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Seven-Day Versus 14-Day Tegoprazan and Tetracycline-Containing Quadruple Therapy for First-Line Eradication of Helicobacter pylori Infection: A Randomized, Open-Label, Noninferiority Trial
IF 4.3 2区 医学
Helicobacter Pub Date : 2025-04-24 DOI: 10.1111/hel.70036
Xue-Ping Nan, Hong-Yu Zhao, Lei-Na Guo, Rui-Qi Zheng, Xi-Lan Wang, Yong-Fen Wang, Yan-Hua Su, Wen-Rong Geng, Xiu-Lan Liu, Hai-Miao Xu, Ke-Lun Zhou, Yu-Ting Guo, Jian-Hua Cao, Zhong-Xue Han, Qing-Zhou Kong, Xiu-Li Zuo, Yan-Qing Li, Yue-Yue Li
{"title":"Seven-Day Versus 14-Day Tegoprazan and Tetracycline-Containing Quadruple Therapy for First-Line Eradication of Helicobacter pylori Infection: A Randomized, Open-Label, Noninferiority Trial","authors":"Xue-Ping Nan,&nbsp;Hong-Yu Zhao,&nbsp;Lei-Na Guo,&nbsp;Rui-Qi Zheng,&nbsp;Xi-Lan Wang,&nbsp;Yong-Fen Wang,&nbsp;Yan-Hua Su,&nbsp;Wen-Rong Geng,&nbsp;Xiu-Lan Liu,&nbsp;Hai-Miao Xu,&nbsp;Ke-Lun Zhou,&nbsp;Yu-Ting Guo,&nbsp;Jian-Hua Cao,&nbsp;Zhong-Xue Han,&nbsp;Qing-Zhou Kong,&nbsp;Xiu-Li Zuo,&nbsp;Yan-Qing Li,&nbsp;Yue-Yue Li","doi":"10.1111/hel.70036","DOIUrl":"https://doi.org/10.1111/hel.70036","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background and Aims</h3>\u0000 \u0000 <p>Tegoprazan, a new class of drugs, is a potassium-competitive acid blocker (P-CAB) that inhibits gastric H+/K+-ATPase through a different mechanism than proton pump inhibitor. Tetracycline also has anti-<i>Helicobacter pylori</i> properties. However, only a few randomized controlled trials (RCTs) have investigated the efficacy of tegoprazan and tetracycline-containing quadruple therapy (TTQT) for treating <i>H. pylori</i> infections, which this RCT explored.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This multicenter RCT included treatment-naïve adults with <i>H. pylori</i> infection who received 7 or 14 days of TTQT (50-mg tegoprazan, 220-mg bismuth potassium citrate, and 1000-mg amoxicillin twice daily with 500-mg tetracycline four times daily). The primary outcome was the eradication rate; secondary endpoints included the incidence of adverse events, treatment compliance, and regimen costs.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The study included 258 patients. The eradication rates in the 7- and 14-day groups were 90.70% (117/129, 95% confidence interval [CI]: 83.98%–94.89%) and 91.47% (118/129, 95% CI: 84.90%–95.45%), respectively, in the intention-to-treat analysis (difference: −0.78%; −7.01%–8.58%; noninferiority <i>p</i> &lt; 0.001); 92.86% (117/126, 95% CI: 86.50%–96.48%) and 93.65% (118/126, 95% CI: 87.47%–97.02%), respectively, in the modified intention-to-treat analysis (difference: 0.79%; 95% CI: −6.36%–7.99%; noninferiority <i>p</i> &lt; 0.001); and 94.35% (117/124, 95% CI: 88.29%–97.50%) and 95.12% (117/123, 95% CI: 89.24%–98.00%), respectively, in the per-protocol analysis (difference: −0.77%; 95% CI: −5.91%–7.48%; noninferiority <i>p</i> &lt; 0.001). Significantly fewer adverse events occurred in the 7-day group than in the 14-day group (22.48% vs. 35.67%, <i>p</i> = 0.020). Treatment compliance did not differ between the two groups.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>The 7- and 14-day TTQT efficacies for the first-line treatment of <i>H. pylori</i> infection were comparable, and fewer adverse effects occurred in the 7-day group. This trial has been registered at Clinical Trials.gov (NCT05997433).</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"30 2","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143865876","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Comparison of Cefuroxime-Based Dual Therapy With Quadruple Therapy in Helicobacter pylori-Infected Treatment-Naive Patients: A Prospective, Multicenter, Randomized Controlled Trial
IF 4.3 2区 医学
Helicobacter Pub Date : 2025-04-18 DOI: 10.1111/hel.70037
Ji-Yan Li, Ji-Chun Song, Xia Tian, Yun-Hua Liu, Xiang-Wu Ding, Ya Lin, Zhen-Yu Zhang, Hai Zhang, De-Min Li, Xiao-Wei Huang, Yun-Lian Hu, Li Li, Hong-Tian Li, Chao-Qun Huang, Pei-Yuan Li
{"title":"Comparison of Cefuroxime-Based Dual Therapy With Quadruple Therapy in Helicobacter pylori-Infected Treatment-Naive Patients: A Prospective, Multicenter, Randomized Controlled Trial","authors":"Ji-Yan Li,&nbsp;Ji-Chun Song,&nbsp;Xia Tian,&nbsp;Yun-Hua Liu,&nbsp;Xiang-Wu Ding,&nbsp;Ya Lin,&nbsp;Zhen-Yu Zhang,&nbsp;Hai Zhang,&nbsp;De-Min Li,&nbsp;Xiao-Wei Huang,&nbsp;Yun-Lian Hu,&nbsp;Li Li,&nbsp;Hong-Tian Li,&nbsp;Chao-Qun Huang,&nbsp;Pei-Yuan Li","doi":"10.1111/hel.70037","DOIUrl":"https://doi.org/10.1111/hel.70037","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>High-Dose Dual Therapy With Amoxicillin Has Shown Advantages to Eradicate <i>Helicobacter pylori</i> (<i>H. pylori</i>), but Not for Penicillin-Allergic Patients. It Is Recommended That Cefuroxime Could Be an Alternative, but Whether Cefuroxime Could Be Used in Dual Therapy Has Not Been Reported. This Study Aimed to Compare the Efficacy, Safety, and Compliance of Cefuroxime-Based Dual Therapy (CDT) With Cefuroxime-Based Bismuth Quadruple Therapy (CQT) to Treat <i>H. pylori</i> Infection.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Materials and Methods</h3>\u0000 \u0000 <p>The Prospective, Multicenter, Open-Label, Randomized Controlled Trial Was Conducted to Enroll Patients With Treatment-Naive <i>H. pylori</i> Infection From 9 Institutions. Patients Were Randomly Assigned to CDT Group (Cefuroxime 500 Mg Three Times/Day and Vonoprazan 20 Mg Twice/Day) or CQT Group (Cefuroxime 500 Mg Twice/Day, Levofloxacin 500 Mg Once/Day, Vonoprazan 20 Mg Twice/Day, and Bismuth 220 Mg Twice/Day), both for 14 Days.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>700 Patients (350 per Group) Were Enrolled. In the Intention-To-Treat Analysis, Eradication Rates Were 76.0% and 86.3% in CDT Group and CQT Group (<i>P</i> = 0.001). In the Modified Intention-To-Treat Analysis, Eradication Rates Were 78.9% and 89.1% (<i>P</i> &lt; 0.001). In the Per-Protocol Analysis, Eradication Rates Were 80.2% and 91.2% (<i>P</i> &lt; 0.001). The Incidence of Adverse Events Was Significantly Lower in CDT Group Than CQT Group (14.4% vs. 29.8%, <i>P</i> &lt; 0.001). Non-inferiority Was Confirmed Between CDT and CQT Group (All <i>P</i> &gt; 0.025). Compliance Was Good in Both Groups (96.0% vs. 92.8%, <i>P</i> = 0.073). Poor Adherence Was a Risk Factor for Reducing the Efficacy in Both Groups.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>CQT Was More Effective Than CDT for <i>H. pylori</i> Eradication, Which Might Be Recommended for Penicillin-Allergic Patients. If There Were Contraindications or Intolerance of CQT, CDT Would Be an Alternative.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Trail Registration</h3>\u0000 \u0000 <p>ChiCTR2300071210</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"30 2","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143845827","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Parietal Cell Antibody Levels Among Chronic Gastritis Patients in a Country With Low Helicobacter pylori Infection: Epidemiology, Histopathological Features, and H. pylori Infection
IF 4.3 2区 医学
Helicobacter Pub Date : 2025-04-18 DOI: 10.1111/hel.70035
Rizki Amalia, Muhammad Miftahussurur, Ari Fahrial Syam, Tomohisa Uchida, Ricky Indra Alfaray, Kartika Afrida Fauzia, Yudith Annisa Ayu Rezkitha, Junko Akada, Takashi Matsumoto, Yoshio Yamaoka
{"title":"Parietal Cell Antibody Levels Among Chronic Gastritis Patients in a Country With Low Helicobacter pylori Infection: Epidemiology, Histopathological Features, and H. pylori Infection","authors":"Rizki Amalia,&nbsp;Muhammad Miftahussurur,&nbsp;Ari Fahrial Syam,&nbsp;Tomohisa Uchida,&nbsp;Ricky Indra Alfaray,&nbsp;Kartika Afrida Fauzia,&nbsp;Yudith Annisa Ayu Rezkitha,&nbsp;Junko Akada,&nbsp;Takashi Matsumoto,&nbsp;Yoshio Yamaoka","doi":"10.1111/hel.70035","DOIUrl":"https://doi.org/10.1111/hel.70035","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Despite the low prevalence of <i>Helicobacter pylori</i> in Indonesia, the high incidence of gastritis, predominantly atrophic gastritis, suggests that factors such as autoimmune gastritis (AIG) contribute to this unusual pattern. This study aims to investigate the epidemiology of AIG, histopathology, and its association with <i>H. pylori</i> status in Indonesia.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>A cross-sectional study was conducted in various regions in Indonesia between 2014 and 2017; 380 eligible sera and gastric biopsies were available when this study was conducted. As many as 138 sera samples were included in this study based on the initial examination by the updated Sydney system. The diagnosis of AIG was confirmed by serologic testing for parietal-cell antibodies (PCA) and detailed histopathological assessment with sparing of antrum histopathological features.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Among the included samples in this study, 78.99% (109/138) were PCA positive (≥ 10 RU/mL) and 0.72% (1/138) were considered to be diagnosed as AIG (spared from antrum histopathological features). The majority of PCA positive cases were <i>H. pylori</i> positive (61/109; 55.96%) with a significant correlation (<i>p</i> &lt; 0.05, <i>R</i> = 0.31). Additionally, a significant association was found between <i>H. pylori</i> infection and PCA level with gastric histopathological features (<i>p</i> &lt; 0.05).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>This study demonstrates that the incidence of gastritis without <i>H. pylori</i> infection in Indonesia is not attributable to AIG, as only a single AIG-positive case was found. These findings underscore the important role of <i>H. pylori</i> as a pathogenic factor in chronic gastritis and highlight its mechanisms in triggering immune responses and driving disease progression and histopathological changes.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"30 2","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143845873","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Association Between Helicobacter pylori Infection and Eosinophilic Esophagitis: Systematic Review and Meta-Analysis 幽门螺杆菌感染与嗜酸性粒细胞食管炎之间的关系:系统回顾与元分析
IF 4.3 2区 医学
Helicobacter Pub Date : 2025-04-18 DOI: 10.1111/hel.70038
Lucía Gutiérrez-Ramírez, Sandra L. Garcia-Dionisio, Sara Feo-Ortega, Jesús González-Cervera, Antonio Tejera-Muñoz, Alfredo J. Lucendo, Ángel Arias
{"title":"The Association Between Helicobacter pylori Infection and Eosinophilic Esophagitis: Systematic Review and Meta-Analysis","authors":"Lucía Gutiérrez-Ramírez,&nbsp;Sandra L. Garcia-Dionisio,&nbsp;Sara Feo-Ortega,&nbsp;Jesús González-Cervera,&nbsp;Antonio Tejera-Muñoz,&nbsp;Alfredo J. Lucendo,&nbsp;Ángel Arias","doi":"10.1111/hel.70038","DOIUrl":"https://doi.org/10.1111/hel.70038","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Exposure to <i>Helicobacter pylori</i> (<i>H. pylori</i>) has been associated with reduced odds of eosinophilic esophagitis (EoE).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Aims</h3>\u0000 \u0000 <p>To conduct a systematic review and meta-analysis of epidemiological studies in order to quantify the association between <i>H. pylori</i> infection and EoE, and to assess the certainty of the evidence linking both conditions.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>A comprehensive literature search was conducted in MEDLINE/PUBMED, EMBASE, and SCOPUS databases (up to September 2024) to identify observational epidemiological studies that assessed the association between objectively measured <i>H. pylori</i> infection and EoE. The risk of study bias was assessed structurally using the ROBINS-E tool. Data were pooled using a random-effects meta-analysis. The certainty of the evidence was assessed using the GRADE approach.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Sixteen studies comprising 30,650 patients and 291,908 controls were included. Exposure to <i>H. pylori</i> was associated with a significant reduction in the odds of EoE (pooled odds ratio [OR] 0.56; 95% CI, 0.46–0.70; <i>I</i><sup>2</sup> 50%) [low-certainty evidence]. The protective effect of <i>H. pylori</i> was stronger in case–control studies (OR 0.49; 95% CI, 0.35–0.69) than in cohort studies (OR 0.76; 95% CI, 0.58–0.98) and was statistically significant in retrospective studies (OR 0.57; 95% CI, 0.45–0.72) and studies with high or very high risk of bias (OR 0.52; 95% CI, 0.42–0.64), but not in prospective studies (OR 0.56; 95% CI, 0.27–1.18) or those with moderate to low risk of bias (OR, 0.91; 95% CI, 0.69–1.21).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>The association between <i>H. pylori</i> and EoE is mainly supported by retrospective studies with a high risk of bias. Further well-designed studies are needed.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Trial Registration</h3>\u0000 \u0000 <p>PROSPERO number: CRD42024586653</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"30 2","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143845828","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Impact of an Electronic Medical Record Quality Improvement Intervention on Helicobacter pylori Treatment and Eradication Rates in a U.S. Hospital System
IF 4.3 2区 医学
Helicobacter Pub Date : 2025-04-16 DOI: 10.1111/hel.70034
Shivani Kastuar, Samanthika Devalaraju, Juan Gomez Cifuentes, Hashem B. El-Serag, Mimi C. Tan
{"title":"Impact of an Electronic Medical Record Quality Improvement Intervention on Helicobacter pylori Treatment and Eradication Rates in a U.S. Hospital System","authors":"Shivani Kastuar,&nbsp;Samanthika Devalaraju,&nbsp;Juan Gomez Cifuentes,&nbsp;Hashem B. El-Serag,&nbsp;Mimi C. Tan","doi":"10.1111/hel.70034","DOIUrl":"https://doi.org/10.1111/hel.70034","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>In this pre- and post-intervention quality improvement (QI) study, the impact of an electronic medical record (EMR) order set for <i>Helicobacter pylori</i> treatment was assessed. We evaluated changes in optimal treatment regimen usage, eradication testing, and successful eradication rates based on the intervention.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Materials and Methods</h3>\u0000 \u0000 <p>Data were collected from patients within the Harris Health System (Houston, TX) with <i>H. pylori</i> infection. The pre-intervention cohort included patients with a positive <i>H. pylori</i> test from January to February 2022. An EMR order set for <i>H. pylori</i> treatment implemented in May 2022 included optimal treatment recommendations using local antibiotic resistance patterns and testing for eradication post-treatment. Comparisons of proportions with optimal treatment and eradication rates between the pre-intervention cohort, an early post-intervention group (June–July 2022), and a late post-intervention group (November–December 2022) were evaluated using chi-square tests.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>We identified 295 patients in the pre-intervention, 414 patients in the early post-intervention, and 320 patients in the late post-intervention cohorts. There was an increase in proportions of optimal treatment (bismuth-quadruple, clarithromycin-quadruple, or rifabutin-triple therapy with a proton pump inhibitor for 14 days) between the pre- and early post-intervention groups from 26.4% to 39.7% (<i>p</i> &lt; 0.01) with a further increase in the late post-intervention group to 85.3% (<i>p</i> &lt; 0.01). The proportion of post-treatment eradication testing within 24 months increased from 56% in the pre-intervention cohort to 65.8% in the early post-intervention cohort (<i>p</i> = 0.01) and 64.9% in the late post-intervention cohort (<i>p</i> = 0.03). In patients with post-treatment eradication testing, there was an increase in successful eradication from 80.6% in the pre-intervention cohort to 88.9% in the early post-intervention cohort (<i>p</i> = 0.03) and 82.6% in the late post-intervention cohort (<i>p</i> = 0.66).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>An EMR order set for <i>H. pylori</i> treatment and eradication testing significantly increased rates of using optimal, evidence-based treatment, post-treatment eradication testing, and confirmed eradication of <i>H. pylori</i> infection.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"30 2","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143840689","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy and Safety of Cefuroxime–Tetracycline-Containing Bismuth Quadruple Therapy for Helicobacter pylori Eradication in Penicillin-Allergic Patients: A Multicenter Randomized Controlled Trial
IF 4.3 2区 医学
Helicobacter Pub Date : 2025-04-16 DOI: 10.1111/hel.70033
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
{"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,&nbsp;Qingzhou Kong,&nbsp;Qiumei Zhang,&nbsp;Lili Zhang,&nbsp;Ruili Li,&nbsp;Teng Zhang,&nbsp;Leina Guo,&nbsp;Xilan Wang,&nbsp;Xiaowei Li,&nbsp;Hongyu Zhao,&nbsp;Fengqing Liu,&nbsp;Yuting Guo,&nbsp;Zhenzhen Zhai,&nbsp;Mingyu Li,&nbsp;Xiaorong Yang,&nbsp;Xiuli Zuo,&nbsp;Xiaoyun Yang,&nbsp;Yueyue Li","doi":"10.1111/hel.70033","DOIUrl":"https://doi.org/10.1111/hel.70033","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <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>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Materials and Methods</h3>\u0000 \u0000 <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>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <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> &lt; 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>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <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>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Trial Registration</h3>\u0000 \u0000 <p>ClinicalTrials.gov ID: NCT06351891</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"30 2","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143836217","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Chronic Infection With Gastric Helicobacters Induces Hepatic Lesions in Mice
IF 4.3 2区 医学
Helicobacter Pub Date : 2025-04-10 DOI: 10.1111/hel.70032
Lornella Seeneevassen, Elodie Sifré, Sadia Khalid, Mathilde Managau, Francis Mégraud, Armelle Ménard, Pierre Dubus, Pirjo Spuul, Christine Varon
{"title":"Chronic Infection With Gastric Helicobacters Induces Hepatic Lesions in Mice","authors":"Lornella Seeneevassen,&nbsp;Elodie Sifré,&nbsp;Sadia Khalid,&nbsp;Mathilde Managau,&nbsp;Francis Mégraud,&nbsp;Armelle Ménard,&nbsp;Pierre Dubus,&nbsp;Pirjo Spuul,&nbsp;Christine Varon","doi":"10.1111/hel.70032","DOIUrl":"https://doi.org/10.1111/hel.70032","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p><i>Helicobacter pylori</i> infection is one of the most prevalent chronic bacterial infections worldwide. This bacillus colonizes the human stomach lifelong, where it induces chronic gastritis, evolving in some cases to gastro-duodenal ulcers, gastric adenocarcinoma, and mucosa-associated lymphoid tissue lymphoma. <i>H. pylori</i> infection has also been associated with extragastric diseases, and clinical data have suggested a role in liver pathogenesis. This retrospective study evaluated the consequences of chronic infection with gastric <i>Helicobacters</i> on liver pathogenesis in a mouse experimental model.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Materials and Methods</h3>\u0000 \u0000 <p>C57BL6 mice were infected with either <i>H. felis</i> (<i>n</i> = 12) or five human and mouse-adapted strains of <i>H. pylori</i> (<i>n</i> = 77) for one year. Uninfected mice were used as negative controls (<i>n</i> = 10). Histopathological analysis of paraffin-embedded liver tissue sections was performed, and scores were determined in a double-blind manner for inflammation and steatosis.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Mice infected with <i>H. felis</i> and several <i>H. pylori</i> strains developed more liver parenchymal inflammation and steatosis, known precursor lesions of liver carcinogenesis, compared to non-infected mice. The presence of liver lesions was positively correlated with the detection of lesions of the gastric mucosa, more particularly gastric inflammation and metaplasia.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Chronic infection of mice with <i>H. felis</i> and <i>H. pylori</i> induces liver pathogenesis characterized by parenchymal inflammation and steatosis, which may be associated with the severity of gastric histopathological lesions. Understanding <i>H. pylori</i> infection's impact on extragastric lesions could <i>in fine</i> help detect and prevent the emergence of other digestive tract-related diseases.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"30 2","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/hel.70032","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143809692","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Real-Time PCR Helicobacter pylori Test in Comparison With Culture and Histology for Helicobacter pylori Detection and Identification of Resistance to Clarithromycin: A Single-Center Real-Life Study
IF 4.3 2区 医学
Helicobacter Pub Date : 2025-04-07 DOI: 10.1111/hel.70031
Kateryna Priadko, Sophie-Anne Gibaud, Amaury Druet, Louise Galmiche, Francis Megraud, Stéphane Corvec, Tamara Matysiak-Budnik
{"title":"Real-Time PCR Helicobacter pylori Test in Comparison With Culture and Histology for Helicobacter pylori Detection and Identification of Resistance to Clarithromycin: A Single-Center Real-Life Study","authors":"Kateryna Priadko,&nbsp;Sophie-Anne Gibaud,&nbsp;Amaury Druet,&nbsp;Louise Galmiche,&nbsp;Francis Megraud,&nbsp;Stéphane Corvec,&nbsp;Tamara Matysiak-Budnik","doi":"10.1111/hel.70031","DOIUrl":"https://doi.org/10.1111/hel.70031","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>In our center, RT-PCR was integrated as a routine method to diagnose <i>Helicobacter pylori</i> due to its higher availability after COVID-19 pandemics. The objective of this study was to assess the feasibility and performance of systematically performed RT-PCR for <i>H. pylori</i> detection and clarithromycin (CLA) resistance in a real-life clinical practice.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Materials and Methods</h3>\u0000 \u0000 <p>One hundred consecutive patients underwent an upper digestive endoscopy during which at least four biopsies (two from the antrum and two from the corpus) were obtained for RT-PCR and culture with antibiogram and four additional biopsies for histology. The results of <i>H. pylori</i> detection were compared among RT-PCR, histology, and bacterial culture, and the results of CLA susceptibility were compared between culture-based antibiogram and RT-PCR.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Out of 100 patients, 64 were positive for <i>H. pylori</i> by RT-PCR, 66 by histology, and 53 by culture, with no statistically significant difference among the three methods (<i>p</i> &gt; 0.05). CLA resistance was found in 8 out of 45 patients (17.7%) by culture and in 12 out of 64 patients (18.7%) by PCR. In 8 <i>H. pylori</i>-positive patients by culture, the antibiogram could not be realized due to lack of viability of the strains. In one patient, after a double checking, discrepant results were observed, requiring a complementary molecular analysis by the French National Reference Center for Helicobacters, which confirmed the existence of a double population of <i>H. pylori</i> strains within biopsies, with and without CLA resistance.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Our study demonstrates that in real-life clinical practice, RT-PCR is feasible and comparable in the ability to detect <i>H. pylori</i> and its resistance to CLA to bacterial culture with antibiogram and histology. Given its rapidity and limited dependence on the operator's interpretation, it appears preferable to the other methods.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"30 2","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/hel.70031","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143786780","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
First-Line Therapy for Helicobacter pylori in Slovenia: Data From 2013 to 2023 of the European Registry on H. pylori Management
IF 4.3 2区 医学
Helicobacter Pub Date : 2025-04-03 DOI: 10.1111/hel.70029
Bojan Tepes, Nataša Brglez Jurečič, Maja Denkovski, Miroslav Vujasinovič, Zdenko Kikec, Jurij Bednarik, Katja Tepes, Anna Cano-Català, Pablo Parra, Leticia Moreira, Olga P. Nyssen, Francis Mégraud, Colm O'Morain, Javier P. Gisbert
{"title":"First-Line Therapy for Helicobacter pylori in Slovenia: Data From 2013 to 2023 of the European Registry on H. pylori Management","authors":"Bojan Tepes,&nbsp;Nataša Brglez Jurečič,&nbsp;Maja Denkovski,&nbsp;Miroslav Vujasinovič,&nbsp;Zdenko Kikec,&nbsp;Jurij Bednarik,&nbsp;Katja Tepes,&nbsp;Anna Cano-Català,&nbsp;Pablo Parra,&nbsp;Leticia Moreira,&nbsp;Olga P. Nyssen,&nbsp;Francis Mégraud,&nbsp;Colm O'Morain,&nbsp;Javier P. Gisbert","doi":"10.1111/hel.70029","DOIUrl":"https://doi.org/10.1111/hel.70029","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Treatment is indicated for all <i>Helicobacter pylori</i> infections. However, the best approach for <i>H. pylori</i> management remains unclear.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p><i>H. pylori</i> eradication data from Hp-EuReg on treatment-naive patients in Slovenia from 2013 to 2023 were included. The regimens prescribed, the number of eradication attempts, effectiveness, adherence, and safety were analyzed. The effectiveness was assessed by modified intention to treat (mITT).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Eight Slovenian medical institutions contributed data for 4016 treatment-naive patients to Hp-EuReg. Of these, 18% did not undergo confirmatory post-treatment; most who did received a urea breath test. Between 2013 and 2018, 7-day triple therapy with amoxicillin and clarithromycin was most frequently used in first-line treatment, with an 88% eradication rate. From 2019 to 2023, a 14-day high-dose PPI (esomeprazole 40 mg b.i.d.) triple therapy with amoxicillin and clarithromycin was used, showing a significantly higher effectiveness at 94% (<i>p</i> &lt; 0.05). Quadruple bismuth-based therapy (esomeprazole 40 mg b.i.d., plus amoxicillin 500 mg, metronidazole 400 mg, and bismuth 120 mg, all q.i.d.) provided a 96.9% eradication rate, though this was not significantly better than the 14-day triple regimen. The <i>H. pylori</i> resistance rate to clarithromycin was 16% from 2013 to 2018, dropping to 13.5% from 2019 to 2023. Side effects were reported by 9.6% of patients, and treatment compliance was &gt; 99%.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>The study suggests that systematic data collection from routine clinical practice in Hp-EuReg can guide first-line <i>H. pylori</i> treatment. Established 90% treatment effectiveness threshold may serve as a surrogate marker for monitoring <i>H. pylori</i> resistance rates to antibiotics. In countries with a <i>H. pylori</i> resistance rate &lt; 15%, such as Slovenia, the 14-day high-dose PPI amoxicillin-clarithromycin regimen is an optimal first-line empirical treatment.</p>\u0000 \u0000 <p><b>Trial Registration:</b> NCT02328131</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"30 2","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143761839","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Helicobacter pylori Eradication Is Associated With a Reduced Risk of Metachronous Gastric Neoplasia by Restoring Immune Function in the Gastric Mucosa
IF 4.3 2区 医学
Helicobacter Pub Date : 2025-04-01 DOI: 10.1111/hel.70030
Min-Jae Kim, Yeonjin Je, Jaeyoung Chun, Young Hoon Youn, Hyojin Park, Ji Hae Nahm, Jie-Hyun Kim
{"title":"Helicobacter pylori Eradication Is Associated With a Reduced Risk of Metachronous Gastric Neoplasia by Restoring Immune Function in the Gastric Mucosa","authors":"Min-Jae Kim,&nbsp;Yeonjin Je,&nbsp;Jaeyoung Chun,&nbsp;Young Hoon Youn,&nbsp;Hyojin Park,&nbsp;Ji Hae Nahm,&nbsp;Jie-Hyun Kim","doi":"10.1111/hel.70030","DOIUrl":"https://doi.org/10.1111/hel.70030","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p><i>Helicobacter pylori</i> infection is a significant contributing factor of gastric cancer. Metachronous neoplasms also pose a risk. The mechanism underlying the impact of <i>H. pylori</i> eradication on preventing metachronous gastric cancer is unclear. This study aimed to investigate immunity changes in gastric mucosa after <i>H. pylori</i> eradication and to identify mechanisms preventing metachronous recurrence.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Materials and Methods</h3>\u0000 \u0000 <p>Patients diagnosed with gastric neoplasm and <i>H. pylori</i> infection, who underwent endoscopic resection, were included. Thirty-six cases of metachronous neoplasms occurring after eradication (metachronous group) were compared to 36 controls matched for age, sex, atrophy, and metaplasia (control group). Histological features and immunohistochemical staining for T-cell (CD3, CD4, and CD8) and immune exhaustion (forkhead/winged helix transcription factor and programmed cell death-ligand 1) markers in the non-tumor-bearing mucosa were evaluated.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>In histologic features, glandular atrophy and intestinal metaplasia in the gastric mucosa significantly improved following <i>H. pylori</i> eradication in the control group (<i>p</i> &lt; 0.001, 0.008), whereas they did not improve in the metachronous group (<i>p</i> = 0.449, 0.609). CD8 and CD8/CD3 ratios increased in the control group (<i>p</i> &lt; 0.001, 0.04), but did not show differences in the metachronous group (<i>p</i> = 0.057, 0.245). The CD4/CD3 ratio and programmed cell death-ligand 1/CD4 expression significantly decreased after <i>H. pylori</i> eradication in the control group (<i>p</i> = 0.003, 0.042), but not in the metachronous group (<i>p</i> = 0.54, 0.55).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>This observational study suggests that <i>H. pylori</i> eradication may prevent the recurrence of gastric neoplasia by improving histological inflammation and overcoming immune exhaustion.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"30 2","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/hel.70030","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143749750","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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