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

作者信息

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

机构信息

Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

Department of Gastroenterology, Chibi General Hospital, Chibi, China.

出版信息

Helicobacter. 2025 Mar-Apr;30(2):e70037. doi: 10.1111/hel.70037.

DOI:10.1111/hel.70037

PMID:40249155

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.