Azithromycin in a triple therapy for H.pylori eradication in active duodenal ulcer

• Published in: World journal of gastroenterology : WJG 2002-10, Vol.8 (5), p.879-882
• Main Authors: Ivashkin, Vladimir T, Lapina, Tatiana L, Bondarenko, Oksana Yu, Sklanskaya, Olga A, Grigoriev, Petr Ya, Vasiliev, Yuri V, Yakovenko, Emilia P, Gulyaev, Pavel V, Fedchenko, Valeri I
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Amoxicillin - administration & dosage; Amoxicillin - adverse effects; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - adverse effects; Anti-Ulcer Agents - administration & dosage; Anti-Ulcer Agents - adverse effects; Azithromycin - administration & dosage; Azithromycin - adverse effects; Drug Therapy, Combination; Duodenal Ulcer - drug therapy; Duodenal Ulcer - microbiology; Female; H. Pylori; Helicobacter Infections - drug therapy; Helicobacter pylori; Humans; Male; Metronidazole - administration & dosage; Metronidazole - adverse effects; Middle Aged; Omeprazole - administration & dosage; Omeprazole - adverse effects; Penicillins - administration & dosage; Penicillins - adverse effects; Treatment Outcome
• ISSN: 1007-9327; 2219-2840
• DOI: 10.3748/wjg.v8.i5.879

To assess and compare the efficacy and safety of two triple regimes: A) metronidazole, amoxicillin and omeprazole, which is still widely used in Russia, and B) azithromycin, amoxicillin and omeprazole in healing active duodenal ulcer and H.pylori eradication. 100 patients with active duodenal ulcer were included in the open, multicentre, randomized study with comparative groups. Patients were randomly assigned to one of the following one-week triple regimes: A) metronidazole 500 mg bid, amoxicillin 1 g bid and omeprazole 20 mg bid (OAM, n=50) and B) azithromycin 1 g od for the first 3 days (total dose 3 g), amoxicillin 1 g bid and omeprazole 20 mg bid (OAA, n=50). Omeprazole 20 mg od was given after the eradication course as a monotherapy for three weeks. The control endoscopy was performed 8 weeks after the entry. H.pylori infection was determined in the entry of the study and four weeks after the cessation of treatment by means of histology and CLO-test. 97 patients completed the study according to the protocol (1 patient of the OAM group did not come to the control endoscopy, 2 patients of the OAA group stopped the treatment because of mild allergic urticaria). Duodenal ulcers were healed in 48 patients of the OAM group (96 %; CI 90.5-100 %) and in 46 patients of the OAA group (92 %; CI 89.5-94.5 %) (p=ns). H.pylori infection was eradicated in 15 out of 50 patients with OAM (30 %; CI 17-43 %) and in 36 out of 50 patients treated with OAA (72 %; CI 59-85 %) (P