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Optimizing Benefits-Harms of H. pylori Screen-and-Treat Programs Tailored to the Regional Settings. 优化幽门螺杆菌筛查和治疗方案的利弊,以适应地区环境。
IF 4.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-03-01 DOI: 10.1111/hel.70111
Duco T Mülder, Yi-Chia Lee, Mario Dinis-Ribeiro, Melissa McLeod, Jin Young Park, Iris Lansdorp-Vogelaar

This article outlines how decision modeling can be used to optimize the cost-effectiveness of H. pylori screen-and-treat programs. Decision models enable the translation of data from pilot studies into locally tailored strategies by adapting test modalities, treatment options, and the need to retest specific to the local setting. We summarize existing evidence from modeling studies, which consistently demonstrate that H. pylori screen-and-treat is cost-effective across diverse populations. In addition, we discuss how decision modeling can support resource allocation, promote health equity, and guide implementation planning. Integrating H. pylori screen-and-treat into established preventive programs, such as colorectal cancer screening, may further increase efficiency and feasibility. The article concludes with a proposed research agenda to advance efficient H. pylori screen-and-treat programs across the globe.

本文概述了如何使用决策建模来优化幽门螺杆菌筛查和治疗方案的成本效益。决策模型能够通过调整测试方式、治疗方案和重新测试的需求,将试点研究的数据转化为适合当地情况的策略。我们总结了来自模型研究的现有证据,这些证据一致表明幽门螺杆菌筛查和治疗在不同人群中具有成本效益。此外,我们还讨论了决策建模如何支持资源分配、促进卫生公平和指导实施计划。将幽门螺杆菌筛查和治疗纳入现有的预防方案,如结直肠癌筛查,可能会进一步提高效率和可行性。文章最后提出了一项研究议程,以促进全球范围内有效的幽门螺杆菌筛查和治疗计划。
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引用次数: 0
Helicobacter pylori, Inflammation, and Long-Term Outcome in Patients With Acute Myocardial Infarction: A Prospective Cohort Study. 幽门螺杆菌、炎症和急性心肌梗死患者的长期预后:一项前瞻性队列研究。
IF 4.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-03-01 DOI: 10.1111/hel.70116
Martin O Sundqvist, Jonatan Wärme, Marcus Hjort, Per Tornvall, Tomas Jernberg, Bertil Lindahl, Alexandru Schiopu, Tomasz Baron, Stefan H Jacobson, Thomas Kahan, David Erlinge, Jonas Spaak, Robin Hofmann

Background: Helicobacter pylori (Hp) and its virulence factor Cytotoxin-associated gene A (CagA) have been linked to myocardial infarction (MI), but the mechanisms are unknown. This study aims to test if Hp infection and CagA are associated with pre-specified inflammatory and vascular biomarkers in patients with MI and to explore whether a broader biomarker panel can predict infection. Furthermore, it aims to investigate the association of Hp infection and biomarkers with major adverse cardiovascular events (MACE) and mortality.

Materials and methods: Hp, CagA serology, and 175 cardiovascular biomarkers were analyzed in 1061 patients with MI admitted between 2008 and 2014. Associations between Hp and seven pre-selected biomarkers were evaluated. Exploratory analyses included all biomarkers using machine-learning models to predict Hp-status. Hp-status and the top predictors were analyzed for associations with outcomes using Cox regression.

Results: Median age was 65 years; 78% were male. Hp and CagA seroprevalence were 45% and 19%, respectively. Patients with Hp had elevated CRP (β = 0.26, 95% CI 0.01-0.51). Predictive performance of Hp-status was moderate (AUC 0.63-0.68). Exploratory analysis identified higher levels of C-C motif chemokine ligand 20 (CCL20) and immunoglobulin heavy constant gamma-3 (IGHG3), and lower levels of TNF-related apoptosis-inducing ligand (TRAIL) in patients with Hp-positivity. Elevated CCL20 and reduced TRAIL, but not Hp, were associated with MACE and all-cause mortality.

Conclusions: Hp may contribute to an inflammatory response in patients with MI, indicated by higher CRP and inflammatory/immune-modulatory biomarkers emerging as its top predictors. Although Hp was not associated with adverse outcomes after MI, its predictive inflammatory biomarkers were associated with MACE and mortality.

Trial registration: The study was not registered as a clinical trial, as it was an observational study.

背景:幽门螺杆菌(Hp)及其毒力因子细胞毒素相关基因A (CagA)与心肌梗死(MI)有关,但其机制尚不清楚。本研究旨在测试Hp感染和CagA是否与心肌梗死患者预先指定的炎症和血管生物标志物相关,并探索更广泛的生物标志物是否可以预测感染。此外,该研究旨在调查Hp感染和生物标志物与主要不良心血管事件(MACE)和死亡率的关系。材料和方法:对2008年至2014年收治的1061例心肌梗死患者的Hp、CagA血清学和175项心血管生物标志物进行分析。评估了Hp与7种预先选择的生物标志物之间的关联。探索性分析包括使用机器学习模型预测hp状态的所有生物标志物。使用Cox回归分析hp状态和最高预测因子与结果的相关性。结果:中位年龄65岁;78%是男性。Hp和CagA血清阳性率分别为45%和19%。Hp患者CRP升高(β = 0.26, 95% CI 0.01-0.51)。hp状态的预测性能一般(AUC为0.63-0.68)。探索性分析发现,在hp阳性患者中,C-C基序趋化因子配体20 (CCL20)和免疫球蛋白重常量γ -3 (IGHG3)水平较高,tnf相关凋亡诱导配体(TRAIL)水平较低。CCL20升高和TRAIL降低与MACE和全因死亡率相关,但与Hp无关。结论:Hp可能促进心肌梗死患者的炎症反应,CRP升高和炎症/免疫调节生物标志物成为其主要预测因素。虽然Hp与心肌梗死后的不良结果无关,但其预测炎症生物标志物与MACE和死亡率相关。试验注册:该研究未注册为临床试验,因为它是一项观察性研究。
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引用次数: 0
Changes of Helicobacter pylori Infection Status and Risk of Precancerous Lesions: A Prospective Cohort Study in Chinese Population. 幽门螺杆菌感染状况及癌前病变风险的变化:中国人群的前瞻性队列研究。
IF 4.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-03-01 DOI: 10.1111/hel.70114
Xufei Xing, Renjia Zhao, Zixuan Cui, Qiaoyi Xu, Ziyu Yuan, Kelin Xu, Tiejun Zhang, Zhenqiu Liu, Yanfeng Jiang, Ming Lu, Weimin Ye, Chen Suo, Xingdong Chen

Objective: To evaluate the associations of both baseline serological profiles and serological transitions of Helicobacter pylori infection patterns with the risk of precancerous gastric lesions (PGLs).

Design: We analyzed data from 6208 participants in the FuSion cohort who underwent gastroscopy examination, with available H. pylori antibody and pepsinogen measurements at both baseline and follow-up. H. pylori status defined by IgG antibodies (Ab) and pepsinogens (PG), classified participants into four ABC groups. Multivariable logistic regression evaluated associations with PGLs across baseline and transition statuses. Trend tests were performed across the ABC groups and infection transition categories.

Results: A significant increasing trend in the PGLs prevalence and severity was observed across the ABC groups (p for trend < 0.05). Analysis of infection transitions revealed graded risk increases for PGLs from consistently negative to remained positive groups. Interestingly, even participants who seroreverted remained at significantly elevated risks of atrophic gastritis (adjusted odds ratio [aOR] = 2.01, 95% CI: 1.67-2.43) and intestinal metaplasia (aOR = 1.72, 95% CI: 1.14-2.51) compared to the persistently negative participants. The sensitivity analyses excluding baseline PG-positive subjects yielded similar results.

Conclusion: Long-term exposure to H. pylori is associated with an increased risk of PGLs, and this risk may remain elevated even after seroreversion.

目的:评估幽门螺杆菌感染模式的基线血清学特征和血清学转变与胃癌前病变(PGLs)风险的关系。设计:我们分析了FuSion队列中6208名参与者的数据,他们接受了胃镜检查,并在基线和随访期间测量了幽门螺杆菌抗体和胃蛋白酶原。通过IgG抗体(Ab)和胃蛋白酶原(PG)来确定幽门螺杆菌的状态,将参与者分为四个ABC组。多变量逻辑回归评估了基线和过渡状态与pgl的关系。在ABC组和感染过渡类别之间进行趋势测试。结果:在ABC组中观察到pgl的患病率和严重程度有显著增加的趋势(p为趋势)。结论:长期暴露于幽门螺杆菌与pgl的风险增加有关,即使在血清逆转后这种风险仍可能升高。
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引用次数: 0
The Association of a Positive Fecal Immunochemical Test With the Risk of Gastroesophageal Cancer: An Age-Sex-H. Pylori Exposure Matched Cohort Study and Cost-Effectiveness Analysis. 粪便免疫化学试验阳性与胃食管癌风险的关系:年龄-性别- h。幽门螺杆菌暴露匹配队列研究及成本-效果分析。
IF 4.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-03-01 DOI: 10.1111/hel.70120
Zohar Levi, Naim Abu-Freha, Doron Boltin, Maya Aharoni Golan, Tom Konikoff, Orly Sneh Arbib, Rachel Gingold Belfer, Sapir Eizenstein, Alex Vilkin, Shiri Kusnir, Adi Turgeman, Tanya Babich, Moshe Leshno, Anath A Flugelman, Hadar Edelman-Klapper, Elizabeth Half-Onn

Background and aims: We evaluated the association between Fecal Immunochemical Test (FIT) results and the risk of gastroesophageal cancer (GEC) in a matched cohort, as well as the cost-effectiveness of a one-time esophagogastroduodenoscopy (EGD) for individuals who tested FIT-positive.

Methods: We formed a cohort of individuals aged 50-75 years who underwent FIT testing at Clalit Health in Israel from 2016 to 2019. For each person with a positive FIT result, we matched three individuals with negative results by age, gender, and H. pylori exposure. We used adjusted hazard ratios (adjHRs) to assess the association between a positive FIT result and the risk of GEC within 36 months. We calculated the incremental cost-effectiveness ratio (ICER) for a one-time EGD costing USD 350 in individuals who tested positive for FIT, and considered it cost-effective if below USD 50,000.

Results: The study included 150,391 individuals (47.6% female, median age 62.4 years). During follow-up, 202 cases of GEC were recorded: 0.17% in FIT-positive individuals (64/37,709) and 0.12% in FIT-negative individuals (138/112,682), adjHR 1.39 (95% CI 1.03-1.87). GEC was also associated with H. pylori exposure (adjHR 1.43, 95% CI 1.08-1.90) and immigration from high-risk countries. A one-time EGD demonstrated favorable cost-effectiveness across various scenarios, with an ICER of USD 25,535/QALY.

Conclusions: This matched-cohort study suggests that individuals with a positive FIT may have an increased risk of GEC, comparable to that of established high-risk populations. Adding a one-time EGD to colonoscopy for FIT-positive individuals may be a cost-effective approach for healthcare systems that can accommodate such interventions.

背景和目的:我们在一个匹配的队列中评估了粪便免疫化学试验(FIT)结果与胃食管癌(GEC)风险之间的关系,以及对FIT检测呈阳性的个体进行一次性食管胃十二指肠镜检查(EGD)的成本效益。方法:我们形成了一组年龄在50-75岁之间的个体,他们于2016年至2019年在以色列的Clalit Health进行了FIT测试。对于每个FIT结果呈阳性的人,我们根据年龄、性别和幽门螺杆菌暴露程度匹配了三个结果呈阴性的人。我们使用校正风险比(adjhr)来评估FIT阳性结果与36个月内GEC风险之间的关系。对于FIT检测呈阳性的个体,我们计算了一次性EGD费用为350美元的增量成本-效果比(ICER),如果低于5万美元,则认为其具有成本效益。结果:该研究纳入150,391例个体(47.6%为女性,中位年龄62.4岁)。随访期间,共记录202例GEC: fitt阳性者0.17% (64/37,709),fitt阴性者0.12% (138/112,682),adjHR 1.39 (95% CI 1.03-1.87)。GEC还与幽门螺杆菌暴露(adjHR 1.43, 95% CI 1.08-1.90)和来自高风险国家的移民有关。一次性EGD在各种情况下都具有良好的成本效益,ICER为25,535美元/QALY。结论:这项配对队列研究表明,FIT阳性的个体患GEC的风险可能增加,与已确定的高危人群相当。在fit阳性个体的结肠镜检查中增加一次性EGD,对于能够适应此类干预措施的卫生保健系统来说,可能是一种具有成本效益的方法。
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引用次数: 0
Efficacy and Safety of Vonoprazan-Based Dual, Triple, and Quadruple Therapies for Helicobacter pylori Eradication: A Randomized Controlled Trial. 以伏诺哌嗪为基础的双联、三联和四联治疗幽门螺杆菌根除的疗效和安全性:一项随机对照试验。
IF 4.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-03-01 DOI: 10.1111/hel.70112
Jin-Yan Zhang, Ji Li, Wei-Feng Huang, Xiao-Yi Lei, Yu-Lin Huang, Gui-Hua Xu, Dong Xu

Background: Vonoprazan (VPZ), a potassium-competitive acid blocker, has shown promising efficacy in Helicobacter pylori (H. pylori) eradication. However, direct comparisons of VPZ-based dual therapy (V-DT), triple therapy (V-TT), and bismuth quadruple therapy (V-BQT) remain limited. This study aimed to evaluate and compare the efficacy, safety, and compliance of these three regimens as first-line treatments for H. pylori infection.

Methods: 375 adults were randomized (1:1:1) to receive V-DT (VPZ 20 mg bid + amoxicillin 1 g tid for 10 days), V-TT (VPZ 20 mg bid + amoxicillin 1 g bid + clarithromycin 500 mg bid for 14 days), or V-BQT (VPZ 20 mg bid + amoxicillin 1 g bid + clarithromycin 500 mg bid + bismuth 240 mg bid for 10 days). The primary outcome was H. pylori eradication rate by intention-to-treat (ITT), modified ITT (mITT), and per-protocol (PP) analyses. Secondary outcomes included adverse events and compliance.

Results: Eradication rates were 92.0% (95% confidence interval [CI]: 85.8%-96.1%), 89.6% (95% CI: 82.9%-94.3%), and 88.8% (95% CI: 81.9%-93.7%) in ITT; 94.3% (95% CI: 88.5%-97.7%), 94.9% (95% CI: 89.3%-98.1%), and 94.1% (95% CI: 88.2%-97.6%) in mITT; and 94.2% (95% CI: 88.4%-97.6%), 95.6% (95% CI: 90.0%-98.5%), and 94.8% (95% CI: 89.0%-98.1%) in PP analyses for V-DT, V-TT, and V-BQT, respectively. The efficacy of V-DT and V-TT was noninferior to that of V-BQT. Adverse events were significantly lower with V-DT (6.4%) than with V-TT (36.0%) and V-BQT (49.6%) (p < 0.001). Compliance exceeded 93% in all groups, with no significant differences (p = 0.250).

Conclusions: All three regimens achieved high eradication rates, with V-DT and V-TT being statistically noninferior to V-BQT. The 10-day V-DT regimen achieved eradication rates comparable to V-BQT with substantially fewer adverse events and reduced antibiotic use, supporting its potential as a simplified first-line option for H. pylori eradication.

Trial registration: Chinese Clinical Trial Registration Number: ChiCTR2300072857.

背景:Vonoprazan (VPZ)是一种钾竞争性酸阻滞剂,在根除幽门螺杆菌(h.p ylori)方面显示出良好的效果。然而,基于vpz的双重治疗(V-DT)、三联治疗(V-TT)和铋四联治疗(V-BQT)的直接比较仍然有限。本研究旨在评估和比较这三种方案作为幽门螺杆菌感染一线治疗的有效性、安全性和依从性。方法:375名成人随机(1:1:1)接受V-DT (VPZ 20 mg bid +阿莫西林1 g bid +克拉霉素500 mg bid,持续10天)、V-TT (VPZ 20 mg bid +阿莫西林1 g bid +克拉霉素500 mg bid,持续14天)或V-BQT (VPZ 20 mg bid +阿莫西林1 g bid +克拉霉素500 mg bid +铋240 mg bid,持续10天)治疗。主要终点是通过意向治疗(ITT)、修改后的ITT (mITT)和每个方案(PP)分析得出的幽门螺杆菌根除率。次要结局包括不良事件和依从性。结果:ITT的根除率分别为92.0%(95%可信区间[CI]: 85.8% ~ 96.1%)、89.6% (95% CI: 82.9% ~ 94.3%)和88.8% (95% CI: 81.9% ~ 93.7%);94.3% (95% CI: 88.5% - -97.7%), 94.9% (95% CI: 89.3% - -98.1%)和94.1% (95% CI: 88.2% - -97.6%)手套;在V-DT、V-TT和V-BQT的PP分析中分别为94.2% (95% CI: 88.4%-97.6%)、95.6% (95% CI: 90.0%-98.5%)和94.8% (95% CI: 89.0%-98.1%)。V-DT和V-TT的疗效不逊于V-BQT。V-DT组的不良事件发生率(6.4%)明显低于V-TT组(36.0%)和V-BQT组(49.6%)(p)。结论:三种方案均获得了较高的根除率,V-DT和V-TT在统计学上不低于V-BQT组。10天的V-DT方案达到了与V-BQT相当的根除率,不良事件显著减少,抗生素使用减少,支持其作为幽门螺杆菌根除的简化一线选择的潜力。试验注册:中国临床试验注册号:ChiCTR2300072857。
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引用次数: 0
Exosome-Based Detection of Helicobacter pylori Infection and Clarithromycin Resistance in Children. 基于外泌体的儿童幽门螺杆菌感染及克拉霉素耐药性检测。
IF 4.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-03-01 DOI: 10.1111/hel.70113
Minghui Song, Jingqing Zeng, Zhanyong Yao, Chundi Xu, Yiqiu Huang, Yuan Xiao, Yi Yu, Jia Li, Xu Xu, Chenchen Shi, Qiuchen Wu, Yonglin Tao, Xing Tang, Gloria Ge, Shenshen Gao, Zhaohui Deng, Xinqiong Wang

Background: The prevalence of Helicobacter pylori (H. pylori) infection in children is high. Current diagnostic methods, particularly invasive techniques like gastroscopy, pose challenges for pediatric populations, highlighting the need for reliable non-invasive alternatives.

Aims: This study aimed to evaluate the diagnostic value of salivary and urinary exosomes for detecting H. pylori infection and clarithromycin resistance in children.

Methods: Saliva and urine samples were collected from children prior to elective gastroscopy. Exosomal DNA was extracted and subjected to qPCR for the detection of H. pylori DNA and clarithromycin resistance. The sensitivity and specificity of the salivary and urinary exosome tests were calculated against the reference standard, and their performance in detecting resistance was compared with tissue-based results.

Results: Among 500 enrolled children, the H. pylori infection rate was 31.6%. Analysis of 500 salivary and 80 urine samples showed that salivary exosomes detected H. pylori with a sensitivity of 93.67% and specificity of 80.11%. Urinary exosomes offered higher specificity (90.56%) but lower sensitivity (62.96%). In the subset of 113 infected children tested for resistance, salivary exosome testing identified clarithromycin resistance in 17.70% of cases, showing a 91.15% concordance with gastric tissue testing (15.93%). The agreement between the two methods was substantial.

Conclusion: Salivary exosome-based detection represents a highly sensitive and well-tolerated non-invasive method for diagnosing H. pylori infection in children. It also demonstrates substantial agreement with invasive methods in identifying clarithromycin resistance, offering a promising tool to guide precise eradication therapy in the pediatric population.

背景:儿童幽门螺杆菌感染率较高。目前的诊断方法,特别是像胃镜检查这样的侵入性技术,对儿科人群构成了挑战,强调需要可靠的非侵入性替代方法。目的:探讨唾液和尿外泌体检测儿童幽门螺杆菌感染及克拉霉素耐药的诊断价值。方法:择期胃镜检查前收集患儿唾液和尿液样本。提取外泌体DNA,采用qPCR检测幽门螺杆菌DNA和克拉霉素耐药性。根据参考标准计算唾液和尿液外泌体检测的敏感性和特异性,并将其检测耐药性的性能与基于组织的结果进行比较。结果:500名入组儿童幽门螺杆菌感染率为31.6%。唾液外泌体检测幽门螺杆菌的敏感性为93.67%,特异性为80.11%。尿外泌体特异性较高(90.56%),敏感性较低(62.96%)。在对113名感染儿童进行耐药性检测的亚群中,唾液外泌体检测发现17.70%的病例对克拉霉素耐药,与胃组织检测(15.93%)的一致性为91.15%。两种方法之间的一致是实质性的。结论:基于唾液外泌体的检测是诊断儿童幽门螺杆菌感染的一种灵敏度高、耐受性好的无创方法。它也证明了在识别克拉霉素耐药性方面与侵入性方法的基本一致,为指导儿科人群的精确根除治疗提供了一个有前途的工具。
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引用次数: 0
Long-Term Effect of Macrolides on Helicobacter pylori Eradication: Data From the European Registry on Helicobacter pylori Management (Hp-EuReg) 大环内酯类药物对幽门螺杆菌根除的长期影响:来自欧洲幽门螺杆菌管理登记处(Hp-EuReg)的数据。
IF 4.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-02-08 DOI: 10.1111/hel.70107
Olga P. Nyssen, Guillermo J. Ortega, Laimas Jonaitis, Ángeles Pérez-Aísa, Bojan Tepes, Alfredo J. Lucendo, Javier Tejedor-Tejada, Renate Bumane, Ana Garre, Jose M. Huguet, Monica Perona, Óscar Núñez, Manuel Pabón-Carrasco, Manuel Castro-Fernández, Miguel Areia, Jesús Barrio, Antonio Moreno Loro, Thomas J. Butler, María Soledad Marcos, Alma Keco-Huerga, Manuel Domínguez Cajal, Maja Denkovski, Matteo Pavoni, György Miklós Buzás, Frode Lerang, Giuseppe Losurdo, Pablo M. Wolfe García, Perminder S. Phull, Samuel J. Martínez-Domínguez, Juozas Kupcinskas, Mārcis Leja, Ricardo Marcos-Pinto, Sinead M. Smith, Antonio Gasbarrini, Veronika Papp, Blas José Gómez Rodríguez, Mónica Sánchez Alonso, Ramón Pajares Villarroya, Pilar Pazo Mejide, Manuel Jiménez-Moreno, Marta Pascual-Mato, Concepción Bravo-Pache, Milagrosa Montes, Anna Cano-Català, Pablo Parra, Leticia Moreira, Francis Mégraud, Colm O’Morain, Luis Bujanda, Javier P. Gisbert, the Hp-EuReg investigators

Background and Aims

Previous antibiotic use influences Helicobacter pylori antibiotic resistance. This study evaluated how prior population-level macrolide (especially clarithromycin) use affects H. pylori eradication success in naïve patients.

Methods

Retrospective, multicenter, ecological study. Multivariate logistic regression was performed with modified intention-to-treat effectiveness as the main outcome. Key variables included first-line clarithromycin-based treatments, therapy duration (7, 10, 14 days), proton pump inhibitor dose (low, standard, high), compliance (> 90%), and clarithromycin consumption (defined daily doses/1000 inhabitants/day, from the European Surveillance of Antimicrobial Consumption Network). Nested hierarchical models incorporated macrolide consumption, matched by year and country, and assessed the interaction between consumption and first-line empirical treatments from the European Registry on H. pylori Management (Hp-EuReg).

Results

The study included 27,549 naïve patients from 23 countries with macrolide consumption data from 2013 to 2022. Higher macrolide consumption, within 0 to 8 years before treatment, was associated with reduced treatment effectiveness. The eradication rate consistently decreased as macrolide consumption increased, particularly within the previous 4 years. The efficacy of triple-clarithromycin-metronidazole, triple-clarithromycin-amoxicillin, and some bismuth-quadruple therapies containing clarithromycin decreased with higher macrolide consumption. At the country level, higher population consumption of clarithromycin 2 years before treatment was associated with a decrease in eradication rates from 93% to 82%.

Conclusion

Higher macrolide consumption in the general population negatively impacts the effectiveness of first-line H. pylori regimens. These findings support that clarithromycin should only be administered as a susceptibility-based therapy, with the strongest negative impact of prior population-level exposure observed within 5 years and diminishing thereafter. ClincialTrials.gov number, NCT02328131.

背景与目的:既往抗生素使用影响幽门螺杆菌耐药性。本研究评估了先前人群水平的大环内酯(特别是克拉霉素)使用如何影响naïve患者幽门螺杆菌根除成功。方法:回顾性、多中心、生态学研究。以修改意向治疗有效性为主要结果进行多变量logistic回归。关键变量包括基于克拉霉素的一线治疗、治疗持续时间(7、10、14天)、质子泵抑制剂剂量(低、标准、高)、依从性(> 90%)和克拉霉素用量(定义日剂量/1000居民/天,来自欧洲抗菌药物消费监测网络)。嵌套分层模型纳入大环内酯类药物的消费,按年份和国家进行匹配,并评估消费与来自欧洲幽门螺杆菌管理登记处(Hp-EuReg)的一线经验治疗之间的相互作用。结果:该研究纳入了来自23个国家的27,549例naïve患者,并收集了2013年至2022年大环内酯类药物的消费数据。治疗前0 ~ 8年内大环内酯类药物的高用量与治疗效果降低有关。随着大环内酯类药物消费量的增加,根除率持续下降,特别是在过去4年内。三联克拉霉素-甲硝唑、三联克拉霉素-阿莫西林和一些含克拉霉素的铋-四联疗法的疗效随着大环内酯用量的增加而下降。在国家一级,治疗前2年较高的人群克拉霉素消费量与根除率从93%下降到82%有关。结论:普通人群中大环内酯类药物的摄入量增加会对幽门螺杆菌一线治疗方案的有效性产生负面影响。这些发现支持克拉霉素只应作为一种基于敏感性的治疗,既往人群水平暴露的最大负面影响在5年内观察到,此后逐渐减弱。ClincialTrials.gov号码:NCT02328131。
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引用次数: 0
Efficacy and Safety of Keverprazan–Amoxicillin Dual Regimen in Initial Eradication of Helicobacter pylori Infection: A Multicenter, Randomized Controlled Trial 一项多中心、随机对照试验:克维拉嗪-阿莫西林双方案对幽门螺杆菌感染的初步根除的有效性和安全性。
IF 4.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-02-05 DOI: 10.1111/hel.70100
Shanshan Wei, Zhihao Huang, Huizhen Xiong, Ji Wu, Dihua Mei, Jing Zhao, Wei Liu, Qingyun Liu, Yu Lin, Fang Liu, Xiang Peng, Honglei Chen

Objectives

The efficacy of keverprazan–amoxicillin dual therapy (KA) in the treatment of Helicobacter pylori (H. pylori) has not yet been demonstrated. Here, we aimed to compare the eradication rate of the KA regimen with esomeprazole-based bismuth quadruple therapy (EBQT) containing amoxicillin and clarithromycin for H. pylori initial eradication in the Chinese population.

Methods

Patients aged between 18–75 years were randomly assigned into KA group or the EBQT group. The KA group patients received keverprazan 20 mg (b.i.d.) and amoxicillin 1.0 g (t.i.d.) for 14 days. The EBQT group patients took esomeprazole 20 mg (b.i.d.), amoxicillin 1.0 g (b.i.d.), clarithromycin 0.5 g (b.i.d.), and bismuth potassium citrate 220 mg (b.i.d.) for 14 days. The primary outcome was the H. pylori eradication rate 28 days after therapy. Secondary outcomes included compliance and adverse events.

Results

A total of 394 patients were enrolled in this study. Eradication rates in the KA group and the EBQT group were 87.88% and 84.18% in intention-to-treat analysis (ITT) (rate difference: 3.70%, 95% CI: −3.14% to 10.53%), 92.55% and 88.24% in modified ITT analysis (rate difference: 4.32%, 95% CI: −1.63% to 10.27%), and 93.99% and 90.56% in per-protocol analysis (PP) (rate difference: 3.43%, 95% CI: −2.05% to 8.92%), respectively. The eradication rates for the KA group were not inferior to those of the EBQT group in ITT, modified ITT, and PP analysis. The incidences of nausea and overall adverse effects in the KA group were significantly lower than those of the EBQT group.

Conclusions

Keverprazan 20 mg twice daily with high-dose amoxicillin demonstrates a noninferior efficacy to bismuth quadruple therapy for initial H. pylori eradication.

Trial Registration

Chinese Clinical Trial Registry, registration No: ChiCTR2400092511

目的:凯维普拉嗪-阿莫西林双重治疗(KA)治疗幽门螺杆菌(H. pylori)的疗效尚未得到证实。在这里,我们的目的是比较KA方案与含有阿莫西林和克拉霉素的以埃索美拉唑为基础的铋四联疗法(EBQT)对中国人群幽门螺杆菌初始根除的根除率。方法:将18 ~ 75岁的患者随机分为KA组和EBQT组。KA组患者给予克维拉赞20 mg(每日一次)、阿莫西林1.0 g(每日一次),连用14 d。EBQT组患者口服埃索美拉唑20 mg(每日一次)、阿莫西林1.0 g(每日一次)、克拉霉素0.5 g(每日一次)、柠檬酸铋钾220 mg(每日一次),连用14天。主要观察指标为治疗后28天幽门螺杆菌根除率。次要结局包括依从性和不良事件。结果:本研究共纳入394例患者。在意向治疗分析(ITT)中,KA组和EBQT组的根除率分别为87.88%和84.18%(率差:3.70%,95% CI: -3.14%至10.53%),在改进的ITT分析中,根除率分别为92.55%和88.24%(率差:4.32%,95% CI: -1.63%至10.27%),在按方案分析(PP)中,根除率分别为93.99%和90.56%(率差:3.43%,95% CI: -2.05%至8.92%)。在ITT、改良ITT和PP分析中,KA组的根除率不低于EBQT组。KA组恶心和总体不良反应发生率明显低于EBQT组。结论:Keverprazan 20mg每日2次联合大剂量阿莫西林治疗幽门螺杆菌的疗效优于铋四联疗法。试验注册:中国临床试验注册中心,注册号:ChiCTR2400092511。
{"title":"Efficacy and Safety of Keverprazan–Amoxicillin Dual Regimen in Initial Eradication of Helicobacter pylori Infection: A Multicenter, Randomized Controlled Trial","authors":"Shanshan Wei,&nbsp;Zhihao Huang,&nbsp;Huizhen Xiong,&nbsp;Ji Wu,&nbsp;Dihua Mei,&nbsp;Jing Zhao,&nbsp;Wei Liu,&nbsp;Qingyun Liu,&nbsp;Yu Lin,&nbsp;Fang Liu,&nbsp;Xiang Peng,&nbsp;Honglei Chen","doi":"10.1111/hel.70100","DOIUrl":"10.1111/hel.70100","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objectives</h3>\u0000 \u0000 <p>The efficacy of keverprazan–amoxicillin dual therapy (KA) in the treatment of <i>Helicobacter pylori</i> (<i>H. pylori</i>) has not yet been demonstrated. Here, we aimed to compare the eradication rate of the KA regimen with esomeprazole-based bismuth quadruple therapy (EBQT) containing amoxicillin and clarithromycin for <i>H. pylori</i> initial eradication in the Chinese population.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Patients aged between 18–75 years were randomly assigned into KA group or the EBQT group. The KA group patients received keverprazan 20 mg (b.i.d.) and amoxicillin 1.0 g (t.i.d.) for 14 days. The EBQT group patients took esomeprazole 20 mg (b.i.d.), amoxicillin 1.0 g (b.i.d.), clarithromycin 0.5 g (b.i.d.), and bismuth potassium citrate 220 mg (b.i.d.) for 14 days. The primary outcome was the <i>H. pylori</i> eradication rate 28 days after therapy. Secondary outcomes included compliance and adverse events.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A total of 394 patients were enrolled in this study. Eradication rates in the KA group and the EBQT group were 87.88% and 84.18% in intention-to-treat analysis (ITT) (rate difference: 3.70%, 95% CI: −3.14% to 10.53%), 92.55% and 88.24% in modified ITT analysis (rate difference: 4.32%, 95% CI: −1.63% to 10.27%), and 93.99% and 90.56% in per-protocol analysis (PP) (rate difference: 3.43%, 95% CI: −2.05% to 8.92%), respectively. The eradication rates for the KA group were not inferior to those of the EBQT group in ITT, modified ITT, and PP analysis. The incidences of nausea and overall adverse effects in the KA group were significantly lower than those of the EBQT group.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Keverprazan 20 mg twice daily with high-dose amoxicillin demonstrates a noninferior efficacy to bismuth quadruple therapy for initial <i>H. pylori</i> eradication.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Trial Registration</h3>\u0000 \u0000 <p>Chinese Clinical Trial Registry, registration No: ChiCTR2400092511</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"31 1","pages":""},"PeriodicalIF":4.3,"publicationDate":"2026-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146124822","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
Gastric Cancer Prevention in Taiwan: Past Achievements and Future Perspectives 台湾的胃癌预防:过去的成就与未来的展望
IF 4.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-01-28 DOI: 10.1111/hel.70102
Shu-Lin Chuang, Teresa Cheng-Chieh Chu, Tsung-Hsien Chiang, Yi-Ru Chen, Wei-Yi Lei, Chien-Lin Chen, Ming-Jong Bair, Jeng-Yih Wu, Deng-Chyang Wu, Felice Tien O'Donnell, Hui-Wen Tien, Sherry Yueh-Hsia Chiu, Hsiu-Chi Cheng, Yu-Hsin Hsu, Tsui-Hsia Hsu, Pei-Chun Hsieh, Li-Ju Lin, Yi-Maun Subeq, Shu-Hui Wen, Chia-Hsiang Chu, Ming-Shiang Wu, Yi-Chia Lee

Population-based screen-and-treat of Helicobacter pylori infection, a well-established cause of gastric cancer, is emerging as an effective strategy to reduce gastric cancer incidence and mortality, in line with recommendations from the working group convened by the International Agency for Research on Cancer. This report reviews the development of the population-based H. pylori screen-and-treat strategy as a healthcare policy for gastric cancer prevention in Taiwan from 2004 to 2025, tracing its evolution from localized pilot programs to regional initiatives and, ultimately, to full population-wide implementation. To support systematic implementation at the population level, Taiwan adopted a three-tiered foundation that includes: (1) a centralized planning committee; (2) screening service delivery through primary care providers, guided by clinical guidelines established by medical societies; and (3) community engagement to raise awareness of stomach health and promote participation in screen-and-treat programs through social media campaigns. Program execution strictly follows the principles of organized screening, supported by standardized quality indicators, integrated digital tracking systems, structured audit mechanisms, and both effectiveness and cost-effectiveness assessments. Strategies are tailored to local contexts: in the Matsu Islands, mass screening using the 13C urea breath test and subsequent eradication treatment led to reductions in H. pylori prevalence and gastric cancer incidence and mortality; in Changhua County, a pragmatic randomized clinical trial showed that stool sample-based screening using H. pylori stool antigen and fecal immunochemical testing improved participation and reduced gastric cancer incidence; and in indigenous communities, household-based approaches utilizing the 13C urea breath test could enhance H. pylori detection rate and reduce the intrafamilial transmission. In addition to the continuous assessment of its effectiveness in preventing both gastric cancer and peptic ulcer disease, it is also essential to evaluate the potential impacts on antibiotic resistance and gut microbial succession after mass H. pylori eradication. All these programs consistently maintain high standards of quality and equity, ensuring accessibility for diverse populations with varying socioeconomic positions. Collectively, it demonstrates how robust scientific evaluations, when combined with organized screening principles and systematic performance monitoring, can be effectively translated into sustainable, evidence-based programs for population-wide gastric cancer prevention.

根据国际癌症研究机构召集的工作组的建议,以人群为基础的幽门螺杆菌感染筛查和治疗正在成为降低胃癌发病率和死亡率的有效策略。幽门螺杆菌感染是一种公认的胃癌病因。本报告回顾2004年至2025年,以人群为基础的幽门螺杆菌筛查和治疗策略作为台湾预防胃癌的医疗保健政策的发展,追溯其从局部试点项目到区域倡议,最终到全面的全民实施。为了支持人口层面的系统实施,台湾采用了三层架构,包括:(1)中央计划委员会;(2)在医学协会制定的临床指南指导下,通过初级保健提供者提供筛查服务;(3)社区参与,通过社交媒体活动提高人们对胃部健康的认识,促进人们参与筛查和治疗项目。项目执行严格遵循有组织的筛选原则,以标准化的质量指标、集成的数字跟踪系统、结构化的审计机制以及有效性和成本效益评估为支撑。根据当地情况量身定制策略:在马祖群岛,使用13C尿素呼气试验进行大规模筛查并随后进行根除治疗,导致幽门螺杆菌患病率和胃癌发病率和死亡率下降;在彰化县,一项实用的随机临床试验显示,使用幽门螺杆菌粪便抗原和粪便免疫化学检测进行粪便样本筛查,提高了参与程度,降低了胃癌发病率;在土著社区,基于家庭的方法使用13C尿素呼气试验可以提高幽门螺杆菌检出率,减少家族内传播。除了持续评估其预防胃癌和消化性溃疡疾病的有效性外,还必须评估大规模幽门螺杆菌根除后对抗生素耐药性和肠道微生物演替的潜在影响。所有这些项目始终保持高标准的质量和公平性,确保不同社会经济地位的不同人群都能获得教育。总的来说,它证明了强大的科学评估,当结合有组织的筛选原则和系统的绩效监测时,可以有效地转化为可持续的,以证据为基础的全民胃癌预防计划。
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引用次数: 0
Tegoprazan-Based Triple Therapy for Helicobacter pylori Eradication: A Phase III Multicenter Randomized Clinical Trial 以替戈拉赞为基础的三联疗法根除幽门螺杆菌:一项III期多中心随机临床试验。
IF 4.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-01-14 DOI: 10.1111/hel.70106
Jae Yong Park, Su Jin Hong, Il Ju Choi, Gwang Ho Baik, Sun Moon Kim, Jong-Jae Park, Seong Woo Jeon, Kyung-Oh Kim, Sang Kil Lee, Hwoon-Yong Jung, Jung-Hwan Oh, Chan Hyuk Park, Sang Wook Kim, Ki-Nam Shim, Sam Ryong Jee, Hee Seok Moon, Jeong Seop Moon, Cheol Woong Choi, Wan-Sik Lee, Jae Gyu Kim

Background

Tegoprazan, a potassium-competitive acid blocker, offers potent and sustained acid inhibition and potentially improves eradication efficacy.

Aim

This study aimed to evaluate the efficacy and safety of tegoprazan-based triple therapy with two dosing regimens compared with that of lansoprazole-based therapy for first-line Helicobacter pylori eradication.

Methods

This randomized, double-blind, active-controlled, multicenter trial was conducted at 19 referral hospitals in South Korea (February 2023–April 2024). Treatment-naïve adults with H. pylori infection were randomized 1:1:1 to receive 14-day triple therapy with tegoprazan, 50 mg (TAC1), tegoprazan, 100 mg (TAC2), or lansoprazole, 30 mg (LAC), each combined with amoxicillin 1000 mg and clarithromycin 500 mg, administered twice daily. The primary endpoint was H. pylori eradication rate in the modified intention-to-treat (mITT) population, with a non-inferiority margin of −10%. Secondary endpoints included subgroup analyses based on clarithromycin resistance and safety assessments.

Results

Of the 564 screened patients, 382 were randomized. In the mITT analysis (mean age, 54.9 years; 54.3% male), eradication rates were 86.0%, 85.5%, and 78.7% for TAC1, TAC2, and LAC, respectively. Both tegoprazan-based regimens met the non-inferiority criteria. Among clarithromycin-resistant infections, the eradication rates were higher for TAC1 (47.8%) and TAC2 (50.0%) than for LAC (35.5%), although the difference was not statistically significant. Safety profiles were comparable across the groups, with no serious drug-related adverse events.

Conclusion

Tegoprazan-based triple therapies, at 50- and 100-mg doses, were non-inferior to lansoprazole-based therapy and were well tolerated. Our findings indicated that tegoprazan-based triple therapy is a viable first-line option for H. pylori eradication.

Trial Registration

ClinicalTrials.gov identifier: NCT05933031

背景:替戈拉赞是一种钾竞争性酸阻滞剂,具有有效和持续的酸抑制作用,并可能提高根除效果。目的:本研究旨在评价以替戈拉赞为基础的两种给药方案三联治疗与以兰索拉唑为基础的治疗一线幽门螺杆菌根除的疗效和安全性。方法:这项随机、双盲、主动对照、多中心试验于2023年2月至2024年4月在韩国19家转诊医院进行。Treatment-naïve成人幽门螺杆菌感染患者以1:1:1的比例随机分组,接受为期14天的三联治疗,分别为替戈拉赞50 mg (TAC1)、替戈拉赞100 mg (TAC2)或兰索拉唑30 mg (LAC),分别联合阿莫西林1000 mg和克拉霉素500 mg,每日两次。主要终点是改良意向治疗(mITT)人群中的幽门螺杆菌根除率,非劣效边际为-10%。次要终点包括基于克拉霉素耐药和安全性评估的亚组分析。结果:在564例筛查患者中,382例被随机化。在mITT分析中(平均年龄54.9岁,男性54.3%),TAC1、TAC2和LAC的根除率分别为86.0%、85.5%和78.7%。两种以替戈拉赞为基础的治疗方案均符合非劣效性标准。在克拉霉素耐药感染中,TAC1(47.8%)和TAC2(50.0%)的根除率高于LAC(35.5%),但差异无统计学意义。两组间的安全性具有可比性,没有发生严重的药物相关不良事件。结论:以替戈拉赞为基础的三联疗法,在50和100毫克剂量下,不低于以兰索拉唑为基础的治疗,并且耐受性良好。我们的研究结果表明,以替戈拉赞为基础的三联疗法是根除幽门螺杆菌的可行的一线选择。试验注册:ClinicalTrials.gov标识符:NCT05933031。
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引用次数: 0
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