基于钾竞争性酸阻滞剂的替戈拉赞与沃克帕唑三联疗法根除幽门螺杆菌的疗效比较：一项随机、双盲、活性对照的前瞻性研究

Comparative Efficacy of Potassium-Competitive Acid Blocker-Based Triple Therapy with Tegoprazan versus Vonoprazan for Eradication: A Randomized, Double-Blind, Active-Controlled Pilot Study.

作者信息

Park Jae Yong, Choi Il Ju, Kim Gwang Ha, Hong Su Jin, Shin Sung Kwan, Jeon Seong Woo, Kim Jae Gyu

机构信息

Division of Gastroenterology, Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.

Center for Gastric Cancer, National Cancer Center, Goyang, Korea.

出版信息

Gut Liver. 2025 Sep 15;19(5):696-705. doi: 10.5009/gnl250067. Epub 2025 Jun 4.

DOI:10.5009/gnl250067

PMID:40462641

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12436048/

Abstract

BACKGROUND/AIMS: Triple therapy with vonoprazan, a potassium-competitive acid blocker, has shown an acceptable eradication rate. The aim of this study was to evaluate the efficacy and safety of tegoprazan-based triple therapy compared with those of vonoprazan-based triple therapy for eradication.

METHODS

This randomized, double-blind, active-controlled, multicenter pilot study included treatment-naive adults with infection. Participants were randomized 1:1:1 to receive tegoprazan 50 mg (TAC 1), tegoprazan 100 mg (TAC 2), or vonoprazan 20 mg (VAC) with amoxicillin 1,000 mg plus clarithromycin 500 mg twice daily for 10 days. The primary outcome was the eradication rate.

RESULTS

Of the 102 enrolled participants, 97 completed the study. The eradication rates in the full analysis set were 60.61% (95% confidence interval [CI], 43.93% to 77.28%), 78.79% (95% CI, 64.84% to 92.74%), and 84.85% (95% CI, 72.62% to 97.08%) in TAC 1, TAC 2, and VAC, respectively. The eradication rates in the per-protocol set were 66.67% (95% CI, 49.80% to 83.54%), 86.67% (95% CI, 74.50% to 98.83%), and 87.50% (95% CI, 76.04% to 98.96%) in TAC 1, TAC 2, and VAC, respectively. In the full analysis set, the eradication rate differences were -6.06% (95% CI, -24.61% to 12.49%) between TAC 2 and VAC and -24.24% (95% CI, -44.92% to -3.56%) between TAC 1 and VAC. In the per-protocol set, the eradication rate differences were -0.83% (95% CI, -19.97% to 17.37%) between TAC 2 and VAC and -20.83% (95% CI, -41.23% to -0.44%) between TAC 1 and VAC. All therapies were well tolerated with no notable safety differences.

CONCLUSIONS

After 10 days, tegoprazan 100 mg showed eradication rates comparable to those of vonoprazan 20 mg, while 50 mg may be insufficient. These findings support future research to optimize tegoprazan dosing in clinical practice (ClinicalTrials.gov; NCT04128917).

摘要

背景/目的：钾离子竞争性酸阻滞剂沃克帕唑三联疗法已显示出可接受的根除率。本研究的目的是评估替戈帕唑三联疗法与沃克帕唑三联疗法在根除幽门螺杆菌方面的疗效和安全性。

方法

这项随机、双盲、活性对照、多中心的初步研究纳入了未接受过治疗的幽门螺杆菌感染成年患者。参与者按1:1:1随机分组，分别接受50毫克替戈帕唑（TAC 1组）、100毫克替戈帕唑（TAC 2组）或20毫克沃克帕唑（VAC组），同时每日两次服用1000毫克阿莫西林加500毫克克拉霉素，疗程为10天。主要结局是根除率。

结果

102名入组参与者中，97名完成了研究。在全分析集中，TAC 1组、TAC 2组和VAC组的根除率分别为60.61%（95%置信区间[CI]，43.93%至77.28%）、78.79%（95%CI，64.84%至92.74%）和84.85%（95%CI，72.62%至97.08%）。在符合方案集中，TAC 1组、TAC 2组和VAC组的根除率分别为66.67%（95%CI，49.80%至83.54%）、86.67%（95%CI，74.50%至98.83%）和87.50%（95%CI，76.04%至98.96%）。在全分析集中，TAC 2组与VAC组之间的根除率差异为-6.06%（95%CI，-24.61%至12.49%），TAC 1组与VAC组之间为-24.24%（95%CI，-44.92%至-3.56%）。在符合方案集中，TAC 2组与VAC组之间的根除率差异为-0.83%（95%CI，-19.97%至17.37%），TAC 1组与VAC组之间为-20.83%（95%CI，-41.23%至-0.44%）。所有治疗耐受性良好，无明显安全性差异。