Institute of Biomedical Informatics, National Yang Ming Chiao Tung University, Taipei, Taiwan.
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Fu Jen Catholic University Hospital, New Taipei, Taiwan.
Helicobacter. 2024 Jul-Aug;29(4):e13129. doi: 10.1111/hel.13129.
Vonoprazan, a potassium-competitive acid blocker, has demonstrated greater potency and a longer duration of acid suppression when compared to the proton pump inhibitors. However, data regarding the comparison between vonoprazan-based triple therapy with standard treatment for first-line Helicobacter pylori treatment are limited. This study aimed to compare the efficacy between 7-day vonoprazan-based triple therapy with high-dose amoxicillin (VAC-7) and 14-day extended sequential therapy (S-14).
This was a single-center prospective randomized controlled trial following a noninferiority design. Subjects over 20 years old with confirmed H. pylori infection were enrolled prospectively from Fu Jen Catholic University Hospital. They were randomly assigned to the VAC-7 or S-14 group. The primary endpoint was the eradication rate in first-line treatment, evaluated by urea breath test, with noninferiority determined using the Farrington-Manning method. The secondary outcome included adverse effect rates and compliance, assessed through self-administered questionnaires.
Between December 2021 and June 2023, a total of 628 patients were recruited. The eradication rates by per-protocol analysis and intention-to-treat analysis were 88.6%/81.8% for VAC-7 and 90.3%/81.4% for S-14, respectively. The VAC-7 was non-inferior to S-14 in terms of ITT analysis. Subjects experienced fewer incidences of nausea, anorexia, dizziness, fatigue, and any severe adverse events in the VAC-7 group. Compliance was higher in the VAC-7 group, with 94% taking all the pills correctly.
Our findings supported the use of 7-day vonoprazan triple therapy with high-dose amoxicillin as the standard first-line treatment for H. pylori infection.
ClinicalTrials.gov identifier: NCT05371249.
与质子泵抑制剂相比，钾离子竞争性酸阻滞剂 vonoprazan 在抑制胃酸方面具有更强的效力和更长的作用持续时间。然而，关于基于 vonoprazan 的三联疗法与幽门螺杆菌一线治疗的标准治疗相比的数据有限。本研究旨在比较 7 天 vonoprazan 三联疗法与高剂量阿莫西林（VAC-7）和 14 天扩展序贯疗法（S-14）之间的疗效。
这是一项采用非劣效性设计的单中心前瞻性随机对照试验。从辅仁大学天主教医院前瞻性招募年龄超过 20 岁且确诊为幽门螺杆菌感染的受试者。他们被随机分配到 VAC-7 或 S-14 组。主要终点是通过尿素呼气试验评估的一线治疗的根除率，采用 Farrington-Manning 方法确定非劣效性。次要结局包括通过自我管理问卷评估的不良反应发生率和依从性。
2021 年 12 月至 2023 年 6 月期间，共招募了 628 名患者。根据意向治疗分析和符合方案分析，VAC-7 组的根除率分别为 88.6%/81.8%，S-14 组的根除率分别为 90.3%/81.4%。VAC-7 在意向治疗分析中不劣于 S-14。VAC-7 组受试者恶心、食欲不振、头晕、疲劳和任何严重不良事件的发生率较低。VAC-7 组的依从性较高，有 94%的患者正确服用了所有药物。
我们的研究结果支持将 7 天 vonoprazan 三联疗法与高剂量阿莫西林作为幽门螺杆菌感染的标准一线治疗。
ClinicalTrials.gov 标识符：NCT05371249。
