Li Meng, Wang Xiaolei, Dong Xinhong, Teng Guigen, Dai Yun, Wang Weihong
Department of Gastroenterology, Peking University First Hospital, Beijing, China.
Department of Gastroenterology, Peking University First Hospital, No. 8 Xishiku Street, Beijing 100034, China.
Therap Adv Gastroenterol. 2025 Aug 22;18:17562848251366156. doi: 10.1177/17562848251366156. eCollection 2025.
Increasing antibiotic resistance compromises therapeutic options for () infection, especially in penicillin-allergic individuals.
This trial aimed to assess the efficacy and safety of 14-day vonoprazan-minocycline (VM) dual therapy against bismuth-containing quadruple therapy (B-quadruple therapy), as initial treatment for infection.
This study was a single-center, open-label, and non-inferiority randomized controlled trial.
In this study, 240 individuals with infection who have not received therapy were randomly assigned 1:1 to either the VM dual therapy group (vonoprazan 20 mg plus minocycline 100 mg, administered twice daily) or the B-quadruple therapy group (rabeprazole 10 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and bismuth potassium citrate 220 mg, all administered twice daily). The primary outcome was to evaluate the non-inferiority of eradication rates between the two groups. Secondary outcomes included assessments of AEs and compliance.
The eradication rates of VM dual group and B-quadruple therapy group were 87.5% and 88.3%, respectively, by intention-to-treat (ITT) analysis; 92.1% and 94.6% by modified ITT (mITT) analysis; and 92.0% and 95.5% by per-protocol (PP) analysis. The eradication rates of the VM group were non-inferior to those of the B-quadruple therapy group in ITT, mITT, and PP analyses (one-sided -values were 0.02, 0.01, and 0.02). The incidence of AEs was higher in the B-quadruple therapy group (28.3%) than in the VM group (16.7%, = 0.03). Good compliance was achieved in both groups ( = 0.60).
The VM dual therapy was not inferior to the B-quadruple therapy in the initial treatment of infection, and the incidence of AEs was lower compared to B-quadruple therapy.
This trial was registered on the Chinese Clinical Trial Registry with the registration number ChiCTR2400081461.
抗生素耐药性不断增加，影响了（）感染的治疗选择，尤其是在对青霉素过敏的个体中。
本试验旨在评估14天伏诺拉生-米诺环素（VM）双联疗法对比含铋四联疗法（B-四联疗法）作为（）感染初始治疗的疗效和安全性。
本研究为单中心、开放标签、非劣效性随机对照试验。
本研究中，240例未接受过治疗的（）感染患者按1:1随机分为VM双联疗法组（伏诺拉生20mg加米诺环素100mg，每日两次给药）或B-四联疗法组（雷贝拉唑10mg、阿莫西林1000mg、克拉霉素500mg和枸橼酸铋钾220mg，均每日两次给药）。主要结局是评估两组根除率的非劣效性。次要结局包括不良事件（AE）和依从性评估。
意向性分析（ITT）显示，VM双联疗法组和B-四联疗法组的根除率分别为87.5%和88.3%；改良意向性分析（mITT）显示分别为92.1%和94.6%；符合方案分析（PP）显示分别为92.0%和95.5%。在ITT、mITT和PP分析中，VM组的根除率不劣于B-四联疗法组（单侧P值分别为0.02、0.01和0.02）。B-四联疗法组的AE发生率（28.3%）高于VM组（16.7%，P = 0.03）。两组均实现了良好的依从性（P = 0.60）。
VM双联疗法在（）感染的初始治疗中不劣于B-四联疗法，且AE发生率低于B-四联疗法。
本试验在中国临床试验注册中心注册，注册号为ChiCTR2400081461。
