Schumacher Brigitte, Neuhaus Horst, Ortner Marianne, Laugier René, Benson Martin, Boyer Jean, Ponchon Thierry, Hagenmüller Friedrich, Grimaud Jean-Charles, Rampal Patrick, Rey Jean-François, Fuchs Karl-Hermann, Allgaier Hans-Peter, Hochberger Jürgen, Stein Hubert J, Armengol Juan Andrés Ramírez, Siersema Peter D, Devière Jacques
Medizinische Klinik, Evangelisches Krankenhaus Düsseldorf, Kirchfeldstrasse 40, 40217 Düsseldorf, Germany.
J Clin Gastroenterol. 2005 Mar;39(3):212-9. doi: 10.1097/01.mcg.0000152751.10268.fa.
The need is well recognized for additional data on endoluminal therapies for gastroesophageal reflux disease (GERD). This prospective multicenter clinical trial was designed to assess safety and effectiveness of Enteryx, a nonresorbable copolymer implanted into the lower esophagus, in reducing usage of proton pump inhibitors (PPIs) and improving reflux symptoms and quality of life.
Enteryx implantation was performed under fluoroscopic visualization without general anesthesia in 93 patients with symptomatic GERD responsive to and relapsing upon cessation of PPI therapy. Subjective and objective data were collected up to 12 months postprocedure. The criterion for treatment success was reduction in PPI dosage of > or =50%.
At 12 months, treatment success was attained in 86% (confidence interval, 77%-93%) of 74 evaluable patients and elimination of PPI therapy in 65% (confidence interval, 53%-76%). The treatment success rate by intent-to-treat analysis was 69% (confidence interval, 58%-78%). Reflux-related heartburn (P < 0.0001), regurgitation symptoms (P = 0.0005), and physical (P < 0.0001) and mental quality of life (P = 0.0012) scores improved. The most frequent complications were chest pain (77%), dysphagia/odynophagia (27%), and sensation of fever (26%).
Enteryx implantation provides an effective and safe alternative for management of gastroesophageal reflux, reducing medication dependency and symptoms and enhancing quality of life.
对于胃食管反流病（GERD）腔内治疗的更多数据需求已得到广泛认可。这项前瞻性多中心临床试验旨在评估Enteryx（一种植入食管下段的不可吸收共聚物）在减少质子泵抑制剂（PPI）使用、改善反流症状和生活质量方面的安全性和有效性。
在93例对PPI治疗有反应且停药后复发的有症状GERD患者中，在无全身麻醉的情况下于透视引导下进行Enteryx植入。术后长达12个月收集主观和客观数据。治疗成功的标准是PPI剂量减少≥50%。
12个月时，74例可评估患者中有86%（置信区间为77%-93%）获得治疗成功，65%（置信区间为53%-76%）停止使用PPI治疗。意向性分析的治疗成功率为69%（置信区间为58%-78%）。与反流相关的烧心（P<0.0001）、反流症状（P = 0.0005）以及身体（P<0.0001）和精神生活质量（P = 0.0012）评分均有所改善。最常见的并发症是胸痛（77%）、吞咽困难/吞咽痛（27%）和发热感（26%）。
Enteryx植入为胃食管反流的治疗提供了一种有效且安全的替代方法，可减少药物依赖和症状并提高生活质量。
