Clinical Impact of High-dose Esomeprazole-amoxicillin Dual Therapy as Rescue Treatment for Helicobacter pylori Infection: A Prospective, Multicenter, Randomized Trial.

IF 2.8 4区 医学 Q2 GASTROENTEROLOGY & HEPATOLOGY
Chao Wang, He-Jie Wang, Keng Li, Yin Wang, Yuan-Yuan Lin, Cheng-Zhao Weng, Jie Chen, Shao-Hua Xie, Wei Jiang, Yu-Cheng Zhu
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引用次数: 0

Abstract

Objective: 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.

Materials and methods: 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.

Results: 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.

Conclusion: 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.

大剂量埃索美拉唑-阿莫西林双重疗法作为幽门螺旋杆菌感染抢救疗法的临床影响:一项前瞻性、多中心、随机试验。
研究目的本研究旨在比较使用埃索美拉唑和阿莫西林的大剂量双重疗法(HDDT)与呋喃唑酮四联疗法(FBQT)治疗无反应幽门螺杆菌(H. pylori)感染患者的有效性和安全性:将 209 名曾接受过无效治疗并前往门诊就诊的幽门螺杆菌感染患者随机分配到 HDDT 组或 FBQT 组。所有患者都接受了为期14天的治疗,并在治疗后4周对幽门螺杆菌根除成功率和治疗方案的安全性进行了评估:14天治疗后,意向治疗(ITT)分析显示,HDDT和FBQT的根除率分别为93.6%和86.9%。在按方案(PP)分析中,HDDT 的根除率为 94.5%,FBQT 为 88.7%。两组的根除率无明显差异。HDDT 的不良反应率(ITT 为 9.1%,PP 为 9.2%)明显低于 FBQT(ITT 为 58.6%,PP 为 59.8%)。多变量分析发现,间隔时间、碱性磷酸酶和血清肌酐水平是影响根除率的因素。FBQT 组和 HDDT 组的间隔时间与幽门螺杆菌根除成功率的接收者操作曲线下面积分别为 0.622 和 0.578。FBQT和HDDT的最佳挽救治疗间隔时间分别为6个月和1年:与 FBQT 相比,使用大剂量埃索美拉唑和阿莫西林的 HDDT 具有治疗幽门螺杆菌感染的疗效,同时还能减少副作用,提高用药依从性。当其他方法无效时,可将 HDDT 作为一种救治选择,并相应优化治疗间隔。
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来源期刊
Journal of clinical gastroenterology
Journal of clinical gastroenterology 医学-胃肠肝病学
CiteScore
5.60
自引率
3.40%
发文量
339
审稿时长
3-8 weeks
期刊介绍: Journal of Clinical Gastroenterology gathers the world''s latest, most relevant clinical studies and reviews, case reports, and technical expertise in a single source. Regular features include cutting-edge, peer-reviewed articles and clinical reviews that put the latest research and development into the context of your practice. Also included are biographies, focused organ reviews, practice management, and therapeutic recommendations.
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