Comparison of Cefuroxime-Based Dual Therapy With Quadruple Therapy in Helicobacter pylori-Infected Treatment-Naive Patients: A Prospective, Multicenter, Randomized Controlled Trial

IF 4.3 2区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Helicobacter Pub Date : 2025-04-18 DOI:10.1111/hel.70037

Ji-Yan Li, Ji-Chun Song, Xia Tian, Yun-Hua Liu, Xiang-Wu Ding, Ya Lin, Zhen-Yu Zhang, Hai Zhang, De-Min Li, Xiao-Wei Huang, Yun-Lian Hu, Li Li, Hong-Tian Li, Chao-Qun Huang, Pei-Yuan Li

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引用次数: 0

Abstract

Background

High-Dose Dual Therapy With Amoxicillin Has Shown Advantages to Eradicate Helicobacter pylori (H. pylori), but Not for Penicillin-Allergic Patients. It Is Recommended That Cefuroxime Could Be an Alternative, but Whether Cefuroxime Could Be Used in Dual Therapy Has Not Been Reported. This Study Aimed to Compare the Efficacy, Safety, and Compliance of Cefuroxime-Based Dual Therapy (CDT) With Cefuroxime-Based Bismuth Quadruple Therapy (CQT) to Treat H. pylori Infection.

Materials and Methods

The Prospective, Multicenter, Open-Label, Randomized Controlled Trial Was Conducted to Enroll Patients With Treatment-Naive H. pylori Infection From 9 Institutions. Patients Were Randomly Assigned to CDT Group (Cefuroxime 500 Mg Three Times/Day and Vonoprazan 20 Mg Twice/Day) or CQT Group (Cefuroxime 500 Mg Twice/Day, Levofloxacin 500 Mg Once/Day, Vonoprazan 20 Mg Twice/Day, and Bismuth 220 Mg Twice/Day), both for 14 Days.

Results

700 Patients (350 per Group) Were Enrolled. In the Intention-To-Treat Analysis, Eradication Rates Were 76.0% and 86.3% in CDT Group and CQT Group (P = 0.001). In the Modified Intention-To-Treat Analysis, Eradication Rates Were 78.9% and 89.1% (P < 0.001). In the Per-Protocol Analysis, Eradication Rates Were 80.2% and 91.2% (P < 0.001). The Incidence of Adverse Events Was Significantly Lower in CDT Group Than CQT Group (14.4% vs. 29.8%, P < 0.001). Non-inferiority Was Confirmed Between CDT and CQT Group (All P > 0.025). Compliance Was Good in Both Groups (96.0% vs. 92.8%, P = 0.073). Poor Adherence Was a Risk Factor for Reducing the Efficacy in Both Groups.

Conclusions

CQT Was More Effective Than CDT for H. pylori Eradication, Which Might Be Recommended for Penicillin-Allergic Patients. If There Were Contraindications or Intolerance of CQT, CDT Would Be an Alternative.

Trail Registration

ChiCTR2300071210

查看原文本刊更多论文

头孢呋辛双重治疗与四联治疗治疗幽门螺杆菌感染初治患者的比较：一项前瞻性、多中心、随机对照试验

背景：大剂量阿莫西林双重治疗对根除幽门螺杆菌有优势，但对青霉素过敏患者无效。推荐头孢呋辛作为替代方案，但头孢呋辛是否可用于双重治疗尚未见报道。本研究旨在比较头孢呋辛双重治疗（CDT）与头孢呋辛铋四联治疗（CQT）治疗幽门螺杆菌感染的疗效、安全性和依从性。材料与方法本研究采用前瞻性、多中心、开放标签、随机对照试验，纳入来自9家医院的初治疗幽门螺杆菌感染患者。患者被随机分配到CDT组（头孢呋辛500 Mg 3次/天，Vonoprazan 20 Mg 2次/天）或CQT组（头孢呋辛500 Mg 2次/天，左氧氟沙星500 Mg 1次/天，Vonoprazan 20 Mg 2次/天，铋220 Mg 2次/天），疗程均为14天。结果入组患者700例，每组350例。在意向治疗分析中，CDT组和CQT组的根除率分别为76.0%和86.3% （P = 0.001）。在修正意向治疗分析中，根除率分别为78.9%和89.1% （P < 0.001）。在Per-Protocol Analysis中，根除率分别为80.2%和91.2% （P < 0.001）。CDT组不良事件发生率明显低于CQT组（14.4% vs 29.8%, P < 0.001）。CDT组与CQT组间无劣效性（P > 0.025）。两组依从性均良好（96.0% vs. 92.8%, P = 0.073）。依从性差是降低两组疗效的危险因素。结论CQT对幽门螺杆菌的根除效果优于CDT，可推荐用于青霉素过敏患者。如果有禁忌症或CQT不耐受，CDT将是一种选择。跟踪注册ChiCTR2300071210

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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.