Clinical Study on the Eradication of Helicobacter pylori by Vonoprazan Combined with Amoxicillin for 10-Day Dual Therapy

IF 1.5 4区 医学 Q3 PHARMACOLOGY & PHARMACY Clinical Pharmacology in Drug Development Pub Date : 2024-01-10 DOI:10.1002/cpdd.1357
Kunfeng Yan, Xiaorong Dai, Zhenxing Li, Weiwei Rong, Lei Chen, Xinxin Diao
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Abstract

Vonoprazan holds significant research promise for Helicobacter pylori eradication, with the goal of determining the most effective drug regimen. In this study, H. pylori patients (426) were enrolled and randomized into 3 groups: an EA14 group (20 mg of esomeprazole qid and 1000 mg of amoxicillin tid for 14 days), a VA14 group (20 mg of vonoprazan bid and 750 mg of amoxicillin qid for 14 days), and a VA10 group (20 mg of vonoprazan bid and 1000 mg of amoxicillin tid for 10 days). Key outcomes encompassed the H. pylori eradication rate, patient adverse effects, and compliance. In the EA14, VA14, and VA10 groups, H. pylori eradication rates were 89.4%, 90.1%, and 88.7% in intention-to-treat analysis, and 94.2%, 94.4%, and 94.6% in per-protocol analysis, respectively. Adverse events incidences were 14.8%, 12.7%, and 5.6%, while compliance rates were 88.7%, 90.9%, and 95.8%, respectively. Notably, the VA10 regimen demonstrated comparable H. pylori eradication rates, adverse effect incidences, and compliance levels to the EA14 and VA14 regimens.

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沃诺普拉赞联合阿莫西林10天双重疗法根除幽门螺旋杆菌的临床研究
沃诺普拉赞在根除幽门螺旋杆菌方面具有重要的研究前景,其目标是确定最有效的药物治疗方案。在这项研究中,426 名幽门螺杆菌患者被随机分为 3 组:EA14 组(20 毫克埃索美拉唑口服,1000 毫克阿莫西林口服,14 天)、VA14 组(20 毫克沃诺普拉赞口服,750 毫克阿莫西林口服,14 天)和 VA10 组(20 毫克沃诺普拉赞口服,1000 毫克阿莫西林口服,10 天)。主要结果包括幽门螺杆菌根除率、患者不良反应和依从性。在EA14、VA14和VA10组中,幽门螺杆菌根除率在意向治疗分析中分别为89.4%、90.1%和88.7%,在按协议分析中分别为94.2%、94.4%和94.6%。不良事件发生率分别为14.8%、12.7%和5.6%,依从率分别为88.7%、90.9%和95.8%。值得注意的是,VA10疗法的幽门螺杆菌根除率、不良反应发生率和依从性水平与EA14和VA14疗法相当。
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来源期刊
CiteScore
3.70
自引率
10.00%
发文量
154
期刊介绍: Clinical Pharmacology in Drug Development is an international, peer-reviewed, online publication focused on publishing high-quality clinical pharmacology studies in drug development which are primarily (but not exclusively) performed in early development phases in healthy subjects.
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