AZITHROMYCIN FOR THE CURE OF HELICOBACTER-PYLORI INFECTION

Objectives: Azithromycin, a new antibiotic chemically related to eryth romycin, has been proposed for the cure of Helicobacter pylori, achiev ing high gastric tissue levels (above the MIC for H. pylori) after ora l administration. The aim of the study was to establish whether azithr omycin plus metronidazole in association with either omeprazole or bis muth subcitrate is useful in curing H. pylori infection of the stomach . Patients and Methods: The study involved 132 dispeptic patients who proved to be H. pylori infected by antral and corpus histology (Giemsa , modified) and rapid urease test (CLO test); the Sydney system was us ed to classify the gastritis. Sixty-three patients received bismuth su bcitrate 120 mg q.i.d. for 14 days plus azithromycin 500 mg o.d. for t he first 3 days plus metronidazole 250 mg q.i.d. for the first 7 days; 69 patients received omeprazole 40 mg for 14 days plus azithromycin 5 00 mg o.d. for the first 3 days plus metronidazole 250 mg q.i.d. for t he first 7 days. Patients were well matched for common clinical variab les. Cure of H. pylori infection was assessed by the same methods 2 mo nths after completion of treatment. Results: Eleven patients dropped o ut of the study, only one reporting side effects (nausea, vomiting, an d epigastric pain). Cumulative ''per protocol'' cure rate was 66.1% (C I 95%, 58.5-75.3%). There was no statistically significant difference between the two treatment groups: 58.9% (CI 95% 48.4-74.6%) versus 72. 3% (CI 95%, 60.7-82.5%). Intention to treat does not substantially mod ify results. Few side effects were recorded. Cured patients showed a s ignificant reduction in the activity of gastritis. Conclusion: azithro mycin, combined with omeprazole and metronidazole, the cure rate of H. pylori was about 70%. The cure of H. pylori infection improves the ac tivity of gastritis.