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

IF 4.3 2区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Helicobacter Pub Date : 2025-04-16 DOI:10.1111/hel.70033

Hui Wang, Qingzhou Kong, Qiumei Zhang, Lili Zhang, Ruili Li, Teng Zhang, Leina Guo, Xilan Wang, Xiaowei Li, Hongyu Zhao, Fengqing Liu, Yuting Guo, Zhenzhen Zhai, Mingyu Li, Xiaorong Yang, Xiuli Zuo, Xiaoyun Yang, Yueyue Li

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引用次数: 0

Abstract

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-Tet BQT group and Cef-Lev BQT group, respectively. Noninferiority of the Cef-Tet BQT group was demonstrated in all three analyses (p < 0.0001). The incidence of adverse events (21.77% vs. 24.19%) and compliance (96.77% vs. 95.97%) were comparable between the two groups.

Conclusions

BQT containing cefuroxime and tetracycline is efficacious and safe for the first-line eradication of H. pylori in penicillin-allergic patients. This regimen provides a viable alternative to circumvent the antimicrobial resistance concerns associated with levofloxacin-based regimens.

Trial Registration

ClinicalTrials.gov ID: NCT06351891

查看原文本刊更多论文

头孢呋辛-含四环素铋四联疗法根除青霉素过敏患者幽门螺杆菌的疗效和安全性：一项多中心随机对照试验

背景：青霉素过敏严重限制了幽门螺杆菌根除的治疗选择。这项多中心随机对照研究旨在评估新型头孢呋辛-四环素-含铋四联疗法（Cef-Tet BQT）作为一线治疗在该人群中的疗效和安全性。材料与方法将确诊幽门螺杆菌感染的青霉素过敏treatment-naïve患者（248例）随机分为2个14天的治疗方案：一组接受头孢呋辛- tet BQT治疗（替戈拉赞50 mg， 2次/ d，柠檬酸铋钾220 mg， 2次/ d，头孢呋辛500 mg， 2次/ d，四环素500 mg， 3次/ d），另一组接受头孢呋辛-左氧氟沙星含铋四联治疗（头孢呋辛-左氧氟沙星BQT治疗）：头孢呋辛500毫克，每日两次，左氧氟沙星500毫克，每日一次)。主要终点评估了根除率的非劣效性，次要终点包括安全性和依从性。结果共有248例患者接受了随机分组。意向治疗（ITT）根除率分别为90.32%（112/124,95%可信区间[CI]: 85.12% ~ 95.52%）和81.45% (101/124,95% CI: 74.61% ~ 88.29%) (p = 0.045)；改良意向治疗（改良意向治疗）根除率分别为91.80% （112/122,95% CI: 86.93% ~ 96.67%）和83.47% (101/121,95% CI: 76.85% ~ 90.09%) (p = 0.048)；Cef-Tet BQT组和Cef-Lev BQT组的PP根除率分别为92.37% （109/118,95% CI: 87.58% ~ 97.16%）和85.34% (99/116,95% CI: 78.90% ~ 91.78%) （p = 0.087）。在所有三个分析中都证明了Cef-Tet BQT组的非劣效性（p < 0.0001）。两组不良事件发生率（21.77% vs. 24.19%）和依从性（96.77% vs. 95.97%）具有可比性。结论头孢呋辛联合四环素BQT治疗青霉素过敏患者幽门螺杆菌一线根除是安全有效的。该方案提供了一种可行的替代方案，以避免与以左氧氟沙星为基础的方案相关的抗菌素耐药性问题。临床试验注册。gov ID: NCT06351891

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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.