Clinic for Gastroenterology and Hepatology, University Clinical Centre of Serbia, Belgrade, Serbia.
Medical Faculty University of Belgrade, Belgrade, Serbia.
Dig Dis. 2023;41(3):377-386. doi: 10.1159/000528389. Epub 2022 Dec 20.
Helicobacter pylori (H. pylori) is the most common chronic bacterial infection. Treatment effectiveness remains a subject of debate considering bacterial antimicrobial resistance. Our aim was to analyze the diagnostic methods and eradication treatments for H. pylori infection in Serbia.
An observational multicenter prospective study was conducted in Serbia, as part of the European Registry on H. pylori Management (Hp-EuReg). Demographics, treatment indication, diagnostic methods, previous eradication attempts, and treatment were collected at AEG-REDCap e-CRF. Modified intention-to-treat (mITT) and per-protocol (PP) effectiveness analyses were performed. Safety, compliance, and bacterial antimicrobial resistance rates were reported. Data were quality checked.
Overall, 283 patients were included, with a mean age of 55 ± 15 years. Dyspepsia (n = 214, 77%) was the most frequent treatment indication, and histology (n = 144, 51%) was the most used diagnostic method. Overall eradication rate was 95% (PP) and 94% (mITT). Most prevalent first-line therapy was quadruple PPI + clarithromycin + amoxicillin + metronidazole, with a 96% effectiveness (p < 0.001). Second-line main treatment choice was triple amoxicillin + levofloxacin, with a 95% effectiveness (p < 0.05). Single-capsule Pylera® was the most prescribed third-line therapy, with 100% effectiveness (p < 0.05). Longer treatment duration was associated with a higher eradication rate in first-line therapy (p < 0.05). Clarithromycin and quinolone resistance rates in first-line were 24% and 8.3%, respectively. The overall adverse events' incidence rate was 13.4%, and therapy compliance was 97%.
Considering the high eradication rate, 14-day non-bismuth quadruple concomitant therapy is a reasonable first-line choice, while quinolone-based therapy and single-capsule Pylera® should be considered as rescue therapy options.
幽门螺杆菌（H. pylori）是最常见的慢性细菌感染。鉴于细菌对抗菌药物的耐药性，治疗效果仍然存在争议。我们的目的是分析塞尔维亚的 H. pylori 感染的诊断方法和根除治疗。
这是一项在塞尔维亚进行的观察性多中心前瞻性研究，作为欧洲 H. pylori 管理登记处（Hp-EuReg）的一部分。在 AEG-REDCap e-CRF 中收集人口统计学、治疗指征、诊断方法、先前的根除尝试和治疗情况。进行了改良意向治疗（mITT）和符合方案（PP）有效性分析。报告了安全性、依从性和细菌对抗菌药物的耐药率。数据经过质量检查。
共有 283 例患者入组，平均年龄为 55 ± 15 岁。消化不良（n = 214，77%）是最常见的治疗指征，组织学（n = 144，51%）是最常用的诊断方法。总体根除率为 95%（PP）和 94%（mITT）。最常见的一线治疗是四联 PPI + 克拉霉素 + 阿莫西林 + 甲硝唑，有效率为 96%（p < 0.001）。二线主要治疗选择是三联阿莫西林+左氧氟沙星，有效率为 95%（p < 0.05）。单胶囊 Pylera®是最常开的三线治疗药物，有效率为 100%（p < 0.05）。一线治疗中，延长治疗时间与更高的根除率相关（p < 0.05）。一线治疗中克拉霉素和喹诺酮类药物的耐药率分别为 24%和 8.3%。总体不良事件发生率为 13.4%，治疗依从性为 97%。
鉴于高根除率，14 天非铋四联同时治疗是合理的一线选择，而基于喹诺酮类的治疗和单胶囊 Pylera®应被视为补救治疗选择。
