Peiwei Li, Yan Li, Yan Chen, Cheng Fang, Qin Du, Yuehua Han
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The primary outcome was the eradication rate. The secondary outcome was adverse effects. Eradication was confirmed by a negative urea breath test at least 6 weeks after the end of therapy.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>A total of 133 patients were included in the study. All of the patients completed the course of medication. We found that 10-day minocycline-amoxicillin quadruple therapy achieved an eradication rate of 83.5% (111/133, 95% CI 80.3%–86.7%) in intention-to-treat analysis and 90.2% (111/123, 95% CI 87.6%–92.8%) in per-protocol analysis. The treatment-emergent adverse events (TEAEs) were 15% (20/133), with the most common adverse event being dizziness (14/133, 10.5%). No severe adverse event was observed.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>Ten-day minocycline-amoxicillin twice daily in bismuth-containing quadruple therapy appears to be effective and safe for naïve <i>H. pylori</i> patients.</p>\n </section>\n </div>","PeriodicalId":45861,"journal":{"name":"JGH Open","volume":"9 8","pages":""},"PeriodicalIF":1.5000,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jgh3.70233","citationCount":"0","resultStr":"{\"title\":\"Efficacy and Safety of 10-Day Minocycline Twice Daily in Bismuth-Containing Quadruple Therapy as the First-Line Treatment of Helicobacter pylori Infection: A Prospective Single-Arm Study\",\"authors\":\"Peiwei Li, Yan Li, Yan Chen, Cheng Fang, Qin Du, Yuehua Han\",\"doi\":\"10.1002/jgh3.70233\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Background</h3>\\n \\n <p>Tetracycline has limited clinical application in <i>Helicobacter pylori</i> treatment because of difficulty in obtaining and increased adverse reactions. As a semisynthetic tetracycline, minocycline has demonstrated good potential for eradicating <i>H. pylori</i> infection. This study aimed to evaluate the efficacy and safety of 10-day minocycline-based quadruple therapy for <i>H. pylori</i> first-line treatment.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>In this prospective trial, treatment-naïve adults with <i>H. pylori</i> infection received eradication therapy with rabeprazole 10 mg, minocycline 100 mg, amoxicillin 1000 mg, and bismuth potassium citrate 220 mg each given twice a day for 10 days. The primary outcome was the eradication rate. The secondary outcome was adverse effects. Eradication was confirmed by a negative urea breath test at least 6 weeks after the end of therapy.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>A total of 133 patients were included in the study. All of the patients completed the course of medication. We found that 10-day minocycline-amoxicillin quadruple therapy achieved an eradication rate of 83.5% (111/133, 95% CI 80.3%–86.7%) in intention-to-treat analysis and 90.2% (111/123, 95% CI 87.6%–92.8%) in per-protocol analysis. The treatment-emergent adverse events (TEAEs) were 15% (20/133), with the most common adverse event being dizziness (14/133, 10.5%). 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引用次数: 0
摘要
背景四环素在幽门螺杆菌治疗中的临床应用有限,因为其难以获得且不良反应增加。二甲胺四环素作为一种半合成四环素,具有良好的根除幽门螺杆菌感染的潜力。本研究旨在评价以二甲胺环素为基础的10天四联疗法对幽门螺杆菌一线治疗的疗效和安全性。方法:在这项前瞻性试验中,treatment-naïve成人幽门螺杆菌感染患者接受根除治疗,包括雷别拉唑10 mg、米诺环素100 mg、阿莫西林1000 mg和柠檬酸铋钾220 mg,每天两次,持续10天。主要结果是根除率。次要结果是不良反应。治疗结束后至少6周尿素呼气试验阴性证实根除。结果133例患者纳入研究。所有患者均完成了疗程。我们发现,在意向治疗分析中,10天二甲胺四环素-阿莫西林四联治疗的根除率为83.5% (111/133,95% CI 80.3%-86.7%),在按方案分析中,根除率为90.2% (111/123,95% CI 87.6%-92.8%)。治疗后出现的不良事件(teae)为15%(20/133),其中最常见的不良事件是头晕(14/133,10.5%)。未观察到严重的不良事件。结论10天二甲胺环素-阿莫西林含铋四联治疗naïve幽门螺杆菌患者是安全有效的。
Efficacy and Safety of 10-Day Minocycline Twice Daily in Bismuth-Containing Quadruple Therapy as the First-Line Treatment of Helicobacter pylori Infection: A Prospective Single-Arm Study
Background
Tetracycline has limited clinical application in Helicobacter pylori treatment because of difficulty in obtaining and increased adverse reactions. As a semisynthetic tetracycline, minocycline has demonstrated good potential for eradicating H. pylori infection. This study aimed to evaluate the efficacy and safety of 10-day minocycline-based quadruple therapy for H. pylori first-line treatment.
Methods
In this prospective trial, treatment-naïve adults with H. pylori infection received eradication therapy with rabeprazole 10 mg, minocycline 100 mg, amoxicillin 1000 mg, and bismuth potassium citrate 220 mg each given twice a day for 10 days. The primary outcome was the eradication rate. The secondary outcome was adverse effects. Eradication was confirmed by a negative urea breath test at least 6 weeks after the end of therapy.
Results
A total of 133 patients were included in the study. All of the patients completed the course of medication. We found that 10-day minocycline-amoxicillin quadruple therapy achieved an eradication rate of 83.5% (111/133, 95% CI 80.3%–86.7%) in intention-to-treat analysis and 90.2% (111/123, 95% CI 87.6%–92.8%) in per-protocol analysis. The treatment-emergent adverse events (TEAEs) were 15% (20/133), with the most common adverse event being dizziness (14/133, 10.5%). No severe adverse event was observed.
Conclusions
Ten-day minocycline-amoxicillin twice daily in bismuth-containing quadruple therapy appears to be effective and safe for naïve H. pylori patients.