Jung Won Lee, Nayoung Kim, Jongchan Lee, So Young Jo, Dong Ho Lee
{"title":"在抗菌药耐药性较高的韩国地区，含替戈拉赞的幽门螺杆菌序贯根除治疗与含埃索美拉唑的序贯根除治疗的疗效比较：一项前瞻性、随机、单一三级中心研究。","authors":"Jung Won Lee, Nayoung Kim, Jongchan Lee, So Young Jo, Dong Ho Lee","doi":"10.1111/hel.13143","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>Treatment with potassium-competitive acid blockers has shown acceptable efficacy in <i>Helicobacter pylori</i> eradication. In regions like Korea, where the clarithromycin resistance rate is high, alternative combinations like non-bismuth quadruple therapies have shown favorable results. This study compared the outcomes of sequential eradication therapy with new potassium-competitive acid blocker tegoprazan and conventional esomeprazole-containing sequential therapy.</p>\n </section>\n \n <section>\n \n <h3> Materials and Methods</h3>\n \n <p>Patients with <i>Helicobacter pylori</i> (<i>H. pylori</i>) infection were consecutively recruited. Patients were allocated to either an esomeprazole-containing sequential or a tegoprazan-containing sequential therapy group. Sequential therapy comprised esomeprazole (40 mg) or tegoprazan (50 mg) plus amoxicillin (1000 mg) twice daily for the initial 5 days, followed by esomeprazole (40 mg) or tegoprazan (50 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice daily for the remaining 5 days. Eradication rate, compliance, and adverse events were recorded.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>A total of 406 patients with <i>H. pylori</i> infection were enrolled in the trial and analyzed per protocol. Eradication rate by intention-to-treat and per-protocol was 83.8% (95% confidence interval [CI]: 78.7–88.9) for esomeprazole-containing sequential therapy, and 87.1% (95% CI: 82.5–91.8) for tegoprazan-containing sequential therapy, with no statistical significance (<i>p</i> = 0.399). Additionally, there was no statistically significant difference in treatment compliance between the two groups. Nausea was more prevalent (23.3%, 27/202) with sequential tegoprazans than with esomeprazole-containing sequential therapy (14.2%, 29/204; <i>p</i> = 0.022).</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>Tegoprazan-containing 10-day sequential eradication treatment demonstrated similar eradication efficacy compared to esomeprazole-containing treatment, even in regions with high antimicrobial resistance, such as Korea.</p>\n </section>\n \n <section>\n \n <h3> Trial Registration</h3>\n \n <p>ClinicalTrials.gov: NCT06382493</p>\n </section>\n </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":null,"pages":null},"PeriodicalIF":4.3000,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/hel.13143","citationCount":"0","resultStr":"{\"title\":\"Efficacy of Tegoprazan-Containing Sequential Eradication Treatment Compared to Esomeprazole-Containing Sequential Eradication of Helicobacter pylori in South Korea, a Region With High Antimicrobial Resistance: A Prospective, Randomized, Single Tertiary Center Study\",\"authors\":\"Jung Won Lee, Nayoung Kim, Jongchan Lee, So Young Jo, Dong Ho Lee\",\"doi\":\"10.1111/hel.13143\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Background</h3>\\n \\n <p>Treatment with potassium-competitive acid blockers has shown acceptable efficacy in <i>Helicobacter pylori</i> eradication. In regions like Korea, where the clarithromycin resistance rate is high, alternative combinations like non-bismuth quadruple therapies have shown favorable results. This study compared the outcomes of sequential eradication therapy with new potassium-competitive acid blocker tegoprazan and conventional esomeprazole-containing sequential therapy.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Materials and Methods</h3>\\n \\n <p>Patients with <i>Helicobacter pylori</i> (<i>H. pylori</i>) infection were consecutively recruited. Patients were allocated to either an esomeprazole-containing sequential or a tegoprazan-containing sequential therapy group. Sequential therapy comprised esomeprazole (40 mg) or tegoprazan (50 mg) plus amoxicillin (1000 mg) twice daily for the initial 5 days, followed by esomeprazole (40 mg) or tegoprazan (50 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice daily for the remaining 5 days. Eradication rate, compliance, and adverse events were recorded.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>A total of 406 patients with <i>H. pylori</i> infection were enrolled in the trial and analyzed per protocol. Eradication rate by intention-to-treat and per-protocol was 83.8% (95% confidence interval [CI]: 78.7–88.9) for esomeprazole-containing sequential therapy, and 87.1% (95% CI: 82.5–91.8) for tegoprazan-containing sequential therapy, with no statistical significance (<i>p</i> = 0.399). Additionally, there was no statistically significant difference in treatment compliance between the two groups. Nausea was more prevalent (23.3%, 27/202) with sequential tegoprazans than with esomeprazole-containing sequential therapy (14.2%, 29/204; <i>p</i> = 0.022).</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusion</h3>\\n \\n <p>Tegoprazan-containing 10-day sequential eradication treatment demonstrated similar eradication efficacy compared to esomeprazole-containing treatment, even in regions with high antimicrobial resistance, such as Korea.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Trial Registration</h3>\\n \\n <p>ClinicalTrials.gov: NCT06382493</p>\\n </section>\\n </div>\",\"PeriodicalId\":13223,\"journal\":{\"name\":\"Helicobacter\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":4.3000,\"publicationDate\":\"2024-10-22\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1111/hel.13143\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Helicobacter\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1111/hel.13143\",\"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.13143","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
Efficacy of Tegoprazan-Containing Sequential Eradication Treatment Compared to Esomeprazole-Containing Sequential Eradication of Helicobacter pylori in South Korea, a Region With High Antimicrobial Resistance: A Prospective, Randomized, Single Tertiary Center Study
Background
Treatment with potassium-competitive acid blockers has shown acceptable efficacy in Helicobacter pylori eradication. In regions like Korea, where the clarithromycin resistance rate is high, alternative combinations like non-bismuth quadruple therapies have shown favorable results. This study compared the outcomes of sequential eradication therapy with new potassium-competitive acid blocker tegoprazan and conventional esomeprazole-containing sequential therapy.
Materials and Methods
Patients with Helicobacter pylori (H. pylori) infection were consecutively recruited. Patients were allocated to either an esomeprazole-containing sequential or a tegoprazan-containing sequential therapy group. Sequential therapy comprised esomeprazole (40 mg) or tegoprazan (50 mg) plus amoxicillin (1000 mg) twice daily for the initial 5 days, followed by esomeprazole (40 mg) or tegoprazan (50 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice daily for the remaining 5 days. Eradication rate, compliance, and adverse events were recorded.
Results
A total of 406 patients with H. pylori infection were enrolled in the trial and analyzed per protocol. Eradication rate by intention-to-treat and per-protocol was 83.8% (95% confidence interval [CI]: 78.7–88.9) for esomeprazole-containing sequential therapy, and 87.1% (95% CI: 82.5–91.8) for tegoprazan-containing sequential therapy, with no statistical significance (p = 0.399). Additionally, there was no statistically significant difference in treatment compliance between the two groups. Nausea was more prevalent (23.3%, 27/202) with sequential tegoprazans than with esomeprazole-containing sequential therapy (14.2%, 29/204; p = 0.022).
Conclusion
Tegoprazan-containing 10-day sequential eradication treatment demonstrated similar eradication efficacy compared to esomeprazole-containing treatment, even in regions with high antimicrobial resistance, such as Korea.
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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