{"title":"7天vs 14天替戈拉赞和含四环素的四联疗法一线根除幽门螺杆菌感染：一项随机、开放标签、非劣效性试验","authors":"Xue-Ping Nan, Hong-Yu Zhao, Lei-Na Guo, Rui-Qi Zheng, Xi-Lan Wang, Yong-Fen Wang, Yan-Hua Su, Wen-Rong Geng, Xiu-Lan Liu, Hai-Miao Xu, Ke-Lun Zhou, Yu-Ting Guo, Jian-Hua Cao, Zhong-Xue Han, Qing-Zhou Kong, Xiu-Li Zuo, Yan-Qing Li, Yue-Yue Li","doi":"10.1111/hel.70036","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background and Aims</h3>\n \n <p>Tegoprazan, a new class of drugs, is a potassium-competitive acid blocker (P-CAB) that inhibits gastric H+/K+-ATPase through a different mechanism than proton pump inhibitor. Tetracycline also has anti-<i>Helicobacter pylori</i> properties. However, only a few randomized controlled trials (RCTs) have investigated the efficacy of tegoprazan and tetracycline-containing quadruple therapy (TTQT) for treating <i>H. pylori</i> infections, which this RCT explored.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>This multicenter RCT included treatment-naïve adults with <i>H. pylori</i> infection who received 7 or 14 days of TTQT (50-mg tegoprazan, 220-mg bismuth potassium citrate, and 1000-mg amoxicillin twice daily with 500-mg tetracycline four times daily). The primary outcome was the eradication rate; secondary endpoints included the incidence of adverse events, treatment compliance, and regimen costs.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>The study included 258 patients. The eradication rates in the 7- and 14-day groups were 90.70% (117/129, 95% confidence interval [CI]: 83.98%–94.89%) and 91.47% (118/129, 95% CI: 84.90%–95.45%), respectively, in the intention-to-treat analysis (difference: −0.78%; −7.01%–8.58%; noninferiority <i>p</i> < 0.001); 92.86% (117/126, 95% CI: 86.50%–96.48%) and 93.65% (118/126, 95% CI: 87.47%–97.02%), respectively, in the modified intention-to-treat analysis (difference: 0.79%; 95% CI: −6.36%–7.99%; noninferiority <i>p</i> < 0.001); and 94.35% (117/124, 95% CI: 88.29%–97.50%) and 95.12% (117/123, 95% CI: 89.24%–98.00%), respectively, in the per-protocol analysis (difference: −0.77%; 95% CI: −5.91%–7.48%; noninferiority <i>p</i> < 0.001). Significantly fewer adverse events occurred in the 7-day group than in the 14-day group (22.48% vs. 35.67%, <i>p</i> = 0.020). Treatment compliance did not differ between the two groups.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>The 7- and 14-day TTQT efficacies for the first-line treatment of <i>H. pylori</i> infection were comparable, and fewer adverse effects occurred in the 7-day group. This trial has been registered at Clinical Trials.gov (NCT05997433).</p>\n </section>\n </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"30 2","pages":""},"PeriodicalIF":4.3000,"publicationDate":"2025-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Seven-Day Versus 14-Day Tegoprazan and Tetracycline-Containing Quadruple Therapy for First-Line Eradication of Helicobacter pylori Infection: A Randomized, Open-Label, Noninferiority Trial\",\"authors\":\"Xue-Ping Nan, Hong-Yu Zhao, Lei-Na Guo, Rui-Qi Zheng, Xi-Lan Wang, Yong-Fen Wang, Yan-Hua Su, Wen-Rong Geng, Xiu-Lan Liu, Hai-Miao Xu, Ke-Lun Zhou, Yu-Ting Guo, Jian-Hua Cao, Zhong-Xue Han, Qing-Zhou Kong, Xiu-Li Zuo, Yan-Qing Li, Yue-Yue Li\",\"doi\":\"10.1111/hel.70036\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Background and Aims</h3>\\n \\n <p>Tegoprazan, a new class of drugs, is a potassium-competitive acid blocker (P-CAB) that inhibits gastric H+/K+-ATPase through a different mechanism than proton pump inhibitor. Tetracycline also has anti-<i>Helicobacter pylori</i> properties. However, only a few randomized controlled trials (RCTs) have investigated the efficacy of tegoprazan and tetracycline-containing quadruple therapy (TTQT) for treating <i>H. pylori</i> infections, which this RCT explored.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>This multicenter RCT included treatment-naïve adults with <i>H. pylori</i> infection who received 7 or 14 days of TTQT (50-mg tegoprazan, 220-mg bismuth potassium citrate, and 1000-mg amoxicillin twice daily with 500-mg tetracycline four times daily). The primary outcome was the eradication rate; secondary endpoints included the incidence of adverse events, treatment compliance, and regimen costs.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>The study included 258 patients. The eradication rates in the 7- and 14-day groups were 90.70% (117/129, 95% confidence interval [CI]: 83.98%–94.89%) and 91.47% (118/129, 95% CI: 84.90%–95.45%), respectively, in the intention-to-treat analysis (difference: −0.78%; −7.01%–8.58%; noninferiority <i>p</i> < 0.001); 92.86% (117/126, 95% CI: 86.50%–96.48%) and 93.65% (118/126, 95% CI: 87.47%–97.02%), respectively, in the modified intention-to-treat analysis (difference: 0.79%; 95% CI: −6.36%–7.99%; noninferiority <i>p</i> < 0.001); and 94.35% (117/124, 95% CI: 88.29%–97.50%) and 95.12% (117/123, 95% CI: 89.24%–98.00%), respectively, in the per-protocol analysis (difference: −0.77%; 95% CI: −5.91%–7.48%; noninferiority <i>p</i> < 0.001). Significantly fewer adverse events occurred in the 7-day group than in the 14-day group (22.48% vs. 35.67%, <i>p</i> = 0.020). Treatment compliance did not differ between the two groups.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusions</h3>\\n \\n <p>The 7- and 14-day TTQT efficacies for the first-line treatment of <i>H. pylori</i> infection were comparable, and fewer adverse effects occurred in the 7-day group. This trial has been registered at Clinical Trials.gov (NCT05997433).</p>\\n </section>\\n </div>\",\"PeriodicalId\":13223,\"journal\":{\"name\":\"Helicobacter\",\"volume\":\"30 2\",\"pages\":\"\"},\"PeriodicalIF\":4.3000,\"publicationDate\":\"2025-04-24\",\"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.70036\",\"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.70036","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
Seven-Day Versus 14-Day Tegoprazan and Tetracycline-Containing Quadruple Therapy for First-Line Eradication of Helicobacter pylori Infection: A Randomized, Open-Label, Noninferiority Trial
Background and Aims
Tegoprazan, a new class of drugs, is a potassium-competitive acid blocker (P-CAB) that inhibits gastric H+/K+-ATPase through a different mechanism than proton pump inhibitor. Tetracycline also has anti-Helicobacter pylori properties. However, only a few randomized controlled trials (RCTs) have investigated the efficacy of tegoprazan and tetracycline-containing quadruple therapy (TTQT) for treating H. pylori infections, which this RCT explored.
Methods
This multicenter RCT included treatment-naïve adults with H. pylori infection who received 7 or 14 days of TTQT (50-mg tegoprazan, 220-mg bismuth potassium citrate, and 1000-mg amoxicillin twice daily with 500-mg tetracycline four times daily). The primary outcome was the eradication rate; secondary endpoints included the incidence of adverse events, treatment compliance, and regimen costs.
Results
The study included 258 patients. The eradication rates in the 7- and 14-day groups were 90.70% (117/129, 95% confidence interval [CI]: 83.98%–94.89%) and 91.47% (118/129, 95% CI: 84.90%–95.45%), respectively, in the intention-to-treat analysis (difference: −0.78%; −7.01%–8.58%; noninferiority p < 0.001); 92.86% (117/126, 95% CI: 86.50%–96.48%) and 93.65% (118/126, 95% CI: 87.47%–97.02%), respectively, in the modified intention-to-treat analysis (difference: 0.79%; 95% CI: −6.36%–7.99%; noninferiority p < 0.001); and 94.35% (117/124, 95% CI: 88.29%–97.50%) and 95.12% (117/123, 95% CI: 89.24%–98.00%), respectively, in the per-protocol analysis (difference: −0.77%; 95% CI: −5.91%–7.48%; noninferiority p < 0.001). Significantly fewer adverse events occurred in the 7-day group than in the 14-day group (22.48% vs. 35.67%, p = 0.020). Treatment compliance did not differ between the two groups.
Conclusions
The 7- and 14-day TTQT efficacies for the first-line treatment of H. pylori infection were comparable, and fewer adverse effects occurred in the 7-day group. This trial has been registered at Clinical Trials.gov (NCT05997433).
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.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
