Combined
Treatment of Peptic Ulcers and Helicobacter pylori Infection with Omeprazole (Ultop), Cla-
rithromycin (Fromilid) and Metronidazole (Efloran)
Fixa B., Špičák J. 1 , Shonová O. 2 , Petr P. 2 , Pátek F. 3 , Zdeněk P. 4 , Ivanuša M. 5 ,
II. katedra interních oborů LF UK, Hradec Králové 1 Klinika gastroenterologie IKEM, Praha 2 Gastroenterologické oddělení nemocnice, České Budějovice 3 II. interní oddělení Masarykovy nemocnice, Ústí nad Labem 4 Gastroenterologické oddělení Fakultní nemocnice Lochotín, Plzeň 5 Krka d.d., Novo Mesto, Slovinsko |
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Summary:
Objective: To evaluate the effectiveness of combined treatment with omeprazole (2×20 mg), clarithromycin
(2×500) and metronidazol (2×400 mg) in the eradication of Helicobacter (H.) pylori infection and in the
treatment of peptic ulcers in this area with regard to the possible different resistance of H. pylori to antibacte-
rial drugs.
Patients and methods: A total of 94 patients with confirmed H. pylori infection from five centres in different
areas of the Czech Republic participated in the study. In 80 patients a duodenal ulcer was involved, in 14
instances gastric ulcer. Combined treatment with three preparations focused on eradication of H. pylori lasted
7 days. As patients with a fresh ulcer were involved, in patients with a duodenal ulcer after termination of
treatment with a combination of three drugs, omeprazole (1×20 mg) treatment was prolonged for another two
weeks and in patients with gastric ulcer for four weeks. Check-up examinations were made four weeks after
termination of combined treatment.
Results: Eradication of H. pylori was successful when evaluated by the „intention to treat“ in 88.3 % (83 of 94
patients), when evaluated „per protocol“ in 92.2 % (83 of 90 patients). Four patients did not finish the study
(two did not attend check-up gastroscopy, two refused). The ulcer was healed in 83 patients (i.e. in 88.3 %)
when evaluating the „intention to treat“, in 92.2 % when evaluating „per protocol“. In all cases with a non-healed ulcer H. pylori was eradicated. Side-effects were recorded in 28 patients (30.1%) and never led to
discontinuation of treatment.
Conclusions: The authors confirmed the effectiveness of combined treatment with omeprazole, with clarithro-
mycin and metranidazole in the eradication of H. pylori and in the treatment of peptic ulcer. The doses of
drugs and results of eradication of H. pylori were consistent with an analogous study MACH 1 (OMC500).
Key words:
Helicobacter pylori – peptic ulcer – treatment – omeprazole – clarithromycin – metronidazole
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