Vonoprazan Improves Efficacy of Bismuth Quadruple Therapy for Helicobacter pylori Rescue Treatment: A Multicenter Randomized Controlled Trial

IF 4.3 2区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Helicobacter Pub Date : 2025-07-13 DOI:10.1111/hel.70056

Tian-Lian Yan, Jing-Hua Wang, Ren-Ke Zhu, Hao-Liang Zhai, Zhen-Zhen Wang, Xin-Li Mao, Xian Shen, Ping Xu, Dan Ma, Xin-Jue He, Jie-Wei Wang, Jian-Guo Gao, Ling-Ling Jiang, Kefang Sun, Ye Chen, Jian-Zhong Sang, Xiao-Qin Liu, Jiao-E Chen, Lan Li

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Abstract

Background

Rescue treatment for non-naive patients with persistent Helicobacter pylori (H. pylori) infection is lacking, especially in areas where tetracycline is unavailable. This trial aimed to evaluate the efficacy and safety of replacing proton pump inhibitor (PPI) with potassium-competitive acid blocker (P-CAB) in bismuth quadruple therapy (BQT) containing amoxicillin and furazolidone as rescue therapy.

Materials and Methods

We conducted a prospective, open-label, noninferiority randomized controlled trial at six institutions in eastern China. A total of 444 patients with a history of H. pylori treatment failure were enrolled and randomly assigned in a 1:1 ratio to either the 14-day P-CAB-BQT group (vonoprazan 20 mg, colloidal bismuth 200 mg, amoxicillin 1000 mg and furazolidone 100 mg, all given twice daily) or the 14-day PPI-BQT group (rabeprazole 10 mg given twice daily, and the same dose of three other drugs as the 14-day P-CAB-BQT group). The primary endpoint was the eradication rate assessed by ¹³C urea breath test. The secondary endpoints were adverse events and compliance.

Results

H. pylori eradication rates of PPI-BQT versus P-CAB-BQT group were 83.8% versus 91.9% in the intention-to-treat (ITT) analysis (treatment difference: 8.1%; 95% CI: 2.1%–14.1%; non-inferiority p < 0.001, p-value for difference = 0.008); 86.1% versus 95.8% in the modified ITT (MITT) analysis (treatment difference: 9.7%; 95% CI: 4.4%–15.0%; non-inferiority p < 0.001, p-value for difference < 0.001); and 86.3% versus 95.6% in the per-protocol (PP) analysis (treatment difference: 9.3%; 95% CI: 3.8%–14.8%; non-inferiority p < 0.001, p-value for difference < 0.001). The P-CAB-BQT regimen was shown to be non-inferior to the PPI-BQT regimen and yielded higher eradication rates across all analysis populations (ITT, MITT, and PP). The overall frequency of adverse events (27.9% and 34.2%, p = 0.151) and compliance (93.7% and 94.6%, p = 0.686) were similar between PPI and P-CAB groups. Among the patients suspected of drug-induced fever (8.6% and 7.2%, p = 0.597), 82.9% experienced fever after administration of furazolidone for > 10 days. The eradication rates were not affected by prior choice of antibiotics and the number of treatment attempts.

Conclusions

The 14-day P-CAB-BQT therapy containing amoxicillin and furazolidone provided a satisfactory eradication rate and a good safety profile as rescue treatment for H. pylori eradication, regardless of prior choice of antibiotics and the number of treatment attempts. Shortening the treatment course to 10–11 days could prevent the majority of drug-induced fevers.

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伏诺哌赞提高铋四联疗法治疗幽门螺杆菌的疗效：一项多中心随机对照试验

背景：对于持续性幽门螺杆菌（h.p ylori）感染的非初发患者缺乏抢救治疗，特别是在无法获得四环素的地区。本试验旨在评价在含阿莫西林和呋喃唑酮的铋四联治疗（BQT）中，用钾竞争酸阻滞剂（P-CAB）替代质子泵抑制剂（PPI）作为抢救治疗的有效性和安全性。材料和方法我们在中国东部的6家机构进行了一项前瞻性、开放标签、非劣效性随机对照试验。共有444名有幽门螺旋杆菌治疗失败史的患者被纳入研究，并按1:1的比例随机分配到14天P-CAB-BQT组（伏诺哌赞20 mg，胶质铋200 mg，阿莫西林1000 mg，呋喃唑酮100 mg，均每日两次）或14天PPI-BQT组（雷别拉唑10 mg，每日两次，其他三种药物与14天P-CAB-BQT组相同剂量）。主要终点为13C尿素呼气试验评估的根除率。次要终点是不良事件和依从性。结果在意向治疗（ITT）分析中，PPI-BQT组与P-CAB-BQT组幽门螺杆菌根除率分别为83.8%和91.9%(治疗差异：8.1%；95% ci: 2.1%-14.1%；非劣效性p <； 0.001， p值差异= 0.008)；在改进的ITT （MITT）分析中为86.1%对95.8%(治疗差异：9.7%；95% ci: 4.4%-15.0%；非劣效性p <； 0.001，差异p值<； 0.001)；按方案（PP）分析为86.3%对95.6%(治疗差异：9.3%；95% ci: 3.8%-14.8%；非劣效性p <； 0.001，差异p值<； 0.001)。P-CAB-BQT方案不逊于PPI-BQT方案，并且在所有分析人群（ITT、MITT和PP）中产生更高的根除率。PPI组和p - cab组总体不良事件发生率（27.9%和34.2%,p = 0.151）和依从性（93.7%和94.6%,p = 0.686）相似。在疑似药物性发热的患者中（8.6%和7.2%,p = 0.597）， 82.9%的患者在服用呋喃唑酮10天后出现发热。根除率不受先前选择的抗生素和治疗次数的影响。结论与先前选择的抗生素和治疗次数无关，联合阿莫西林和呋喃唑酮的14天P-CAB-BQT治疗作为幽门螺杆菌根除的挽救治疗具有令人满意的根除率和良好的安全性。将疗程缩短至10-11天可以预防大多数药物性发热。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Helicobacter 医学-微生物学

CiteScore

8.40

自引率

9.10%

发文量

审稿时长

2 months

期刊介绍： Helicobacter is edited by Professor David Y Graham. The editorial and peer review process is an independent process. Whenever there is a conflict of interest, the editor and editorial board will declare their interests and affiliations. Helicobacter recognises the critical role that has been established for Helicobacter pylori in peptic ulcer, gastric adenocarcinoma, and primary gastric lymphoma. As new helicobacter species are now regularly being discovered, Helicobacter covers the entire range of helicobacter research, increasing communication among the fields of gastroenterology; microbiology; vaccine development; laboratory animal science.