1. [Efficacy of high-dose dual therapy for Helicobacter pylori infection eradication in servicemen: a randomized controlled trial].
- Author
-
Zhang XM, Min HC, Chen J, Zhi JL, Dong HX, Kong JY, Meng JY, Sun G, Wang ZK, Pan F, Peng LH, and Yang YS
- Subjects
- Male, Humans, Female, Young Adult, Adult, Bismuth, Anti-Bacterial Agents therapeutic use, Amoxicillin adverse effects, Drug Therapy, Combination, Treatment Outcome, Proton Pump Inhibitors therapeutic use, Helicobacter Infections, Helicobacter pylori
- Abstract
Objective: To assess the efficacy and cost-effectiveness of high-dose dual therapy compared with bismuth-containing quadruple therapy for treating Helicobacter pylori( H.pylori ) infection in servicemen patients. Methods: A total of 160 H. pylori -infected, treatment-naive servicemen, including 74 men and 86 women, aged from 20 years to 74 years, with a mean (SD) age of 43 (13) years, tested in the First Center of Chinese PLA General Hospital from March 2022 to May 2022 were enrolled in this open-label, randomized controlled clinical trial. Patients were randomly allocated into 2 groups: the 14-day high-dose dual therapy group and the bismuth-containing quadruple therapy group. Eradication rates, adverse events, patient compliance, and drug costs were compared between the two groups. The t -test was used for continuous variables, and the Chi-square test for categorical variables. Results: No significant difference in H. pylori eradication rates were found between high-dose dual therapy and bismuth-containing quadruple therapy by ITT, mITT and PP analysis[ITT:90.0% (95% CI 81.2%-95.6%) vs. 87.5% (95% CI 78.2%-93.8%), χ
2 =0.25, P =0.617;mITT:93.5% (95% CI 85.5%-97.9%) vs. 93.3% (95% CI 85.1%-97.8%), χ2 <0.01, P =1.000; PP: 93.5% (95% CI 85.5%-97.9%) vs. 94.5% (95% CI 86.6%-98.5%), χ2 <0.01, P =1.000 ]. The dual therapy group exhibited significantly less overall side effects compared with the quadruple therapy group [21.8% (17/78) vs. 38.5% (30/78), χ2 =5.15, P =0.023]. There were no significant differences in the compliance rates between the two groups [98.7%(77/78) vs. 94.9%(74/78), χ2 =0.83, P =0.363]. The cost of medications in the dual therapy was 32.0% lower compared with that in the quadruple therapy (472.10 RMB vs. 693.94 RMB). Conclusions: The dual regimen has a favorable effect on the eradication of H. pylori infection in servicemen patients. Based on the ITT analysis, the eradication rate of the dual regimen is grade B (90%, good). Additionally, it exhibited a lower incidence of adverse events, better compliance and significantly reduced cost. The dual regimen is expected to be a new choice for the first-line treatment of H. pylori infection in servicemen but needs further evaluation.- Published
- 2023
- Full Text
- View/download PDF