First-Line Therapy for Helicobacter pylori in Slovenia: Data From 2013 to 2023 of the European Registry on H. pylori Management

IF 4.3 2区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Helicobacter Pub Date : 2025-04-03 DOI:10.1111/hel.70029

Bojan Tepes, Nataša Brglez Jurečič, Maja Denkovski, Miroslav Vujasinovič, Zdenko Kikec, Jurij Bednarik, 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

Treatment is indicated for all Helicobacter pylori infections. However, the best approach for H. pylori management remains unclear.

Methods

H. pylori eradication data from Hp-EuReg on treatment-naive patients in Slovenia from 2013 to 2023 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

Eight Slovenian medical institutions contributed data for 4016 treatment-naive patients to Hp-EuReg. Of these, 18% did not undergo confirmatory post-treatment; most who did received a urea breath test. Between 2013 and 2018, 7-day triple therapy with amoxicillin and clarithromycin was most frequently used in first-line treatment, with an 88% eradication rate. From 2019 to 2023, a 14-day high-dose PPI (esomeprazole 40 mg b.i.d.) triple therapy with amoxicillin and clarithromycin was used, showing a significantly higher effectiveness at 94% (p < 0.05). Quadruple bismuth-based therapy (esomeprazole 40 mg b.i.d., plus amoxicillin 500 mg, metronidazole 400 mg, and bismuth 120 mg, all q.i.d.) provided a 96.9% eradication rate, though this was not significantly better than the 14-day triple regimen. The H. pylori resistance rate to clarithromycin was 16% from 2013 to 2018, dropping to 13.5% from 2019 to 2023. Side effects were reported by 9.6% of patients, and treatment compliance was > 99%.

Conclusions

The study suggests that systematic data collection from routine clinical practice in Hp-EuReg can guide first-line H. pylori treatment. Established 90% treatment effectiveness threshold may serve as a surrogate marker for monitoring H. pylori resistance rates to antibiotics. In countries with a H. pylori resistance rate < 15%, such as Slovenia, the 14-day high-dose PPI amoxicillin-clarithromycin regimen is an optimal first-line empirical treatment.

Trial Registration: NCT02328131

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背景所有幽门螺旋杆菌感染都需要治疗。然而，治疗幽门螺杆菌的最佳方法仍不明确。方法本文纳入了 Hp-EuReg 提供的 2013 年至 2023 年斯洛文尼亚接受过治疗的患者的幽门螺杆菌根除数据。对处方方案、根除尝试次数、有效性、依从性和安全性进行了分析。疗效通过改良意向治疗（mITT）进行评估。结果 8 家斯洛文尼亚医疗机构向 Hp-EuReg 提供了 4016 名未经治疗患者的数据。其中，18%的患者未接受治疗后确诊；大部分接受治疗的患者接受了尿素呼气试验。2013年至2018年期间，阿莫西林和克拉霉素的7天三联疗法最常用于一线治疗，根除率为88%。从2019年到2023年，使用了14天大剂量PPI（埃索美拉唑40毫克，每天两次）与阿莫西林和克拉霉素的三联疗法，显示出显著较高的有效率，达到94%（p <0.05）。以铋剂为基础的四联疗法（埃索美拉唑 40 毫克，每天两次，外加阿莫西林 500 毫克、甲硝唑 400 毫克和铋剂 120 毫克，每天三次）的根除率为 96.9%，但与 14 天的三联疗法相比，效果并不明显。2013年至2018年，克拉霉素的幽门螺杆菌耐药率为16%，2019年至2023年降至13.5%。9.6%的患者报告了副作用，治疗依从性为> 99%。结论该研究表明，从 Hp-EuReg 的常规临床实践中系统地收集数据可以指导幽门螺杆菌的一线治疗。既定的 90% 治疗有效阈值可作为监测幽门螺杆菌对抗生素耐药率的替代指标。在幽门螺杆菌耐药率为15%的国家，如斯洛文尼亚，14天大剂量PPI阿莫西林-卡里霉素方案是最佳的一线经验性治疗方案。试验注册：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.