Wang Chao, Wang He-Jie, Li Keng, Wang Yin, Lin Yuan-Yuan, Weng Cheng-Zhao, Chen Jie, Xie Shao-Hua, Jiang Wei, Zhu Yu-Cheng
Department of Gastroenterology and Hepatology, Zhongshan Hospital (Xiamen), Fudan University.
Department of Xiamen Municipal Clinical Research Center for Cancer Therapy, Zhongshan Hospital (Xiamen), Fudan University.
J Clin Gastroenterol. 2025 Oct 1;59(9):833-841. doi: 10.1097/MCG.0000000000002100.
This study aimed to compare the effectiveness and safety of high-dose dual therapy (HDDT) using esomeprazole and amoxicillin to furazolidone-based quadruple therapy (FBQT) in treating nonresponsive patients with Helicobacter pylori ( H. pylori ) infection.
A total of 209 patients with H. pylori infection, who had previously received ineffective treatment and visited an outpatient clinic, were randomly assigned to either the HDDT or FBQT groups. All patients underwent a 14-day treatment regimen, and the success rates of H. pylori eradication and safety of the treatment regimens were assessed 4 weeks posttreatment.
Following the 14-day treatment period, the intention-to-treat (ITT) analysis revealed eradication rates of 93.6% for HDDT and 86.9% for FBQT. In the per-protocol (PP) analysis, eradication rates were 94.5% for HDDT and 88.7% for FBQT. No significant difference in eradication rates was observed between the two groups. HDDT exhibited significantly lower rates of adverse reactions (9.1% in ITT and 9.2% in PP) compared with FBQT (58.6% in ITT and 59.8% in PP). Multivariate analysis identified interval time, alkaline phosphatase, and serum creatinine level as factors influencing the eradication rate. The area under the receiver operating curve of the interval time between the FBQT group and the HDDT group and the success of H. pylori eradication were 0.622 and 0.578, respectively. The optimal salvage treatment intervals were determined as 6 months for FBQT and 1 year for HDDT.
HDDT using high-dose esomeprazole and amoxicillin demonstrated efficacy in treating H. pylori infection, with the added benefits of reduced side effects and improved medication compliance compared with FBQT. HDDT can be considered a rescue treatment option when other methods fail, with treatment intervals optimized accordingly.
本研究旨在比较使用埃索美拉唑和阿莫西林的高剂量双联疗法（HDDT）与基于呋喃唑酮的四联疗法（FBQT）在治疗幽门螺杆菌（H. pylori）感染无反应患者中的有效性和安全性。
共有209例曾接受过无效治疗且前来门诊就诊的幽门螺杆菌感染患者被随机分配至HDDT组或FBQT组。所有患者均接受为期14天治疗方案，治疗后4周评估幽门螺杆菌根除成功率及治疗方案的安全性。
在为期14天的治疗期后，意向性分析（ITT）显示HDDT的根除率为93.6%，FBQT为86.9%。符合方案分析（PP）中，HDDT的根除率为94.5%，FBQT为88.7%。两组间根除率无显著差异。与FBQT（ITT中为58.6%，PP中为59.8%）相比，HDDT的不良反应发生率显著更低（ITT中为9.1%，PP中为9.2%）。多因素分析确定间隔时间、碱性磷酸酶和血清肌酐水平为影响根除率的因素。FBQT组与HDDT组间隔时间与幽门螺杆菌根除成功的受试者工作特征曲线下面积分别为0.622和0.578。确定FBQT的最佳挽救治疗间隔为6个月，HDDT为1年。
使用高剂量埃索美拉唑和阿莫西林的HDDT在治疗幽门螺杆菌感染方面显示出疗效，与FBQT相比，具有副作用减少和用药依从性提高的额外益处。当其他方法失败时，HDDT可被视为一种挽救治疗选择，并相应优化治疗间隔。
