12个月抗反流黏膜消融治疗的疗效与安全性

Efficacy and safety of anti-reflux mucosal ablation therapy at 12 months.

作者信息

Koduri Krithi Krishna, Singla Neeraj, Maragoni Rajesh Goud, Jagtap Nitin, Singh Aniruddha Pratap, Kalapala Rakesh, Reddy D Nageshwar

机构信息

Department of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, 500 082, India.

出版信息

Indian J Gastroenterol. 2025 Jun 11. doi: 10.1007/s12664-025-01761-z.

DOI:10.1007/s12664-025-01761-z

PMID:40498286

Abstract

BACKGROUND AND OBJECTIVES

Anti-reflux mucosal ablation (ARMA) is a minimally invasive therapy for patients with proton pump inhibitor (PPI) controlled gastro-esophageal reflux disease (GERD). This study evaluated the safety and efficacy of ARMA over 12 months.

METHODS

This single-center prospective study included PPI-dependent GERD patients (acid exposure time [AET] > 6% or AET > 4.2% with reflux episodes > 80 on 24-h-pH-impedance monitoring). ARMA was performed in a standardized fashion using hybrid technique (sub-mucosal lift followed by ablation). Patients were evaluated using the GERD health-related quality of life questionnaire (HRQL) at baseline, three months and 12 months, with 24-h-pH-impedance monitoring at baseline and 12 months.

RESULTS

Total 216 patients (67.1% males, mean age = 38.7 years) underwent ARMA. At baseline, 123 (56.9%) patients had Hill's grade I and 93 (43.1%) had Hill's grade II on endoscopy. Ninety (41.7%) patients had Los Angeles (LA) grade A and 2 (0.93%) had LA grade B. There was a significant improvement in GERD-HRQL score from 43.8 (12.6) at baseline to 20.6 (13.8) at three months and to 8.3 (12.3) at 12 months (p = 0.001). The mean (SD) heartburn and regurgitation scores improved from 22.9 (10.8) and 20.6 (9.4) at baseline to 11.1 (8.7) and 9.5 (8.7) at three months and 3.9 (6.9) and 3.9 (6.9) at 12 months, respectively (p = 0.001). The AET (median [IQR]) decreased from 11.9 (15.9) to 7.6 (10.8) (n = 125, p = 0.009) at 12 months and the median DeMeester score reduced from 42.4 (47.1) to 26.2 (32.3) (p = 0.001). There was also a significant decrease in number of patients with AET 4% to 6% and > 6% and reflux episodes 40-80 and > 80 and DeMeester score > 14.72, as well as an increase in patients with AET < 4% and reflux episodes < 40. There was a significant improvement in Hill's grading and endoscopic esophagitis at one year. No major adverse events were observed.

CONCLUSION

In PPI-dependent GERD patients, ARMA resulted in sustained symptom reduction and improved quality of life at 12 months. This procedure is relatively simple, widely accessible and has a good safety profile.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov (NCT04243668).

摘要

背景与目的

抗反流黏膜切除术（ARMA）是一种用于质子泵抑制剂（PPI）控制的胃食管反流病（GERD）患者的微创治疗方法。本研究评估了ARMA在12个月内的安全性和有效性。

方法

这项单中心前瞻性研究纳入了依赖PPI的GERD患者（24小时pH阻抗监测显示酸暴露时间[AET]＞6%或AET＞4.2%且反流发作次数＞80次）。采用混合技术（黏膜下抬举后消融）以标准化方式进行ARMA。在基线、3个月和12个月时使用GERD健康相关生活质量问卷（HRQL）对患者进行评估，并在基线和12个月时进行24小时pH阻抗监测。

结果

共有216例患者（67.1%为男性，平均年龄38.7岁）接受了ARMA。基线时，123例（56.9%）患者在内镜检查中为希尔I级，93例（43.1%）为希尔II级。90例（41.7%）患者为洛杉矶（LA）A级，2例（0.93%）为LA B级。GERD-HRQL评分从基线时的43.8（12.6）显著改善至3个月时的20.6（13.8）以及12个月时的8.3（12.3）（p = 0.001）。烧心和反流评分的均值（标准差）分别从基线时的22.9（10.8）和20.6（9.4）改善至3个月时的11.1（8.7）和9.5（8.7）以及12个月时的3.9（6.9）和3.9（6.9）（p = 0.001）。12个月时AET（中位数[四分位间距]）从11.9（15.9）降至7.6（10.8）（n = 125，p = 0.009），DeMeester评分中位数从42.4（47.1）降至26.2（32.3）（p = 第0.001）。AET为4%至6%和＞6%以及反流发作次数为40 - 80次和＞80次且DeMeester评分＞14.72的患者数量也显著减少，而AET＜4%和反流发作次数＜40次的患者数量增加。1年后希尔分级和内镜下食管炎有显著改善。未观察到重大不良事件。