[The high-dose dual therapy for eradication of Helicobacter pylori: efficacy and safety].

Abstract

Background: The article presents the results of a prospective open-label comparative interventional study of the efficacy and safety of high-dose dual therapy (HDDT) for eradicating Helicobacter pylori infection.

Aim: To evaluate the efficacy and safety of HDDT of the H. pylori eradication regimen, as well as the possible increase in the efficacy of this regimen with the addition of rebamipide.

Materials and methods: All patients with verified H. pylori infection were randomized into three groups depending on the treatment regimen. The Era-AmIPP group (n = 24) received HDDT (esomeprazole 120 mg/day and amoxicillin 3000 mg/day) for 14 days. The Era-RebAmIPP group (n = 121) received HDDT with rebamipide 300 mg/day for 14 days. The comparison group (n = 101) received conventional triple eradication therapy enhanced with bismuth tripotassium dicitrate for 14 days. The effectiveness of eradication was evaluated at 4-6 weeks after the end of therapy. Particular attention was paid to assessing the safety of therapy, the incidence of adverse events, and treatment adherence.

Results: The study included 246 patients. Low efficacy (87.5% [95% confidence interval [CI] 69.0-95.7]) of HDDT was shown. Adding rebamipide 300 mg/day to HDDT increased the eradication rate to 96.3% (95% CI 90.9-98.6). The efficacy of the Era-RebAmIPP regimen in patients previously treated with conventional eradication regimens was 91.7% (95% CI 64.6-98.5). Adverse events were reported in 37.5% (95% CI 21.2-57.3) patients in the Era-AmIPP group, 19.8% (95% CI 13.7-27.8) in the Era-RebAmIPP group, and 31.3% (95% CI 22.9-41.1) in the comparison group (p = 0.07).

Conclusion: The efficacy of the Era-RebAmIPP regimen is comparable to conventional triple therapy with bismuth. To assess the effectiveness of this regimen, larger-scale studies are required in various regions of our country.