Efficacy Evaluation Of Helicobacter Pylori With Ten-day Sequential Therapy And Standard Triple-drug Therapy

Backgroud:Helicobacter pylori(H.pylori, HP)is closely related to the prevention of the disease of Chronic gastritis, Peptic ulcer, Gastric cancer and Gastric mucosa-associated lymphoid tissue lymphoma. Eradication of HP has important clinical significance. With the widespread use of antibiotics, HP resistance to conventional therapy significantly increased the urgent clinical need for a program to improve the eradication rate of HP. The sequential therapy (PPI+amoxicillin for 5 days, followed by PPI+clarithromycin+tinidazole for next 5 days) which was proposed in 2002 by the Italian scholar can improve the eradication rate of HP (89%vs77%) more significantly than the standard triple therapy. But now most of the data of the sequential therapy is from the HP infection in high southern Europe region. China needs to further sequential therapy in clinical validation.Objective:To determine whether the sequential therapy is better than the standard triple-drug therapy in treatment of H pylori infection for adults.Methods:Ninety-seven patients with H pylori positive were randomly divided two groups. Forty-five patients received a 10-day sequential therapy [esomeprazole (20 mg, twice daily) plus amoxicillin and clavulante potassium (685.5mg,twice daily) for the first 5 days, followed by esomeprazole (20mg,twice daily), clarithromycin (500 mg, twice) and tinidazole (500mg,twice) for the remaining 5 days].Fifty-two patients received a 10-day triple therapy [esomeprazole (20 mg), amoxicillin and clavulante potassium (685.5mg,twice daily) and clarithromycin (500 mg),twice daily].H pylori eradication was checked four weeks after treatment using 14C-urea breath test.Results:97 patients with H. pylori infection were included in our study.91 patients completed in the whole trial,patients were lost in the follow-up(3 patients received the 10-day sequential therapy and 3 patients received the 10-day triple therapy).The eradication rate of the 10-day sequential therapy group was 91.1%(intention-to-treat, ITT) and 90.5%(per-protocol analysis, PP).The standard triple-drug therapy group was 82.7%(ITT) and 81.5%(PP).There was not significiant difference between two groups(P=0.225 ITT, P=0.229 PP).6 patients had side-effects, the sequential-therapy group 3 patients(diarrhea 1 patient, dysgeusia 1 patient and anorexia 1 patient),the standard-triple-drug-therapy group 3 patients(nausea/vomiting 1 patient, diarrhea 1 patient and headache 1 patient). Side-effects rate between the sequential-therapy group and the standard-triple-drug-therapy group were 6.67%and 5.55%,respectively,the difference was no statistic meaning(P>0.05). All side-effects disappeared in the end of treatment and did not affect the treatment.Conclusions:The 10-day sequential therapy achieves a higher eradication rate than the 10-day standard triple-drug therapy in adults, but the difference was no statistic meaning. However, from the cost-effectiveness point of view, the 10-day sequential therapy is more economical than the standard triple therapy for 10 days.