{"title":"四环素每日三次与含铋四联疗法每日四次作为幽门螺旋杆菌感染的一线治疗：一项多中心、非劣效性、随机对照试验。","authors":"Yu-Ming Ding, Qiu-Mei Zhang, Rui-Li Li, Zhong-Xue Han, Qing Zhao, Li-Dong Xu, Ke-Yu Wang, Xue-Ping Nan, Miao Duan, Shu-Yan Zeng, Qing-Zhou Kong, Hui Wang, Xiao-Qi Wu, Ning Zhang, Yan-Qing Li, Xiu-Li Zuo, Yue-Yue Li","doi":"10.1111/hel.13121","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>Current guidelines recommend bismuth-containing quadruple therapy for patients newly diagnosed with <i>Helicobacter pylori</i> (<i>H. pylori</i>) infection. We aimed to compare the efficacy and safety of tetracycline administered three times daily versus four times daily in bismuth-containing quadruple therapy for first-line treatment of <i>H. pylori</i> infection.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>This multicenter, noninferiority, randomized controlled study, conducted in China, recruited treatment-naïve adults with <i>H. pylori</i> infection, randomized 1:1 into two treatment groups to receive either of the following bismuth-containing quadruple therapies: esomeprazole 20 mg twice-daily; bismuth 220 mg twice-daily; amoxicillin 1000 mg twice-daily; and tetracycline 500 mg three times daily (TET-T) versus 500 mg four times daily (TET-F). At least 6 weeks post-treatment, a <sup>13</sup>C-urea breath test was performed to evaluate <i>H. pylori</i> eradication.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>In total, 406 patients were randomly assigned to the two treatment groups. Intention-to-treat eradication rates were 91.63% (186/203; 95% confidence interval [CI] 87.82%–95.44%) versus 90.15% (183/203; 95% CI 86.05%–94.25%) (<i>p</i> = 0.0005) and per-protocol eradication rates were 95.34% (184/193; 95% CI 92.36%–98.31%) versus 95.72% (179/187; 95% CI 92.82%–98.62%) (<i>p</i> = 0.0002) for the TET-T and TET-F group, respectively. TET-T-treated patients had a lower incidence of adverse effects than TET-F-treated patients (21.61% vs. 31.63%, <i>p</i> = 0.024), with no significant differences in compliance to treatment between the groups.</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>As a first-line therapy for <i>H. pylori</i> infection, the eradication rate of the TET-T therapy was noninferior to that of the TET-F therapy while significantly reducing the incidence of adverse reactions.</p>\n </section>\n \n <section>\n \n <h3> Trial Registration</h3>\n \n <p>ClinicalTrials.gov identifier: NCT05431075</p>\n </section>\n </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"29 4","pages":""},"PeriodicalIF":4.3000,"publicationDate":"2024-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Tetracycline Three Times Daily Versus Four Times Daily in Bismuth-Containing Quadruple Therapy as the First-Line Treatment of Helicobacter pylori Infection: A Multicenter, Noninferiority, Randomized Controlled Trial\",\"authors\":\"Yu-Ming Ding, Qiu-Mei Zhang, Rui-Li Li, Zhong-Xue Han, Qing Zhao, Li-Dong Xu, Ke-Yu Wang, Xue-Ping Nan, Miao Duan, Shu-Yan Zeng, Qing-Zhou Kong, Hui Wang, Xiao-Qi Wu, Ning Zhang, Yan-Qing Li, Xiu-Li Zuo, Yue-Yue Li\",\"doi\":\"10.1111/hel.13121\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Background</h3>\\n \\n <p>Current guidelines recommend bismuth-containing quadruple therapy for patients newly diagnosed with <i>Helicobacter pylori</i> (<i>H. pylori</i>) infection. We aimed to compare the efficacy and safety of tetracycline administered three times daily versus four times daily in bismuth-containing quadruple therapy for first-line treatment of <i>H. pylori</i> infection.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>This multicenter, noninferiority, randomized controlled study, conducted in China, recruited treatment-naïve adults with <i>H. pylori</i> infection, randomized 1:1 into two treatment groups to receive either of the following bismuth-containing quadruple therapies: esomeprazole 20 mg twice-daily; bismuth 220 mg twice-daily; amoxicillin 1000 mg twice-daily; and tetracycline 500 mg three times daily (TET-T) versus 500 mg four times daily (TET-F). At least 6 weeks post-treatment, a <sup>13</sup>C-urea breath test was performed to evaluate <i>H. pylori</i> eradication.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>In total, 406 patients were randomly assigned to the two treatment groups. Intention-to-treat eradication rates were 91.63% (186/203; 95% confidence interval [CI] 87.82%–95.44%) versus 90.15% (183/203; 95% CI 86.05%–94.25%) (<i>p</i> = 0.0005) and per-protocol eradication rates were 95.34% (184/193; 95% CI 92.36%–98.31%) versus 95.72% (179/187; 95% CI 92.82%–98.62%) (<i>p</i> = 0.0002) for the TET-T and TET-F group, respectively. TET-T-treated patients had a lower incidence of adverse effects than TET-F-treated patients (21.61% vs. 31.63%, <i>p</i> = 0.024), with no significant differences in compliance to treatment between the groups.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusion</h3>\\n \\n <p>As a first-line therapy for <i>H. pylori</i> infection, the eradication rate of the TET-T therapy was noninferior to that of the TET-F therapy while significantly reducing the incidence of adverse reactions.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Trial Registration</h3>\\n \\n <p>ClinicalTrials.gov identifier: NCT05431075</p>\\n </section>\\n </div>\",\"PeriodicalId\":13223,\"journal\":{\"name\":\"Helicobacter\",\"volume\":\"29 4\",\"pages\":\"\"},\"PeriodicalIF\":4.3000,\"publicationDate\":\"2024-08-04\",\"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.13121\",\"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.13121","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
Tetracycline Three Times Daily Versus Four Times Daily in Bismuth-Containing Quadruple Therapy as the First-Line Treatment of Helicobacter pylori Infection: A Multicenter, Noninferiority, Randomized Controlled Trial
Background
Current guidelines recommend bismuth-containing quadruple therapy for patients newly diagnosed with Helicobacter pylori (H. pylori) infection. We aimed to compare the efficacy and safety of tetracycline administered three times daily versus four times daily in bismuth-containing quadruple therapy for first-line treatment of H. pylori infection.
Methods
This multicenter, noninferiority, randomized controlled study, conducted in China, recruited treatment-naïve adults with H. pylori infection, randomized 1:1 into two treatment groups to receive either of the following bismuth-containing quadruple therapies: esomeprazole 20 mg twice-daily; bismuth 220 mg twice-daily; amoxicillin 1000 mg twice-daily; and tetracycline 500 mg three times daily (TET-T) versus 500 mg four times daily (TET-F). At least 6 weeks post-treatment, a 13C-urea breath test was performed to evaluate H. pylori eradication.
Results
In total, 406 patients were randomly assigned to the two treatment groups. Intention-to-treat eradication rates were 91.63% (186/203; 95% confidence interval [CI] 87.82%–95.44%) versus 90.15% (183/203; 95% CI 86.05%–94.25%) (p = 0.0005) and per-protocol eradication rates were 95.34% (184/193; 95% CI 92.36%–98.31%) versus 95.72% (179/187; 95% CI 92.82%–98.62%) (p = 0.0002) for the TET-T and TET-F group, respectively. TET-T-treated patients had a lower incidence of adverse effects than TET-F-treated patients (21.61% vs. 31.63%, p = 0.024), with no significant differences in compliance to treatment between the groups.
Conclusion
As a first-line therapy for H. pylori infection, the eradication rate of the TET-T therapy was noninferior to that of the TET-F therapy while significantly reducing the incidence of adverse reactions.
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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