道关节辅助装置 (UESAD) 有效降低了喉回流病 (LPRD) 症状和唾液素水平. 外部状体压力,即使在较低的水平上,也被证明是安全的,并且可以很好地容忍LPRD管理.
科学领域:
- 胃肠病学 胃肠病学
- 耳鼻喉科 耳鼻喉科 耳鼻喉科
- 医疗器械 医疗器械
背景情况:
- 喉回流性疾病 (LPRD) 提供有限的有效治疗选择.
- 上胃关节辅助装置 (UESAD) 是一种非侵入性装置,施加外部状体压力以减轻反流事件.
- 以前的未经控制的研究表明,UESAD在改善LPRD症状方面具有有效性.
研究的目的:
- 评估UESAD在LPRD患者中对标准抗分泌疗法耐药性的疗效.
- 进行第一个随机对照试验 (RCT),比较治疗与低压UESAD应用.
- 评估反流症状指数 (RSI) 和唾液氨酸度的变化作为主要和次要结局.
主要方法:
- 一项随机对照试验招募了具有客观LPRD和持续症状的成年人,尽管使用了抗分泌疗法.
- 参与者被分配1:1到8周的UESAD干预 (治疗20-30 mmHg) 或对照剂 (低压4-11 mmHg).
- 主要结局是RSI的变化,唾液辛度和不良事件作为次要结局.
主要成果:
- 在治疗和低压UESAD组之间没有观察到RSI改善的显著差异.
- 两组都显示RSI得分和唾液素度显著降低.
- 没有报告任何严重不良事件,这表明UESAD的安全性概况有利.
结论:
- 应用外部状体压力的UESAD是一种安全,非侵入性和耐受良好的LPRD治疗方法.
- 随着治疗和较低的UESAD压力水平,实现了显著的症状改善和素水平的降低.
- 即使在较低的水平上,外部状体压力也代表了耐火性LPRD的有效治疗方式.
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