Bakulina N V, Ponomarenko V A, Kerimova A S, Thai Hien T, Shikhmagomedova A S, Veliev A M, Savilova I V
Mechnikov North-Western State Medical University.
Russian University of Medicine.
Ter Arkh. 2025 Aug 28;97(8):642-650. doi: 10.26442/00403660.2025.08.203300.
The article presents the results of a prospective open-label comparative interventional study of the efficacy and safety of high-dose dual therapy (HDDT) for eradicating infection.
To evaluate the efficacy and safety of HDDT of the eradication regimen, as well as the possible increase in the efficacy of this regimen with the addition of rebamipide.
All patients with verified infection were randomized into three groups depending on the treatment regimen. The Era-AmIPP group ( = 24) received HDDT (esomeprazole 120 mg/day and amoxicillin 3000 mg/day) for 14 days. The Era-RebAmIPP group ( = 121) received HDDT with rebamipide 300 mg/day for 14 days. The comparison group ( = 101) received conventional triple eradication therapy enhanced with bismuth tripotassium dicitrate for 14 days. The effectiveness of eradication was evaluated at 4-6 weeks after the end of therapy. Particular attention was paid to assessing the safety of therapy, the incidence of adverse events, and treatment adherence.
The study included 246 patients. Low efficacy (87.5% [95% confidence interval [CI] 69.0-95.7]) of HDDT was shown. Adding rebamipide 300 mg/day to HDDT increased the eradication rate to 96.3% (95% CI 90.9-98.6). The efficacy of the Era-RebAmIPP regimen in patients previously treated with conventional eradication regimens was 91.7% (95% CI 64.6-98.5). Adverse events were reported in 37.5% (95% CI 21.2-57.3) patients in the Era-AmIPP group, 19.8% (95% CI 13.7-27.8) in the Era-RebAmIPP group, and 31.3% (95% CI 22.9-41.1) in the comparison group ( = 0.07).
The efficacy of the Era-RebAmIPP regimen is comparable to conventional triple therapy with bismuth. To assess the effectiveness of this regimen, larger-scale studies are required in various regions of our country.
本文介绍了一项前瞻性开放标签比较干预性研究的结果，该研究旨在探讨大剂量双重疗法（HDDT）根除感染的疗效和安全性。
评估HDDT根除方案的疗效和安全性，以及添加瑞巴派特后该方案疗效可能的提高情况。
所有确诊感染的患者根据治疗方案随机分为三组。Era-AmIPP组（n = 24）接受HDDT（埃索美拉唑120毫克/天和阿莫西林3000毫克/天）治疗14天。Era-RebAmIPP组（n = 121）接受HDDT联合瑞巴派特300毫克/天治疗14天。对照组（n = 101）接受含枸橼酸铋钾强化的传统三联根除疗法治疗14天。在治疗结束后4 - 6周评估根除效果。特别关注评估治疗的安全性、不良事件发生率和治疗依从性。
该研究纳入了246例患者。结果显示HDDT疗效较低（87.5% [95%置信区间[CI] 69.0 - 95.7]）。HDDT添加瑞巴派特300毫克/天后根除率提高到96.3%（95% CI 90.9 - 用传统根除方案治疗过的患者中，Era-RebAmIPP方案的疗效为91.7%（95% CI 64.6 - 98.5）。Era-AmIPP组37.5%（95% CI 21.2 - 57.3）的患者报告了不良事件，Era-RebAmIPP组为19.8%（95% CI 13.7 - 27.8），对照组为31.3%（95% CI 22.9 - 41.1）（P = 0.07）。
Era-RebAmIPP方案的疗效与含铋传统三联疗法相当。为评估该方案的有效性，我国各地区需要开展更大规模的研究。 98.6）。
