Effect of the transcutaneous electrical stimulation system on esophageal-acid exposure in patients non-responsive to once-daily proton-pump inhibitor:proof-of-concept study  

经皮电刺激系统对标准剂量质子泵抑制剂无应答患者食管酸暴露的治疗效果:概念验证性研究

作　　者：Ram Dickman Sigal Levy Tsachi Tsadok Perets Maor Hazani-Pauker Doron Boltin Hemda Schmilovitz-Weiss Issa Nidal Matan Siterman Dan Carter Ronnie Fass Rachel Gingold-Belfer 

机构地区：[1]Department of Gastroenterology,Rabin Medical Center,Beilinson Campuses,Petah Tikva and Sackler Faculty of Medicine,Tel Aviv University,Tel Aviv,Israel [2]Statistics Education Unit,Academic College of Tel Aviv-Yafo,Tel Aviv-Yafo,Israel [3]Department of Surgery B,Rabin Medical Center,Hasharon Campus,Petah Tikva and Sackler Faculty of Medicine,Tel Aviv University,Tel Aviv,Israel [4]Division of Gastroenterology and Hepatology,Chaim Sheba Medical Center,Ramat Gan and Sackler Faculty of Medicine,Tel Aviv University,Tel Aviv,Israel [5]Division of Gastroenterology and Hepatology,Metrohealth Medical Center,Cleveland,OH,USA

出　　处：《Gastroenterology Report》2021年第4期323-328,I0002,共7页胃肠病学报道（英文）

摘　　要：Background:Gastroesophageal reflux disease(GERD)is a common disorder.Overall,≤35%of GERD patients fail the standard dose of proton-pump-inhibitor(PPI)treatment.Due to the high prevalence and low satisfaction rate with treatment failure,there is an unmet need for new treatment.Our aim was to evaluate whether the use of the transcutaneous electrical stimulation system(TESS)can reduce esophageal-acid exposure in GERD patients unresponsive to standard-dose PPI.Methods:We enrolled 10 patients suffering from heartburn and regurgitation with an abnormal esophageal-acid exposure(off PPIs)who failed standard-dose PPI.After the placement of a wireless esophageal pH capsule,all patients were treated with TESS.The primary end point was the reduction in the baseline(pretreatment)24-hour percent total time pH<4 and/or DeMeester score by 50%.Results:Seven GERD patients(five females and two males,aged 49.3610.1 years)completed the study.At baseline,the mean percent total time pH<4 was 12.064.9.Following TESS,the mean percent total time pH<4 dropped to 5.563.4,4.562.6,3.762.9,and 4.462.5 on Days 1,2,3,and 4,respectively.At baseline,the mean DeMeester score was 39.0618.5.After TESS,the mean DeMeester score dropped to 15.869.2,13.266.8,11.269.4,and 12.066.8 on Days 1,2,3,and 4,respectively.Conclusion:TESS is a safe and potentially effective modality in reducing esophageal-acid exposure in GERD patients unresponsive to standard-dose PPI.A larger and prospective controlled study is needed to verify these preliminary results.背景:胃食管反流病(GERD)是一种常见病。有接近35%的GERD患者无法通过标准剂量质子泵抑制剂(PPI)治疗控制症状。考虑到PPI治疗的高失败率和低满意度,GERD患者需要一种新的治疗方法。本研究旨在评估经皮电刺激系统(TESS)能否减轻标准剂量PPI治疗失败的GERD患者的食管酸暴露。方法:我们前瞻性入组了10例标准剂量PPI治疗失败、具有烧心和反流症状且食管酸暴露异常的GERD患者。在放置了食管pH胶囊后,所有患者予以TESS治疗。主要研究终点是24小时内pH<4时长占比下降和/或DeMeester评分减少50%。结果:最终7例GERD患者完成研究,其中男性2例,女性5例,年龄(49.3˘10.1)岁。治疗前24小时内pH<4时长占比为(12.0˘4.9)%;TESS治疗后14天,该占比分别为(5.5˘3.4)%、(4.5˘2.6)%、(3.7˘2.9)%和(4.4˘2.5)%。治疗前平均DeMeester评分为39.0˘18.5;TESS治疗14天,该评分分别降至15.8˘9.2、13.2˘6.8、11.2˘9.4和12.0˘6.8。结论:对于标准剂量PPI治疗失败的GERD患者,TESS是一种安全且潜在有效的治疗方法,可以减轻食管酸暴露。需要大样本前瞻性对照研究来验证上述初步结果。

关 键 词：gastroesophageal reflux disease transcutaneous electrical stimulation system proton-pump inhibitor 

分 类 号：R57[医药卫生—消化系统]