Background and Aims

GERD patients frequently complain of regurgitation of gastric contents. Medical therapy with proton-pump inhibitors (PPIs) is frequently ineffective in alleviating regurgitation symptoms, because PPIs do nothing to restore a weak lower esophageal sphincter. Our aim was to compare effectiveness of increased PPI dosing with laparoscopic magnetic sphincter augmentation (MSA) in patients with moderate-to-severe regurgitation despite once-daily PPI therapy.

Methods

One hundred fifty-two patients with GERD, aged ≥21 years with moderate-to-severe regurgitation despite 8 weeks of once-daily PPI therapy, were prospectively enrolled at 21 U.S. sites. Participants were randomized 2:1 to treatment with twice-daily (BID) PPIs (N = 102) or to laparoscopic MSA (N = 50). Standardized foregut symptom questionnaires and ambulatory esophageal reflux monitoring were performed at baseline and at 6 months. Relief of regurgitation, improvement in foregut questionnaire scores, decrease in esophageal acid exposure and reflux events, discontinuation of PPIs, and adverse events were the measures of efficacy.

Results

Per protocol, 89% (42/47) of treated patients with MSA reported relief of regurgitation compared with 10% (10/101) of the BID PPI group (P < .001) at the 6-month primary endpoint. By intention-to-treat analysis, 84% (42/50) of patients in the MSA group and 10% (10/102) in the BID PPI group met this primary endpoint (P < .001). Eighty-one percent (38/47) of patients with MSA versus 8% (7/87) of patients with BID PPI had ≥50% improvement in GERD–health-related quality of life scores (P < .001), and 91% (43/47) remained off of PPI therapy. A normal number of reflux episodes and acid exposures was observed in 91% (40/44) and 89% (39/44) of MSA patients, respectively, compared with 58% (46/79) (P < .001) and 75% (59/79) (P = .065) of BID PPI patients at 6 months. No significant safety issues were observed. In MSA patients, 28% reported transient dysphagia; 4% reported ongoing dysphagia.

Conclusion

Patients with GERD with moderate-to-severe regurgitation, especially despite once-daily PPI treatment, should be considered for minimally invasive treatment with MSA rather than increased PPI therapy. (Clinical trial registration number: NCT02505945.)

中文翻译：

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腹腔镜括约肌增强与双剂量质子泵抑制剂治疗GERD中度至重度反流：一项随机对照试验

背景和目标

GERD患者经常抱怨胃内容物反流。质子泵抑制剂（PPI）的药物治疗通常无法缓解反流症状，因为PPI并不能恢复弱的食管下括约肌。我们的目的是比较尽管每天进行PPI疗法，但对中度至重度反流患者使用PPI剂量增加与腹腔镜电磁括约肌增强（MSA）的效果。

方法

尽管每天进行一次PPI治疗8周，但有152例年龄≥21岁的GERD患者，年龄≥21岁，在美国的21个地点进行了前瞻性研究。参与者以2：1的比例随机接受每日两次（BID）PPI（N = 102）或腹腔镜MSA（N = 50）的治疗。在基线和6个月时进行标准化的前肠症状调查表和动态食管反流监测。缓解反流，改善前肠调查问卷评分，减少食管酸暴露和反流事件，中止PPI和不良事件是疗效的衡量标准。

结果

根据协议， 在6个月的主要终点研究中，有89％（42/47）的MSA治疗患者报告了反流缓解，而BID PPI组的这一比例为10％（10/101）（P <.001）。通过意向性治疗分析，MSA组中84％（42/50）的患者和BID PPI组中10％（10/102）的患者达到了该主要终点（P  <.001）。MSA患者的81％（38/47）与BID PPI患者的8％（7/87）相比，与GERD-健康相关的生活质量得分提高了50％以上（P  <.001），和91 ％（43/47）仍未使用PPI治疗。在MSA患者中，分别有91％（40/44）和89％（39/44）的患者出现正常的反流发作和酸暴露，而58％（46/79）的患者则是正常（P  <.001）和75 ％（59/79）（P = .065）BID PPI患者在6个月时。没有观察到重大的安全问题。在MSA患者中，有28％的人报告了暂时性吞咽困难。4％的人报告吞咽困难。

结论

具有中度至重度反流的GERD患者，尤其是尽管每天进行一次PPI治疗，仍应考虑采用MSA进行微创治疗，而不是增加PPI治疗。（临床试验注册号：NCT02505945。）