Aurelien Amiot, Jérémy Hacoon, Frederic Heluwaert, François Mion, Dominique Lamarque, Driffa Moussata, Maroua Mimouni, Jean-Charles Delchier, Isabelle Durand-Zaleski, Etienne Audureau, Sylvie Bastuji-Garin, for the HEPYSE Study Group
{"title":"根除幽门螺旋杆菌的 14 天定制 PCR 指导三联疗法与 14 天非铋剂伴随四联疗法:多中心、开放标签随机非劣效性对照试验","authors":"Aurelien Amiot, Jérémy Hacoon, Frederic Heluwaert, François Mion, Dominique Lamarque, Driffa Moussata, Maroua Mimouni, Jean-Charles Delchier, Isabelle Durand-Zaleski, Etienne Audureau, Sylvie Bastuji-Garin, for the HEPYSE Study Group","doi":"10.1111/hel.13076","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>The systematic use of susceptibility testing and tailored first-line treatment for <i>Helicobacter pylori</i> eradication has yet to be established.</p>\n </section>\n \n <section>\n \n <h3> Aim</h3>\n \n <p>To compare 14-day tailored PCR-guided triple therapy to 14-day non-Bismuth concomitant quadruple therapy for first-line <i>Helicobacter pylori</i> eradication.</p>\n </section>\n \n <section>\n \n <h3> Patients and Methods</h3>\n \n <p>We performed a multicenter, parallel-group, randomized noninferiority controlled trial. Naive adult patients with <i>Helicobacter pylori</i> infection were treated with 14-day tailored PCR-guided triple therapy (esomeprazole 40 mg and amoxicillin 1000 mg b.d. plus clarithromycin 500 mg or levofloxacin 500 mg b.d. according to clarithromycin susceptibility) or 14-day non-Bismuth concomitant quadruple therapy (esomeprazole 40 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and metronidazole 500 mg b.d.). The primary endpoint was <i>H. pylori</i> eradication.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>We screened 991 patients for eligibility and randomized 241 patients. The first-line eradication rate was 99.2% in the tailored PCR-guided group and 95.9% in the control group (ITT population; absolute difference of +3.30%, with a lower bound of CI at −0.68%). Both first-line therapies were well tolerated, with a formally significant difference in favor of the tailored PCR-guided group (61.4% vs. 41.2%, <i>p</i> = 0.003). Economic analyses revealed a lower cost of the tailored PCR-guided arm, with a 92% chance of being jointly more effective and less expensive than the control arm in the ITT population.</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>In a country with a high level of clarithromycin resistance, the results of our study demonstrated the noninferiority of 14-day tailored PCR-guided triple therapy as a first-line <i>H. pylori</i> eradication therapy compared to 14-day non-Bismuth quadruple therapy (ClinicalTrials.gov NCT02576236).</p>\n </section>\n </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"29 2","pages":""},"PeriodicalIF":4.3000,"publicationDate":"2024-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/hel.13076","citationCount":"0","resultStr":"{\"title\":\"14-day tailored PCR-guided triple therapy versus 14-day non-Bismuth concomitant quadruple therapy for Helicobacter pylori eradication: A multicenter, open-label randomized noninferiority controlled trial\",\"authors\":\"Aurelien Amiot, Jérémy Hacoon, Frederic Heluwaert, François Mion, Dominique Lamarque, Driffa Moussata, Maroua Mimouni, Jean-Charles Delchier, Isabelle Durand-Zaleski, Etienne Audureau, Sylvie Bastuji-Garin, for the HEPYSE Study Group\",\"doi\":\"10.1111/hel.13076\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Background</h3>\\n \\n <p>The systematic use of susceptibility testing and tailored first-line treatment for <i>Helicobacter pylori</i> eradication has yet to be established.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Aim</h3>\\n \\n <p>To compare 14-day tailored PCR-guided triple therapy to 14-day non-Bismuth concomitant quadruple therapy for first-line <i>Helicobacter pylori</i> eradication.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Patients and Methods</h3>\\n \\n <p>We performed a multicenter, parallel-group, randomized noninferiority controlled trial. Naive adult patients with <i>Helicobacter pylori</i> infection were treated with 14-day tailored PCR-guided triple therapy (esomeprazole 40 mg and amoxicillin 1000 mg b.d. plus clarithromycin 500 mg or levofloxacin 500 mg b.d. according to clarithromycin susceptibility) or 14-day non-Bismuth concomitant quadruple therapy (esomeprazole 40 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and metronidazole 500 mg b.d.). The primary endpoint was <i>H. pylori</i> eradication.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>We screened 991 patients for eligibility and randomized 241 patients. The first-line eradication rate was 99.2% in the tailored PCR-guided group and 95.9% in the control group (ITT population; absolute difference of +3.30%, with a lower bound of CI at −0.68%). Both first-line therapies were well tolerated, with a formally significant difference in favor of the tailored PCR-guided group (61.4% vs. 41.2%, <i>p</i> = 0.003). 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14-day tailored PCR-guided triple therapy versus 14-day non-Bismuth concomitant quadruple therapy for Helicobacter pylori eradication: A multicenter, open-label randomized noninferiority controlled trial
Background
The systematic use of susceptibility testing and tailored first-line treatment for Helicobacter pylori eradication has yet to be established.
Aim
To compare 14-day tailored PCR-guided triple therapy to 14-day non-Bismuth concomitant quadruple therapy for first-line Helicobacter pylori eradication.
Patients and Methods
We performed a multicenter, parallel-group, randomized noninferiority controlled trial. Naive adult patients with Helicobacter pylori infection were treated with 14-day tailored PCR-guided triple therapy (esomeprazole 40 mg and amoxicillin 1000 mg b.d. plus clarithromycin 500 mg or levofloxacin 500 mg b.d. according to clarithromycin susceptibility) or 14-day non-Bismuth concomitant quadruple therapy (esomeprazole 40 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and metronidazole 500 mg b.d.). The primary endpoint was H. pylori eradication.
Results
We screened 991 patients for eligibility and randomized 241 patients. The first-line eradication rate was 99.2% in the tailored PCR-guided group and 95.9% in the control group (ITT population; absolute difference of +3.30%, with a lower bound of CI at −0.68%). Both first-line therapies were well tolerated, with a formally significant difference in favor of the tailored PCR-guided group (61.4% vs. 41.2%, p = 0.003). Economic analyses revealed a lower cost of the tailored PCR-guided arm, with a 92% chance of being jointly more effective and less expensive than the control arm in the ITT population.
Conclusion
In a country with a high level of clarithromycin resistance, the results of our study demonstrated the noninferiority of 14-day tailored PCR-guided triple therapy as a first-line H. pylori eradication therapy compared to 14-day non-Bismuth quadruple therapy (ClinicalTrials.gov NCT02576236).
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.