沃克沙星联合阿莫西林治疗10天与14天根除感染的疗效和成本效益分析：一项前瞻性、多中心、随机对照试验。
Efficacy and cost-effectiveness analysis of 10-day versus 14-day eradication of infection with vonoprazan amoxicillin: a prospective, multicenter, randomized controlled trial.
作者信息
Dong Yunfan, Duan Zhaotao, Liu Min, Ding Yanbing, Chen Guangxia, Wang Ruifang, Xu Xiaodan, Ding Lixia, Zhan Qiang, Pan Chengyu, Li Hui, Yang Faming, Dai Xiaorong, Li Xiangsu, Wu Xudong, Peng Peng, Wang Jianrong, Hu Kewei, Hu Duanmin, Jie Qiong, Zhang Zhenyu
机构信息
Department of Gastroenterology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
Department of Gastroenterology, Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, China.
出版信息
Front Pharmacol. 2025 Mar 24;16:1543352. doi: 10.3389/fphar.2025.1543352. eCollection 2025.
OBJECTIVES
To evaluate the efficacy and cost-effectiveness of 10-day vonoprazan-amoxicillin (VA) dual therapy compared to 14-day VA therapy.
METHODS
A non-inferiority trial was carried out at 10 clinical centers to recruit patients with H. pylori infection. Subjects were assigned at random to either the group for 10-day or 14-day, and where given vonoprazan 20 mg bid and amoxicillin 1 g tid. Comparisons were made in terms of eradication rates, adverse events, cost-effectiveness, and compliance.
RESULTS
914 participants were enrolled and randomly assigned to either the 10-day or 14-day VA groups. Using the intention-to-treat principle and multiple imputation for missing outcomes, the analysis showed an eradication rate of 88.79% in the 10-day group and 92.37% in the 14-day group (P = 0.064). The eradication rates were 89.14% and 93.35% by per-protocol analysis (P = 0.037). There were no significant differences in adverse events or compliance between the groups (P > 0.05). Logistic regression analysis indicated that smoking and prior failure of eradication were risk factors influencing the eradication rate (P < 0.05). For the economic evaluation, the cost-effectiveness ratio (CER) of the 10-day group was 426.30 yuan, the CER of the 14-day group was 485.27 yuan, and the incremental cost-effectiveness ratio was 1680.23 yuan. In probability sensitivity analysis, the cost-effectiveness acceptability curve showed that when the willingness-to-pay(WTP) threshold was below 1742 yuan, the 10-day group was more cost-effective. When the WTP threshold was above 1742 yuan, the 14-day group was more cost-effective.
CONCLUSION
In this study, the 10-day VA was not found to be inferior to the 14-day VA. Compared with the 14-day group, the 10-day group is more cost-effective, but as the WTP threshold increases to 1742 yuan, the probability of the 14-day group being more cost-effective was greater than that of the 10-day group. Smoking and previous eradication attempts were associated with the eradication failure of VA therapy.
CLINICAL TRIAL REGISTRATION
https://clinicaltrials.gov/, identifier NCT05469685.
目的
评估10天伏诺拉生-阿莫西林（VA）双联疗法与14天VA疗法的疗效和成本效益。
方法
在10个临床中心进行了一项非劣效性试验，以招募幽门螺杆菌感染患者。受试者被随机分配到10天组或14天组，并给予伏诺拉生20毫克每日两次和阿莫西林1克每日三次。在根除率、不良事件、成本效益和依从性方面进行了比较。
结果
914名参与者被纳入并随机分配到10天或14天VA组。采用意向性分析原则和对缺失结局的多重填补法，分析显示10天组的根除率为88.79%，14天组为92.37%（P = 0.064）。按符合方案分析，根除率分别为89.14%和93.35%（P = 0.037）。两组之间在不良事件或依从性方面无显著差异（P > 0.05）。逻辑回归分析表明，吸烟和既往根除失败是影响根除率的危险因素（P < 0.05）。对于经济评估，10天组的成本效益比（CER）为426.30元，14天组的CER为485.27元，增量成本效益比为1680.23元。在概率敏感性分析中，成本效益可接受性曲线显示，当支付意愿（WTP）阈值低于1742元时，10天组更具成本效益。当WTP阈值高于1742元时，14天组更具成本效益。
结论
在本研究中，未发现10天VA疗法劣于14天VA疗法。与14天组相比，10天组更具成本效益，但随着WTP阈值增加到1742元，14天组更具成本效益的概率大于10天组。吸烟和既往根除尝试与VA疗法的根除失败有关。
临床试验注册
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