Second- and Third-Line Therapies for Helicobacter pylori Eradication in Slovenia: Data From 2013–2023 of the European Registry on H. pylori Management

IF 4.6 2区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Helicobacter Pub Date : 2025-10-30 DOI:10.1111/hel.70085

Bojan Tepes, Maja Denkovski, Nataša Brglez Jurecic, Katja Tepes, Anna Cano-Català, Pablo Parra, Leticia Moreira, Olga P. Nyssen, Francis Mégraud, Colm O'Morain, Javier P. Gisbert

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引用次数: 0

Abstract

Background

The best approach for H. pylori second- and third-line management remains unclear. The aim of this study was to evaluate the effectiveness and safety of second- and third-line H. pylori eradication regimens in Slovenia using a centralized registration database.

Methods

Patients second- and third-line eradication data from Slovenia registered in the European Registry on H. pylori Management (Hp-EuReg) from 2013 to 2024 were included. The regimens prescribed, the number of eradication attempts, effectiveness, adherence and safety were analyzed. The effectiveness was assessed by modified intention to treat (mITT).

Results

We have included 402 s-line and 81 third-line eradication regimens. By mITT analysis > 90% eradication rate for second-line regimens were achieved with 14 day quadruple regimen proton pump inhibitor (PPI) amoxicillin (A) levofloxacin (L) bismuth oxide (B) (95.7%; 95% CI 78.1%–99.9%),10 day and 14 day regimen with a PPI + A + L (90.9%, 95% CI 75.7%–98.1% and 90.2%, 95% CI 85.5%–94.9% respectively) and a 10-day regimen with a PPI combined with bismuth quadruple therapy as single capsule (100%, 95% CI 80.5%–100%). The overall eradication rate for second-line empirical treatments was 86% (95% CI 81.9%–90%), while for culture-guided treatments, it was 89.2% (95% CI 74.6%–97%; p > 0.05). In third-line treatment, the PPI and single-capsule combination therapy was the only regimen to achieve an optimal cure rate of 94.1% (95% CI 71.3%–99.9%). The eradication rate for empirical treatment was 84.4% (95% CI 72.7%–96.1%), while for culture-guided treatment it was 84.6% (95% CI 54.6%–98.1%; p > 0.05). Adverse effects were reported by 52 patients in second-line regimens (12.9%), and treatment was discontinued in 0.7% of cases, and by 12 patients (14.8%) in third-line regimens with no need for treatment discontinuation.

Conclusions

In Slovenia, H. pylori eradication therapy appears to be effective and safe in real-world clinical practice.

Trial Registration

Registered at ClinicalTrials. Gov (NCT02328131)

查看原文本刊更多论文

斯洛文尼亚根除幽门螺杆菌的二线和三线疗法：2013-2023年欧洲幽门螺杆菌管理登记处的数据

背景幽门螺杆菌二线和三线治疗的最佳方法尚不清楚。本研究的目的是利用集中登记数据库评估斯洛文尼亚二线和三线幽门螺杆菌根除方案的有效性和安全性。方法纳入2013年至2024年在欧洲幽门螺杆菌管理登记处（Hp-EuReg）登记的斯洛文尼亚患者的二线和三线根除数据。分析了处方方案、根除次数、有效性、依从性和安全性。采用改良治疗意向（mITT）评价疗效。结果纳入402个s线和81个三线根除方案。采用质子泵抑制剂（PPI）、阿莫西林(A)、左氧氟沙星(L)、氧化铋(B)的14天四联方案（95.7%,95% CI 78.1%-99.9%）、PPI + A + L的10天和14天方案（分别为90.9%,95% CI 75.7%-98.1%和90.2%,95% CI 85.5%-94.9%）和PPI联合铋四联单胶囊治疗的10天方案（100%,95% CI 80.5%-100%），二线方案的根除率达到90%。二线经验处理的总根除率为86% (95% CI 81.9%-90%)，而培养引导处理的总根除率为89.2% （95% CI 74.6%-97%; p > 0.05）。在三线治疗中，PPI和单胶囊联合治疗是唯一达到94.1%最佳治愈率的方案（95% CI 71.3%-99.9%）。经验处理的根除率为84.4% (95% CI 72.7% ~ 96.1%)，而培养引导处理的根除率为84.6% （95% CI 54.6% ~ 98.1%; p > 0.05）。二线方案中有52例（12.9%）患者报告了不良反应，0.7%的病例停止治疗，三线方案中有12例（14.8%）患者报告了不需要停药的不良反应。结论在斯洛文尼亚，幽门螺杆菌根除治疗在现实世界的临床实践中似乎是有效和安全的。在ClinicalTrials注册。政府(NCT02328131)

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来源期刊

Helicobacter 医学-微生物学

CiteScore

8.40

自引率

9.10%

发文量

审稿时长

2 months

期刊介绍： Helicobacter is edited by Professor David Y Graham. The editorial and peer review process is an independent process. Whenever there is a conflict of interest, the editor and editorial board will declare their interests and affiliations. Helicobacter recognises the critical role that has been established for Helicobacter pylori in peptic ulcer, gastric adenocarcinoma, and primary gastric lymphoma. As new helicobacter species are now regularly being discovered, Helicobacter covers the entire range of helicobacter research, increasing communication among the fields of gastroenterology; microbiology; vaccine development; laboratory animal science.