Gastroenterology Unit, Versilia Hospital, Lido di Camaiore, Italy.
Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM), and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain.
United European Gastroenterol J. 2023 Feb;11(1):103-113. doi: 10.1002/ueg2.12348. Epub 2022 Dec 23.
The optimal management of naïve and not naïve Helicobacter pylori patients remains unclear. Therefore, it is essential to evaluate whether the actual clinical practice mirrors the indications suggested by the guidelines. This study aimed to assess the effectiveness and the safety of the empirical first- and second-line treatments prescribed to patients enroled at Italian centres participating in the European Registry on H. pylori Management (Hp-EuReg).
The Hp-EuReg is an international multicentre prospective non-interventional registry starting in 2013 aiming to evaluate the management of H. pylori infection by European gastroenterologists. Patients were registered in an e-CRF by AEG-REDCap. Variables assessed included demographics, previous eradication attempts, treatment regimen, effectiveness, and tolerance.
Overall, 3723 patients from 2013 to February 2021 were included: 2996 and 727 received an empirical first- and second-line treatment, respectively. According to the modified ITT analysis, among the first-line regimens, only the bismuth quadruple therapy with three-in-one-single capsule (BQT-TSC), the concomitant, and the sequential treatment - all lasting 10 days - achieved an eradication rate >90%. Among the second-line regimens, only the 10-day BQT-TSC reported an effectiveness >90%. High-dose PPI twice daily also significantly increased the effectiveness of some therapies. The BQT-TSC was the regimen with the highest incidence of adverse events.
Only quadruple therapies lasting at least 10 days achieved over 90% eradication rates among the empirical first- and second-line regimens. It remains unclear whether high-dose PPI twice daily can improve the efficacy of quadruple treatment.
目前尚不清楚初治和非初治幽门螺杆菌患者的最佳治疗方案。因此，评估实际临床实践是否符合指南建议的指征非常重要。本研究旨在评估在意大利参与幽门螺杆菌管理欧洲注册中心（Hp-EuReg）的中心注册的患者中，经验性一线和二线治疗的疗效和安全性。
Hp-EuReg 是一项国际性、多中心、前瞻性、非干预性注册研究，于 2013 年启动，旨在评估欧洲胃肠病学家对幽门螺杆菌感染的管理。患者通过 AEG-REDCap 在电子病例报告表（e-CRF）中进行登记。评估的变量包括人口统计学、既往根除尝试、治疗方案、疗效和耐受性。
2013 年至 2021 年 2 月期间，共纳入 3723 例患者：2996 例和 727 例分别接受经验性一线和二线治疗。根据改良意向治疗（ITT）分析，在一线治疗方案中，只有三联单胶囊铋剂四联疗法（BQT-TSC）、同时和序贯治疗——所有治疗方案均持续 10 天——的根除率>90%。在二线治疗方案中，只有 10 天 BQT-TSC 的疗效>90%。高剂量质子泵抑制剂（PPI）每日两次也显著提高了某些治疗的疗效。 BQT-TSC 是不良反应发生率最高的方案。
只有持续至少 10 天的四联疗法才能在经验性一线和二线治疗方案中达到>90%的根除率。高剂量 PPI 每日两次是否能提高四联疗法的疗效仍不清楚。
