engleski

Ranitidine bismuth citrate (RBC) and azithromycin with or without amoxicillin in the eradication of H. pylori in patients with peptic ulcer

Efficacy and safety of dual therapy with RBC and azithromycin, and triple therapy with RBC, azithromycin and amoxicillin in H. pylori eradication was compared in a multicentric, open, randomised parallel group study. 159 H. pylori positive patients, detected by CLOtest (confirmed by histopathology and 13C-urea breath test) with endoscopically diagnosed duodenal or gastric ulcer, and who have signed written informed consent, were randomly treated with either RBC 400 mg bid for 28 days and azithromycin 1 god for 3 days, with RBC 400 mg bid for 28 days, azithromycin 1 god for 3 days, and amoxicillin 500 mg bid for 7 days. Control endoscopy for assessment of H. pylori eradication and ulcer healing was performed 4 weeks after completion of therapy. 144 patients were evaluable for efficacy analysis. H. pylori eradication (H. pylori negative by 13Curea-breath test, histopathology and CLOtest) was achieved in 56/72 patients treated with dual therapy (per protocol analysis 78% ; intention-to-treat analysis 78%), and in 62/72 patients treated with triple therapy (PP 86%, ITT 86%). Ulcers were healed in 65/72 (92%) and 70/72 (96%), respectively. Mild gastrointestinal side effects were recorded in 3 patients treated with dual therapy and 2 patients treated with triple therapy. Triple one-week therapy with RBC, azithromycin (3 days) and amoxicillin achieved H. pylori eradication of 86% (Maastricht's efficacy requirements ITT > 80%), with a few side effects. In addition, dual therapy with RBC and azithromycin achieved remarkably high eradication rate of 78%.

Helicobacter pylori; therapy; ranitidine bismuth citrat; azithromycin

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