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Single-arm prospective observational study shows effective H. pylori eradication in a high-resistance area, suggesting method viability.
Objective: To assess the feasibility, effectiveness, and safety of susceptibility-guided individualised H. pylori therapy in a region without prior resistance data, using a single-arm prospective observational design. Methods: This prospective study included patients with confirmed H. pylori infection undergoing gastroscopy at Beijing Huairou Hospital (April 2023–May 2024). Molecular testing targeted 23S rRNA mutations (A2142G, A2142C, A2143G) for clarithromycin (CLA) and gyrA mutations (Asn87→Lys/Thr) for levofloxacin (LVX). Patients were assigned to three susceptibility-guided groups: CLA-sensitive, CLA-resistant+LVX-sensitive, and CLA-resistant+LVX-resistant, each receiving 14-day bismuth-containing quadruple therapy. Eradication was confirmed by ¹³C urea breath test 4– 8 weeks post-treatment. Results: Intention-to-treat (ITT) eradication rate was 82.3% (per-protocol [PP]: 87.2%). ITT rates by group: CLA-S 81.8%, CLA-R-LVX-S 83.3%, CLA-R-LVX-R 85.0% (P=0.921). PP rates: 86.3%, 92.1%, 85.0% (P=0.602). No significant differences in compliance or safety (P=0.849; P=0.467). Conclusion: Susceptibility-guided therapy achieved 85– 90% eradication regardless of resistance profile. Although the ITT rate (82.3%) fell short of the 90% guideline threshold, it remains clinically acceptable in a moderate-to-high resistance setting (Huairou: CLA resistance 26.7%, LVX 28.8%, dual 8.6%), supporting the value of susceptibility testing.
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Qi et al. (2026) studied this question.
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