Scholarlink

<p>Rising antibiotic resistance has compromised the efficacy of standard <i>Helicobacter pylori</i> (<i>H. pylori</i>) eradication regimens. This multicenter trial aimed to evaluate whether a simplified tegoprazan-based triple therapy (TAD) is non-inferior to tegoprazan-based bismuth quadruple therapy (TADB) in a high-resistance setting. In this randomized, open-label, non-inferiority trial conducted across nine centers in China, 274 treatment-naïve patients were randomized (1:1) to receive either Group TAD (tegoprazan 50&#xa0;mg, amoxicillin 1000&#xa0;mg, doxycycline 100&#xa0;mg) or Group TADB (TAD plus bismuth potassium citrate 600&#xa0;mg) twice daily for 14 days. In the per-protocol (PP) analysis, eradication rates were 91.7% (111/121) for Group TAD and 96.0% (120/125) for Group TADB. Using the Newcombe score method against a pre-specified non-inferiority margin of -10%, the difference in per-protocol eradication rates was − 4.3% (95% CI: -9.8% to 2.0%), successfully establishing statistical non-inferiority. Intention-to-treat (ITT) analysis yielded consistent results (83.5% vs. 85.1%, <i>P</i> = 0.835). Group TAD demonstrated a significantly superior safety profile (22.6% vs. 46.1% AEs, <i>P</i> &lt; 0.001). A simplified tegoprazan-based triple therapy is non-inferior to its bismuth-containing counterpart, offering high efficacy with a significantly improved safety profile and reduced pill burden. Chinese Clinical Trial Registry, ChiCTR2500102215. Registered 2025-05-12 (Retrospectively registered).</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

A randomized noninferiority trial comparing tegoprazan triple therapy and bismuth quadruple therapy for Helicobacter pylori eradication

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年8月5日

查看全文
  • Qingjie Zhou,
  • Junyan Du,
  • Changbo Sun,
  • Zhen Luo,
  • Haifan Yan,
  • Xia Chen,
  • Jiaxin Liu,
  • Hanting Ye,
  • Jiang Liu,
  • Quan Dong,
  • Jingjing Lu,
  • Lian Liu,
  • Shenbao Wu,
  • Yingying Chen,
  • Weiping Fang,
  • Yaoming Zeng,
  • Wenling Yuan,
  • Jiejun Lin,
  • Huang Su,
  • Jie Pan

摘要

Rising antibiotic resistance has compromised the efficacy of standard Helicobacter pylori (H. pylori) eradication regimens. This multicenter trial aimed to evaluate whether a simplified tegoprazan-based triple therapy (TAD) is non-inferior to tegoprazan-based bismuth quadruple therapy (TADB) in a high-resistance setting. In this randomized, open-label, non-inferiority trial conducted across nine centers in China, 274 treatment-naïve patients were randomized (1:1) to receive either Group TAD (tegoprazan 50 mg, amoxicillin 1000 mg, doxycycline 100 mg) or Group TADB (TAD plus bismuth potassium citrate 600 mg) twice daily for 14 days. In the per-protocol (PP) analysis, eradication rates were 91.7% (111/121) for Group TAD and 96.0% (120/125) for Group TADB. Using the Newcombe score method against a pre-specified non-inferiority margin of -10%, the difference in per-protocol eradication rates was − 4.3% (95% CI: -9.8% to 2.0%), successfully establishing statistical non-inferiority. Intention-to-treat (ITT) analysis yielded consistent results (83.5% vs. 85.1%, P = 0.835). Group TAD demonstrated a significantly superior safety profile (22.6% vs. 46.1% AEs, P < 0.001). A simplified tegoprazan-based triple therapy is non-inferior to its bismuth-containing counterpart, offering high efficacy with a significantly improved safety profile and reduced pill burden. Chinese Clinical Trial Registry, ChiCTR2500102215. Registered 2025-05-12 (Retrospectively registered).