Zhang Jie, Cao Xin, Ma Kai, Jiang Yizhou, Qin Xiangrong, Wang Xiaoyong
Department of Endocrinology, Affiliated Changzhou No. 2 People's Hospital of Nanjing Medical University, Changzhou Medical Center, Nanjing Medical University, Changzhou, China.
Department of Gastroenterology, Affiliated Changzhou No. 2 People's Hospital of Nanjing Medical University, Changzhou Medical Center, Nanjing Medical University, 68 Gehu Middle Road, Wujing District, Changzhou, 213000, Jiangsu, China.
Sci Rep. 2025 Jan 9;15(1):1537. doi: 10.1038/s41598-025-85628-5.
Patients with diabetes have a high risk of failure of H. pylori eradication therapy. The present study aims to evaluate the efficacy and safety of vonoprazan-amoxicillin (VA) dual therapy for the treatment of H. pylori infection in patients with type-2 diabetes mellitus (T2DM), and determine the influence of H. pylori eradication on the glycated hemoglobin A1C (A1C) level. The present prospective, single-center, single-arm, clinical trial enrolled 75 T2DM patients diagnosed with H. pylori infection. The patients were treated with the VA dual therapy regimen, which comprised of vonoprazan (20 mg, twice daily) and amoxicillin (750 mg, thrice daily), for 14 days (14-day VA dual therapy). The eradication rate in the intention-to-treat analysis and per-protocol analysis was 84.00% (63/75) and 87.14% (61/70), respectively. The multivariate analysis revealed that the independent risk factors for H. pylori eradication failure were smoking (OR: 4.59, 95% CI: 1.20-17.58, p = 0.026) and elevated A1C level (OR: 1.65, 95% CI: 1.01-2.68, p = 0.044). Patients in the successful eradication group presented with a significant decrease in the A1C level at 3 months, post-treatment, when compared to the pre-eradication level (7.70 ± 1.05% vs. 7.23 ± 1.00%, p = 0.006). VA dual therapy is a safe and effective regimen for patients with T2DM.
糖尿病患者幽门螺杆菌根除治疗失败的风险较高。本研究旨在评估沃克哌唑-阿莫西林（VA）双联疗法治疗2型糖尿病（T2DM）患者幽门螺杆菌感染的疗效和安全性，并确定幽门螺杆菌根除对糖化血红蛋白A1C（A1C）水平的影响。本项前瞻性、单中心、单臂临床试验纳入了75例诊断为幽门螺杆菌感染的T2DM患者。患者接受VA双联疗法，该疗法由沃克哌唑（20mg，每日两次）和阿莫西林（750mg，每日三次）组成，疗程为14天（14天VA双联疗法）。意向性分析和符合方案分析中的根除率分别为84.00%（63/75）和87.14%（61/70）。多因素分析显示，幽门螺杆菌根除失败的独立危险因素为吸烟（OR：4.59，95%CI：1.20-17.58，p=0.026）和A1C水平升高（OR：1.65，95%CI：1.01-2.68，p=0.044）。与根除前水平相比，成功根除组患者在治疗后3个月时A1C水平显著降低（7.70±1.05% vs. 7.23±1.00%，p=0.006）。VA双联疗法对T2DM患者是一种安全有效的治疗方案。
