{"title":"头孢呋辛-含四环素铋四联疗法根除青霉素过敏患者幽门螺杆菌的疗效和安全性：一项多中心随机对照试验","authors":"Hui Wang, Qingzhou Kong, Qiumei Zhang, Lili Zhang, Ruili Li, Teng Zhang, Leina Guo, Xilan Wang, Xiaowei Li, Hongyu Zhao, Fengqing Liu, Yuting Guo, Zhenzhen Zhai, Mingyu Li, Xiaorong Yang, Xiuli Zuo, Xiaoyun Yang, Yueyue Li","doi":"10.1111/hel.70033","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>Penicillin allergy significantly restricts therapeutic options for <i>Helicobacter pylori</i> eradication. This multicenter randomized controlled study was designed to evaluate the efficacy and safety of a novel cefuroxime–tetracycline-containing bismuth quadruple therapy (Cef-Tet BQT) as first-line treatment in this population.</p>\n </section>\n \n <section>\n \n <h3> Materials and Methods</h3>\n \n <p>Penicillin-allergic treatment-naïve patients with confirmed <i>H. pylori</i> infection (<i>N</i> = 248) were randomized to two 14-day regimens: one received Cef-Tet BQT (Tegoprazan 50 mg twice a day, bismuth potassium citrate 220 mg twice daily, cefuroxime 500 mg twice daily, tetracycline 500 mg three times daily), and the other received cefuroxime–levofloxacin-containing bismuth quadruple therapy (Cef-Lev BQT: cefuroxime 500 mg twice daily, levofloxacin 500 mg once daily). The primary endpoint assessed noninferiority of eradication rates, with secondary endpoints including safety profiles and adherence.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>In total, 248 patients underwent randomization. The intention-to-treat (ITT) eradication rates were 90.32% (112/124, 95% confidence interval [CI]: 85.12%–95.52%) and 81.45% (101/124, 95% CI: 74.61%–88.29%) (<i>p</i> = 0.045); the modified intention-to-treat (MITT) eradication rates were 91.80% (112/122, 95% CI: 86.93%–96.67%) and 83.47% (101/121, 95% CI: 76.85%–90.09%) (<i>p</i> = 0.048); and the per-protocol (PP) eradication rates were 92.37% (109/118, 95% CI: 87.58%–97.16%) and 85.34% (99/116, 95% CI: 78.90%–91.78%) (<i>p</i> = 0.087) in the Cef-Tet BQT group and Cef-Lev BQT group, respectively. Noninferiority of the Cef-Tet BQT group was demonstrated in all three analyses (<i>p</i> < 0.0001). The incidence of adverse events (21.77% vs. 24.19%) and compliance (96.77% vs. 95.97%) were comparable between the two groups.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>BQT containing cefuroxime and tetracycline is efficacious and safe for the first-line eradication of <i>H. pylori</i> in penicillin-allergic patients. This regimen provides a viable alternative to circumvent the antimicrobial resistance concerns associated with levofloxacin-based regimens.</p>\n </section>\n \n <section>\n \n <h3> Trial Registration</h3>\n \n <p>ClinicalTrials.gov ID: NCT06351891</p>\n </section>\n </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"30 2","pages":""},"PeriodicalIF":4.3000,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy and Safety of Cefuroxime–Tetracycline-Containing Bismuth Quadruple Therapy for Helicobacter pylori Eradication in Penicillin-Allergic Patients: A Multicenter Randomized Controlled Trial\",\"authors\":\"Hui Wang, Qingzhou Kong, Qiumei Zhang, Lili Zhang, Ruili Li, Teng Zhang, Leina Guo, Xilan Wang, Xiaowei Li, Hongyu Zhao, Fengqing Liu, Yuting Guo, Zhenzhen Zhai, Mingyu Li, Xiaorong Yang, Xiuli Zuo, Xiaoyun Yang, Yueyue Li\",\"doi\":\"10.1111/hel.70033\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Background</h3>\\n \\n <p>Penicillin allergy significantly restricts therapeutic options for <i>Helicobacter pylori</i> eradication. This multicenter randomized controlled study was designed to evaluate the efficacy and safety of a novel cefuroxime–tetracycline-containing bismuth quadruple therapy (Cef-Tet BQT) as first-line treatment in this population.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Materials and Methods</h3>\\n \\n <p>Penicillin-allergic treatment-naïve patients with confirmed <i>H. pylori</i> infection (<i>N</i> = 248) were randomized to two 14-day regimens: one received Cef-Tet BQT (Tegoprazan 50 mg twice a day, bismuth potassium citrate 220 mg twice daily, cefuroxime 500 mg twice daily, tetracycline 500 mg three times daily), and the other received cefuroxime–levofloxacin-containing bismuth quadruple therapy (Cef-Lev BQT: cefuroxime 500 mg twice daily, levofloxacin 500 mg once daily). The primary endpoint assessed noninferiority of eradication rates, with secondary endpoints including safety profiles and adherence.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>In total, 248 patients underwent randomization. The intention-to-treat (ITT) eradication rates were 90.32% (112/124, 95% confidence interval [CI]: 85.12%–95.52%) and 81.45% (101/124, 95% CI: 74.61%–88.29%) (<i>p</i> = 0.045); the modified intention-to-treat (MITT) eradication rates were 91.80% (112/122, 95% CI: 86.93%–96.67%) and 83.47% (101/121, 95% CI: 76.85%–90.09%) (<i>p</i> = 0.048); and the per-protocol (PP) eradication rates were 92.37% (109/118, 95% CI: 87.58%–97.16%) and 85.34% (99/116, 95% CI: 78.90%–91.78%) (<i>p</i> = 0.087) in the Cef-Tet BQT group and Cef-Lev BQT group, respectively. Noninferiority of the Cef-Tet BQT group was demonstrated in all three analyses (<i>p</i> < 0.0001). The incidence of adverse events (21.77% vs. 24.19%) and compliance (96.77% vs. 95.97%) were comparable between the two groups.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusions</h3>\\n \\n <p>BQT containing cefuroxime and tetracycline is efficacious and safe for the first-line eradication of <i>H. pylori</i> in penicillin-allergic patients. This regimen provides a viable alternative to circumvent the antimicrobial resistance concerns associated with levofloxacin-based regimens.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Trial Registration</h3>\\n \\n <p>ClinicalTrials.gov ID: NCT06351891</p>\\n </section>\\n </div>\",\"PeriodicalId\":13223,\"journal\":{\"name\":\"Helicobacter\",\"volume\":\"30 2\",\"pages\":\"\"},\"PeriodicalIF\":4.3000,\"publicationDate\":\"2025-04-16\",\"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.70033\",\"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.70033","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 Cefuroxime–Tetracycline-Containing Bismuth Quadruple Therapy for Helicobacter pylori Eradication in Penicillin-Allergic Patients: A Multicenter Randomized Controlled Trial
Background
Penicillin allergy significantly restricts therapeutic options for Helicobacter pylori eradication. This multicenter randomized controlled study was designed to evaluate the efficacy and safety of a novel cefuroxime–tetracycline-containing bismuth quadruple therapy (Cef-Tet BQT) as first-line treatment in this population.
Materials and Methods
Penicillin-allergic treatment-naïve patients with confirmed H. pylori infection (N = 248) were randomized to two 14-day regimens: one received Cef-Tet BQT (Tegoprazan 50 mg twice a day, bismuth potassium citrate 220 mg twice daily, cefuroxime 500 mg twice daily, tetracycline 500 mg three times daily), and the other received cefuroxime–levofloxacin-containing bismuth quadruple therapy (Cef-Lev BQT: cefuroxime 500 mg twice daily, levofloxacin 500 mg once daily). The primary endpoint assessed noninferiority of eradication rates, with secondary endpoints including safety profiles and adherence.
Results
In total, 248 patients underwent randomization. The intention-to-treat (ITT) eradication rates were 90.32% (112/124, 95% confidence interval [CI]: 85.12%–95.52%) and 81.45% (101/124, 95% CI: 74.61%–88.29%) (p = 0.045); the modified intention-to-treat (MITT) eradication rates were 91.80% (112/122, 95% CI: 86.93%–96.67%) and 83.47% (101/121, 95% CI: 76.85%–90.09%) (p = 0.048); and the per-protocol (PP) eradication rates were 92.37% (109/118, 95% CI: 87.58%–97.16%) and 85.34% (99/116, 95% CI: 78.90%–91.78%) (p = 0.087) in the Cef-Tet BQT group and Cef-Lev BQT group, respectively. Noninferiority of the Cef-Tet BQT group was demonstrated in all three analyses (p < 0.0001). The incidence of adverse events (21.77% vs. 24.19%) and compliance (96.77% vs. 95.97%) were comparable between the two groups.
Conclusions
BQT containing cefuroxime and tetracycline is efficacious and safe for the first-line eradication of H. pylori in penicillin-allergic patients. This regimen provides a viable alternative to circumvent the antimicrobial resistance concerns associated with levofloxacin-based regimens.
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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