Abstract
ObjectivesThe antimicrobial resistance of Helicobacter pylori (H. pylori) in most countries and regions has increased significantly. It has not been fully confirmed whether the detection of H. pylori resistance gene mutation can replace antibiotic drug sensitivity test to guide the clinical personalized treatment. The objective of this study was to assess and compare the efficacy of different antimicrobial resistance-guided quadruple therapies in refractory H. pylori-infected individuals who had undergone unsuccessful prior eradication treatments.MethodsFrom January 2019 to February 2020, genotypic and phenotypic resistances were determined by polymerase chain reaction (PCR), whole genome sequencing (WGS) and broth microdilution test, respectively, in 39 H. pylori-infected patients who have failed eradication for at least twice. The patients were retreated with bismuth quadruple therapy for 14 days according to individual antibiotic resistance results. Eradication status was determined by the 13C-urea breath test.ResultsThe overall eradication rate was 79.5% (31/39, 95% CI 64.2–89.5%) in the intention-to-treat (ITT) analysis and 88.6% (31/35, 95% CI 73.5–96.1%) in the per- protocol analysis (PP) analysis. The presence of amoxicillin resistance (OR, 15.60; 95% CI, 1.34–182.09; p = 0.028), female sex (OR, 12.50; 95% CI, 1.10–142.31; p = 0.042) and no less than 3 prior eradication treatments (OR, 20.25; 95% CI, 1.67–245.44; p = 0.018), but not the methods for guiding therapy (p > 0.05) were associated with treatment failure. Resistance-guided therapy achieved eradication rates of more than 80% in these patients. The eradication rate of H. pylori in the phenotypic resistance-guided group was correlated well with genotype resistance-guided groups, including PCR and WGS.ConclusionCulture or molecular method guiding therapy can enable personalized, promise salvage treatments, and achieve comparably high eradication rates in patients with refractory H. pylori infection. The detection of H. pylori resistance mutations has a good clinical application prospect.Protocol Study Register[clinicaltrials.gov], identifier [ChiCTR1800020009].
Highlights
Helicobacter pylori (H. pylori) is a Gram-negative microaerophilic bacterium that persistently colonizes the stomach of approximately 50% of the world’s population, equivalent to approximately 4.4 billion people (O’Connor et al, 2017)
Thirty-six H. pylori strains were isolated from 39 patients, and eventually 35 patients were analyzed for H. pylori eradication as a result of 1 follow-up loss (Figure 2)
This was the first study to compare the prevalence of refractory antibiotic resistance of six antibiotics in H. pylori by using phenotypic drug susceptibility testing (DST) and polymerase chain reaction (PCR)-based assays as well as whole-genome sequencing (WGS)-based assays at the same time
Summary
Helicobacter pylori (H. pylori) is a Gram-negative microaerophilic bacterium that persistently colonizes the stomach of approximately 50% of the world’s population, equivalent to approximately 4.4 billion people (O’Connor et al, 2017). This infection establishes lifelong chronic progressive gastric inflammation, leading to a stepwise progression through gastric atrophy, intestinal metaplasia, and dysplasia, to the development of carcinoma (McColl, 2010). Curing H. pylori infection has been proved remarkably difficult as the cure rates of empirical treatments are often
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