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.
目的： 评估高剂量双联方案与含铋剂四联方案治疗军人幽门螺杆菌（H. pylori）感染的有效性、性价比等。 方法： 随机对照研究。纳入2022年3至5月就诊于解放军总医院第一医学中心的共160例H. pylori感染、首次接受治疗的军人患者，其中男性74例、女性86例，年龄20~74（43±13）岁。患者随机分配到高剂量双联组和含铋剂四联组，疗程均为14 d。比较两组H. pylori根除率、不良反应、依从性和治疗费用。连续变量用t检验，分类变量进行χ2检验。 结果： 按意向治疗（ITT）、按改良意向治疗（mITT）以及按方案（PP）分析，高剂量双联组根除率与四联组相比，两组根除率差异无统计学意义。ITT：90.0%（95%CI 81.2%~95.6%）比 87.5%（95%CI 78.2%~93.8%），χ2=0.25，P=0.617；mITT：93.5%（95%CI 85.5%~97.9%）比 93.3%（95%CI 85.1%~97.8%），χ2<0.01，P=1.000；PP：93.5%（95%CI 85.5%~97.9%）比 94.5%（95%CI 86.6%~98.5%），χ2<0.01，P=1.000。高剂量双联组不良事件发生率低于四联组［21.8%（17/78）比 38.5%（30/78），χ2=5.15，P=0.023］。高剂量双联组依从性为98.7%（77/78），四联组为94.9%（74/78），两组差异无统计学意义（χ2=0.83，P=0.363）。高剂量双联方案每个疗程药费（人民币472.10元）比四联方案（人民币693.94元）减少32.0%。 结论： 高剂量双联方案对军人H. pylori感染根除率高，根除效果达B级。高剂量双联方案不良反应发生率低、依从性好、成本显著降低，有望成为军人H. pylori感染首次根除治疗的新选择，值得进一步临床验证和推广研究。.