The MACH2 Study : Role of omeprazole in Eradication of Helicobacter pylori with 1-week triple therapies.
Background & Aims
The role of omeprazole in triple therapy and the impact of Helicobacter pylori resistance on treatment outcome are not established.
This study investigated the role of omeprazole and influence of primary H. pylon resistance on eradication and development of secondary resistance.
Patients (n=539) with a history of duodenal ulcer and a positive H. pylon screening test result were randomized into 4 groups.
OAC group received 20 mg omeprazole, 1000 mg amoxicillin, and 500 mg clarithromycin ; OMC group received 20 mg omeprazole, 400 mg metronidazole, and 250 mg clarithromycin ; and AC (amoxicillin, 1000 mg, and clarithromycin, 500 mg) and MC (metronidazole, 400 mg, and clarithromycin, 250 mg) groups received no omeprazole.
All doses were administered twice daily for 1 week.
H. pylori status was assessed before and after therapy by 13C-urea breath test.
Susceptibility testing was performed at entry and in patients with persistent infection after therapy.
Eradication (intention to treat [n=514]/per protocol [n=449]) was 94%/95% for OAC, 26%/25% for AC (P<0.001), 87%/91% for OMC, and 69%/72% for MC (P<0.001).
Primary resistance was 27% for metronidazole, 3% for clarithromycin, and 0% for amoxicillin.
Eradication in primary metronidazole-susceptible/-resistant strains was 95%/76% for OMC and 86%/43% for MC. (...)
Mots-clés Pascal : Ulcère, Duodénum, Helicobacter pylori, Spirillaceae, Spirillales, Bactérie, Oméprazole, Protocole thérapeutique, Randomisation, Clarithromycine, Amoxicilline, Résistance traitement, Eradication, Evaluation, Homme, Benzimidazole dérivé, Macrolide, Appareil digestif pathologie, Intestin pathologie, Antiulcéreux, Inhibiteur enzyme, Inhibiteur pompe proton, Antisécrétoire, Antibiotique, Antibactérien, Etude MACH2
Mots-clés Pascal anglais : Ulcer, Duodenum, Helicobacter pylori, Spirillaceae, Spirillales, Bacteria, Omeprazole, Therapeutic protocol, Randomization, Clarithromycin, Amoxicillin, Negative therapeutic reaction, Eradication, Evaluation, Human, Benzimidazole derivatives, Macrolide, Digestive diseases, Intestinal disease, Antiulcer agent, Enzyme inhibitor, Proton pump inhibitor, Antisecretory agent, Antibiotic, Antibacterial agent
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 99-0233876
Code Inist : 002B02H. Création : 16/11/1999.