沃克帕唑与基于埃索美拉唑的高剂量双联疗法一线根除治疗的疗效和安全性比较：一项随机对照试验。

Comparative efficacy and safety of vonoprazan versus esomeprazole-based high-dose dual therapies for first-line eradication: a randomized controlled trial.

作者信息

Tai Wei-Chen, Lu Lung-Sheng, Yang Shih-Cheng, Wang Hsin-Ming, Wu Cheng-Kun, Yao Chih-Chien, Huang Pao-Yuan, Lee Yu-Chi, Chuah Seng-Kee, Liang Chih-Ming

机构信息

Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.

Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung, Taiwan.

出版信息

Therap Adv Gastroenterol. 2025 Sep 20;18:17562848251378066. doi: 10.1177/17562848251378066. eCollection 2025.

DOI:10.1177/17562848251378066

PMID:40984972

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12450270/

Abstract

BACKGROUND

Effective () eradication depends on maintaining intragastric pH >6 and overcoming antibiotic resistance. High-dose dual therapy (HDDT) with a proton pump inhibitor (PPI) and amoxicillin has shown promising results.

OBJECTIVES

To compare the efficacy of 14-day vonoprazan-based (VA) and esomeprazole-based (EA) HDDT for eradication and evaluate the impact of antibiotic resistance.

DESIGN

Randomized controlled trial (RCT).

METHODS

A total of 121 patients with confirmed infection were randomized to receive either VA therapy (vonoprazan 20 mg twice daily plus amoxicillin 750 mg four times daily (QID)) or EA therapy (esomeprazole 40 mg three times daily plus amoxicillin 750 mg QID) for 14 days. Eradication was assessed by the ¹³C-urea breath test at week 8. Antibiotic susceptibility testing was performed on cultured isolates.

RESULTS

Baseline demographic and clinical characteristics were comparable between the VA and EA groups. In the intention-to-treat analysis, eradication rates were 86.9% (95% confidence interval (CI): 78.4%-95.4%) in the VA group and 81.7% (95% CI: 71.3%-89.4%) in the EA group ( = 0.430). Per-protocol (PP) analysis showed eradication rates of 93.0% (95% CI: 86.4%-99.6%) for VA and 84.5% (95% CI: 73.8%-92.1%) for EA ( = 0.150), indicating no statistically significant difference. Adverse events (AEs) were mild and similar between groups (5.3% in VA vs 5.2% in EA, = 0.983), with constipation and diarrhea being the most reported. Both groups achieved 100% compliance. Antibiotic resistance patterns did not significantly affect outcomes.

CONCLUSION

Both VA and EA-HDDT regimens demonstrated comparable efficacy, excellent compliance, and minimal AEs. Although VA therapy achieved a >90% eradication rate in the PP analysis, our study was underpowered to confirm superiority. Therefore, larger, adequately powered RCTs are warranted to validate the potential superiority of VA.

TRIAL REGISTRATION

ClinicalTrials.gov: NCT06811207.

摘要

背景

有效的幽门螺杆菌根除取决于维持胃内pH值>6并克服抗生素耐药性。质子泵抑制剂（PPI）与阿莫西林的高剂量双联疗法（HDDT）已显示出有前景的结果。

目的

比较基于沃克帕唑（VA）和埃索美拉唑（EA）的14天HDDT方案根除幽门螺杆菌的疗效，并评估抗生素耐药性的影响。

设计

随机对照试验（RCT）。

方法

总共121例确诊幽门螺杆菌感染的患者被随机分配接受VA疗法（沃克帕唑20mg每日两次加阿莫西林750mg每日四次）或EA疗法（埃索美拉唑40mg每日三次加阿莫西林750mg每日四次），疗程14天。在第8周通过¹³C-尿素呼气试验评估根除情况。对培养的分离株进行抗生素敏感性测试。

结果

VA组和EA组的基线人口统计学和临床特征具有可比性。在意向性分析中，VA组的根除率为86.9%（95%置信区间（CI）：78.4%-95.4%），EA组为81.7%（95%CI：71.3%-89.4%）（P=0.430）。符合方案（PP）分析显示，VA组的根除率为93.0%（95%CI：86.4%-99.6%），EA组为84.5%（95%CI：73.8%-92.1%）（P=0.150），表明无统计学显著差异。不良事件（AE）轻微，两组相似（VA组为5.3%，EA组为5.2%，P=0.983），最常报告的是便秘和腹泻。两组的依从性均达到100%。抗生素耐药模式对结果没有显著影响。