Minnesota Gastroenterology, PA, Plymouth, Minnesota; Department of Medicine, University of Minnesota, Minneapolis, Minnesota; Abbott-Northwestern Hospital, Minneapolis, Minnesota.
Clin Gastroenterol Hepatol. 2017 Sep;15(9):1326-1337. doi: 10.1016/j.cgh.2016.12.019. Epub 2016 Dec 24.
A magnetic implant for the treatment of gastroesophageal reflux disease (GERD) was Food and Drug Administration-approved in 2012 and has been extensively evaluated. The device is a ring of magnets that are placed around the gastroesophageal junction, augmenting the native lower esophageal sphincter and preventing reflux yet preserving lower esophageal sphincter physiologic function and allowing belching and vomiting. Magnetic force is advantageous, being permanent and precise, and forces between magnets decrease with esophageal displacement. Multiple patient cohorts have been studied using the magnetic device, and trials establish consistent, long-term improvement in pH data, GERD symptom scores, and proton-pump inhibitor use. A 5-year Food and Drug Administration trial demonstrated that most patients achieved normal pH scores, 85% stopped proton-pump inhibitors, and GERD health-related quality of life symptom scores improved from 27 to 4 at 5 years. Seven studies have compared magnetic augmentation with laparoscopic Nissen fundoplication and demonstrated that the magnetic device achieved comparable efficacy with regard to proton-pump inhibitor cessation, GERD symptom score improvement, and heartburn and regurgitation scores. However, to date there have been no randomized, controlled trials comparing the 2 techniques, and the study cohorts are not necessarily comparable regarding hiatal hernia size, severity of reflux, body mass index scores, or esophagitis scores. Dysphagia incidence was similar in both groups. Reoperation rates and safety profiles were also comparable, but the magnetic device demonstrated significant beneficial differences in allowing belching and vomiting. The magnetic device is safe, with the main adverse event being dysphagia with an approximate 3%-5% chronic incidence. Device removals in clinical trials have been between 0% and 7% and were uneventful. There have been no erosions, perforations, or infections in FDA clinical trials; erosions have rarely been noted in practice. Magnetic augmentation of the lower esophageal sphincter is a safe and effective operation for GERD, and should be considered a surgical option for those seeking a fundic-sparing operation, particularly those with parameters consistent with study cohorts. Additional randomized, controlled trials are underway.
一种用于治疗胃食管反流病（GERD）的磁性植入物于 2012 年获得美国食品和药物管理局批准，并已得到广泛评估。该设备是一个环绕胃食管交界处的磁环，增强了天然的食管下括约肌，防止反流，同时保留食管下括约肌的生理功能，并允许打嗝和呕吐。磁力具有永久性和精确性的优势，并且磁力随食管位移而减小。已经使用磁性装置对多个患者队列进行了研究，试验确立了 pH 数据、GERD 症状评分和质子泵抑制剂使用的长期一致改善。一项为期 5 年的美国食品和药物管理局试验表明，大多数患者的 pH 评分正常，85%的患者停止使用质子泵抑制剂，GERD 相关生活质量症状评分从 5 年时的 27 分提高到 4 分。有 7 项研究比较了磁性增强与腹腔镜 Nissen 胃底折叠术，结果表明，在质子泵抑制剂停药、GERD 症状评分改善以及烧心和反流评分方面，磁性装置具有相似的疗效。然而，迄今为止，尚无比较这两种技术的随机对照试验，并且研究队列在食管裂孔疝大小、反流严重程度、体重指数评分或食管炎评分方面不一定具有可比性。两组的吞咽困难发生率相似。再次手术率和安全性状况也相似，但磁性装置在允许打嗝和呕吐方面表现出显著的有益差异。磁性装置是安全的，主要不良事件是约 3%-5%的慢性发病率的吞咽困难。临床试验中的设备移除率在 0%-7%之间，且无不良事件。美国食品和药物管理局临床试验中没有发生糜烂、穿孔或感染；在实践中很少注意到糜烂。食管下括约肌的磁性增强是 GERD 的一种安全有效的手术方法，对于寻求保留胃底手术的患者，特别是与研究队列参数一致的患者，应将其视为一种手术选择。正在进行额外的随机对照试验。
