Ambulatory Reflux Monitoring Guides Proton Pump Inhibitor Discontinuation in Patients With Gastroesophageal Reflux Symptoms: A Clinical Trial.
Ambulatory Reflux Monitoring Guides Proton Pump Inhibitor Discontinuation in Patients With Gastroesophageal Reflux Symptoms: A Clinical Trial.
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DOI：
10.1053/j.gastro.2020.09.013
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发表时间：
2021-01
期刊：
影响因子：
29.4
通讯作者：
Pandolfino JE
中科院分区：
文献类型：
--
作者：
Yadlapati R;Masihi M;Gyawali CP;Carlson DA;Kahrilas PJ;Nix BD;Jain A;Triggs JR;Vaezi MF;Kia L;Kaizer A;Pandolfino JE
质子泵抑制剂（PPI）治疗无法为高达50%的胃食管反流症状患者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，但目前还没有一种诊断方法来确定适合停止PPI治疗的候选人。本研究旨在检查长期无线反流监测的临床效用，以预测停用PPI的能力。这项双盲临床试验在两个中心进行了三年多，招募了患有胃灼热、反流和/或胸痛等食管症状和PPI反应不足的成人。参与者接受了长时间的无线反流监测（关闭PPI ≥7天）和为期3周的PPI停止干预。主要结局是对PPI停药的耐受性（停药或恢复PPI）。使用反流症状问卷电子日记（RESQ-eD）量化症状负担。在128名入组者中，100名参与者符合入选标准（平均年龄48.6岁; 41名男性）。34例（34%）受试者停用PPI。PPI停药的最强预测因子是酸暴露时间（AET）>4.0%的天数（OR 1.82;p<0.001）。与AET>4.0%的4天参与者相比，AET> 4.0%的0天参与者停用PPI的几率增加了10倍。停用PPI组与恢复PPI组相比，症状负担减轻程度更大（RESQ-eD：−43.7% vs −5.3%;p=0.04）。在具有典型反流症状、PPI反应不充分且没有严重食管炎的患者中，反流监测中的酸暴露可预测在不出现症状升级的情况下停用PPI的能力。提前监测胃酸抑制的反流可以限制不必要的PPI使用，并指导个性化管理。ClinicalTrials.gov：NCT03202537
Proton pump inhibitor (PPI) therapy fails to provide adequate symptom control in up to 50% of patients with gastroesophageal reflux symptoms. While 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 ability to discontinue PPI. This double-blinded clinical trial performed over three years at two 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 PPI for ≥7 days) and a three-week PPI cessation intervention. Primary outcome was tolerance of PPI cessation (discontinued or resumed PPI). 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 male). Thirty-four (34%) participants discontinued PPI. The strongest predictor of PPI discontinuation was number of days with acid exposure time (AET)>4.0% (OR 1.82;p<0.001). 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=0.04). Among patients with typical reflux symptoms, inadequate PPI response, and absence of severe esophagitis, acid exposure on reflux monitoring predicted ability to discontinue PPI without symptom escalation. Upfront reflux monitoring off acid suppression can limit unnecessary PPI use and guide personalized management. ClinicalTrials.gov:NCT03202537
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影响因子：
2.3
作者：
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通讯作者：
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