吞咽困难、安全性和有效性：RefluxStop 手术在食管动力无效（IEM）的 GERD 患者中的应用：瑞士多中心长达 3 年的结果
Dysphagia, Safety, and Effectiveness of the RefluxStop Procedure in GERD Patients With Ineffective Esophageal Motility (IEM): Multicenter Results in Switzerland for Up to 3 Years.
文献信息
| PMID | 42976041 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Joerg Zehetner |
| 作者单位 | Department of Visceral Surgery, Hirslanden Clinic Beau-Site, Bern, Switzerland. |
| 期刊 | Surgical laparoscopy, endoscopy & percutaneous techniques |
| SCI 分区 | Q3 |
| IF | 1.2 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 咽喉科 |
中文摘要
背景： 目前，胃食管反流病（GERD）合并食管动力无效（IEM）的患者治疗效果并不理想。采用标准抗反流手术时，吞咽困难常会加重。RefluxStop 通过一种不环绕食管的新机制治疗酸反流。本研究评估 RefluxStop 手术在 IEM 受试者中长达 3 年的吞咽困难、安全性和疗效。
方法： 在瑞士伯尔尼大学 Inselspital 医院和 Hirslanden Clinic Beau-Site 开展的一项研究者发起的联合研究中，回顾性评估 RefluxStop 在两个 IEM-GERD 队列中的临床结局。主要结局为吞咽困难的发生率。次要结局包括 GERD 健康相关生活质量（GERD-HRQL）的改善、食物通过相关事件，以及严重的操作相关或器械相关不良事件（即 SAEs、SADEs）。
结果： 连续 60 例（n=60）IEM 受试者接受了 RefluxStop 手术，随访时间为 3 至 47 个月（平均 13 个月）。GERD-HRQL 评分的中位（Q25-Q75）改善为 89%（83% 至 96%），具有统计学显著性（P<0.001；Wilcoxon 检验）。在末次随访时，92% 的受试者 GERD-HRQL 评分改善 >50%。在达到 1 年随访的 40 例受试者中，n=14/40（35%）在基线时有吞咽困难，其中 12 例缓解或改善，1 例加重。因此，与不变或加重状态相比，吞咽困难改善的可能性显著更高（P=0.013）。
结论： RefluxStop 手术治疗 GERD 被用于 IEM 患者（n=60），该群体目前尚无最佳治疗方法；其良好结果维持长达 3 年，GERD-HRQL 评分（中位 89%）和吞咽困难（1 年时 86% 缓解或改善）均有极佳改善。
英文摘要
BACKGROUND: Patients with gastroesophageal reflux disease (GERD) and ineffective esophageal motility (IEM) do not have optimal outcomes today. With standard-of-care antireflux procedures, dysphagia often worsens. RefluxStop treats acid reflux via a novel mechanism without encircling the esophagus. This study assesses dysphagia, safety, and efficacy of the RefluxStop procedure in subjects with IEM for up to 3 years.
METHODS: Clinical outcomes of RefluxStop in two IEM-GERD cohorts were evaluated retrospectively, in a combined investigator-initiated study at University Inselspital and Hirslanden Clinic Beau-Site in Switzerland. The primary outcome was incidence of dysphagia. The secondary outcomes included improvement in GERD Health-Related Quality of Life (GERD-HRQL), food passageway-related events, and serious procedure- or device-related adverse events (ie, SAEs, SADEs).
RESULTS: Sixty (n=60) consecutive subjects with IEM underwent the RefluxStop procedure, with a follow-up ranging between 3 and 47 months (mean 13 mo). Median (Q25-Q75) improvement in GERD-HRQL score was 89% (83% to 96%) with statistical significance (P<0.001; Wilcoxon test). At last follow-up, 92% of the subjects experienced >50% improvement in GERD-HRQL score. Of the 40 subjects that reached 1-year follow-up, n=14/40 (35%) had dysphagia at baseline, which resolved or improved in 12 subjects and worsened in one. Thus, there was a significantly higher likelihood of dysphagia improvement compared with unchanged or worsened status (P=0.013).
CONCLUSIONS: RefluxStop surgical management for GERD was used in patients with IEM (n=60), a group which currently has no optimal treatment, and maintained favorable results for up to 3 years with excellent improvement of GERD-HRQL score (median 89%) and dysphagia (86% resolved or improved at 1y).