Efficacy of high-dose dual therapy for Helicobacter pylori infection eradication in servicemen: a randomized controlled trial.
10.3760/cma.j.cn112138-20220524-00401
- Author:
Xiao Mei ZHANG
1
;
Han Chen MIN
2
;
Jing CHEN
2
;
Jun Li ZHI
1
;
Hong Xia DONG
1
;
Jin Yan KONG
1
;
Jiang Yun MENG
1
;
Gang SUN
1
;
Zi Kai WANG
1
;
Fei PAN
1
;
Li Hua PENG
1
;
Yun Sheng YANG
1
Author Information
1. Department of Gastroenterology and Hepatology, the First Medical Center, Chinese PLA General Hospital, Beijing 100853, China.
2. Department of Gastroenterology and Hepatology, the First Medical Center, Chinese PLA General Hospital, Beijing 100853, China Medical School of Chinese PLA, Beijing 100853, China.
- Publication Type:Journal Article
- MeSH:
Male;
Humans;
Female;
Young Adult;
Adult;
Helicobacter Infections;
Helicobacter pylori;
Bismuth;
Anti-Bacterial Agents/therapeutic use*;
Amoxicillin/adverse effects*;
Drug Therapy, Combination;
Treatment Outcome;
Proton Pump Inhibitors/therapeutic use*
- From:
Chinese Journal of Internal Medicine
2023;62(5):520-525
- CountryChina
- Language:Chinese
-
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%), χ2=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.
