Risultati per: ACG: linee guida sul trattamento dell’infezione da Helicobacter pylori

Screening for, and treating, Helicobacter pylori (H. pylori) in the general population or patients with early gastric neoplasia could reduce incidence of, and mortality from, gastric cancer. We updated a meta-analysis of randomized controlled trials (RCTs) examining this issue.

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Introduction
Helicobacter pylori is a major health problem, with the high prevalence of H. pylori and the increasing antibiotic resistance rate in China. Antibiotic resistance is the main reason for the failure of H. pylori eradication. This study aims to evaluate the efficacy and safety of susceptibility-guided quadruple therapy with antibiotic resistance using the string test coupled with quantitative PCR (qPCR) for H. pylori eradication.

Methods and analysis
This is a multicentre, open, randomised clinical trial that will enroll 324 patients with H. pylori infection. Patients will be randomised to two groups for a 14-day treatment: Treatment group will be treated with proton pump inhibitor (PPI), bismuth with two different kinds of antibiotics susceptibly guided by string test coupled with qPCR, while control group will be treated empirically with PPI, bismuth with two different kinds of antibiotics. The types and dosages of bismuth, PPI and antibiotics administered in this trial are based on the 2022 Chinese Guidelines for the treatment of H. pylori infection and the Sixth Chinese National Consensus Report on the management of H. pylori infection. The primary endpoint is the eradication rate, while secondary endpoints include compliance, the incidence of adverse events and adverse drug reactions.

Ethics and dissemination
This study was approved by the ethics committee of the Third People’s Hospital of Zhengzhou (No. 2024-04-001-K02). The results will be published in the appropriate peer-reviewed journal.

Trial registration number
ChiCTR2400082768.

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Background
Bismuth quadruple therapies (BQTs) including bismuth, a proton pump inhibitor (PPI) and two antibiotics have been shown to be highly effective for treating Helicobacter pylori infection even in areas of high bacterial antibiotic resistance.

Objective
To describe the time trends of use, effectiveness and safety of BQT in Europe using the European Registry on Helicobacter pylori Management (Hp-EuReg).

Design
Patients registered in the Hp-EuReg from 2013 to 2021 who had received BQT were included. The regimens prescribed, the number of eradication attempts, effectiveness, adherence and safety were analysed. The effectiveness was assessed by modified intention to treat (mITT). Time-trend and multivariate analyses were performed to determine variables that predicted treatment success.

Results
Of the 49 690 patients included in the Hp-EuReg, 15 582 (31%) had received BQT. BQT use increased from 8.6% of all treatments in 2013 to 39% in 2021. Single-capsule BQT—containing bismuth, metronidazole and tetracycline—plus a PPI (single-capsule BQT, ScBQT) was the most frequent treatment mode (43%). Schemes that obtained an effectiveness above 90% were the 10-day ScBQT and 14-day BQT using tetracycline plus metronidazole, or amoxicillin plus either clarithromycin or metronidazole. Only ScBQT achieved above 90% cure rates in all the geographical areas studied. Using the ScBQT scheme, adherence, the use of standard or high-dose PPIs, 14-day prescriptions and the use of BQT as first-line treatment were significantly associated with higher mITT effectiveness.

Conclusion
The use of BQT increased notably in Europe over the study period. A 10-day ScBQT was the scheme that most consistently achieved optimal effectiveness.

Trial registration number
NCT02328131.

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