| Abstract: | AIM: To assess and compare the efficacy and safety of twotriple regimes: A) metronidazole, amoxicillin and omeprazole,which is still widely used in Russia, and B) azithromycin,amoxicillin and omeprazole in healing active duodenal ulcerand H.pylori eradication. METHODS: 100 patients with active duodenal ulcer wereincluded in the open, multicentre, randomized study withcomparative groups. Patients were randomly assigned toone of the following one-week triple regimes: A)metronidazole 500 mg bid, amoxicillin 1 g bid and omeprazole20 mg bid (OAM, n＝50) and B) azithromycin 1 g od for thefirst 3 days (total dose 3 g), amoxicillin 1 g bid andomeprazole 20 mg bid (OAA, n＝50). Omeprazole 20 mg odwas given after the eradication course as a monotherapyfor three weeks. The control endoscopy was performed 8weeks after the entry. H. pylori infection was determined inthe entry of the study and four weeks after the cessation oftreatment by means of histology and CLO-test.RESULTS: 97 patients completed the study according tothe protocol (1 patient of the OAM group did not come tothe control endoscopy, 2 patients of the OAA group stoppedthe treatment because of mild allergic urticaria). Duodenalulcers 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 eradicatedin 15 out of 50 patients with OAM (30 %; CI 17-43 %) andin 36 out of 50 patients treated with OAA (72 %; CI 59-85 %)(P＜0.001)-ITT analysis.CONCLUSION: The triple therapy with omeprazole,amoxicillin and metronidazole failed to eradicate H. pylori inthe majority of patients, which is an essential argument towithdraw this regimen out of the national recommendations.Macrolide with amoxicillin are preferable to achieve highereradication rates. Azithromycin (1 g od for the first 3 days)can be considered as a successful component of the triplePPI-based regimen. |
