斯洛文尼亚幽门螺杆菌的一线治疗：2013年至2023年欧洲幽门螺杆菌管理登记数据。

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

作者信息

Tepes Bojan, Jurečič Nataša Brglez, Denkovski Maja, Vujasinovič Miroslav, Kikec Zdenko, Bednarik Jurij, Tepes Katja, Cano-Català Anna, Parra Pablo, Moreira Leticia, Nyssen Olga P, Mégraud Francis, O'Morain Colm, Gisbert Javier P

机构信息

Diagnostic Center, Rogaška Slatina, Slovenia.

Diagnostic Center, Bled, Slovenia.

出版信息

Helicobacter. 2025 Mar-Apr;30(2):e70029. doi: 10.1111/hel.70029.

DOI:10.1111/hel.70029

PMID:40178062

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.

摘要

背景

所有幽门螺杆菌感染均需进行治疗。然而，幽门螺杆菌管理的最佳方法仍不明确。

方法

纳入了来自Hp-EuReg的2013年至2023年斯洛文尼亚初治患者的幽门螺杆菌根除数据。分析了所开的治疗方案、根除尝试次数、有效性、依从性和安全性。有效性通过改良意向性治疗（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例初治患者的数据。其中，18%的患者未进行治疗后确认；大多数进行确认的患者接受了尿素呼气试验。2013年至2018年，一线治疗中最常使用阿莫西林和克拉霉素的7天三联疗法，根除率为88%。2019年至2023年，使用了含埃索美拉唑40mg每日两次的14天高剂量质子泵抑制剂（PPI）联合阿莫西林和克拉霉素的三联疗法，有效性显著更高，为94%（p<0.05）。含铋四联疗法（埃索美拉唑40mg每日两次，加阿莫西林500mg、甲硝唑400mg和铋120mg，均每日四次）的根除率为96.9%，但并不显著优于14天三联疗法。2013年至2018年，幽门螺杆菌对克拉霉素的耐药率为16%，2019年至2023年降至13.5%。9.6%的患者报告有副作用，治疗依从性>99%。