Department of Gastroenterology, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa, Universidad Autónoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain.
Department of Surgical and Medical Sciences, University of Bologna, Bologna, Italy.
Clin Gastroenterol Hepatol. 2022 Oct;20(10):2243-2257. doi: 10.1016/j.cgh.2021.12.025. Epub 2021 Dec 23.
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.
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.
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.
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.
首次根除幽门螺杆菌（H. pylori）尝试后，约 20%的患者仍会受到感染。本研究旨在评估欧洲二线经验性治疗的有效性和安全性。
这项国际性、多中心、前瞻性、非干预性登记研究旨在评估欧洲胃肠病学家对 H. pylori 管理的决策和结果。所有既往接受过根除治疗的感染成年患者均由西班牙胃肠病学会-研究电子数据采集进行登记，直至 2021 年 2 月。排除对青霉素过敏和接受药敏指导治疗的患者。进行数据监测以确保数据质量。
总体而言，有 5055 例患者接受了经验性二线治疗。最常开具的是含阿莫西林和左氧氟沙星的三联疗法（33%）。根据改良意向治疗分析，总体有效率为 82%，在符合方案人群中为 83%。在一线含克拉霉素治疗失败后，含莫西沙星的三联疗法或含铋剂的左氧氟沙星四联疗法（含铋剂）可获得最佳根除效果（>90%）。在接受含左氧氟沙星或莫西沙星的三联疗法以及左氧氟沙星-铋剂四联治疗的患者中，采用高剂量质子泵抑制剂的 14 天方案可优化治愈率。然而，含 1 剂三联胶囊或左氧氟沙星-铋剂四联疗法可在不考虑质子泵抑制剂剂量、治疗持续时间或既往一线治疗的情况下产生可靠的根除率。总体不良事件发生率为 28%，其中大多数（85%）为轻度。有 3 例患者发生 3 例严重不良事件（0.3%）需要住院治疗。
包括 14 天喹诺酮三联疗法、14 天左氧氟沙星-铋剂四联疗法、14 天四环素-铋剂经典四联疗法和 10 天铋剂四联疗法（作为 1 剂胶囊）在内的经验性二线方案提供了最佳疗效。然而，评估的许多其他二线治疗方案报告的根除率较低。临床试验注册号：NCT02328131。
