2013年至2021年期间治疗幽门螺杆菌感染的含铋四联疗法的使用情况、有效性和安全性的演变：欧洲幽门螺杆菌管理登记处（Hp-EuReg）的结果

IF 23 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Gut Pub Date : 2024-10-26 DOI:10.1136/gutjnl-2024-332804

Llum Olmedo, Xavier Calvet, Emili Gené, Dmitry S Bordin, Irina Voynovan, M. Castro-Fernandez, Manuel Pabón-Carrasco, Alma Keco-Huerga, Ángeles Perez-Aisa, Alfredo J Lucendo, Luís Rodrigo, Aiman S Sarsenbaeva, Igor B Khlinov, Galyna Fadieienko, Oleg Zaytsev, Ángel Lanas, Samuel J Martínez-Domínguez, Enrique Alfaro, Laimas Jonaitis, Óscar Núñez, Rinaldo Pellicano, Luis Hernández, Oleksiy Gridnyev, Juozas Kupcinskas, Antonio Gasbarrini, Doron Boltin, Yaron Niv, Gülüstan Babayeva, Ricardo Marcos-Pinto, Bojan Tepes, Marino Venerito, Veronika Papp, Frode Lerang, Mārcis Leja, Perminder S Phull, Wojciech Marlicz, Michael Doulberis, Sinead M Smith, Vladimir Milivojevic, Lumir Kunovsky, Antonio Mestrovic, Tamara Matysiak-Budnik, Halis Simsek, Anna Cano-Català, Ignasi Puig, Leticia Moreira, Pablo Parra, Olga P Nyssen, Francis Megraud, Colm O'Morain, Javier P Gisbert

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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%). 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引用次数: 0

摘要

背景铋剂四联疗法（BQTs）包括铋剂、一种质子泵抑制剂（PPI）和两种抗生素，即使在细菌对抗生素耐药性较高的地区，该疗法对治疗幽门螺旋杆菌感染也非常有效。目的利用欧洲幽门螺杆菌管理登记处（Hp-EuReg）描述欧洲使用 BQT 的时间趋势、有效性和安全性。设计纳入 2013 年至 2021 年在 Hp-EuReg 登记并接受过 BQT 治疗的患者。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。进行了时间趋势和多变量分析，以确定预测治疗成功的变量。结果在纳入 Hp-EuReg 的 49 690 名患者中，15 582 人（31%）接受了 BQT 治疗。BQT在所有治疗中的使用率从2013年的8.6%增至2021年的39%。含铋剂、甲硝唑和四环素的单胶囊BQT加PPI（单胶囊BQT，ScBQT）是最常见的治疗模式（43%）。有效率超过 90% 的方案是使用四环素加甲硝唑或阿莫西林加克拉霉素或甲硝唑的 10 天 ScBQT 和 14 天 BQT。在研究的所有地区中，只有 ScBQT 的治愈率超过 90%。使用 ScBQT 方案、坚持治疗、使用标准或大剂量 PPIs、14 天处方以及将 BQT 作为一线治疗与较高的 mITT 有效率显著相关。结论在研究期间，欧洲 BQT 的使用明显增加。为期 10 天的 ScBQT 是最能持续获得最佳疗效的方案。试验注册号[NCT02328131][1]。与该研究相关的所有数据均包含在文章中或作为在线补充信息上传。[1]:/lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02328131&atom=%2Fgutjnl%2Fearly%2F2024%2F10%2F25%2Fgutjnl-2024-332804.atom

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Evolution of the use, effectiveness and safety of bismuth-containing quadruple therapy for Helicobacter pylori infection between 2013 and 2021: results from the European registry on H. pylori management (Hp-EuReg)

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][1]. All data relevant to the study are included in the article or uploaded as online supplemental information. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02328131&atom=%2Fgutjnl%2Fearly%2F2024%2F10%2F25%2Fgutjnl-2024-332804.atom

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来源期刊

Gut 医学-胃肠肝病学

CiteScore

45.70

自引率

2.40%

发文量

284

审稿时长

1.5 months

期刊介绍： Gut is a renowned international journal specializing in gastroenterology and hepatology, known for its high-quality clinical research covering the alimentary tract, liver, biliary tree, and pancreas. It offers authoritative and current coverage across all aspects of gastroenterology and hepatology, featuring articles on emerging disease mechanisms and innovative diagnostic and therapeutic approaches authored by leading experts. As the flagship journal of BMJ's gastroenterology portfolio, Gut is accompanied by two companion journals: Frontline Gastroenterology, focusing on education and practice-oriented papers, and BMJ Open Gastroenterology for open access original research.