engleski

Azithromycin and Ranitidine Bismuth Citrate with/without Amoxicillin for Helicobacter pylori Eradication

In a multicentric, open, randomised study, efficacy and safety of dual therapy with azithromycin (AZI) and ranitidine bismuth citrate (RBC), and triple therapy with AZI, RBC and amoxicillin (AMO) in H. pylori eradication was compared. 159 H. pylori positive patients, detected by CLOtest (confirmed by histopathology and 13C-UBT) with endoscopically diagnosed duodenal/gastric ulcer, who signed written informed consent to participate, were randomly treated with either AZI 1 g od for 3 days and RBC 400 mg bid for 7 days, or with AZI 1 g od for 3 days, RBC 400 mg bid for 7 days and AMO 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 available for efficacy analysis. H. pylori eradication (H. pylori negative by 13C-UBT, 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 67/72 (92%) and 69/72 (96%), respectively. Mild gastrointestinal side effects were recorded in 3 patients treated with dual therapy and 2 patients treated with triple therapy. Conclusion: triple one-week therapy with RBC, AZI (3 days) and AMO achieved H. pylori eradication of 86% (Maastricht’s efficacy requirements ITT>80%), with a few side effects. In addition, dual therapy with RBC and AZI (3 days) achieved remarkably high eradication rate of 78%.

Helicobacter pylori; therapy; ranitidine bismuth citrate; RBC; azithromycin; amoxicillin

nije evidentirano