幽门螺杆菌感染及其根除对胃食管反流病患者的影响：一项平行分组、双盲、安慰剂对照的多中心研究。

The effect of Helicobacter pylori infection and eradication in patients with gastro-oesophageal reflux disease: A parallel-group, double-blind, placebo-controlled multicentre study.

机构信息

University Hospital Zürich, Zürich, Switzerland ; Zurich Center for Integrative Human Physiology (ZIHP), Zurich, Switzerland.

Menne Biomed, Tübingen, Germany.

出版信息

United European Gastroenterol J. 2013 Aug;1(4):226-35. doi: 10.1177/2050640613484020.

DOI:10.1177/2050640613484020

PMID:24917966

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4040789/

Abstract

OBJECTIVES

This study aimed to resolve controversy regarding the effects of Helicobacter pylori eradication therapy and H. pylori infection in gastro-oesophageal reflux disease.

DESIGN

A randomized, double-blind, multicentre trial was performed in patients presenting with reflux symptoms. H. pylori-positive patients were randomized to receive either antibiotics or placebo for 7 days. H. pylori-negative patient controls received placebo. All received esomeprazole 20 mg b.d. for 7 days, followed by 40 mg o.d. to complete an 8-week course, and were followed up for 32 weeks by telephone.

RESULTS

In this study, 198/589 (34%) patients were H. pylori-positive and 113 H. pylori-negative patients served as controls. Baseline endoscopy revealed 63% Los Angeles grade 0A and 37% Los Angeles grade BCD oesophagitis with no difference between patient groups. Symptom improvement on esomeprazole was seen in 89%. H. pylori eradication was successful in 82%. H. pylori eradication had no effect on symptomatic relapse (hazard ratio 1.15, 95% CI 0.74-1.8; p = 0.5). Overall, H. pylori-positive patients had a lower probability of relapse compared to H. pylori-negative controls (hazard ratio 0.6, 95% CI 0.43-0.85; p = 0.004). Relapse hazard was modulated also by oesophagitis grade (BCD vs. 0A, hazard ratio 2.1, 95% CI 1.5-3.0).

CONCLUSION

Relapse of gastro-oesophageal reflux disease symptoms after a course of high dose acid suppression took longer for H. pylori-positive patients than H. pylori-negative controls; however eradication therapy had no effect on the risk of relapse; ClincialTrials.gov number, NCT00574925.

摘要

目的

本研究旨在解决关于幽门螺杆菌（H. pylori）根除治疗和 H. pylori 感染对胃食管反流病（GERD）影响的争议。

设计

在出现反流症状的患者中进行了一项随机、双盲、多中心试验。H. pylori 阳性患者被随机分为接受抗生素或安慰剂治疗 7 天。H. pylori 阴性患者对照接受安慰剂。所有患者均接受埃索美拉唑 20mg，每日 2 次，共 7 天，然后改为每日 40mg，完成 8 周疗程，并通过电话随访 32 周。

结果

在这项研究中，589 例患者中有 198 例（34%）为 H. pylori 阳性，113 例 H. pylori 阴性患者作为对照。基线内镜检查显示 63%为洛杉矶分级 0A，37%为洛杉矶分级 BCD 食管炎，两组患者无差异。埃索美拉唑治疗后症状改善率为 89%。H. pylori 根除成功率为 82%。H. pylori 根除对症状复发无影响（风险比 1.15，95%CI 0.74-1.8；p=0.5）。总体而言，H. pylori 阳性患者复发的可能性低于 H. pylori 阴性对照组（风险比 0.6，95%CI 0.43-0.85；p=0.004）。食管炎分级（BCD 与 0A）也调节了复发风险（比值比 2.1，95%CI 1.5-3.0）。