ABSTRACT
OBJECTIVE: To investigate the efficacy, safety and compliance of optimized concomitant therapy for the first-line eradication of Helicobacter pylori infection through a prospective, single-center and open-label cohort study. METHODS: From January 2014 to October 2018, 200 nafive patients with Helicobacter pylori infection and dyspepsia received 14 d concomitant therapy (esomeprazole 40 mg, amoxicillin 1 000 mg, clarithromycin 500 mg and tinidazole 500 mg, twice daily orally). Safety and compliance were assessed 1-3 days after eradication. The therapeutic outcome was determined by 13C-urea breath test 4-8 weeks after eradication. Some patients underwent strain culture, antibiotic sensitivity testing and CYP2C19 polymorphism assay. RESULTS: The eradication rates of optimized concomitant therapy: intention-to-treat analysis 88.0% (95% confidence interval 83.0%-92.0%), modified intention-to-treat analysis 91.2% (87.0%-94.8%) and per-protocol analysis 93.0% (89.2%-96.2%). 43.1% of patients had adverse reactions, the majority were mild to moderate, and only 3.0% of patients discontinued medication because of intolerance to adverse reactions. Patients with good compliance accounted for 94.4%. Variate analyses showed that poor compliance and clarithromycin resistance were the independent risk factors for eradication failure. CONCLUSION: Optimized concomitant therapy (14 d duration and double dose of esomeprazole) achieved good efficacy, safety and compliance for the first-line eradication of Helicobacter pylori infection.