Peng Ruolin, Cai Pengpeng, Zhang Zhimei, Lv Shengxiang, Chen Guangxia, Xu Yuling, He Bin, Sun Min, Dai Xiaorong, Yan Kunfeng, Shen Lu, Wang Jianrong, Li Wei, Yin Rui, Ge Jianxin, Hu Duanmin, Hu Kewei, Xu Xiaodan, Li Hui, Pan Chengyu, Duan Zhaotao, Gao Xuefeng, Zhang Zhenyu, Liu Wanli
Department of Gastroenterology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.
Department of Gastroenterology, Sir Run Run Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.
Helicobacter. 2025 May-Jun;30(3):e70050. doi: 10.1111/hel.70050.
Limited research has explored the efficacy of reduced amoxicillin dosages in vonoprazan-amoxicillin (VA) dual therapy for Helicobacter pylori eradication in China, and this study aimed to assess the noninferiority of these lower dosages compared to the standard high dose (3 g/d).
This was a noninferiority study with a -10% margin. H. pylori-positive patients from 13 centers in Jiangsu Province, China, were randomly assigned in a 1:1:1 ratio to receive a 14-day treatment, consisting of vonoprazan (20 mg BID) and high-dose amoxicillin (1 g TID, HVA), medium-dose amoxicillin (1 g BID, MVA), or low-dose amoxicillin (0.5 g TID, LVA). The eradication rates, adverse events (AEs), and medication adherence were compared.
From January 13, 2023 to July 6, 2024, a total of 900 patients were enrolled. According to the intention-to-treat (ITT) and per-protocol (PP) analyses, the eradication rates for HVA, MVA, and LVA groups were 93.2% and 93.2%, 91.6% and 91.5%, and 87.0% and 86.8%, respectively. The efficacy of MVA was noninferior to HVA in ITT analysis (difference: -1.6%, 97.5% CI: -7.0% to 3.8%, p < 0.001) and PP analysis (difference: -1.7%, 97.5% CI: -7.1% to 3.7%, p < 0.001); LVA's effectiveness was less than HVA in ITT analysis (difference: -6.2%, 97.5% CI: -12.2% to -0.2%, p = 0.076) and PP analysis (difference:-6.4%, 97.5% CI: -12.4% to -0.3%, p = 0.089). The incidence of AEs and medication compliance among the three groups was similar.
A 14-day VA regimen requires ≥ 2 g/d amoxicillin to maintain noninferior eradication efficacy versus 3 g/d, supporting dose reduction without compromising effectiveness.
ClinicalTrials.gov identifier: NCT05649540.
在中国，针对伏诺拉生-阿莫西林（VA）双联疗法中降低阿莫西林剂量用于根除幽门螺杆菌的疗效研究有限，本研究旨在评估这些较低剂量与标准高剂量（3g/d）相比的非劣效性。
这是一项非劣效性研究，非劣效界值为-10%。来自中国江苏省13个中心的幽门螺杆菌阳性患者按1:1:1的比例随机分配，接受为期14天的治疗，治疗方案包括伏诺拉生（20mg，每日两次）和高剂量阿莫西林（1g，每日三次，HVA）、中剂量阿莫西林（1g，每日两次，MVA）或低剂量阿莫西林（0.5g，每日三次，LVA）。比较根除率、不良事件（AE）和用药依从性。
2023年1月13日至2024年7月6日，共纳入900例患者。根据意向性分析（ITT）和符合方案分析（PP），HVA组、MVA组和LVA组的根除率分别为93.2%和93.2%、91.6%和91.5%、87.0%和86.8%。在ITT分析（差异：-1.6%，97.5%CI：-7.0%至3.8%，p<0.001）和PP分析（差异：-1.7%，97.5%CI：-7.1%至3.7%，p<0.0L）中，MVA的疗效不劣于HVA；在ITT分析（差异：-6.2%，97.5%CI：-12.2%至-0.2%，p=0.076）和PP分析（差异：-6.4%，97.5%CI：-12.4%至-0.3%，p=0.089）中，LVA的疗效低于HVA。三组的不良事件发生率和用药依从性相似。
14天的VA治疗方案需要≥2g/d的阿莫西林以维持相对于3g/d的非劣效根除疗效，这支持在不影响疗效的情况下降低剂量。
ClinicalTrials.gov标识符：NCT056L9540。
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