Eradication Efficacy Of Modified Dual Therapy As Rescue Treatment For Patients Of Helicobacter Pylori Infection

BackgroundHelicobacter pylori(HP),which infects approximately 4.4 billion people worldwide,is one of the most common infections in humans.HP infection is associated with many gastrointestinal diseases and has been shown to be an important risk factor for gastric cancer.Our guidelines recommend eradication treatment for HP infection regardless of the presence or absence of symptoms.However,the eradication rate of bismuth quadruple therapy,which is now the main first-line eradication program,is gradually decreasing,which may be related to the increasing rate of antibiotic resistance in HP.Modified dual therapy was defined as a combination of Amoxicillin and Proton-pump inhibitors(PPIs)for 14 days by adjusting the dose and frequency of the drug.Several studies have shown that modified dual therapy can achieve clinically satisfactory eradication rates and reduce the use of unnecessary antibiotics when used for primary HP infection.There are relatively few studies available on the use of modified dual therapy for the rescue treatment of HP,and even when recent guidelines recommend this program as a rescue treatment option,the clinical evidence is insufficient.Therefore,this study aimed to further evaluate the efficacy of modified dual therapy for the rescue treatment of HP-infected patients and to clarify whether this regimen can achieve clinically satisfactory results as rescue treatment.ObjectivesTo evaluate the efficacy and safety of modified dual therapy(Esomeprazole and amoxicillin)and bismuth quadruple therapy(Esomeprazole,bismuth potassium citrate,amoxicillin,and clarithromycin)in the rescue treatment of Helicobacter pylori.Methods140 patients who failed to eradicate Helicobacter pylori infection in the DigestiveDepartment of Qingdao Municipal Hospital from October 2020 to May 2022 were included,Patients were randomly divided into experimental group(modified dual therapy group:Esomeprazole 20mg+Amoxicillin 0.75g,4 times/day)and control group(bismuth quadruple therapy group:Esomeprazole 20mg+Bismuth potassium citrate 220mg+Amoxicillin 1.0g+Clarithromycin 0.5g,2 times/day)in the ratio of 1:1 to receive a 14-day course of HP rescue therapy.All patients were reexamined by 13C urea breath test 1 month after the end of the course of treatment without taking PPIs or antibiotics to determine whether HP was eradicated successfully.The primary observation was whether the HP eradication was successful,and secondary observations were the incidence of adverse effects,relief of gastrointestinal symptoms,and compliance of patients during drug administration.SPSS25.0 software was used for statistical analysis,and t-test and chi-square test were used for comparison between groups.ResultsThe final 140 patients were enrolled in this study.A total of 5 patients were excluded from the study,2 in the experimental group(1 refused to reexamine the 13C breath test;1 self-discontinued)and 3 in the control group(1 could not tolerate adverse reactions;2 self-discontinued),the other patients completed the course of treatment and reexamination.HP was eradicated successfully in 58 patients in the experimental group and 51 patients in the control group.According to the analysis of intention-to-treat(ITT),the remedial eradication rates of the experimental group and the control group were 82.9%(58/70)and 72.9%(51/70),and the difference between the two groups was not statistically significant(P=0.154).According to the per-protocol(PP)analysis,the remedial eradication rate was 85.3%(58/68)in the experimental group and 76.1%(51/67)in the control group.There was no significant difference in the eradication rate between the two groups(P=0.177).The lower limits of the 95%confidence intervals(CI)for the difference in eradication rates between the two groups in the ITT analysis and the PP analysis were-3.65%and-4.03%,respectively,both greater than the prespecified noninferiority bounds(-10%),the eradication effect of HP in the experimental group was not inferior to that in the control group.In the aspect of symptom improvement,the improvement rates of the two groups were 75.8%(47/62)and 71.9%(46/64)respectively at the end of one month of the treatment,and there was no significant difference between the two groups(P=0.616).There was no significant difference in compliance between the two groups(P=1.000).In terms of adverse reactions,the total adverse reaction rates of the experimental group and the control group were 8.8%(6/68)and 22.4%(15/67)respectively,and the total adverse reaction rates were statistically significant(P=0.030).The incidence of adverse reactions in the control group was significantly higher than that in the experimental group.Among the adverse reactions such as nausea,diarrhea,and dry mouth,although the incidence of the experimental group was lower than that of the control group,the difference was not statistically significant.In the analysis of relevant factors affecting the eradication rate,gender,age,BMI,history of smoking and alcohol,and family history of gastric cancer had no significant effect on the eradication rate of HP in both groups.The number of previous eradications had no significant effect on the experimental group.However,the number of eradication was significantly different in the control group.The rates of eradication were 81.0%(47/58)and 44.4%(4/9)in the first and ≥2 times of eradication respectively,and the difference was statistically significant(P=0.048).ConclusionsIn HP rescue therapy,the modified dual therapy using esomeprazole and amoxicillin is no worse than the bismuth quadruple therapy consisting of esomeprazole,bismuth potassium citrate,amoxicillin,and clarithromycin,which not only can achieve clinical satisfactory eradication effect,but also has less adverse effects,and can be a new choice for HP rescue therapy.