Efficacy and Safety of Cefuroxime–Tetracycline‐Containing Bismuth Quadruple Therapy for Helicobacter pylori Eradication in Penicillin‐Allergic Patients: A Multicenter Randomized Controlled Trial

作者：Hui Wang, Qingzhou Kong, Qiumei Zhang, Lili Zhang, Ruili Li, Teng Zhang, Lei Guo, Xilan Wang, Xiaowei Li, Hongyu Zhao, Fengqing Liu, Yuting Guo, Zhenzhen Zhai, Mingyu Li, Xiaorong Yang, Xiaorong Yang, Xiuli Zuo, Xiaoyun Yang, Xiaoyun Yang, Yueyue Li · 发表于：Helicobacter · 年份：2025 · DOI：10.1111/hel.70033 · 被引用次数：6 · 研究领域：Helicobacter pylori-related gastroenterology studies、Clostridium difficile and Clostridium perfringens research、Microscopic Colitis

BACKGROUND: Penicillin allergy significantly restricts therapeutic options for Helicobacter pylori eradication. This multicenter randomized controlled study was designed to evaluate the efficacy and safety of a novel cefuroxime-tetracycline-containing bismuth quadruple therapy (Cef-Tet BQT) as first-line treatment in this population. MATERIALS AND METHODS: Penicillin-allergic treatment-naïve patients with confirmed H. pylori infection (N = 248) were randomized to two 14-day regimens: one received Cef-Tet BQT (Tegoprazan 50 mg twice a day, bismuth potassium citrate 220 mg twice daily, cefuroxime 500 mg twice daily, tetracycline 500 mg three times daily), and the other received cefuroxime-levofloxacin-containing bismuth quadruple therapy (Cef-Lev BQT: cefuroxime 500 mg twice daily, levofloxacin 500 mg once daily). The primary endpoint assessed noninferiority of eradication rates, with secondary endpoints including safety profiles and adherence. RESULTS: In total, 248 patients underwent randomization. The intention-to-treat (ITT) eradication rates were 90.32% (112/124, 95% confidence interval [CI]: 85.12%-95.52%) and 81.45% (101/124, 95% CI: 74.61%-88.29%) (p = 0.045); the modified intention-to-treat (MITT) eradication rates were 91.80% (112/122, 95% CI: 86.93%-96.67%) and 83.47% (101/121, 95% CI: 76.85%-90.09%) (p = 0.048); and the per-protocol (PP) eradication rates were 92.37% (109/118, 95% CI: 87.58%-97.16%) and 85.34% (99/116, 95% CI: 78.90%-91.78%) (p = 0.087) in the Cef-T...