使用RefluxStop植入物进行酸性逆流管理:具有3年结果的前性多中心试验
László Harsányi1, Zsolt Kincses2, Áron Altorjay3
1Department of Surgery, Transplantation and Gastroenterology, Semmelweis University, Üllői Út 78., Budapest, H-1082, Hungary. harsanyi.laszlo@semmelweis.hu.
Digestive diseases and sciences
|December 20, 2024
概括
RefluxStop为GERD提供了一种安全有效的腹腔镜解决方案,可以显著改善生活质量,而不会围绕食道. 三年后的结果显示,没有与设备相关的不良事件,并且GERD症状减少了93%.
科学领域:
- 胃肠病学 胃肠病学
- 手术创新 在外科创新.
- 医疗器械技术 医疗器械技术
背景情况:
- 胃食道逆流性疾病 (GERD) 影响了许多人,通常通过常规手术进行管理,这些手术会带来不良事件的风险.
- RefluxStop是一种新型的植入物,用于腹腔镜治疗GERD,旨在恢复胃食道结节的功能,而不需要围绕食道.
研究的目的:
- 评估 RefluxStop 植入物在慢性 GERD 患者的 3 年安全性和有效性.
- 评估 RefluxStop 对生活质量,药物使用和特定 GERD 症状的影响.
主要方法:
- 进行了一项前性单臂多中心临床试验.
- 50名患有慢性GERD的患者用RefluxStop植入物进行了治疗.
- 随访持续了三年,分析了安全性和有效性数据.
主要成果:
- 在47名患者中,在3年内,没有发生与设备相关的不良事件,侵蚀,迁移或爆炸.
- 观察到显著的改善:GERD-HRQL得分降低93.1%,每日排泄率降低97.9%,基线鼻完全消失.
- 在3年的随访中,没有患者需要定期的每日质子抑制剂 (PPI) 治疗;98%的患者经历了缺食症的改善.
结论:
- RefluxStop手术是一种安全有效的治疗GERD,避免食道包围和压力.
- 植入物显著改善了患者的生活质量,由高GERD-HRQL得分的降低和消除PPI依赖所证明.
- 长期的随访证实了该设备在控制GERD症状,包括反和消化不良等方面的有效性.
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