基于沃诺普拉赞的七天三联疗法作为幽门螺杆菌一线治疗与延长序列疗法的比较：随机对照试验

IF 4.3 2区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Helicobacter Pub Date : 2024-08-20 DOI:10.1111/hel.13129

Yu-Tse Chiu, Fu-Jen Lee, Chen-Ya Kuo, Yu-Tsung Chen, Yang-Chao Lin, Kai-Shun Liang, Chun-Ying Wu, Ro-Ting Lin, Jaw-Town Lin, Chi-Yang Chang

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引用次数: 0

摘要

背景：沃诺普拉赞是一种钾竞争性酸阻滞剂，与质子泵抑制剂相比，它的药效更强，抑酸时间更长。然而，在幽门螺旋杆菌的一线治疗中，基于沃诺普拉赞的三联疗法与标准疗法之间的比较数据十分有限。本研究旨在比较基于冯诺普拉赞的 7 天三联疗法与大剂量阿莫西林（VAC-7）和 14 天延长序列疗法（S-14）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。研究对象来自辅仁大学附属医院，年龄在 20 岁以上，确诊幽门螺杆菌感染。他们被随机分配到 VAC-7 组或 S-14 组。主要终点是一线治疗的根除率，通过尿素呼气试验进行评估，采用法林顿-曼宁法确定非劣效性。次要结果包括不良反应率和依从性，通过自填问卷进行评估：2021 年 12 月至 2023 年 6 月期间，共招募了 628 名患者。按协议分析和意向治疗分析得出的根除率分别为：VAC-7为88.6%/81.8%，S-14为90.3%/81.4%。在 ITT 分析中，VAC-7 不劣于 S-14。在 VAC-7 组中，受试者出现恶心、厌食、头晕、疲劳和任何严重不良反应的情况较少。VAC-7组的依从性更高，94%的受试者正确服用了所有药片：我们的研究结果支持将7天vonoprazan三联疗法联合大剂量阿莫西林作为治疗幽门螺杆菌感染的标准一线疗法：试验注册：ClinicalTrials.gov identifier：NCT05371249。

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Seven-Day Vonoprazan-Based Triple Therapy as First-Line Helicobacter pylori Treatment in Comparison With Extended Sequential Therapy: A Randomized Controlled Trial

Background

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).

Materials and Methods

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.

Results

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.

Conclusions

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.

Trial Registration: ClinicalTrials.gov identifier: NCT05371249

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来源期刊

Helicobacter 医学-微生物学

CiteScore

8.40

自引率

9.10%

发文量

审稿时长

2 months

期刊介绍： Helicobacter is edited by Professor David Y Graham. The editorial and peer review process is an independent process. Whenever there is a conflict of interest, the editor and editorial board will declare their interests and affiliations. Helicobacter recognises the critical role that has been established for Helicobacter pylori in peptic ulcer, gastric adenocarcinoma, and primary gastric lymphoma. As new helicobacter species are now regularly being discovered, Helicobacter covers the entire range of helicobacter research, increasing communication among the fields of gastroenterology; microbiology; vaccine development; laboratory animal science.