{"title":"伏诺哌赞与以埃索美拉唑为基础的高剂量双重治疗一线幽门螺杆菌根除的疗效和安全性比较：一项随机对照试验","authors":"Wei-Chen Tai, Lung-Sheng Lu, Shih-Cheng Yang, Hsin-Ming Wang, Cheng-Kun Wu, Chih-Chien Yao, Pao-Yuan Huang, Yu-Chi Lee, Seng-Kee Chuah, Chih-Ming Liang","doi":"10.1177/17562848251378066","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Effective <i>Helicobacter pylori</i> (<i>H. pylori</i>) eradication depends on maintaining intragastric pH >6 and overcoming antibiotic resistance. High-dose dual therapy (HDDT) with a proton pump inhibitor (PPI) and amoxicillin has shown promising results.</p><p><strong>Objectives: </strong>To compare the efficacy of 14-day vonoprazan-based (VA) and esomeprazole-based (EA) HDDT for <i>H. pylori</i> eradication and evaluate the impact of antibiotic resistance.</p><p><strong>Design: </strong>Randomized controlled trial (RCT).</p><p><strong>Methods: </strong>A total of 121 patients with confirmed <i>H. pylori</i> infection were randomized to receive either VA therapy (vonoprazan 20 mg twice daily plus amoxicillin 750 mg four times daily (QID)) or EA therapy (esomeprazole 40 mg three times daily plus amoxicillin 750 mg QID) for 14 days. Eradication was assessed by the ¹³C-urea breath test at week 8. Antibiotic susceptibility testing was performed on cultured isolates.</p><p><strong>Results: </strong>Baseline demographic and clinical characteristics were comparable between the VA and EA groups. In the intention-to-treat analysis, eradication rates were 86.9% (95% confidence interval (CI): 78.4%-95.4%) in the VA group and 81.7% (95% CI: 71.3%-89.4%) in the EA group (<i>p</i> = 0.430). Per-protocol (PP) analysis showed eradication rates of 93.0% (95% CI: 86.4%-99.6%) for VA and 84.5% (95% CI: 73.8%-92.1%) for EA (<i>p</i> = 0.150), indicating no statistically significant difference. Adverse events (AEs) were mild and similar between groups (5.3% in VA vs 5.2% in EA, <i>p</i> = 0.983), with constipation and diarrhea being the most reported. Both groups achieved 100% compliance. Antibiotic resistance patterns did not significantly affect outcomes.</p><p><strong>Conclusion: </strong>Both VA and EA-HDDT regimens demonstrated comparable efficacy, excellent compliance, and minimal AEs. Although VA therapy achieved a >90% eradication rate in the PP analysis, our study was underpowered to confirm superiority. Therefore, larger, adequately powered RCTs are warranted to validate the potential superiority of VA.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT06811207.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251378066"},"PeriodicalIF":3.4000,"publicationDate":"2025-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12450270/pdf/","citationCount":"0","resultStr":"{\"title\":\"Comparative efficacy and safety of vonoprazan versus esomeprazole-based high-dose dual therapies for first-line <i>Helicobacter pylori</i> eradication: a randomized controlled trial.\",\"authors\":\"Wei-Chen Tai, Lung-Sheng Lu, Shih-Cheng Yang, Hsin-Ming Wang, Cheng-Kun Wu, Chih-Chien Yao, Pao-Yuan Huang, Yu-Chi Lee, Seng-Kee Chuah, Chih-Ming Liang\",\"doi\":\"10.1177/17562848251378066\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Effective <i>Helicobacter pylori</i> (<i>H. pylori</i>) eradication depends on maintaining intragastric pH >6 and overcoming antibiotic resistance. High-dose dual therapy (HDDT) with a proton pump inhibitor (PPI) and amoxicillin has shown promising results.</p><p><strong>Objectives: </strong>To compare the efficacy of 14-day vonoprazan-based (VA) and esomeprazole-based (EA) HDDT for <i>H. pylori</i> eradication and evaluate the impact of antibiotic resistance.</p><p><strong>Design: </strong>Randomized controlled trial (RCT).</p><p><strong>Methods: </strong>A total of 121 patients with confirmed <i>H. pylori</i> infection were randomized to receive either VA therapy (vonoprazan 20 mg twice daily plus amoxicillin 750 mg four times daily (QID)) or EA therapy (esomeprazole 40 mg three times daily plus amoxicillin 750 mg QID) for 14 days. Eradication was assessed by the ¹³C-urea breath test at week 8. Antibiotic susceptibility testing was performed on cultured isolates.</p><p><strong>Results: </strong>Baseline demographic and clinical characteristics were comparable between the VA and EA groups. In the intention-to-treat analysis, eradication rates were 86.9% (95% confidence interval (CI): 78.4%-95.4%) in the VA group and 81.7% (95% CI: 71.3%-89.4%) in the EA group (<i>p</i> = 0.430). Per-protocol (PP) analysis showed eradication rates of 93.0% (95% CI: 86.4%-99.6%) for VA and 84.5% (95% CI: 73.8%-92.1%) for EA (<i>p</i> = 0.150), indicating no statistically significant difference. Adverse events (AEs) were mild and similar between groups (5.3% in VA vs 5.2% in EA, <i>p</i> = 0.983), with constipation and diarrhea being the most reported. Both groups achieved 100% compliance. Antibiotic resistance patterns did not significantly affect outcomes.</p><p><strong>Conclusion: </strong>Both VA and EA-HDDT regimens demonstrated comparable efficacy, excellent compliance, and minimal AEs. Although VA therapy achieved a >90% eradication rate in the PP analysis, our study was underpowered to confirm superiority. Therefore, larger, adequately powered RCTs are warranted to validate the potential superiority of VA.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT06811207.</p>\",\"PeriodicalId\":48770,\"journal\":{\"name\":\"Therapeutic Advances in Gastroenterology\",\"volume\":\"18 \",\"pages\":\"17562848251378066\"},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2025-09-20\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12450270/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Therapeutic Advances in Gastroenterology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/17562848251378066\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic Advances in Gastroenterology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/17562848251378066","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
Comparative efficacy and safety of vonoprazan versus esomeprazole-based high-dose dual therapies for first-line Helicobacter pylori eradication: a randomized controlled trial.
Background: Effective Helicobacter pylori (H. pylori) eradication depends on maintaining intragastric pH >6 and overcoming antibiotic resistance. High-dose dual therapy (HDDT) with a proton pump inhibitor (PPI) and amoxicillin has shown promising results.
Objectives: To compare the efficacy of 14-day vonoprazan-based (VA) and esomeprazole-based (EA) HDDT for H. pylori eradication and evaluate the impact of antibiotic resistance.
Design: Randomized controlled trial (RCT).
Methods: A total of 121 patients with confirmed H. pylori infection were randomized to receive either VA therapy (vonoprazan 20 mg twice daily plus amoxicillin 750 mg four times daily (QID)) or EA therapy (esomeprazole 40 mg three times daily plus amoxicillin 750 mg QID) for 14 days. Eradication was assessed by the ¹³C-urea breath test at week 8. Antibiotic susceptibility testing was performed on cultured isolates.
Results: Baseline demographic and clinical characteristics were comparable between the VA and EA groups. In the intention-to-treat analysis, eradication rates were 86.9% (95% confidence interval (CI): 78.4%-95.4%) in the VA group and 81.7% (95% CI: 71.3%-89.4%) in the EA group (p = 0.430). Per-protocol (PP) analysis showed eradication rates of 93.0% (95% CI: 86.4%-99.6%) for VA and 84.5% (95% CI: 73.8%-92.1%) for EA (p = 0.150), indicating no statistically significant difference. Adverse events (AEs) were mild and similar between groups (5.3% in VA vs 5.2% in EA, p = 0.983), with constipation and diarrhea being the most reported. Both groups achieved 100% compliance. Antibiotic resistance patterns did not significantly affect outcomes.
Conclusion: Both VA and EA-HDDT regimens demonstrated comparable efficacy, excellent compliance, and minimal AEs. Although VA therapy achieved a >90% eradication rate in the PP analysis, our study was underpowered to confirm superiority. Therefore, larger, adequately powered RCTs are warranted to validate the potential superiority of VA.
期刊介绍：
Therapeutic Advances in Gastroenterology is an open access journal which delivers the highest quality peer-reviewed original research articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of gastrointestinal and hepatic disorders. The journal has a strong clinical and pharmacological focus and is aimed at an international audience of clinicians and researchers in gastroenterology and related disciplines, providing an online forum for rapid dissemination of recent research and perspectives in this area.
The editors welcome original research articles across all areas of gastroenterology and hepatology.
The journal publishes original research articles and review articles primarily. Original research manuscripts may include laboratory, animal or human/clinical studies – all phases. Letters to the Editor and Case Reports will also be considered.
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