{"title":"10天vs 14天Vonoprazan和阿莫西林双重治疗一线根除幽门螺杆菌感染：一项多中心随机对照试验","authors":"Zhiqiang Song, Xiuli Zuo, Zhenyu Zhang, Xuehong Wang, Ya Lin, Yueyue Li, Xiaojun Xu, Yun Huang, Qiuyan Wang, Yanyan Shi, Liya Zhou","doi":"10.1111/hel.70070","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>The optimal duration for vonoprazan and amoxicillin dual therapy (VA-DT) remains unclear, and studies on gastric acid suppression of vonoprazan during eradication are still lacking.</p>\n </section>\n \n <section>\n \n <h3> Objective</h3>\n \n <p>This study conducted a multicenter, randomized controlled trial to compare the eradication efficacy between 10 and 14-day VA-DT, and to identify the dynamic changes of gastric pH during treatment.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>This study included 418 naïve adult patients with <i>Helicobacter pylori</i> infection, who were randomly divided into 10 or 14-day VA-DT groups (vonoprazan 20 mg twice daily and amoxicillin 1000 mg thrice daily). <sup>13</sup>C-urea breath tests were conducted at 4–8 weeks after eradication to evaluate the success of treatment. 24-h intragastric pH was monitored in 22 patients.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Ten and 14-day VA-DT demonstrated eradication rates of 83.3% vs. 88.0% (rate difference: −4.8%, 95% confidence interval: −11.6% to −2.0%) in intention-to-treat analysis, 87.9% vs. 93.9% (−6.0%, −11.9% to −0.3%) in modified intention-to-treat analysis, and 89.1% vs. 95.3% (−6.1%, −11.8% to −0.7%) in per-protocol analysis, respectively. Vonoprazan showed excellent gastric acid suppression during eradication, with the time percentages of pH > 6 at 75.3% and 97.2% and the median pH levels at 7.4 and 7.8 on the 1st and 7th days, respectively. Furthermore, gastric pH exceeded 6 approximately 4–5 h after the first dose and remained stable at 7–9 thereafter.</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>The noninferiority of eradication efficacy between 10- and 14-day VA-DT in the first-line treatment was not established, indicating that 10-day therapy cannot be used as a substitute for 14-day therapy. Vonoprazan exerted excellent gastric acid suppression during eradication.</p>\n </section>\n \n <section>\n \n <h3> Trial Registration</h3>\n \n <p>Chinese Clinical Trial Registry: ChiCTR2200057625</p>\n </section>\n </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"30 5","pages":""},"PeriodicalIF":4.3000,"publicationDate":"2025-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Ten-Day Versus 14-Day Vonoprazan and Amoxicillin Dual Therapy for the Firstline Eradication of Helicobacter pylori Infection: A Multicenter, Randomized Controlled Trial\",\"authors\":\"Zhiqiang Song, Xiuli Zuo, Zhenyu Zhang, Xuehong Wang, Ya Lin, Yueyue Li, Xiaojun Xu, Yun Huang, Qiuyan Wang, Yanyan Shi, Liya Zhou\",\"doi\":\"10.1111/hel.70070\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Background</h3>\\n \\n <p>The optimal duration for vonoprazan and amoxicillin dual therapy (VA-DT) remains unclear, and studies on gastric acid suppression of vonoprazan during eradication are still lacking.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Objective</h3>\\n \\n <p>This study conducted a multicenter, randomized controlled trial to compare the eradication efficacy between 10 and 14-day VA-DT, and to identify the dynamic changes of gastric pH during treatment.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>This study included 418 naïve adult patients with <i>Helicobacter pylori</i> infection, who were randomly divided into 10 or 14-day VA-DT groups (vonoprazan 20 mg twice daily and amoxicillin 1000 mg thrice daily). <sup>13</sup>C-urea breath tests were conducted at 4–8 weeks after eradication to evaluate the success of treatment. 24-h intragastric pH was monitored in 22 patients.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>Ten and 14-day VA-DT demonstrated eradication rates of 83.3% vs. 88.0% (rate difference: −4.8%, 95% confidence interval: −11.6% to −2.0%) in intention-to-treat analysis, 87.9% vs. 93.9% (−6.0%, −11.9% to −0.3%) in modified intention-to-treat analysis, and 89.1% vs. 95.3% (−6.1%, −11.8% to −0.7%) in per-protocol analysis, respectively. Vonoprazan showed excellent gastric acid suppression during eradication, with the time percentages of pH > 6 at 75.3% and 97.2% and the median pH levels at 7.4 and 7.8 on the 1st and 7th days, respectively. Furthermore, gastric pH exceeded 6 approximately 4–5 h after the first dose and remained stable at 7–9 thereafter.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusion</h3>\\n \\n <p>The noninferiority of eradication efficacy between 10- and 14-day VA-DT in the first-line treatment was not established, indicating that 10-day therapy cannot be used as a substitute for 14-day therapy. Vonoprazan exerted excellent gastric acid suppression during eradication.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Trial Registration</h3>\\n \\n <p>Chinese Clinical Trial Registry: ChiCTR2200057625</p>\\n </section>\\n </div>\",\"PeriodicalId\":13223,\"journal\":{\"name\":\"Helicobacter\",\"volume\":\"30 5\",\"pages\":\"\"},\"PeriodicalIF\":4.3000,\"publicationDate\":\"2025-09-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Helicobacter\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1111/hel.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":"Helicobacter","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1111/hel.70070","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
Ten-Day Versus 14-Day Vonoprazan and Amoxicillin Dual Therapy for the Firstline Eradication of Helicobacter pylori Infection: A Multicenter, Randomized Controlled Trial
Background
The optimal duration for vonoprazan and amoxicillin dual therapy (VA-DT) remains unclear, and studies on gastric acid suppression of vonoprazan during eradication are still lacking.
Objective
This study conducted a multicenter, randomized controlled trial to compare the eradication efficacy between 10 and 14-day VA-DT, and to identify the dynamic changes of gastric pH during treatment.
Methods
This study included 418 naïve adult patients with Helicobacter pylori infection, who were randomly divided into 10 or 14-day VA-DT groups (vonoprazan 20 mg twice daily and amoxicillin 1000 mg thrice daily). 13C-urea breath tests were conducted at 4–8 weeks after eradication to evaluate the success of treatment. 24-h intragastric pH was monitored in 22 patients.
Results
Ten and 14-day VA-DT demonstrated eradication rates of 83.3% vs. 88.0% (rate difference: −4.8%, 95% confidence interval: −11.6% to −2.0%) in intention-to-treat analysis, 87.9% vs. 93.9% (−6.0%, −11.9% to −0.3%) in modified intention-to-treat analysis, and 89.1% vs. 95.3% (−6.1%, −11.8% to −0.7%) in per-protocol analysis, respectively. Vonoprazan showed excellent gastric acid suppression during eradication, with the time percentages of pH > 6 at 75.3% and 97.2% and the median pH levels at 7.4 and 7.8 on the 1st and 7th days, respectively. Furthermore, gastric pH exceeded 6 approximately 4–5 h after the first dose and remained stable at 7–9 thereafter.
Conclusion
The noninferiority of eradication efficacy between 10- and 14-day VA-DT in the first-line treatment was not established, indicating that 10-day therapy cannot be used as a substitute for 14-day therapy. Vonoprazan exerted excellent gastric acid suppression during eradication.
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.
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