The Efficacy And Safety Of High Dose Dual Therapy For The Eradication Treatment-naive Of Helicobacter Pylori

Objective To evaluate the efficacy and safety of high-dose dual therapy for Helicobacter pylori(H.pylori)eradication.Methods A total of 577 H.pylori-infected,treatment-naive patients in General Hospital of Ningxia Medical University from December 2019 to May 2022 were randomly allocated into 2 groups:the 14-day high-dose dual therapy group(Esomeprazole+amoxicillin)and the bismuth-containing quadruple therapy group(Esomeprazole+bismuth+amoxicillin+clarithromycin),of which 277 cases were in the high-dose dual therapy group,bismuth-containing A total of 300 cases in the bismuth-containing quadruple therapy group,14 days of treatment.Telephone follow up will be conducted at the beginning of one-week treatment and after the end of treatment;Urea breath tests were follow up 4 weeks after treatment later.Eradication rates,drug-related adverse events,medication compliance and treatment cost were compared between the 2 groups,The eradication rate of each program was analyzed by ITT analysis and PP analysis.Results Among the 277 patients in the high-dose dual therapy group,258 patients completed the trial.Among the 300 patients in the bismuth-containing quadruple group,282 patients completed the trial.1.There were 142 males and 135 females in the high-dose dual group,with an average age of(41.95±10.8)years;There were 149 males and 151 females in the bismuth-containing quadruple therapy group,with an average age of(40.93±8.1)years;There was no significant difference in gender and age between the two groups(P>0.05).2.Statistical analysis results of eradication rate:(1)ITT analysis: The eradication rates of the high-dose dual therapy group were 86.2%,the bismuth-containing quadruple therapy group were 88.0%.There were no significant differences in the eradication rates between two groups in Intention-to-treat analysis(P >0.05).(2)PP analysis: The eradication rates of the high-dose dual therapy group were 92.6%,the bismuth-containing quadruple therapy group were 93.6%.There were no significant differences in the eradication rates between two groups in Per-protocol analysis(P>0.05).3.Adverse reaction rate: The high-dose dual therapy group adverse reaction rate was6.6%,the bismuth-containing quadruple group adverse reaction rate was 18.4%,There were significant differences in the adverse reaction rates between two groups in analysis(P<0.05).4.The medication compliance of high-dose dual therapy group was 93.1%,medication compliance of bismuth-containing quadruple therapy group was 93.3%,there was no significant difference in compliance between two groups(P>0.05).5.Treatment cost: The C/E value of the high-dose dual group that completed the whole course of treatment was 4.63,and the C/E value of the bismuth-containing quadruple group was 5.87 The cost-effectiveness ratio of the high-dose dual group was higher than that of the bismuth-containing quadruple group,and its treatment cost was lower.Conclusion The high-dose dual therapy achieves a high eradication rate comparable to that with bismuth-containing quadruple therapy but with fewer adverse events.