Yadlapati Rena, Masihi Melina, Gyawali C Prakash, Carlson Dustin A, Kahrilas Peter J, Nix Billy Darren, Jain Anand, Triggs Joseph R, Vaezi Michael F, Kia Leila, Kaizer Alexander, Pandolfino John E
Division of Gastroenterology, University of California, San Diego School of Medicine, La Jolla, California.
Division of Gastroenterology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
Gastroenterology. 2021 Jan;160(1):174-182.e1. doi: 10.1053/j.gastro.2020.09.013. Epub 2020 Sep 16.
Proton pump inhibitor (PPI) therapy fails to provide adequate symptom control in up to 50% of patients with gastroesophageal reflux symptoms. Although a proportion do not require ongoing PPI therapy, a diagnostic approach to identify candidates appropriate for PPI cessation is not available. This study aimed to examine the clinical utility of prolonged wireless reflux monitoring to predict the ability to discontinue PPIs.
This double-blinded clinical trial performed over 3 years at 2 centers enrolled adults with troublesome esophageal symptoms of heartburn, regurgitation, and/or chest pain and inadequate PPI response. Participants underwent prolonged wireless reflux monitoring (off PPIs for ≥7 days) and a 3-week PPI cessation intervention. Primary outcome was tolerance of PPI cessation (discontinued or resumed PPIs). Symptom burden was quantified using the Reflux Symptom Questionnaire electronic Diary (RESQ-eD).
Of 128 enrolled, 100 participants met inclusion criteria (mean age, 48.6 years; 41 men). Thirty-four participants (34%) discontinued PPIs. The strongest predictor of PPI discontinuation was number of days with acid exposure time (AET) > 4.0% (odds ratio, 1.82; P < .001). Participants with 0 days of AET > 4.0% had a 10 times increased odds of discontinuing PPI than participants with 4 days of AET > 4.0%. Reduction in symptom burden was greater among the discontinued versus resumed PPI group (RESQ-eD, -43.7% vs -5.3%; P = .04).
Among patients with typical reflux symptoms, inadequate PPI response, and absence of severe esophagitis, acid exposure on reflux monitoring predicted the ability to discontinue PPIs without symptom escalation. Upfront reflux monitoring off acid suppression can limit unnecessary PPI use and guide personalized management. (ClinicalTrials.gov, Number: NCT03202537).
在高达50%的胃食管反流症状患者中，质子泵抑制剂（PPI）治疗未能提供充分的症状控制。虽然一部分患者不需要持续的PPI治疗，但目前尚无用于识别适合停用PPI的患者的诊断方法。本研究旨在探讨延长无线反流监测对预测停用PPI能力的临床实用性。
这项为期3年的双盲临床试验在2个中心开展，纳入有烧心、反流和/或胸痛等令人困扰的食管症状且PPI反应不佳的成年人。参与者接受了延长的无线反流监测（停用PPI≥7天）和为期3周的PPI停药干预。主要结局是对停用PPI的耐受性（停用或重新开始使用PPI）。使用反流症状问卷电子日记（RESQ-eD）对症状负担进行量化。
128名入组者中，100名参与者符合纳入标准（平均年龄48.6岁；41名男性）。34名参与者（34%）停用了PPI。PPI停用的最强预测因素是酸暴露时间（AET）>4.0%的天数（优势比，1.82；P<.001）。AET>4.0%天数为0天的参与者停用PPI的几率比AET>4.0%天数为4天的参与者高10倍。与重新开始使用PPI的组相比，停用PPI组的症状负担减轻更大（RESQ-eD，-43.7%对-5.3%；P=.04）。
在有典型反流症状、PPI反应不佳且无严重食管炎的患者中，反流监测时的酸暴露可预测在无症状加重的情况下停用PPI的能力。在无酸抑制情况下进行前期反流监测可限制不必要PPI的使用并指导个性化管理。（ClinicalTrials.gov编号：NCT03202537）
