Background & Aims

After a first Helicobacter pylori eradication attempt, approximately 20% of patients will remain infected. The aim of the current study was to assess the effectiveness and safety of second-line empiric treatment in Europe.

Methods

This international, multicenter, prospective, non-interventional registry aimed to evaluate the decisions and outcomes of H pylori management by European gastroenterologists. All infected adult cases with a previous eradication treatment attempt were registered with the Spanish Association of Gastroenterology–Research Electronic Data Capture until February 2021. Patients allergic to penicillin and those who received susceptibility-guided therapy were excluded. Data monitoring was performed to ensure data quality.

Results

Overall, 5055 patients received empiric second-line treatment. Triple therapy with amoxicillin and levofloxacin was prescribed most commonly (33%). The overall effectiveness was 82% by modified intention-to-treat analysis and 83% in the per-protocol population. After failure of first-line clarithromycin-containing treatment, optimal eradication (>90%) was obtained with moxifloxacin-containing triple therapy or levofloxacin-containing quadruple therapy (with bismuth). In patients receiving triple therapy containing levofloxacin or moxifloxacin, and levofloxacin–bismuth quadruple treatment, cure rates were optimized with 14-day regimens using high doses of proton pump inhibitors. However, 3-in-1 single capsule or levofloxacin–bismuth quadruple therapy produced reliable eradication rates regardless of proton pump inhibitor dose, duration of therapy, or previous first-line treatment. The overall incidence of adverse events was 28%, and most (85%) were mild. Three patients developed serious adverse events (0.3%) requiring hospitalization.

Conclusions

Empiric second-line regimens including 14-day quinolone triple therapies, 14-day levofloxacin–bismuth quadruple therapy, 14-day tetracycline–bismuth classic quadruple therapy, and 10-day bismuth quadruple therapy (as a single capsule) provided optimal effectiveness. However, many other second-line treatments evaluated reported low eradication rates. ClincialTrials.gov number: NCT02328131.

中文翻译：

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欧洲幽门螺杆菌管理登记处 (Hp-EuReg) 5000 名患者的经验性二线治疗

背景与目标

在第一次尝试根除幽门螺杆菌后，大约 20% 的患者仍会受到感染。本研究的目的是评估欧洲二线经验性治疗的有效性和安全性。

方法

这个国际、多中心、前瞻性、非干预性注册旨在评估欧洲胃肠病学家对幽门螺杆菌管理的决策和结果。截至 2021 年 2 月，所有曾尝试过根除治疗的成人感染病例均已在西班牙胃肠病学研究电子数据采集协会登记。对青霉素过敏的患者和接受药敏指导治疗的患者被排除在外。进行数据监控，确保数据质量。

结果

总体而言，5055 名患者接受了经验性二线治疗。最常见的是阿莫西林和左氧氟沙星三联疗法（33%）。根据修改后的意向治疗分析，总体有效性为 82%，在符合方案的人群中总体有效性为 83%。一线克拉霉素治疗失败后，采用含莫西沙星三联疗法或含左氧氟沙星四联疗法（含铋剂）获得最佳根除率（>90%）。在接受左氧氟沙星或莫西沙星三联疗法以及左氧氟沙星-铋四联疗法的患者中，使用高剂量质子泵抑制剂的 14 天治疗方案可优化治愈率。然而，无论质子泵抑制剂剂量、治疗持续时间或之前的一线治疗如何，三合一单胶囊或左氧氟沙星-铋四联疗法都能产生可靠的根除率。不良事件的总体发生率为 28%，大多数（85%）是轻微的。三名患者出现严重不良事件（0.3%），需要住院治疗。

结论

经验性二线治疗方案包括 14 天喹诺酮三联疗法、14 天左氧氟沙星-铋四联疗法、14 天四环素-铋经典四联疗法和 10 天铋四联疗法（作为单粒胶囊）提供了最佳疗效。然而，许多其他评估的二线治疗报告根除率较低。ClincialTrials.gov 编号：NCT02328131。