The Efficacy Observation Of Bismuth-based Quadruple Therapy As First-line Treatment For Helicobacter Pylori Infection

Background and aimsThe eradication therapy of Helicobacter pylori (H.pylori) is a hot topic when it has been discovered。The past 20 years people have been looking for safe, efficient and economical treatment! The current consensus in Europe and our latest recommended first-line therapy of H.pylori infection is the standard PPI-based triple therapy, but because antibiotics, metronidazole and clarithromycin resistant strains of H.pylori increased in the world, resulting the eradication rate of the PPI-based triple therapy declining。A large sample of clinical research reports of many countries in United States, southern Europe and Asia showed that:eradication rate of PPI-based triple therapy dropped to 80% or less; another foreign report showed that PPI triple therapy eradication rate dropped to 67.2%。so it is necessary to seek a more effective regimen for first-line treatment! A domestic study showed that:when coupled with bismuth, the MIC of metronidazole or clarith-romycin resistant strains of H.pylori were lower, and it became sensitive。Inclusion in the PPI-based triple therapy with bismuth can improve the sensitivity of antibiotics and reduce drug resistance, thereby enhancing eradication rate。This study used standard PPI-based triple therapy + bismuth (esomeprazole + clarithromycin + amoxicillin + bismuth potassium citrate) quadruple therapy as first treatment for patients with H.pylori infection, compared with standard PPI-based triple therapy, to observe the efficacy of bismuth-based quadruple therapy, and try to find a new efficient,safe and economic first-line treatment for H.pylori infection。 Patients and methods1.A total of 136 patients with H.pylori related peptic ulcer or chronic gastritis were randomized into two group。The bismuth-containing quadruple group received esomeprazole 20mg, clarithromycin 0.5g, amoxicillin 1.0g, and bismuth potassium citrate 220 mg, twice a day for 7 days。The standard triple group received 7-day twice-daily treatment with esomeprazole 20mg, clarithromycin 0.5g and amoxicillin 1.0g。2.Outcome of eradication therapy was assessed by 14C-urea breath test performed at least 4 weeks after the end of treatment and 2 weeks after taking PPIs。14C-UBT showed negative means H.pylori was eradicated, otherwise, means failed。3.Followed up and record the status of patients'gastric symptoms and adverse reaction, observed their compliance and tolerance。4.cost-effectiveness analysis:Cost C= the whole drug expenses of each patient during eradication therapy in the study, calculate the cost-effectiveness ratio (C/E) and the incremental cost-effectiveness ratio (△C/△E)。5.Statistical method:all the parameters were analyzed by the SPSS 14.0。The eradication rate of H.pylori was analyzed by intention-to-treat(ITT) analysis and per-protocol(PP) analysis。Enumeration data was analyzed by Chi-square test or Fisher's exact test。The significant standard was P<0.05。Results1.On ITT and PP analysis, the eradication rates of the quadruple therapy group were 82.09% and 88.71%, and that of the triple therapy group were 66.67% and 73.02%, the eradication rate of bismuth-containing quadruple therapy group higher than that of triple therapy group, There has an significant difference by statistics (P<0.05)。2.The eradication rate of patients with peptic ulcer was higher than that of patients with chronic gastritis in the two groups, the eradication rate of patients with peptic ulcer or chronic gastritis was similar between the two groups (P>0.05)。3.The rates of gastric symptoms in the two groups were 95.16% and 85.71% respectively (P>0.05); Side effects were observed generally minor and were comparable between groups (12.90% vs 11.11%, P>0.05)。4.Costs of quadruple therapy group and triple therapy group were RMB 368.1 and RMB 352.1, The cost-effectiveness rations of two groups were 4.15 and 4.82。The incremental cost-effectiveness ration of quadruple therapy group was 1.02 as against triple therapy group。Conclusions1.Compared with standard triple therapy regimen, bismuth-containing quadruple therapy regimen has similar therapeutic effect and side effects, but higher eradication rate。2.The eradication rate of patients with peptic ulcer is higher than that of patients with chronic gastritis in both groups。3.Comparing with the standard triple therapy regimen, the 7-days bismuth-containing quadruple therapy regimen has higher eradication rate, fewer side effects and patient compliance is good, but cost has no significant difference。Therefore, It's an safe, effective and economic regimens as first-line treatment for H.pylori infection, which can be recommended for clinical practice。...