| Objective:Helicobacter pylori(Hp)is recognized as a class I carcinogen by the International Cancer Research Group.It is of great clinical significance to eradicate Hp.《The Fifth National consensus report on the treatment of Helicobacter pylori infection》recommended bismuth quadruple therapy with proton pump inhibitor as acid inhibitor as the first-line treatment.The purpose of this study was to investigate the efficacy and safety of vonoprazan fumarate combined with amoxicillin in the treatment of Hp infection,and to compare it with bismuth quadruple therapy,so as to explore a new method for clinical treatment of Hp.Methods:From June 2021 to January 2022,274 patients who were diagnosed as Hp positive by Ureabreathtest(UBT)and met the inclusion criteria but did not meet the following exclusion criteria were enrolled in this study.The subjects were randomly divided into experimental group and control group according to 1:1 ratio.There were137 cases in the experimental group and 137 cases in the control group.The trial group was treated with 20 mg vonoprazan fumarate+1 g amoxicillin 1 g,take it twice a day for 14 consecutive days,orally before meal and 30min after meal,while the control group was treated with esomeprazole magnesium enteric-coated capsule20 mg+amoxicillin 1 g+furazolidone 0.1 g+colloidal bismuth tartrate capsule 220mg,take it twice a day for 14 consecutive days.Antibiotics should be taken orally after meal and before other meals.At least four weeks after the end of the course of treatment,the drug should be stopped for at least four weeks,and then returned to Yichun people’s Hospital to perform UBT again.During and after taking medicine,the subjects were followed up by telephone,a follow-up record card was set up,according to the contents of the record card,the adverse reactions and the improvement of clinical symptoms were recorded.The Hp eradication rate,clinical symptom relief,incidence of adverse reactions,drug compliance and cost were compared between the two groups.Resutls:According to intentional analysis(ITT analysis),the Hp eradication rates in the test and control groups were78.10%(107/137)VS 82.48%(113/137),χ~2=0.830,P>0.05,and there was no statistically significant difference between the eradication rates of Hp in the two groups.The eradication rate of Hp in the test group was 85.60%(107/125)and the eradication rate of Hp in the control group was 89.68%(113/126),χ~2=0.966,P>0.05,and there was no statistically significant difference between the eradication rate of Hp in the two groups of patients compared by conforming to the protocol data analysis(PP analysis).The remission rate of clinical symptoms:91.23%(52/57)in the test group and 92.45%(49/53)in the control group;P>0.05,the difference was not statistically significant.Comparison of the incidence of total adverse reactions between the two groups:11.68%(16/137)vs.24.82%(34/137)in the test group vs.the control group,χ~2=14.066,P<0.05,the difference was statistically significant.Comparison of patient compliance between the two groups:99.27%(136/137)vs.97.08%(133/137)in the trial vs.control group,χ~2=0.815,P>0.05,no statistically significant difference.The treatment cost was 285.18 yuan in the test group and 225.81 yuan in the control group.Conclusions:The combined therapy of vonoprazan fumarate and amoxicillin has the same eradication rate of Helicobacter pylori as bismuth quadruple therapy,high safety and less adverse reactions than bismuth quadruple therapy,so it is expected to be a new choice for the treatment of Helicobacter pylori. |
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