Bismuth-based quadruple therapy versus standard triple therapy for the eradication of Helicobacter pylori in Belgium: a multicentre, non-blinded randomized, prospective study.

IF 1.3 4区医学 Q4 GASTROENTEROLOGY & HEPATOLOGY

Acta gastro-enterologica Belgica Pub Date : 2024-04-01 DOI:10.51821/87.2.12142

S François, F Mana, R Ntounda, V Lamy, S Cadranel, P Bontems, V Miendje Deyi, E Macken, S Kindt

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引用次数: 0

Abstract

Background: Helicobacter pylori (Hp) infection predisposes to malignant and non-malignant diseases warranting eradication. In Belgium, resistance rates for clarithromycin demonstrate regional variations making the use of standard triple therapy (STT) borderline acceptable. According to a recent Belgian survey, STT and bismuth-based quadruple therapy (BQT), are equally frequent prescribed as first line treatment for treatment naïve Hp positive patients. This study aims to evaluate the eradication rates (ER) of BQT versus STT.

Methods: Multicentre, non-blinded randomized, prospective study comparing ER in treatment-naïve Hp positive patients. ER were compared by intention to treat (ITT) and per protocol (PP) analysis.

Results: Overall 250 patients were included (STT 126, BQT 124). Seventeen patients were lost to follow-up (6,8%). No significant difference in ER between BQT and STT was observed in ITT (73% vs 68%, p= 0,54) neither in PP analysis (81% vs 75%, p= 0,33). Side effects and endoscopic findings were comparable between groups. Post-hoc analysis showed no differences according to gender or site allocation.

Conclusion: The numerical advantage of BQT did not translate in a significant improvement of ER when compared with STT. These results question the cost-effectiveness of BQT, while confirming the suboptimal eradication rates on STT. A nationwide monitoring of resistance patterns, maximal investments in treatment adherence as well as a detailed follow-up of the changing treatment landscape are mandatory to continuously optimise Hp ER in Belgium.

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比利时根除幽门螺杆菌的铋剂四联疗法与标准三联疗法：一项多中心、非盲法随机前瞻性研究。

背景：幽门螺杆菌（Hp）感染易导致恶性和非恶性疾病，因此必须根除。在比利时，克拉霉素的耐药率存在地区差异，这使得使用标准三联疗法（STT）成为可接受的边缘疗法。根据比利时最近的一项调查，标准三联疗法和铋剂四联疗法（BQT）作为一线疗法用于治疗Hp阳性患者的频率相同。本研究旨在评估 BQT 与 STT 的根除率（ER）：多中心、非盲法、随机、前瞻性研究，比较对 Hp 阳性患者的根除率。通过意向治疗（ITT）和按方案（PP）分析比较ER：共纳入 250 名患者（STT 126 人，BQT 124 人）。17名患者失去了随访机会（6.8%）。在 ITT（73% vs 68%，P= 0.54）和 PP 分析（81% vs 75%，P= 0.33）中，BQT 和 STT 的 ER 均无明显差异。各组的副作用和内窥镜检查结果相当。事后分析表明，性别和手术部位分配无差异：结论：与 STT 相比，BQT 在数字上的优势并不能显著改善 ER。这些结果对 BQT 的成本效益提出了质疑，同时也证实了 STT 的根除率并不理想。要持续优化比利时的 Hp ER，就必须在全国范围内对抗药性模式进行监测，对坚持治疗进行最大程度的投资，并对不断变化的治疗情况进行详细跟踪。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Acta gastro-enterologica Belgica Medicine-Gastroenterology

CiteScore

2.30

自引率

20.00%

发文量

期刊介绍： The Journal Acta Gastro-Enterologica Belgica principally publishes peer-reviewed original manuscripts, reviews, letters to editors, book reviews and guidelines in the field of clinical Gastroenterology and Hepatology, including digestive oncology, digestive pathology, as well as nutrition. Pure animal or in vitro work will not be considered for publication in the Journal. Translational research papers (including sections of animal or in vitro work) are considered by the Journal if they have a clear relationship to or relevance for clinical hepato-gastroenterology (screening, disease mechanisms and/or new therapies). Case reports and clinical images will be accepted if they represent an important contribution to the description, the pathogenesis or the treatment of a specific gastroenterology or liver problem. The language of the Journal is English. Papers from any country will be considered for publication. Manuscripts submitted to the Journal should not have been published previously (in English or any other language), nor should they be under consideration for publication elsewhere. Unsolicited papers are peer-reviewed before it is decided whether they should be accepted, rejected, or returned for revision. Manuscripts that do not meet the presentation criteria (as indicated below) will be returned to the authors. Papers that go too far beyond the scope of the journal will be also returned to the authors by the editorial board generally within 2 weeks. The Journal reserves the right to edit the language of papers accepted for publication for clarity and correctness, and to make formal changes to ensure compliance with AGEB’s style. Authors have the opportunity to review such changes in the proofs.