Tao Lulong, Qian Haisheng, Zhang Leyao, Luo Peipei, Ma Shijie, Yan Jin, Liu Yajun, Chen Meihong, Tao Yuwen, Shi Jinjin, Zhang Guoxin, Ye Feng
Department of Gastroenterology, The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiansgsu, China.
Department of Gastroenterology, Wuxi Ninth People's Hospital Affiliated to Soochow University, Wuxi, Jiangssu, China.
Helicobacter. 2025 Jul-Aug;30(4):e70062. doi: 10.1111/hel.70062.
A 10 day vonoprazan-amoxicillin (VA) regimen (amoxicillin 750 mg four times daily) achieved > 90% Helicobacter pylori (H. pylori) eradication rates in the initial treatment. Whether less frequent dosing or shorter duration provides comparable efficacy remains unclear. This study aimed to evaluate the efficacy of simplified 7 or 10-day VA regimens to determine the optimal first-line strategy.
In this multicenter, randomized, open-label, non-inferiority trial, treatment-naive H. pylori-positive patients were randomly assigned (1:1:1:1) to four treatment groups: VA-T7 (amoxicillin 1000 mg three times daily for 7 days), VA-Q7 (amoxicillin 750 mg four times daily for 7 days), VA-T10 (amoxicillin 1000 mg three times daily for 10 days), and VA-Q10 (amoxicillin 750 mg four times daily for 10 days). All the patients received vonoprazan 20 mg twice daily. The primary outcome was the eradication rate. The secondary outcomes included adverse events and adherence.
A total of 500 patients were enrolled. The eradication rates of the VA-T7, VA-Q7, VA-T10, and VA-Q10 groups were 84.0%, 81.6%, 91.2%, and 90.4% by intention-to-treat (ITT) analysis; 86.8%, 83.6%, 92.7%, and 92.6% by modified intention-to-treat (mITT) analysis; 88.2%, 85.7%, 93.4%, and 94.1% by per-protocol (PP) analysis, respectively. The efficacy of VA-T10 was non-inferior to that of VA-Q10 (p = 0.002; p = 0.001; p = 0.002 in the ITT, mITT and PP analyses, respectively). Both 7-day regimens failed to meet the non-inferiority margin of -10%. No significant effect of dosing frequency on eradication rates was observed. Adverse events and adherence were comparable among the groups.
The VA-T10 regimen is effective, well-tolerated, and suitable for first-line H. pylori eradication, whereas 7-day regimens are not recommended due to eradication rates < 90%.
ClinicalTrials.gov identifier: ChiCTR2400079754 (www.chictr.org.cn).
10天的沃克酰胺-阿莫西林（VA）方案（阿莫西林750mg，每日4次）在初始治疗中幽门螺杆菌（H. pylori）根除率>90%。给药频率降低或疗程缩短是否能提供相当的疗效尚不清楚。本研究旨在评估简化的7天或10天VA方案的疗效，以确定最佳一线治疗策略。
在这项多中心、随机、开放标签、非劣效性试验中，初治的H. pylori阳性患者被随机分配（1:1:1:1）至四个治疗组：VA-T7（阿莫西林1000mg，每日3次，共7天）、VA-Q7（阿莫西林750mg，每日4次，共7天）、VA-T10（阿莫西林1000mg，每日3次，共10天）和VA-Q10（阿莫西林750mg，每日4次，共10天）。所有患者均接受沃克酰胺20mg，每日2次。主要结局是根除率。次要结局包括不良事件和依从性。
共纳入500例患者。意向性分析（ITT）显示，VA-T7、VA-Q7、VA-T10和VA-Q10组的根除率分别为84.0%、81.6%、91.2%和90.4%；改良意向性分析（mITT）显示分别为86.8%、83.6%、92.7%和92.6%；符合方案分析（PP）显示分别为88.2%、85.7%、93.4%和94.1%。VA-T10的疗效不劣于VA-Q10（ITT分析中p = 0.002；mITT分析中p = 0.001；PP分析中p = 0.002）。两种7天方案均未达到-10%的非劣效界值。未观察到给药频率对根除率有显著影响。各组间不良事件和依从性相当。
VA-T10方案有效、耐受性良好，适用于一线根除H. pylori，而7天方案因根除率<90%不推荐使用。
ClinicalTrials.gov标识符：ChiCTR2400079754（www.chictr.org.cn）
