engleski

Second-line treatment for Helicobacter pylori infection based on moxifloxacin triple therapy: randomized controlled trial

Standard quadruple second-line therapy for eradication of Helicobacter pylori infection, consisting of proton pump inhibitor (PPI), bismuth, metronidazole, and tetracycline, often fails and shows poor compliance. The aim of our study was to prove the efficacy and tolerability of moxifloxacin-based triple therapy as an alternative second-line protocol. One hundred and sixty patients, in whom the initial standard PPI triple therapy had failed to eradicate H. pylori infection, were included into the study. The initial H. pylori status was assessed by means of 13C-urea breath test. The patients were randomized to one of the following 7-day treatment regimens: (1) OMM: omeprazole 20 mg bid, moxifloxacin 400 mg/day, metronidazole 500 mg tid ; and (2) OBMT: omeprazole 20 mg bid, colloidal bismuth subcitrate 120 mg qid, metronidazole 500 mg tid, tetracycline 500 mg qid. One week after the completion of therapy, the drug compliance and adverse events were evaluated. H. pylori status was re-assessed six weeks after the end of therapy, by 13C-urea breath test. The eradication rates were 73.2% (60/82) and 78.9% (60/76) with moxifloxacin-based triple therapy, and 53.8% (42/78) and 64.6% (42/65) with bismuth-based quadruple therapy, by intention-to-treat (p = 0.018) and per-protocol (p = 0.088) analyses, respectively. Adverse events were described in 12/82 patients in the OMM group and in 18/78 patients in the OBMT group. Compliance for therapy was 92.7% in the OMM group and 83.3% in the OBMT group. Moxifloxacin-based triple therapy is highly effective second-line eradication treatment for H. pylori infection. Due to its high safety and tolerability, this protocol represents the adequate alternative to the standard bismuth-based quadruple therapy

Helicobacter pylori; moxifloxacin; second-line therapy; quadruple therapy; triple therapy

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