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Response to “Re-Evaluating the Adverse Events With the Same-Dosage Regimen in Hemodialysis Patients Undergoing Helicobacter pylori Eradication” 对“重新评估血透患者根除幽门螺杆菌不良事件的同剂量方案”的回应。
IF 4.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-10-09 DOI: 10.1111/hel.70080
Mitsushige Sugimoto, Shu Sahara
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引用次数: 0
Letter to the Editor: “Gastric Cancer Endoscopic Screening in an Intermediate-Risk Country—A Dual-Center Pilot Program” 致编辑的信:“胃癌内镜筛查在一个中等风险国家——双中心试点项目”。
IF 4.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-10-07 DOI: 10.1111/hel.70076
Abubakar Afzal, Zaib Un Nisa
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引用次数: 0
Droplet Digital PCR-Based Detection of Clarithromycin Resistance on Rapid Urease Test Samples Predicts Helicobacter pylori Eradication Success: A New Zealand Cohort Study 基于微滴数字pcr的快速脲酶检测样品克拉霉素耐药性预测幽门螺杆菌根除成功:新西兰队列研究
IF 4.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-09-26 DOI: 10.1111/hel.70075
Stephen James Inns, Samantha Sowerbutts, Bibek Yumnam, Kate Payne, Georgina Wheller, Mali Camberis, Thomas Mules

Background

Helicobacter pylori (H. pylori) infection is a major cause of peptic ulcer disease and gastric cancer. Rising clarithromycin resistance has significantly reduced the efficacy of standard triple therapy. In Aotearoa New Zealand, the prevalence and impact of antibiotic resistance remain incompletely defined, limiting the development of effective treatment strategies.

Methods and Aims

This study evaluated the feasibility and clinical utility of detecting clarithromycin resistance genes using droplet digital polymerase chain reaction (ddPCR) on stored Rapid Urease Test (RUT) samples—a relatively novel application of molecular diagnostics. We also assessed the association between resistance status and treatment outcomes following empiric first-line triple therapy. Patients with positive RUT tests during gastroscopy were treated with omeprazole-based triple therapy and followed up with H. pylori stool antigen testing to confirm eradication.

Results

Among 84 patients, clarithromycin resistance genes were detected in 13 (15.5%). Overall eradication was achieved in 74 (88.1%) patients. However, eradication success was significantly lower in those with resistance (38.5%) compared to those without (97.2%, p < 0.001). Infection burden, treatment regimen, and duration were not associated with eradication rates, supporting resistance status as the primary determinant of treatment outcome. Resistance rates were similar between Māori and Pacific patients (18.2%) and other ethnic groups (14.8%), although sample sizes limited definitive conclusions.

Conclusions

ddPCR testing on stored RUT samples is a feasible and effective method for detecting clarithromycin resistance. This study demonstrates that clarithromycin resistance, rather than infection burden, treatment regimen, or duration, drives eradication failure in New Zealand. Tailored therapy based on molecular resistance testing may enhance treatment success and support antibiotic stewardship. These findings justify the development of PCR-guided treatment pathways and provide a strong rationale for extending this approach to non-invasive stool-based testing suitable for use in primary care and screening programs.

背景幽门螺杆菌感染是消化性溃疡和胃癌的主要原因。克拉霉素耐药性的上升显著降低了标准三联疗法的疗效。在新西兰奥特罗阿,抗生素耐药性的流行和影响仍然不完全确定,限制了有效治疗策略的发展。方法与目的本研究评价了在快速脲酶试验(RUT)样品上应用液滴数字聚合酶链反应(ddPCR)检测克拉霉素耐药基因的可行性和临床应用。我们还评估了经验性一线三联治疗后耐药状态与治疗结果之间的关系。胃镜检查中RUT检测阳性的患者接受奥美拉唑三联疗法,并随访幽门螺杆菌粪便抗原检测以确认根除。结果84例患者中检出克拉霉素耐药基因13例(15.5%)。74例(88.1%)患者实现了整体根除。然而,耐药组的根除成功率(38.5%)明显低于无耐药组(97.2%,p < 0.001)。感染负担、治疗方案和持续时间与根除率无关,支持耐药性状况是治疗结果的主要决定因素。虽然样本量限制了明确的结论,但Māori和太平洋患者(18.2%)以及其他种族患者(14.8%)的耐药率相似。结论应用ddPCR检测保存的RUT样品是检测克拉霉素耐药性的一种可行、有效的方法。这项研究表明,在新西兰,导致根除失败的原因不是感染负担、治疗方案或持续时间,而是克拉霉素耐药性。基于分子耐药检测的量身定制治疗可以提高治疗成功率并支持抗生素管理。这些发现证明了pcr引导治疗途径的发展,并为将这种方法扩展到适合用于初级保健和筛查计划的无创粪便检测提供了强有力的依据。
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引用次数: 0
Resilience of the Gut Microbiome to Short Proton Pump Inhibitor Therapy With or Without High-Dosage L. reuteri in H. pylori-Infected Adults 在幽门螺杆菌感染的成人中,有或没有大剂量罗伊氏乳杆菌的短质子泵抑制剂治疗对肠道微生物群的恢复力
IF 4.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-09-24 DOI: 10.1111/hel.70064
Stefano Bibbò, Gustav Ahlström, Giovanni Mario Pes, David Y. Graham, Lars Engstrand, Elettra Merola, Maria Pina Dore

Background

Helicobacter pylori eradication therapy typically consists of a combination of antibiotics and an antisecretory drug. Probiotics may be added to reduce side effects and possibly improve outcomes.

Materials and Methods

We conducted a double-blind, randomized trial of pantoprazole plus either Lactobacillus reuteri (Gastrus) (high dose) or a matching placebo to assess the impact on the gut microbiota of H. pylori-positive adults. Fecal samples were collected at baseline and after one and 2 months for shotgun metagenomic sequencing.

Results

A total of 26 patients were recruited and completed therapy. L. reuteri was only detected in the group that received supplemental L. reuteri and only at the 1-month post-treatment interval. L. reuteri failed to colonize for long-term the gut, and challenge with L. reuteri failed to alter alpha-diversity (Shannon index) or beta-diversity (community ordination) metrics at any time point. Machine learning (PLS-DA) analysis identified the presence of L. reuteri as the most distinguishing feature at 1 month. No other taxa showed a significant difference between groups.

Conclusion

Short-term administration of pantoprazole and L. reuteri had no lasting effects on gut microbial composition. While L. reuteri transiently bloomed during supplementation, the overall gut microbiota showed resilience, returning to baseline shortly after therapy.

Trial Registration

Identifier: NCT03404440

背景:幽门螺杆菌根除治疗通常包括抗生素和抗分泌药物的联合治疗。可以添加益生菌以减少副作用并可能改善结果。材料和方法:我们进行了一项双盲,随机试验,泮托拉唑加罗伊氏乳杆菌(Gastrus)(高剂量)或匹配的安慰剂,以评估对幽门螺杆菌阳性成人肠道微生物群的影响。在基线、1个月和2个月后收集粪便样本进行鸟枪宏基因组测序。结果:共招募26例患者并完成治疗。罗伊氏乳杆菌仅在补充罗伊氏乳杆菌组中检测到,并且仅在治疗后1个月的间隔中检测到。罗伊氏乳杆菌无法在肠道长期定植,罗伊氏乳杆菌的挑战也无法在任何时间点改变α -多样性(Shannon指数)或β -多样性(群落协调)指标。机器学习(PLS-DA)分析确定罗伊氏乳杆菌的存在是1个月时最显著的特征。其他类群间无显著差异。结论:短期给药泮托拉唑和罗伊氏乳杆菌对肠道微生物组成无持久影响。虽然补充期间罗伊氏乳杆菌短暂繁殖,但整体肠道微生物群显示出弹性,在治疗后不久恢复到基线水平。试验注册:标识符:NCT03404440。
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引用次数: 0
Overall and Stratified Accuracies of H. pylori Serology Testing: A Multicenter Study of 8497 Screening-Naïve Adults 幽门螺杆菌血清学检测的整体和分层准确性:一项8497 Screening-Naïve成人的多中心研究
IF 4.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-09-21 DOI: 10.1111/hel.70074
Mei-Jyh Chen, Yu-Jen Fang, Chien-Chuan Chen, Chieh-Chang Chen, Jiing-Chyuan Luo, Ming-Jong Bair, Po-Yueh Chen, Chu-Kuang Chou, Ji-Yuh Lee, Tsung-Hua Yang, Jian-Jyun Yu, Chia-Chi Kuo, Min-Chin Chiu, Chi-Yi Chen, Chia-Tung Shun, Wen-Hao Hu, Min-Horn Tsai, Yao-Chun Hsu, Cheng-Hao Tseng, Chi-Yang Chang, Jaw-Town Lin, Emad M. El-Omar, Yi-Chia Lee, Ming-Shiang Wu, Jyh-Ming Liou, the Taiwan Gastrointestinal Disease and Helicobacter Consortium

Background

Population-based Helicobacter pylori screening is a promising strategy for gastric cancer prevention in high-prevalence regions. Although serology is recommended for treatment-naïve individuals, its accuracy in large-scale screening remains uncertain. This multicenter study evaluated serology against biopsy-based tests and assessed the influence of age and atrophic status to inform stratified screening policies.

Materials and Methods

In this multicenter diagnostic study, 8497 treatment-naïve adults undergoing upper endoscopy across nine hospitals in Taiwan were tested for H. pylori using serology, rapid urease test (RUT), histology, and culture. Serum pepsinogen I and II levels were measured to define serological atrophic gastritis (AG). Diagnostic performance was assessed against a composite reference standard (≥ 2 positive results among RUT, histology, and culture), with subgroup analyses by age and AG status.

Results

Serology showed a sensitivity of 94.5% (95% CI: 93.7–95.4) and specificity of 86.0% (95% CI: 85.0–87.0), with a diagnostic odds ratio (DOR) of 106.4. RUT, histology, and culture had higher specificities (97.1%, 94.3%, and 98.2%, respectively) but lower sensitivities (88.6%, 92.3%, and 90.2%, respectively). In individuals aged ≤ 45 years, serology demonstrated 95.2% sensitivity, 93.1% specificity, and a DOR of 268.9 (95% CI: 183.4–394.3). Among participants with AG, serologic specificity declined to 62.4% (95% CI: 53.3–71.5) versus 87.2% (95% CI: 86.0–88.5) in those without AG. The overall negative likelihood ratio was 0.06, and 0.05 among younger adults.

Conclusions

Serology is an accurate, non-invasive tool for H. pylori detection in younger, treatment-naïve adults without gastric atrophy in high-prevalence regions. In older individuals or those with atrophic gastritis, confirmatory testing is warranted, supporting age-atrophy–based algorithms to optimize screening strategies.

背景:以人群为基础的幽门螺杆菌筛查是高流行地区预防胃癌的一种很有前景的策略。虽然建议对treatment-naïve个体进行血清学检查,但其在大规模筛查中的准确性仍不确定。这项多中心研究评估了血清学和基于活检的检查,并评估了年龄和萎缩状态的影响,为分层筛查政策提供信息。材料与方法本研究以台湾9家医院的8497名成人(treatment-naïve)为研究对象,采用血清学、快速脲酶试验(RUT)、组织学及培养检测幽门螺杆菌。测定血清胃蛋白酶原I和II水平以确定血清学萎缩性胃炎(AG)。根据综合参考标准(RUT、组织学和培养≥2例阳性结果)评估诊断效果,并根据年龄和AG状态进行亚组分析。结果血清学敏感性为94.5% (95% CI: 93.7 ~ 95.4),特异性为86.0% (95% CI: 85.0 ~ 87.0),诊断优势比(DOR)为106.4。RUT、组织学和培养具有较高的特异性(分别为97.1%、94.3%和98.2%),但敏感性较低(分别为88.6%、92.3%和90.2%)。在年龄≤45岁的个体中,血清学显示95.2%的敏感性,93.1%的特异性,DOR为268.9 (95% CI: 183.4-394.3)。在患有AG的参与者中,血清学特异性下降到62.4% (95% CI: 53.3-71.5),而在没有AG的参与者中,血清学特异性下降到87.2% (95% CI: 86.0-88.5)。总体负似然比为0.06,在年轻人中为0.05。结论血清学是一种准确、无创的幽门螺杆菌检测工具,适用于高流行地区年轻、treatment-naïve无胃萎缩的成年人。在老年人或萎缩性胃炎患者中,验证性测试是必要的,支持基于年龄萎缩的算法来优化筛查策略。
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引用次数: 0
Helicobacter pylori Pathogenic Factors and Their Interactions With the Gastric Microbiome 幽门螺杆菌致病因素及其与胃微生物群的相互作用
IF 4.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-09-21 DOI: 10.1111/hel.70072
Camilia Metadea Aji Savitri, Takashi Matsumoto, Kartika Afrida Fauzia, Ricky Indra Alfaray, Langgeng Agung Waskito, Yudith Annisa Ayu Rezkitha, Tomohisa Uchida, Muhammad Miftahussurur, Yoshio Yamaoka

Background

Variations in Helicobacter pylori infection rates and pathogenicity do not explain the global gastric cancer incidence, indicating that other bacteria may play a role. We investigated the pathogenic factors of H. pylori and their interactions with the gastric microbiome in a population with low gastric cancer but high gastritis rates in Indonesia.

Methods

The study included 66 H. pylori-positive gastric biopsies. DNA was extracted from the bacterial cultures to examine the pathogenic factors of H. pylori. The 16S rRNA V3–V4 region was sequenced using next-generation sequencing. The microbiome analysis concentrated on α-diversity and β-diversity, along with absolute and relative abundances. Correlation analysis and predicted functional inference were conducted using SECOM and PICRUSt2.

Results

Helicobacter predominates in H. pylori-infected stomachs, limiting other bacteria. Although α-diversity was non-significant, virulent H. pylori genotypes showed greater microbial diversity, suggesting co-colonization by other taxa. Some taxa were notably abundant across pathogenic subtypes (p < 0.05), such as Veillonella sp. in East Asian-type CagA H. pylori and Klebsiella without babB. The β-diversity results indicated that microbial diversity and abundance varied according to polymorphisms in patients with different H. pylori CagA types, sabA status, homA/B, and iceA subtypes (PERMANOVA test; p < 0.05). H. pylori dominance remains unchanged when atrophy worsens, alongside decreased microbial diversity (p < 0.05 for atrophy stage 0 vs. stages 1 and 2). Microbial correlation analysis revealed that Helicobacter only had a positive linear relationship with Veillonella (SECOM(Pearson2) = 0.51, SECOM(Distance) = 0.60), whereas Streptococcus sp. correlated with several gastric taxa. Predicted functional inference showed several pathways to be depleted when atrophy progresses.

Conclusion

Various pathogenic factors impact microbial diversity, and bacteria cohabiting in the gastric environment might shape disease outcomes. Additionally, our study uncovers relationships among genera present in the stomach. More research is needed to explore how non-Helicobacter species induce or possibly safeguard against gastric pathologies.

背景幽门螺杆菌感染率和致病性的差异并不能解释全球胃癌发病率的变化,表明可能有其他细菌在其中起作用。我们研究了幽门螺杆菌的致病因素及其与胃微生物群的相互作用,研究对象是印度尼西亚一个胃癌发病率低但胃炎发病率高的人群。方法选取66例幽门螺旋杆菌阳性胃活检。从细菌培养物中提取DNA以检测幽门螺杆菌的致病因素。采用新一代测序技术对16S rRNA V3-V4区进行测序。微生物组主要分析α-多样性和β-多样性,以及绝对丰度和相对丰度。使用SECOM和PICRUSt2进行相关性分析和预测功能推断。结果幽门螺旋杆菌感染胃中以幽门螺旋杆菌为主,限制了其他细菌。尽管α-多样性不显著,但毒性幽门螺杆菌基因型显示出更大的微生物多样性,表明有其他分类群的共定殖。一些类群在不同致病亚型中数量显著丰富(p < 0.05),如东亚型CagA中的Veillonella sp. H. pylori和无babB的Klebsiella。β-多样性结果表明,不同幽门螺杆菌CagA型、sabA状态、homA/B和iceA亚型患者的微生物多样性和丰度根据多态性而变化(PERMANOVA检验;p < 0.05)。当萎缩恶化时,幽门螺杆菌优势保持不变,同时微生物多样性减少(萎缩0期与1期和2期相比p <; 0.05)。微生物相关性分析显示,幽门螺杆菌仅与细微杆菌呈线性正相关(SECOM(Pearson2) = 0.51, SECOM(Distance) = 0.60),而链球菌与胃内多个分类群呈线性正相关。预测的功能推断显示,当萎缩进展时,几个通路被耗尽。结论多种致病因素影响微生物多样性,细菌在胃环境中的同居可能影响疾病的预后。此外,我们的研究揭示了胃中存在的属之间的关系。需要更多的研究来探索非幽门螺杆菌物种如何诱导或可能保护胃部病变。
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引用次数: 0
Impact of a FIT Based Colorectal Cancer Screening Program on Gastric Cancer Incidence, Early Diagnosis and Patients' Survival 基于FIT的结直肠癌筛查项目对胃癌发病率、早期诊断及患者生存的影响
IF 4.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-09-12 DOI: 10.1111/hel.70071
João Carlos Silva, Pedro Leite-Silva, Fernando Tavares, Maria José Bento, Diogo Libânio, Mário Dinis-Ribeiro

Background and Aims

In countries with an intermediate incidence of gastric cancer (GC), it has been suggested that offering an upper gastrointestinal endoscopy (UGIE) to individuals referred for a screening colonoscopy following a positive result in the fecal immunochemical test (FIT) may be cost-effective. This study was designed to evaluate the impact of a FIT-based screening program on GC incidence, early diagnosis, and mortality.

Methods

Population-based retrospective cohort study in northern Portugal. Data on GC cases were retrieved from the Portuguese National Cancer Registry (RON). GC stage at diagnosis (with early stages defined as T1) and net survival estimates were compared between 2014 and 2016 and the first 3 years of the FIT-based screening program (2018–2020), during which 165,967 tests were performed.

Results

The odds of GC detection were significantly higher among FIT-positive individuals compared to those with a negative result (OR = 2.87; 95% CI: 1.76–4.49). Of the 10,372 individuals who completed FIT screening and underwent colonoscopy, 51% (n = 5281) also underwent UGIE. The proportion of early-stage diagnoses increased by 14% (95% CI: 12–15), and 3-year net survival improved from 42% (95% CI: 40–43) to 48% (95% CI: 47–50).

Discussion

Despite the absence of a formal GC screening program, more than half of FIT-screened individuals who underwent colonoscopy also underwent UGIE. The period following the implementation of FIT-based screening was associated with increased early-stage detection and improved survival. These findings support the potential value of offering UGIE combined with colonoscopy for FIT-positive individuals, at least in regions with intermediate GC incidence.

背景和目的在胃癌(GC)发病率中等的国家,有研究表明,在粪便免疫化学试验(FIT)结果阳性的个体转诊进行筛查结肠镜检查时,提供上消化道内窥镜检查(UGIE)可能具有成本效益。本研究旨在评估基于fit的筛查方案对胃癌发病率、早期诊断和死亡率的影响。方法在葡萄牙北部进行基于人群的回顾性队列研究。GC病例的数据从葡萄牙国家癌症登记处(RON)检索。比较了2014年至2016年和基于fit的筛查计划的前3年(2018-2020年)的GC诊断阶段(早期阶段定义为T1)和净生存估计,在此期间进行了165,967次检测。结果fitt阳性者的GC检出率明显高于阴性者(OR = 2.87; 95% CI: 1.76 ~ 4.49)。在10,372名完成FIT筛查并接受结肠镜检查的个体中,51% (n = 5281)也接受了UGIE。早期诊断的比例增加了14% (95% CI: 12-15), 3年净生存率从42% (95% CI: 40-43)提高到48% (95% CI: 47-50)。尽管没有正式的GC筛查方案,但在接受结肠镜检查的fit筛查患者中,超过一半的人也接受了UGIE。实施fitt筛查后的一段时间与早期检测增加和生存率提高有关。这些发现支持了UGIE联合结肠镜检查对fit阳性个体的潜在价值,至少在GC发生率中等的地区。
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引用次数: 0
Multi-Omics Analysis Revealed Characterization of Gastric Microbiome and Metabolome in Helicobacter pylori-Induced Progression of MASLD 多组学分析揭示了幽门螺杆菌诱导的MASLD进展中胃微生物组和代谢组的特征
IF 4.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-09-07 DOI: 10.1111/hel.70069
Han Chen, Yan Wang, Yuting Shao, Wei Su, Shuo Li, Yun Liu, Xiaoying Zhou

Background

Several clinical studies have demonstrated that Helicobacter pylori (Hp) infection may exacerbate the progression of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD); however, the underlying mechanisms remain unclear. This study aims to investigate the characterization of the gastric microbiome and metabolome in relation to the progression of MASLD induced by Hp infection.

Methods

We established a high-fat diet (HFD) obese mouse model, both with and without Hp infection, to compare alterations in serum and liver metabolic phenotypes. Subsequently, a multi-omics analysis was performed, combining gastric 16S rRNA amplicon sequencing, targeted energy metabolomics, and liver metabolomics sequencing to investigate the correlations among gastric microbiota, energy metabolism, and hepatic metabolism following Hp infection.

Results

HFD mice infected with Hp exhibited a more severe liver steatosis phenotype compared with Hp-negative controls. Hp infection triggers gastric dysbiosis, resulting in a notable enrichment of the Helicobacter genus, which subsequently becomes the dominant bacterial community. This shift leads to a significant rise in the abundance of other bacteria, such as Enterococcus, Streptococcus, and Staphylococcus, while concurrently reducing beneficial bacterial taxa such as Bifidobacterium. Analysis of bacterial functional enrichment and gastric energy metabolomics consistently reveals elevated glycolytic pathway activity in gastric tissue following Hp infection. Furthermore, liver metabolomics indicate increased activities of both glycolytic and lipid metabolic pathways in the liver. The disturbance of the gastric microbiota–metabolism axis is significantly and positively correlated with the hepatic lactate content and severity of hepatic steatosis and inflammation.

Conclusion

Hp infection may influence liver metabolism through microbial-metabolic interactions within the gastrohepatic axis, potentially exacerbating the progression of hepatic steatosis. Further studies are necessary to verify these potential causal relationships.

一些临床研究表明,幽门螺杆菌(Hp)感染可能会加剧代谢功能障碍相关脂肪变性肝病(MASLD)的进展;然而,潜在的机制仍不清楚。本研究旨在探讨Hp感染诱导的MASLD进展中胃微生物组和代谢组的特征。方法建立高脂饮食(HFD)肥胖小鼠模型,比较血清和肝脏代谢表型的变化。随后,我们进行了多组学分析,结合胃16S rRNA扩增子测序、靶向能量代谢组学和肝脏代谢组学测序,研究Hp感染后胃微生物群、能量代谢和肝脏代谢之间的相关性。结果与Hp阴性对照相比,Hp感染的HFD小鼠表现出更严重的肝脏脂肪变性表型。Hp感染引发胃生态失调,导致幽门螺杆菌属显著富集,随后成为优势菌群。这种转变导致其他细菌的丰度显著增加,如肠球菌、链球菌和葡萄球菌,同时减少了双歧杆菌等有益细菌分类群。细菌功能富集和胃能量代谢组学分析一致显示Hp感染后胃组织糖酵解途径活性升高。此外,肝脏代谢组学表明肝脏糖酵解和脂质代谢途径的活性增加。胃微生物代谢轴的紊乱与肝脏乳酸含量、肝脏脂肪变性和炎症的严重程度呈显著正相关。结论Hp感染可能通过胃肝轴内的微生物代谢相互作用影响肝脏代谢,可能加剧肝脂肪变性的进展。需要进一步的研究来验证这些潜在的因果关系。
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引用次数: 0
Ten-Day Versus 14-Day Vonoprazan and Amoxicillin Dual Therapy for the Firstline Eradication of Helicobacter pylori Infection: A Multicenter, Randomized Controlled Trial 10天vs 14天Vonoprazan和阿莫西林双重治疗一线根除幽门螺杆菌感染:一项多中心随机对照试验
IF 4.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-09-04 DOI: 10.1111/hel.70070
Zhiqiang Song, Xiuli Zuo, Zhenyu Zhang, Xuehong Wang, Ya Lin, Yueyue Li, Xiaojun Xu, Yun Huang, Qiuyan Wang, Yanyan Shi, Liya Zhou

Background

The optimal duration for vonoprazan and amoxicillin dual therapy (VA-DT) remains unclear, and studies on gastric acid suppression of vonoprazan during eradication are still lacking.

Objective

This study conducted a multicenter, randomized controlled trial to compare the eradication efficacy between 10 and 14-day VA-DT, and to identify the dynamic changes of gastric pH during treatment.

Methods

This study included 418 naïve adult patients with Helicobacter pylori infection, who were randomly divided into 10 or 14-day VA-DT groups (vonoprazan 20 mg twice daily and amoxicillin 1000 mg thrice daily). 13C-urea breath tests were conducted at 4–8 weeks after eradication to evaluate the success of treatment. 24-h intragastric pH was monitored in 22 patients.

Results

Ten and 14-day VA-DT demonstrated eradication rates of 83.3% vs. 88.0% (rate difference: −4.8%, 95% confidence interval: −11.6% to −2.0%) in intention-to-treat analysis, 87.9% vs. 93.9% (−6.0%, −11.9% to −0.3%) in modified intention-to-treat analysis, and 89.1% vs. 95.3% (−6.1%, −11.8% to −0.7%) in per-protocol analysis, respectively. Vonoprazan showed excellent gastric acid suppression during eradication, with the time percentages of pH > 6 at 75.3% and 97.2% and the median pH levels at 7.4 and 7.8 on the 1st and 7th days, respectively. Furthermore, gastric pH exceeded 6 approximately 4–5 h after the first dose and remained stable at 7–9 thereafter.

Conclusion

The noninferiority of eradication efficacy between 10- and 14-day VA-DT in the first-line treatment was not established, indicating that 10-day therapy cannot be used as a substitute for 14-day therapy. Vonoprazan exerted excellent gastric acid suppression during eradication.

Trial Registration

Chinese Clinical Trial Registry: ChiCTR2200057625

vonoprazan和阿莫西林双重治疗(VA-DT)的最佳持续时间尚不清楚,vonoprazan在根除过程中抑制胃酸的研究仍然缺乏。目的本研究通过多中心随机对照试验,比较10天和14天VA-DT的根除效果,并了解治疗期间胃pH值的动态变化。方法纳入418例naïve成人幽门螺杆菌感染患者,随机分为10天或14天VA-DT组(伏诺哌赞20 mg, 2次/ d,阿莫西林1000 mg, 3次/ d)。在根除后4-8周进行13c -尿素呼气试验以评估治疗成功。对22例患者进行24小时胃内pH监测。结果在意向治疗分析中,10天和14天VA-DT的根除率分别为83.3%对88.0%(率差为- 4.8%,95%可信区间为- 11.6%至- 2.0%),在改良意向治疗分析中为87.9%对93.9%(- 6.0%,- 11.9%至- 0.3%),在按方案分析中为89.1%对95.3%(- 6.1%,- 11.8%至- 0.7%)。Vonoprazan在根除过程中表现出良好的胃酸抑制作用,在第1天和第7天pH >; 6的时间百分比分别为75.3%和97.2%,pH中位数分别为7.4和7.8。此外,胃pH在第一次给药后约4-5小时超过6,此后稳定在7-9。结论一线治疗10天和14天VA-DT根除效果的非劣效性尚未建立,说明10天治疗不能代替14天治疗。Vonoprazan在根除过程中表现出良好的胃酸抑制作用。中国临床试验注册中心:ChiCTR2200057625
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引用次数: 0
Helicobacter pylori Infection and Metachronous Gastric Cancer in Elderly Patients With Gastric Cancer Aged ≥ 75 Years Who Underwent Endoscopic Submucosal Dissection 年龄≥75岁高龄胃癌患者行内镜下粘膜夹层的幽门螺杆菌感染与异时性胃癌
IF 4.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-09-01 DOI: 10.1111/hel.70068
Young-Il Kim, Jong Yeul Lee, Chan Gyoo Kim, Il Ju Choi

Background and Aims

Helicobacter pylori (Hp) infection is associated with metachronous gastric cancer (GC) after endoscopic submucosal dissection resection (ESD) in patients with early GC (EGC), but this association has not been well investigated in elderly patients. This study investigated whether Hp infection status was associated with metachronous GC after ESD in patients aged ≥ 75 years.

Methods

This retrospective study involved 298 EGC patients aged ≥ 75 years who underwent ESD. The Hp-negative group (n = 233) included patients with negative or eradicated Hp infection, whereas the Hp-positive group (n = 65) included patients with persistently positive infection or failed eradication. The primary outcome was metachronous GC occurring at ≥ 1 year after ESD.

Results

The median patient age was 78 years (interquartile range [IQR]: 76–80 years). During a median follow-up of 4.4 years (IQR: 2.9–5.9 years), metachronous GC occurred in 16 (6.9% [16/233], 16.3 cases/1000 person-year) and 10 (15.4% [10/65], 37.5 cases/1000 person-year) patients in the Hp-negative and Hp-positive groups, respectively. The incidence of metachronous cancer was higher in the Hp-positive group than in the Hp-negative group (p = 0.035, log-rank test). In a multivariate analysis, persistent Hp infection was an independent risk factor for metachronous GC (age- and sex-adjusted hazard ratio, 2.33; 95% CI: 1.05–5.17).

Conclusions

Persistent H. pylori infection status was associated with a higher risk of metachronous GC, and H. pylori treatment needs to be provided in elderly patients aged ≥ 75 years and older with EGC undergoing ESD.

背景与目的幽门螺杆菌(Hp)感染与早期胃癌(EGC)患者内镜下粘膜下剥离切除术(ESD)后的异时性胃癌(GC)相关,但这种相关性在老年患者中尚未得到很好的研究。本研究调查了年龄≥75岁的患者ESD后Hp感染状态是否与异时性GC相关。方法回顾性研究298例年龄≥75岁的EGC患者行ESD治疗。Hp阴性组(n = 233)包括Hp阴性或根除的患者,而Hp阳性组(n = 65)包括持续阳性感染或根除失败的患者。主要终点为发生在ESD后≥1年的异时性GC。结果患者年龄中位数为78岁(四分位数间距[IQR]: 76 ~ 80岁)。在中位随访4.4年(IQR: 2.9-5.9年)期间,hp阴性组和hp阳性组分别有16例(6.9%[16/233],16.3例/1000人年)和10例(15.4%[10/65],37.5例/1000人年)患者发生异时性GC。hp阳性组异时性癌的发生率高于hp阴性组(p = 0.035, log-rank检验)。在一项多变量分析中,持续性Hp感染是异时性GC的独立危险因素(年龄和性别调整后的危险比为2.33;95% CI: 1.05-5.17)。结论持续幽门螺杆菌感染与异时性胃癌发生风险增高相关,≥75岁高龄高龄高龄的EGC患者行ESD治疗需给予幽门螺杆菌治疗。
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