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Reply: Is Tailored Bismuth Quadruple Therapy (With Clarithromycin or Furazolidone) Based on Fecal Molecular Susceptibility Testing in First-Line Helicobacter pylori Eradication Treatment More Effective? A Three-Arm, Multicenter Randomized Clinical Trial 回复:基于粪便分子药敏试验的定制铋四联疗法(克拉霉素或呋喃唑酮)在一线幽门螺杆菌根除治疗中更有效吗?一项三组、多中心随机临床试验
IF 4.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-05-11 DOI: 10.1111/hel.70043
Xinlu Ren, Zhiqiang Song
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引用次数: 0
Characterization of Fecal Microbial Communities in Patients With Type 2 Diabetes Mellitus Combined With Helicobacter pylori Infection 2型糖尿病合并幽门螺杆菌感染患者粪便微生物群落特征
IF 4.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-05-07 DOI: 10.1111/hel.70041
Xiaoyan He, Han Chen, Fengdan Chen, Wei Su, Yan Wang, Die Hu, Jianwen Hu, Xiaoying Zhou

Background

Helicobacter pylori (H. pylori) infection has the capacity to alter the gut microbiota composition. There is a significant correlation between H. pylori infection and type 2 diabetes mellitus (T2DM). Further research is necessary to explore whether gut microbiota plays a role in the relationship between H. pylori and T2DM.

Method

Fecal samples were obtained from 44 patients with T2DM, including 20 who tested positive for H. pylori and 24 who tested negative. Intestinal microbiota composition was analyzed via 16S rRNA V3-V4 amplicon sequencing. Differences in microbial distribution and significant microbial biomarkers were identified between H. pylori positive and negative groups. A Spearman correlation analysis assessed the relationship between intestinal microbiota and glycemic parameters. Additionally, PICRUSt2 was used to predict intestinal bacterial functions.

Results

Results indicate that in H. pylori (+) T2DM patients, HbA1c levels were significantly higher (8.9% vs. 8.1%, p = 0.021), while both the C-peptide peak (3.70 vs. 5.98 ng/mL, p = 0.040) and fasting C-peptide levels (1.42 vs. 2.31 ng/mL, p = 0.008) were significantly lower compared to H. pylori (−) T2DM groups. A total of 11 colonic phyla and 100 genera were identified in all fecal samples. In groups positive for H. pylori, there was a significant enrichment of the phylum Proteobacteria, while the genera Lactobacillus, Butyricimonas, and Akkermansia were significantly reduced (all p < 0.05). Correlation analysis showed that the abundance of the genera Butyricimonas (p = 0.01) and Akkermansia (p = 0.048) were negatively correlated with fasting plasma glucose. KEGG pathway analysis indicated a significant enrichment of methylmalonyl-CoA mutase and succinyl-CoA in H. pylori-infected T2DM patients.

Conclusions

This study suggests that T2DM patients with H. pylori infection exhibit more impaired pancreatic islet function potentially due to H. pylori-induced alterations in the gut microbiota.

背景幽门螺杆菌(h.p ylori)感染能够改变肠道菌群组成。幽门螺杆菌感染与2型糖尿病(T2DM)有显著相关性。肠道菌群是否在幽门螺杆菌与T2DM的关系中发挥作用,还需要进一步的研究。方法对44例T2DM患者进行粪便标本采集,其中幽门螺旋杆菌阳性20例,阴性24例。通过16S rRNA V3-V4扩增子测序分析肠道菌群组成。在幽门螺杆菌阳性组和阴性组之间,微生物分布和显著的微生物生物标志物存在差异。Spearman相关分析评估了肠道微生物群与血糖参数之间的关系。此外,PICRUSt2被用于预测肠道细菌功能。结果与幽门螺杆菌(+)型T2DM组相比,HbA1c水平显著升高(8.9% vs. 8.1%, p = 0.021),而c肽峰值(3.70 vs. 5.98 ng/mL, p = 0.040)和空腹c肽水平(1.42 vs. 2.31 ng/mL, p = 0.008)均显著降低。所有粪便标本共鉴定出11个结肠门100个属。在幽门螺杆菌阳性的组中,变形杆菌门的数量显著增加,而乳酸杆菌、丁酸单胞菌和Akkermansia属的数量显著减少(p < 0.05)。相关分析显示,丁酸单胞菌属丰度(p = 0.01)和Akkermansia属丰度(p = 0.048)与空腹血糖呈负相关。KEGG通路分析显示,在幽门螺杆菌感染的T2DM患者中,甲基丙二酰辅酶a变化酶和琥珀酰辅酶a显著富集。结论:本研究表明,幽门螺杆菌感染的T2DM患者胰岛功能受损更严重,可能是由于幽门螺杆菌诱导的肠道微生物群改变。
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引用次数: 0
The Optimal Age of Helicobacter pylori Screen-and-Treat for Gastric Cancer Prevention in the United States 美国幽门螺杆菌筛查与治疗预防胃癌的最佳年龄
IF 4.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-05-06 DOI: 10.1111/hel.70039
Duco T. Mülder, James F. O'Mahony, Dianqin Sun, Luuk A. van Duuren, Rosita van den Puttelaar, Matthias Harlass, Weiran Han, Robert J. Huang, Manon C. W. Spaander, Uri Ladabaum, Iris Lansdorp-Vogelaar

Background

Recent American College of Gastroenterology (ACG) guidelines recommend screening and eradicating Helicobacter pylori (H. pylori) in high-risk racial groups to prevent gastric cancer (GC), but do not provide guidance on the age to screen. We aimed to determine the optimal age for H. pylori screen-and-treat.

Materials and Methods

We developed a new microsimulation model, MISCAN-gastric, which was calibrated to SEER incidence and clinical studies on the natural history of GC. One-time screen-and-treat at ages 20–65 was compared to a no-screening scenario in terms of cumulative incidence reduction, number needed-to-screen (NNS) and number needed-to-treat (NNT) to prevent one GC case. The NNS represents the number of individuals that require testing to prevent one GC case, while the NNT reflects the number requiring treatment. The optimal age was investigated for a high-risk population subgroup (non-Hispanic [NH] Black males) and compared to other subgroups.

Results

Without screening, 332 noncardia GC cases occurred in a population of 100,000 NH Black males. H. pylori screen-and-treat reduced cumulative incidence by 43% when performed at age 20, but only by 5% when performed at age 65. The NNS was lowest at age 30 and increased markedly at older ages. The estimated NNS for test-ages 20, 30, 40, and 65 were 645, 563, 769, and 5487, respectively. The NNT was lowest at the youngest age (261) and increased with age to 448 at age 40 and 3681 at age 65. The NNT and NNS were substantially higher in groups with lower GC risk: the optimal NNT was four times higher in NH White females compared to non-Hispanic Black males.

Conclusion

H. pylori screen-and-treat maximized population benefits when performed before age 40, emphasizing the need for early interventions. When performed at the optimal age, the benefits of H. pylori screen-and-treat may outweigh the harms for high-risk racial groups.

最近美国胃肠病学学会(ACG)的指南建议在高危种族人群中筛查和根除幽门螺杆菌(H. pylori)以预防胃癌(GC),但没有提供筛查年龄的指导。我们的目的是确定幽门螺杆菌筛查和治疗的最佳年龄。材料和方法我们建立了一个新的微观模拟模型MISCAN-gastric,该模型被校准为SEER发生率和GC自然史的临床研究。将20-65岁的一次性筛查和治疗方案与未筛查方案进行比较,以减少累积发病率,需要筛查的数量(NNS)和需要治疗的数量(NNT)来预防一个GC病例。NNS代表需要检测以预防一个GC病例的人数,而NNT反映需要治疗的人数。研究了高危人群亚组(非西班牙裔[NH]黑人男性)的最佳年龄,并与其他亚组进行比较。结果在未筛查的情况下,10万名NH黑人男性中发生了332例非心源性GC病例。在20岁时进行幽门螺杆菌筛查和治疗可使累积发病率降低43%,但在65岁时仅降低5%。NNS在30岁时最低,随着年龄的增长显著增加。测试年龄为20岁、30岁、40岁和65岁的估计NNS分别为645、563、769和5487。NNT在最年轻时最低(261岁),随着年龄的增长而增加,40岁时为448岁,65岁时为3681岁。在GC风险较低的组中,NNT和NNS明显更高:NH白人女性的最佳NNT比非西班牙裔黑人男性高4倍。结论在40岁前进行幽门螺杆菌筛查治疗可使人群获益最大化,强调早期干预的必要性。当在最佳年龄进行时,幽门螺杆菌筛查和治疗的好处可能超过对高危种族群体的危害。
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引用次数: 0
HIF-1α-Induced GPR171 Expression Mediates CCL2 Secretion by Mast Cells to Promote Gastric Inflammation During Helicobacter pylori Infection hif -1α-诱导GPR171表达介导肥大细胞分泌CCL2促进幽门螺杆菌感染胃炎症
IF 4.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-05-04 DOI: 10.1111/hel.70042
Hanmei Yuan, Yuetong Li, Hui Wu, Jin Zhang, Tingting Xia, Bin Li, Chao Wu

Background

Helicobacter pylori (H. pylori) infection is one of the most important risk factors for chronic gastritis, gastric ulcers, and gastric cancer. Mast cells act as a crucial regulator in bacterial infection. The mechanisms underlying mast cell activation and their role in H. pylori infection remain poorly understood.

Materials and Methods

In gastric mucosal tissue, the number of mast cells, G-protein-coupled receptor 171 (GPR171) and CCL2 expression were detected by immunohistochemistry (IHC) or immunofluorescence between H. pylori-negative and H. pylori-positive patients. Mast cells were co-cultured with H. pylori, and transcriptome sequencing, RT-qPCR, and Western blotting (WB) were performed to identify receptors involved in mast cell activation. WB, chromatin immunoprecipitation (ChIP), and dual-luciferase reporter assays were conducted to investigate the molecular mechanism by which HIF-1α regulates GPR171 expression. Lentiviral knockdown, ELISA, WB, and IHC were used to evaluate the role of GPR171 during H. pylori infection. An in vivo mouse model of H. pylori infection was employed to assess the effects of GPR171 blockade on CCL2 expression and gastric mucosal inflammation.

Results

In the study, we found that mast cell numbers were greatly increased and correlated with the severity of inflammation in H. pylori-infected patients. We found a new receptor, GPR171, was upregulated and involved in mast cell activation upon H. pylori infection. Furthermore, H. pylori infection induced the expression of GPR171 by promoting the activation of hypoxia-inducible factor 1 alpha (HIF-1α), which directly bound to hypoxia response elements in the GPR171 promoter and regulated its transcriptional activity. Blockade or loss of GPR171 in mast cells partially inhibited CCL2 secretion via the ERK1/2 signaling pathway. In the human gastric mucosa, CCL2 derived from mast cells was associated with gastric inflammation during H. pylori infection. In vivo murine studies indicated that H. pylori infection significantly upregulated CCL2 expression, while GPR171 inhibition partially reduced CCL2 levels and alleviated gastric mucosal inflammation.

Conclusions

We provide a novel mechanism that H. pylori activates mast cells to promote gastric inflammation.

背景幽门螺杆菌感染是慢性胃炎、胃溃疡和胃癌最重要的危险因素之一。肥大细胞在细菌感染中起着至关重要的调节作用。肥大细胞激活的机制及其在幽门螺杆菌感染中的作用仍然知之甚少。材料与方法采用免疫组化(IHC)或免疫荧光法检测胃粘膜肥大细胞数量、g蛋白偶联受体171 (GPR171)和CCL2的表达。肥大细胞与幽门螺杆菌共培养,通过转录组测序、RT-qPCR和Western blotting (WB)鉴定参与肥大细胞活化的受体。采用WB、染色质免疫沉淀(ChIP)和双荧光素酶报告基因法研究HIF-1α调控GPR171表达的分子机制。采用慢病毒敲除、ELISA、WB和免疫组化方法评价GPR171在幽门螺杆菌感染中的作用。采用幽门螺杆菌感染小鼠体内模型,研究阻断GPR171对CCL2表达及胃黏膜炎症的影响。结果本研究发现,幽门螺杆菌感染患者肥大细胞数量显著增加,且肥大细胞数量与炎症严重程度相关。我们发现一种新的受体GPR171在幽门螺杆菌感染时被上调并参与肥大细胞的激活。此外,幽门螺杆菌感染通过促进缺氧诱导因子1α (HIF-1α)的激活来诱导GPR171的表达,HIF-1α直接结合GPR171启动子中的缺氧反应元件并调节其转录活性。肥大细胞中GPR171的阻断或缺失通过ERK1/2信号通路部分抑制CCL2的分泌。在人胃粘膜中,源自肥大细胞的CCL2与幽门螺杆菌感染期间的胃炎症有关。小鼠体内研究表明,幽门螺杆菌感染可显著上调CCL2表达,而抑制GPR171可部分降低CCL2水平,减轻胃黏膜炎症。结论提供了一种新的幽门螺旋杆菌激活肥大细胞促进胃炎症的机制。
{"title":"HIF-1α-Induced GPR171 Expression Mediates CCL2 Secretion by Mast Cells to Promote Gastric Inflammation During Helicobacter pylori Infection","authors":"Hanmei Yuan,&nbsp;Yuetong Li,&nbsp;Hui Wu,&nbsp;Jin Zhang,&nbsp;Tingting Xia,&nbsp;Bin Li,&nbsp;Chao Wu","doi":"10.1111/hel.70042","DOIUrl":"https://doi.org/10.1111/hel.70042","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p><i>Helicobacter pylori</i> (<i>H. pylori</i>) infection is one of the most important risk factors for chronic gastritis, gastric ulcers, and gastric cancer. Mast cells act as a crucial regulator in bacterial infection. The mechanisms underlying mast cell activation and their role in <i>H. pylori</i> infection remain poorly understood.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Materials and Methods</h3>\u0000 \u0000 <p>In gastric mucosal tissue, the number of mast cells, G-protein-coupled receptor 171 (GPR171) and CCL2 expression were detected by immunohistochemistry (IHC) or immunofluorescence between <i>H. pylori</i>-negative and <i>H. pylori</i>-positive patients. Mast cells were co-cultured with <i>H. pylori</i>, and transcriptome sequencing, RT-qPCR, and Western blotting (WB) were performed to identify receptors involved in mast cell activation. WB, chromatin immunoprecipitation (ChIP), and dual-luciferase reporter assays were conducted to investigate the molecular mechanism by which HIF-1α regulates GPR171 expression. Lentiviral knockdown, ELISA, WB, and IHC were used to evaluate the role of GPR171 during <i>H. pylori</i> infection. An in vivo mouse model of <i>H. pylori</i> infection was employed to assess the effects of GPR171 blockade on CCL2 expression and gastric mucosal inflammation.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>In the study, we found that mast cell numbers were greatly increased and correlated with the severity of inflammation in <i>H. pylori-</i>infected patients. We found a new receptor, GPR171, was upregulated and involved in mast cell activation upon <i>H. pylori</i> infection. Furthermore, <i>H. pylori</i> infection induced the expression of GPR171 by promoting the activation of hypoxia-inducible factor 1 alpha (HIF-1α), which directly bound to hypoxia response elements in the GPR171 promoter and regulated its transcriptional activity. Blockade or loss of GPR171 in mast cells partially inhibited CCL2 secretion via the ERK1/2 signaling pathway. In the human gastric mucosa, CCL2 derived from mast cells was associated with gastric inflammation during <i>H. pylori</i> infection. In vivo murine studies indicated that <i>H. pylori</i> infection significantly upregulated CCL2 expression, while GPR171 inhibition partially reduced CCL2 levels and alleviated gastric mucosal inflammation.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>We provide a novel mechanism that <i>H. pylori</i> activates mast cells to promote gastric inflammation.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"30 3","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/hel.70042","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143905010","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
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 7天vs 14天替戈拉赞和含四环素的四联疗法一线根除幽门螺杆菌感染:一项随机、开放标签、非劣效性试验
IF 4.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY 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

Background and Aims

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-Helicobacter pylori properties. However, only a few randomized controlled trials (RCTs) have investigated the efficacy of tegoprazan and tetracycline-containing quadruple therapy (TTQT) for treating H. pylori infections, which this RCT explored.

Methods

This multicenter RCT included treatment-naïve adults with H. pylori 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.

Results

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 p < 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 p < 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 p < 0.001). Significantly fewer adverse events occurred in the 7-day group than in the 14-day group (22.48% vs. 35.67%, p = 0.020). Treatment compliance did not differ between the two groups.

Conclusions

The 7- and 14-day TTQT efficacies for the first-line treatment of H. pylori infection were comparable, and fewer adverse effects occurred in the 7-day group. This trial has been registered at Clinical Trials.gov (NCT05997433).

背景和目的 Tegoprazan 是一种新型药物,属于钾竞争性胃酸阻滞剂 (P-CAB),通过与质子泵抑制剂不同的机制抑制胃 H+/K+-ATP 酶。四环素还具有抗幽门螺旋杆菌的作用。然而,只有少数随机对照试验(RCT)研究了替高普拉赞和含四环素的四联疗法(TTQT)治疗幽门螺杆菌感染的疗效,本研究对此进行了探讨。 方法 这项多中心 RCT 研究纳入了对幽门螺杆菌感染治疗不敏感的成人患者,他们接受了 7 天或 14 天的 TTQT 治疗(50 毫克替戈普拉赞、220 毫克枸橼酸铋钾、1000 毫克阿莫西林,每天两次,加上 500 毫克四环素,每天四次)。主要结果是根除率;次要终点包括不良反应发生率、治疗依从性和治疗费用。 结果 该研究共纳入 258 名患者。7天组和14天组的根除率分别为90.70%(117/129,95% 置信区间[CI]:83.98%-94.89%)和91.47%(118/129,95% 置信区间[CI]:84.90%-95.45%)。在意向治疗分析中,分别为92.86%(117/126,95% CI:86.50%-96.48%)和93.65%(118/126,95% CI:87.在修正的意向治疗分析中,分别为92.86%(117/126,95% CI:86.50%-96.48%)和93.65%(118/126,95% CI:87.47%-97.02%)(差异:0.79%;95% CI:-6.36%-7.99%;非劣效P< 0.001);以及94.35%(117/124,95% CI:88.29%-97.50%)和95.12%(117/123,95% CI:89.24%-98.00%)(差异:-0.77%;95% CI:-5.91%-7.48%;非劣效性 p <;0.001)。7 天组发生的不良事件明显少于 14 天组(22.48% 对 35.67%,P = 0.020)。两组的治疗依从性没有差异。 结论 7天和14天TTQT一线治疗幽门螺杆菌感染的疗效相当,7天组发生的不良反应较少。该试验已在 Clinical Trials.gov (NCT05997433) 上注册。
{"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 头孢呋辛双重治疗与四联治疗治疗幽门螺杆菌感染初治患者的比较:一项前瞻性、多中心、随机对照试验
IF 4.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY 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

Background

High-Dose Dual Therapy With Amoxicillin Has Shown Advantages to Eradicate Helicobacter pylori (H. pylori), 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 H. pylori Infection.

Materials and Methods

The Prospective, Multicenter, Open-Label, Randomized Controlled Trial Was Conducted to Enroll Patients With Treatment-Naive H. pylori 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.

Results

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 (P = 0.001). In the Modified Intention-To-Treat Analysis, Eradication Rates Were 78.9% and 89.1% (P < 0.001). In the Per-Protocol Analysis, Eradication Rates Were 80.2% and 91.2% (P < 0.001). The Incidence of Adverse Events Was Significantly Lower in CDT Group Than CQT Group (14.4% vs. 29.8%, P < 0.001). Non-inferiority Was Confirmed Between CDT and CQT Group (All P > 0.025). Compliance Was Good in Both Groups (96.0% vs. 92.8%, P = 0.073). Poor Adherence Was a Risk Factor for Reducing the Efficacy in Both Groups.

Conclusions

CQT Was More Effective Than CDT for H. pylori Eradication, Which Might Be Recommended for Penicillin-Allergic Patients. If There Were Contraindications or Intolerance of CQT, CDT Would Be an Alternative.

Trail Registration

ChiCTR2300071210

背景:大剂量阿莫西林双重治疗对根除幽门螺杆菌有优势,但对青霉素过敏患者无效。推荐头孢呋辛作为替代方案,但头孢呋辛是否可用于双重治疗尚未见报道。本研究旨在比较头孢呋辛双重治疗(CDT)与头孢呋辛铋四联治疗(CQT)治疗幽门螺杆菌感染的疗效、安全性和依从性。材料与方法本研究采用前瞻性、多中心、开放标签、随机对照试验,纳入来自9家医院的初治疗幽门螺杆菌感染患者。患者被随机分配到CDT组(头孢呋辛500 Mg 3次/天,Vonoprazan 20 Mg 2次/天)或CQT组(头孢呋辛500 Mg 2次/天,左氧氟沙星500 Mg 1次/天,Vonoprazan 20 Mg 2次/天,铋220 Mg 2次/天),疗程均为14天。结果入组患者700例,每组350例。在意向治疗分析中,CDT组和CQT组的根除率分别为76.0%和86.3% (P = 0.001)。在修正意向治疗分析中,根除率分别为78.9%和89.1% (P < 0.001)。在Per-Protocol Analysis中,根除率分别为80.2%和91.2% (P < 0.001)。CDT组不良事件发生率明显低于CQT组(14.4% vs 29.8%, P < 0.001)。CDT组与CQT组间无劣效性(P > 0.025)。两组依从性均良好(96.0% vs. 92.8%, P = 0.073)。依从性差是降低两组疗效的危险因素。结论CQT对幽门螺杆菌的根除效果优于CDT,可推荐用于青霉素过敏患者。如果有禁忌症或CQT不耐受,CDT将是一种选择。跟踪注册ChiCTR2300071210
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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 幽门螺杆菌低感染率国家慢性胃炎患者的壁细胞抗体水平:流行病学、组织病理学特征和幽门螺杆菌感染
IF 4.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY 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

Background

Despite the low prevalence of Helicobacter pylori 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 H. pylori status in Indonesia.

Methods

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.

Results

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 H. pylori positive (61/109; 55.96%) with a significant correlation (p < 0.05, R = 0.31). Additionally, a significant association was found between H. pylori infection and PCA level with gastric histopathological features (p < 0.05).

Conclusion

This study demonstrates that the incidence of gastritis without H. pylori infection in Indonesia is not attributable to AIG, as only a single AIG-positive case was found. These findings underscore the important role of H. pylori as a pathogenic factor in chronic gastritis and highlight its mechanisms in triggering immune responses and driving disease progression and histopathological changes.

背景尽管幽门螺杆菌在印度尼西亚的患病率很低,但胃炎(主要是萎缩性胃炎)的发病率很高,这表明自身免疫性胃炎(AIG)等因素导致了这种不寻常的模式。本研究旨在调查印度尼西亚AIG的流行病学、组织病理学及其与幽门螺杆菌状态的关系。方法2014 - 2017年在印度尼西亚不同地区进行横断面研究;本研究进行时,有380例符合条件的血清和胃活检。根据更新后的Sydney系统进行的初步检查,本研究纳入了多达138份血清样本。通过对顶骨细胞抗体(PCA)的血清学检测和详细的组织病理学评估,保留了胃窦的组织病理学特征,证实了AIG的诊断。结果本研究纳入的样本中,78.99%(109/138)为PCA阳性(≥10 RU/mL), 0.72%(1/138)被认为诊断为AIG(未见上颌窦组织病理特征)。大多数PCA阳性病例为幽门螺杆菌阳性(61/109;55.96%),相关性显著(p < 0.05, R = 0.31)。此外,幽门螺杆菌感染和PCA水平与胃组织病理学特征有显著相关性(p < 0.05)。结论本研究表明印度尼西亚无幽门螺杆菌感染的胃炎的发生率不能归因于AIG,因为仅发现一例AIG阳性病例。这些发现强调了幽门螺杆菌作为慢性胃炎致病因子的重要作用,并强调了其在触发免疫反应、推动疾病进展和组织病理学改变方面的机制。
{"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 Q1 GASTROENTEROLOGY & HEPATOLOGY 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

Background

Exposure to Helicobacter pylori (H. pylori) has been associated with reduced odds of eosinophilic esophagitis (EoE).

Aims

To conduct a systematic review and meta-analysis of epidemiological studies in order to quantify the association between H. pylori infection and EoE, and to assess the certainty of the evidence linking both conditions.

Methods

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 H. pylori 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.

Results

Sixteen studies comprising 30,650 patients and 291,908 controls were included. Exposure to H. pylori was associated with a significant reduction in the odds of EoE (pooled odds ratio [OR] 0.56; 95% CI, 0.46–0.70; I2 50%) [low-certainty evidence]. The protective effect of H. pylori 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).

Conclusions

The association between H. pylori and EoE is mainly supported by retrospective studies with a high risk of bias. Further well-designed studies are needed.

Trial Registration

PROSPERO number: CRD42024586653

暴露于幽门螺杆菌(h.p ylori)与嗜酸性粒细胞性食管炎(EoE)的发生率降低有关。目的对流行病学研究进行系统回顾和荟萃分析,以量化幽门螺杆菌感染与EoE之间的关系,并评估两者相关证据的确定性。方法在MEDLINE/PUBMED、EMBASE和SCOPUS数据库(截止2024年9月)中进行全面的文献检索,以确定观察性流行病学研究,评估客观测量的幽门螺杆菌感染与EoE之间的关系。采用ROBINS-E工具对研究偏倚风险进行结构性评估。采用随机效应荟萃分析汇总数据。使用GRADE方法评估证据的确定性。结果纳入16项研究,包括30,650例患者和291,908例对照。幽门螺杆菌暴露与EoE发生率显著降低相关(合并优势比[OR] 0.56;95% ci, 0.46-0.70;I2 50%)[低确定性证据]。在病例对照研究中,幽门螺杆菌的保护作用更强(OR 0.49;95% CI, 0.35-0.69)比队列研究(OR 0.76;95% CI, 0.58-0.98),在回顾性研究中具有统计学意义(OR 0.57;95% CI, 0.45-0.72)和高或非常高偏倚风险的研究(or 0.52;95% CI, 0.42-0.64),但在前瞻性研究中没有(OR 0.56;95% CI, 0.27-1.18)或中低偏倚风险(or, 0.91;95% ci, 0.69-1.21)。结论幽门螺杆菌与EoE的相关性主要由具有高偏倚风险的回顾性研究支持。需要进一步精心设计的研究。试验注册号:CRD42024586653
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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 电子病历质量改进干预对美国医院系统幽门螺杆菌治疗和根除率的影响
IF 4.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-04-16 DOI: 10.1111/hel.70034
Shivani Kastuar, Samanthika Devalaraju, Juan Gomez Cifuentes, Hashem B. El-Serag, Mimi C. Tan

Background

In this pre- and post-intervention quality improvement (QI) study, the impact of an electronic medical record (EMR) order set for Helicobacter pylori treatment was assessed. We evaluated changes in optimal treatment regimen usage, eradication testing, and successful eradication rates based on the intervention.

Materials and Methods

Data were collected from patients within the Harris Health System (Houston, TX) with H. pylori infection. The pre-intervention cohort included patients with a positive H. pylori test from January to February 2022. An EMR order set for H. pylori 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.

Results

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% (p < 0.01) with a further increase in the late post-intervention group to 85.3% (p < 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 (p = 0.01) and 64.9% in the late post-intervention cohort (p = 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 (p = 0.03) and 82.6% in the late post-intervention cohort (p = 0.66).

Conclusions

An EMR order set for H. pylori treatment and eradication testing significantly increased rates of using optimal, evidence-based treatment, post-treatment eradication testing, and confirmed eradication of H. pylori infection.

背景在这项干预前和干预后质量改善(QI)研究中,评估了电子病历(EMR)对幽门螺杆菌治疗的影响。我们评估了基于干预的最佳治疗方案使用、根除试验和成功根除率的变化。资料和方法收集Harris卫生系统(Houston, TX)幽门螺旋杆菌感染患者的数据。干预前队列包括2022年1月至2月幽门螺杆菌检测阳性的患者。2022年5月实施的幽门螺杆菌治疗EMR命令包括使用当地抗生素耐药性模式和治疗后根除检测的最佳治疗建议。采用卡方检验对干预前队列、干预后早期组(2022年6月至7月)和干预后晚期组(2022年11月至12月)的最佳治疗比例和根除率进行比较。结果我们确定了干预前295例患者,干预后早期414例患者,干预后晚期320例患者。在干预前和干预后早期组中,最佳治疗(四联铋、四联克拉霉素或利法布汀三联治疗联合质子泵抑制剂14天)的比例从26.4%增加到39.7% (p < 0.01),干预后晚期组进一步增加到85.3% (p < 0.01)。治疗后24个月内根除检测的比例从干预前的56%上升到干预后早期的65.8% (p = 0.01)和干预后晚期的64.9% (p = 0.03)。在治疗后进行根除试验的患者中,成功根除率从干预前的80.6%增加到干预后早期的88.9% (p = 0.03),干预后晚期的82.6% (p = 0.66)。结论设置幽门螺杆菌治疗和根除检测的EMR单可显著提高最佳循证治疗、治疗后根除检测和幽门螺杆菌感染确诊根除率。
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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 头孢呋辛-含四环素铋四联疗法根除青霉素过敏患者幽门螺杆菌的疗效和安全性:一项多中心随机对照试验
IF 4.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY 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

Background

Penicillin allergy significantly restricts therapeutic options for Helicobacter pylori 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.

Materials and Methods

Penicillin-allergic treatment-naïve patients with confirmed H. pylori infection (N = 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.

Results

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%) (p = 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%) (p = 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%) (p = 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 (p < 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.

Conclusions

BQT containing cefuroxime and tetracycline is efficacious and safe for the first-line eradication of H. pylori in penicillin-allergic patients. This regimen provides a viable alternative to circumvent the antimicrobial resistance concerns associated with levofloxacin-based regimens.

Trial Registration

ClinicalTrials.gov ID: NCT06351891

背景:青霉素过敏严重限制了幽门螺杆菌根除的治疗选择。这项多中心随机对照研究旨在评估新型头孢呋辛-四环素-含铋四联疗法(Cef-Tet BQT)作为一线治疗在该人群中的疗效和安全性。材料与方法将确诊幽门螺杆菌感染的青霉素过敏treatment-naïve患者(248例)随机分为2个14天的治疗方案:一组接受头孢呋辛- tet BQT治疗(替戈拉赞50 mg, 2次/ d,柠檬酸铋钾220 mg, 2次/ d,头孢呋辛500 mg, 2次/ d,四环素500 mg, 3次/ d),另一组接受头孢呋辛-左氧氟沙星含铋四联治疗(头孢呋辛-左氧氟沙星BQT治疗):头孢呋辛500毫克,每日两次,左氧氟沙星500毫克,每日一次)。主要终点评估了根除率的非劣效性,次要终点包括安全性和依从性。结果共有248例患者接受了随机分组。意向治疗(ITT)根除率分别为90.32%(112/124,95%可信区间[CI]: 85.12% ~ 95.52%)和81.45% (101/124,95% CI: 74.61% ~ 88.29%) (p = 0.045);改良意向治疗(改良意向治疗)根除率分别为91.80% (112/122,95% CI: 86.93% ~ 96.67%)和83.47% (101/121,95% CI: 76.85% ~ 90.09%) (p = 0.048);Cef-Tet BQT组和Cef-Lev BQT组的PP根除率分别为92.37% (109/118,95% CI: 87.58% ~ 97.16%)和85.34% (99/116,95% CI: 78.90% ~ 91.78%) (p = 0.087)。在所有三个分析中都证明了Cef-Tet BQT组的非劣效性(p < 0.0001)。两组不良事件发生率(21.77% vs. 24.19%)和依从性(96.77% vs. 95.97%)具有可比性。结论头孢呋辛联合四环素BQT治疗青霉素过敏患者幽门螺杆菌一线根除是安全有效的。该方案提供了一种可行的替代方案,以避免与以左氧氟沙星为基础的方案相关的抗菌素耐药性问题。临床试验注册。gov ID: NCT06351891
{"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}
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Helicobacter
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