Ju Zhang, Xinzhao Wang, Shujie Song, Xiaoming Zhu, Ting Lv, Lingling Wang, Lei Lei, Yuhui Wang, Yali Lei, Yating Wang, Xiaojing Zhu, Lifeng Zhang, Min Chen, Yongquan Shi
{"title":"Vonoprazan和大剂量阿莫西林双重治疗幽门螺杆菌感染的疗效和安全性：一项多中心随机对照试验。","authors":"Ju Zhang, Xinzhao Wang, Shujie Song, Xiaoming Zhu, Ting Lv, Lingling Wang, Lei Lei, Yuhui Wang, Yali Lei, Yating Wang, Xiaojing Zhu, Lifeng Zhang, Min Chen, Yongquan Shi","doi":"10.1002/ueg2.70070","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Vonoprazan and amoxicillin dual therapy has demonstrated favorable efficacy in the initial treatment of Helicobacter pylori (H. pylori) infection. This study aimed to evaluate the efficacy and safety of vonoprazan and high-dose amoxicillin (VHA) dual therapy for H. pylori rescue treatment.</p><p><strong>Methods: </strong>This was an open label, multicenter, non-inferiority, and randomized controlled clinical trial conducted at four institutions in both central and northwestern China. A total of 688 H. pylori-infected patients who had failed previous treatments were randomly assigned (1:1) to receive either VHA dual therapy or the tetracycline- and furazolidone-based bismuth-containing quadruple therapy (TFEB) for 14 days. Eradication rates, adverse event (AE) rates, and the patient compliance were compared between the two groups.</p><p><strong>Results: </strong>The eradication rates in the VHA and TFEB groups were 73.8% and 76.2% (p = 0.481), respectively, by intention-to-treat (ITT) analysis; 81.9% and 85.6% (p = 0.215), respectively, by modified ITT (MITT) analysis; and 82.1% and 85.6% (p = 0.248), respectively, by per-protocol (PP) analysis. VHA therapy remained non-inferior to TFEB in ITT, MITT, and PP analyses. The overall AE incidence in the VHA group was significantly lower compared with that in the TFEB group (13.4% vs.. 28.5%, p < 0.001). Patients' compliance was similar between the two groups. A history of multiple prior eradication failures was an independent risk factor (2 failures: OR = 0.566, p = 0.032; ≥ 3 failures: OR = 0.335, p < 0.001) reducing the efficacy of H. pylori rescue therapy.</p><p><strong>Conclusion: </strong>The 14-day VHA dual therapy was non-inferior to bismuth-containing quadruple therapy, with a lower incidence of adverse events and good compliance, and may represent an effective alternative for H.pylori rescue treatment.</p><p><strong>Trial registration: </strong>This trial was registered at ClinicalTrials.gov (No. NCT06168084).</p>","PeriodicalId":23444,"journal":{"name":"United European Gastroenterology Journal","volume":" ","pages":""},"PeriodicalIF":5.8000,"publicationDate":"2025-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy and Safety of Vonoprazan and High-Dose Amoxicillin Dual Therapy for Rescue Treatment of Helicobacter pylori Infection: A Multicenter Randomized Controlled Trial.\",\"authors\":\"Ju Zhang, Xinzhao Wang, Shujie Song, Xiaoming Zhu, Ting Lv, Lingling Wang, Lei Lei, Yuhui Wang, Yali Lei, Yating Wang, Xiaojing Zhu, Lifeng Zhang, Min Chen, Yongquan Shi\",\"doi\":\"10.1002/ueg2.70070\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Vonoprazan and amoxicillin dual therapy has demonstrated favorable efficacy in the initial treatment of Helicobacter pylori (H. pylori) infection. This study aimed to evaluate the efficacy and safety of vonoprazan and high-dose amoxicillin (VHA) dual therapy for H. pylori rescue treatment.</p><p><strong>Methods: </strong>This was an open label, multicenter, non-inferiority, and randomized controlled clinical trial conducted at four institutions in both central and northwestern China. A total of 688 H. pylori-infected patients who had failed previous treatments were randomly assigned (1:1) to receive either VHA dual therapy or the tetracycline- and furazolidone-based bismuth-containing quadruple therapy (TFEB) for 14 days. Eradication rates, adverse event (AE) rates, and the patient compliance were compared between the two groups.</p><p><strong>Results: </strong>The eradication rates in the VHA and TFEB groups were 73.8% and 76.2% (p = 0.481), respectively, by intention-to-treat (ITT) analysis; 81.9% and 85.6% (p = 0.215), respectively, by modified ITT (MITT) analysis; and 82.1% and 85.6% (p = 0.248), respectively, by per-protocol (PP) analysis. VHA therapy remained non-inferior to TFEB in ITT, MITT, and PP analyses. The overall AE incidence in the VHA group was significantly lower compared with that in the TFEB group (13.4% vs.. 28.5%, p < 0.001). Patients' compliance was similar between the two groups. A history of multiple prior eradication failures was an independent risk factor (2 failures: OR = 0.566, p = 0.032; ≥ 3 failures: OR = 0.335, p < 0.001) reducing the efficacy of H. pylori rescue therapy.</p><p><strong>Conclusion: </strong>The 14-day VHA dual therapy was non-inferior to bismuth-containing quadruple therapy, with a lower incidence of adverse events and good compliance, and may represent an effective alternative for H.pylori rescue treatment.</p><p><strong>Trial registration: </strong>This trial was registered at ClinicalTrials.gov (No. NCT06168084).</p>\",\"PeriodicalId\":23444,\"journal\":{\"name\":\"United European Gastroenterology Journal\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":5.8000,\"publicationDate\":\"2025-06-21\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"United European Gastroenterology Journal\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1002/ueg2.70070\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"United European Gastroenterology Journal","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/ueg2.70070","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
Efficacy and Safety of Vonoprazan and High-Dose Amoxicillin Dual Therapy for Rescue Treatment of Helicobacter pylori Infection: A Multicenter Randomized Controlled Trial.
Background: Vonoprazan and amoxicillin dual therapy has demonstrated favorable efficacy in the initial treatment of Helicobacter pylori (H. pylori) infection. This study aimed to evaluate the efficacy and safety of vonoprazan and high-dose amoxicillin (VHA) dual therapy for H. pylori rescue treatment.
Methods: This was an open label, multicenter, non-inferiority, and randomized controlled clinical trial conducted at four institutions in both central and northwestern China. A total of 688 H. pylori-infected patients who had failed previous treatments were randomly assigned (1:1) to receive either VHA dual therapy or the tetracycline- and furazolidone-based bismuth-containing quadruple therapy (TFEB) for 14 days. Eradication rates, adverse event (AE) rates, and the patient compliance were compared between the two groups.
Results: The eradication rates in the VHA and TFEB groups were 73.8% and 76.2% (p = 0.481), respectively, by intention-to-treat (ITT) analysis; 81.9% and 85.6% (p = 0.215), respectively, by modified ITT (MITT) analysis; and 82.1% and 85.6% (p = 0.248), respectively, by per-protocol (PP) analysis. VHA therapy remained non-inferior to TFEB in ITT, MITT, and PP analyses. The overall AE incidence in the VHA group was significantly lower compared with that in the TFEB group (13.4% vs.. 28.5%, p < 0.001). Patients' compliance was similar between the two groups. A history of multiple prior eradication failures was an independent risk factor (2 failures: OR = 0.566, p = 0.032; ≥ 3 failures: OR = 0.335, p < 0.001) reducing the efficacy of H. pylori rescue therapy.
Conclusion: The 14-day VHA dual therapy was non-inferior to bismuth-containing quadruple therapy, with a lower incidence of adverse events and good compliance, and may represent an effective alternative for H.pylori rescue treatment.
Trial registration: This trial was registered at ClinicalTrials.gov (No. NCT06168084).
期刊介绍：
United European Gastroenterology Journal (UEG Journal) is the official Journal of the United European Gastroenterology (UEG), a professional non-profit organisation combining all the leading European societies concerned with digestive disease. UEG’s member societies represent over 22,000 specialists working across medicine, surgery, paediatrics, GI oncology and endoscopy, which makes UEG a unique platform for collaboration and the exchange of knowledge.
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