Efficacy Of Rabeprazole-based Bismuth-containing Quadruple Therapy For Helicobacter Pylori Eradication-a Multi-center, Randomized,Parallel Controlled Clinical Study

Background:H.pylori infection is a public health problem, especially in developing country. It has been associated to many upper gastrointestinal diseases, such as chronic gastritis, gastric cancer, peptic ulcer and MALT lymphoma. The rapid emergence of antibiotic-resistant strains of H.pylori has significantly reduced the effectiveness of treatment in recent years, making it a top priority to establish a safe and cost-effective first-line eradication therapy.Objective:By a randomized, multi-center, parallel controlled trial, we aim at finding an optimal treatment through making observation on the H. pylori eradication rates and making cost-effectiveness analysis of each group.Method:Diagnosed with H. pylori related peptic ulcer or chronic gastritis and treatment-naive patients were randomized into three groups:group A (10days of rabeprazole lOmg+furazolidone0.1g+amoxicillin1g+colloidal bismuth pectin200mg); group B (10days of rabeprazole20mg+furazolidone0.1g+amoxicillin1g+colloidal bismuth pectin200mg); group C (14days of rabeprazole10mg+furazolidone O.lg+amoxicillin1g+colloidal bismuth pectin200mg). All the drugs above were taken twice a day. Outcome of eradication therapy was evaluated by13C-UBT. Make analysis on the eradication rate of each group and C/E.Results:A total of277potentially-eligible adults agreed to participate, but16patients were dropped. The overall sample was balanced in terms of age, sex, endoscopic diagnosis, and history of smoking and so on. In ITT analyses, the H. pylori eradication rates of each group were as follows:65.2%(60of92) in group A,72.7%(72/99) in group B,70.9%(61/86)in group C.PP analyses results were68.2%(60of88) in group A,79.1%(72/91) in group B,74.4%(61/82) in group C (P>0.05), whose C/E were2.0,2.7and2.6. The H.pylori eradication rates of18-59age group and60～70age group were75.6%(164of217).65.9%(29of44)(P>0.05)Conclusion:A standard-dose10-day regimen of rabeprazole, amoxicillin, and furazolidone is equally effective but cheaper than its high-dose regimen in the treatment of H. pylori. Prolonging the duration of bismuth-based quadruple therapy form10days to14days dosen’t improve H.pylori eradication rate significantly. There is no difference of H.pylori eradication among non-erosive gastritis, erosive gastritis and peptic ulcer. Eradication rates also dose not differ significantly between18～59age group and60～70age group.