Developing effective non-antibiotic antimicrobial strategies is essential for combating global antibiotic resistance, including resistance stemming from Helicobacter pylori (H. pylori) treatment. Nanomaterials offer a promising and innovative approach for non-antibiotic anti-H. pylori treatment strategies. This review highlights the progress made in the use of metallic and nonmetallic nanoparticles, as well as nanozymes, to directly inhibit H. pylori growth. Moreover, we summarize advances made in the direct targeting of H. pylori by nanomaterials and the stimuli-responsive release of nanoparticles in the stomach. Additionally, we explore the recent advancements in multifunctional nanoplatforms that integrate physical methods, such as light, heat, ultrasound, and magnetism, with nanomaterials to synergistically treat H. pylori infections. Finally, we briefly address the existing challenges and future directions in this field. In summary, we highlight that with ongoing research, nanomaterials may serve as a promising treatment strategy for H. pylori eradication.
{"title":"Combatting Helicobacter pylori: A Focus on Nanomaterials","authors":"Xuanping Wang, Xihui Felicia Chan, Yuyo Go, Yishen Wang, Tingyu Li, Gangshi Wang","doi":"10.1111/hel.70004","DOIUrl":"10.1111/hel.70004","url":null,"abstract":"<div>\u0000 \u0000 <p>Developing effective non-antibiotic antimicrobial strategies is essential for combating global antibiotic resistance, including resistance stemming from <i>Helicobacter pylori</i> (<i>H. pylori</i>) treatment. Nanomaterials offer a promising and innovative approach for non-antibiotic anti-<i>H. pylori</i> treatment strategies. This review highlights the progress made in the use of metallic and nonmetallic nanoparticles, as well as nanozymes, to directly inhibit <i>H. pylori</i> growth. Moreover, we summarize advances made in the direct targeting of <i>H. pylori</i> by nanomaterials and the stimuli-responsive release of nanoparticles in the stomach. Additionally, we explore the recent advancements in multifunctional nanoplatforms that integrate physical methods, such as light, heat, ultrasound, and magnetism, with nanomaterials to synergistically treat <i>H. pylori</i> infections. Finally, we briefly address the existing challenges and future directions in this field. In summary, we highlight that with ongoing research, nanomaterials may serve as a promising treatment strategy for <i>H. pylori</i> eradication.</p>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"29 6","pages":""},"PeriodicalIF":4.3,"publicationDate":"2024-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142894198","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}
Vivek Mishra, Debabrata Dash, Aditya K. Panda, Sushil Kumar Pathak
<div> <section> <h3> Background</h3> <p><i>Helicobacter pylori</i> infection is a major global health concern and has been associated with a number of gastrointestinal disorders. Probiotics, especially <i>Lactobacillus</i> spp., have been suggested to have beneficial effect in managing <i>H. pylori</i> infection. This meta-analysis of randomized control trials (RCTs) aimed to evaluate the effect of <i>Lactobacillus</i> spp. supplementation on <i>H. pylori</i> eradication rates and associated side effects when combined with standard therapy.</p> </section> <section> <h3> Materials and Methods</h3> <p>Relevant studies were retrieved from PubMed, Scopus, Google Scholar and the Cochrane Library. Comprehensive Meta-Analysis (CMA) Software 4.0 was used for all the statistical analyses. TSA 0.9.5.10 Beta software was used for the trial sequential analysis (TSA). GRADEpro GDT was used to assess the certainty of evidence.</p> </section> <section> <h3> Results</h3> <p>An analysis of 26 selected studies showed that supplementing with <i>Lactobacillus</i> spp. significantly increased the rates of <i>H. pylori</i> eradication in per-protocol (PP) analysis (Overall risk ratio [RR] = 1.063, <i>p</i> = 0.000, 95% CI of −0.21 to 2.11; adults: RR = 1.050, <i>p</i> = 0.005, 95% CI = −0.55 to 2.03, children: RR = 1.223, <i>p</i> = 0.001, 95% CI = −13.35 to 4.55). In comparison to quadruple therapy, <i>Lactobacillus</i> spp. supplementation to triple therapy showed significant benefit (RR: 1.124; <i>p</i> = 0.000, 95% CI of −0.48 to 2.61). <i>L. reuteri</i> supplementation indicated better efficacy (RR: 1.049; <i>p</i> = 0.055, 95% CI of −0.56 to 3.26) than <i>Lactobacillus</i> GG (RR: 0.980; <i>p</i> = 0.595, 95% CI of −0.69 to 1.21). The 28–30 day (RR: 1.103; <i>p</i> = 0.003, 95% CI of −2.14 to 4.19) and 14-day supplementation periods (RR: 1.102; p = 0.003, 95% CI of −1.69 to 3.51) showed the most improvement. The analysis also revealed that <i>Lactobacillus</i> spp. significantly reduced gastrointestinal side effects: nausea/vomiting (RR: 0.566; <i>p</i> = 0.037, −3.11 to 1.45), diarrhea (RR: 0.324; <i>p</i> = 0.000, −5.46 to 0.48), and abdominal pain (RR: 0.438; <i>p</i> = 0.007, −5.65 to 4.22). The effect on bloating was non-significant (RR: 0.820; <i>p</i> = 0.498, −4.01 to 0.96). TSA graphs validated sufficient evidence for the conclusions.</p> </section> <section> <h3> Conclusion</h3> <p><i>Lactobacillus</i> spp. significantly enhances <i>H. pylori</i> eradication rates and may reduce gastrointestinal side effects when used alongside standard therapy, offering a promising adjunctive treatment option. The evidence was supported by TSA and asse
{"title":"Efficacy of Lactobacillus spp. Supplementation in Helicobacter pylori Eradication: A Systematic Meta-Analysis of Randomized Controlled Trials With Trial Sequential Analysis","authors":"Vivek Mishra, Debabrata Dash, Aditya K. Panda, Sushil Kumar Pathak","doi":"10.1111/hel.70006","DOIUrl":"10.1111/hel.70006","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p><i>Helicobacter pylori</i> infection is a major global health concern and has been associated with a number of gastrointestinal disorders. Probiotics, especially <i>Lactobacillus</i> spp., have been suggested to have beneficial effect in managing <i>H. pylori</i> infection. This meta-analysis of randomized control trials (RCTs) aimed to evaluate the effect of <i>Lactobacillus</i> spp. supplementation on <i>H. pylori</i> eradication rates and associated side effects when combined with standard therapy.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Materials and Methods</h3>\u0000 \u0000 <p>Relevant studies were retrieved from PubMed, Scopus, Google Scholar and the Cochrane Library. Comprehensive Meta-Analysis (CMA) Software 4.0 was used for all the statistical analyses. TSA 0.9.5.10 Beta software was used for the trial sequential analysis (TSA). GRADEpro GDT was used to assess the certainty of evidence.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>An analysis of 26 selected studies showed that supplementing with <i>Lactobacillus</i> spp. significantly increased the rates of <i>H. pylori</i> eradication in per-protocol (PP) analysis (Overall risk ratio [RR] = 1.063, <i>p</i> = 0.000, 95% CI of −0.21 to 2.11; adults: RR = 1.050, <i>p</i> = 0.005, 95% CI = −0.55 to 2.03, children: RR = 1.223, <i>p</i> = 0.001, 95% CI = −13.35 to 4.55). In comparison to quadruple therapy, <i>Lactobacillus</i> spp. supplementation to triple therapy showed significant benefit (RR: 1.124; <i>p</i> = 0.000, 95% CI of −0.48 to 2.61). <i>L. reuteri</i> supplementation indicated better efficacy (RR: 1.049; <i>p</i> = 0.055, 95% CI of −0.56 to 3.26) than <i>Lactobacillus</i> GG (RR: 0.980; <i>p</i> = 0.595, 95% CI of −0.69 to 1.21). The 28–30 day (RR: 1.103; <i>p</i> = 0.003, 95% CI of −2.14 to 4.19) and 14-day supplementation periods (RR: 1.102; p = 0.003, 95% CI of −1.69 to 3.51) showed the most improvement. The analysis also revealed that <i>Lactobacillus</i> spp. significantly reduced gastrointestinal side effects: nausea/vomiting (RR: 0.566; <i>p</i> = 0.037, −3.11 to 1.45), diarrhea (RR: 0.324; <i>p</i> = 0.000, −5.46 to 0.48), and abdominal pain (RR: 0.438; <i>p</i> = 0.007, −5.65 to 4.22). The effect on bloating was non-significant (RR: 0.820; <i>p</i> = 0.498, −4.01 to 0.96). TSA graphs validated sufficient evidence for the conclusions.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p><i>Lactobacillus</i> spp. significantly enhances <i>H. pylori</i> eradication rates and may reduce gastrointestinal side effects when used alongside standard therapy, offering a promising adjunctive treatment option. The evidence was supported by TSA and asse","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"29 6","pages":""},"PeriodicalIF":4.3,"publicationDate":"2024-12-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142894200","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}
Jin Hee Noh, Kee Don Choi, Hee Kyong Na, Ji Yong Ahn, Jeong Hoon Lee, Kee Wook Jung, Do Hoon Kim, Ho June Song, Gin Hyug Lee, Hwoon-Yong Jung
Background/Aims
Determining antibiotic use history accurately is challenging due to its reliance on patient recall. By determining macrolide exposure using the Korean drug utilization review (DUR) system, we analyzed the impact of previous macrolide use on antibiotic resistance profiles and compared the eradication rate between tailored therapy based on macrolide exposure history and empirical therapy.
Methods
Patients with confirmed Helicobacter pylori (H. pylori) infection who agreed to access prescription information using the Health Insurance Review and Assessment Service DUR system were enrolled between 2021 and 2023. Patients received tailored therapy, which was clarithromycin (CLR)-based triple therapy in cases without macrolide exposure and bismuth quadruple (BQ) therapy in cases with macrolide exposure. The empirical therapy group was prospectively recruited at the same time to compare the eradication rate.
Results
A total of 418 patients (tailored therapy group, n = 57; empirical therapy group, n = 361) were analyzed. Among the tailored therapy group, 24.6% took macrolide antibiotics for the past 5 years. CLR resistance rates were higher in patients with previous macrolide use than in those without (66.7% vs. 7.5%, p < 0.001). The tailored therapy group showed a higher eradication rate than the empirical therapy group for intention-to-treat (ITT), modified intention-to-treat (MITT), and per-protocol (PP) analyses (ITT, 86.0% vs. 75.6%; MITT, 94.2% vs. 80.3%; PP, 94.2% vs. 85.1%).
Conclusions
Previous macrolide exposure identified using the DUR system was associated with a higher rate of CLR resistance. Tailored therapy based on macrolide exposure history led to higher eradication rates compared to empirical therapy.
背景/目的由于依赖于患者回忆，准确确定抗生素使用史具有挑战性。通过使用韩国药物利用审查（DUR）系统确定大环内酯暴露情况，我们分析了以前使用大环内酯对抗生素耐药性的影响，并比较了基于大环内酯暴露史的定制治疗和经验治疗的根除率。方法选取2021年至2023年同意通过健康保险审查和评估服务DUR系统获取处方信息的确诊幽门螺杆菌感染患者。患者接受了量身定制的治疗，即在没有大环内酯暴露的病例中采用克拉霉素（CLR）三联治疗，在大环内酯暴露的病例中采用铋四联治疗。同时前瞻性招募经验治疗组，比较根除率。结果共418例患者(定制治疗组，n = 57；经验治疗组（n = 361）。在定制治疗组中，近5年服用大环内酯类抗生素的占24.6%。既往使用大环内酯类药物的患者的CLR耐药率高于未使用大环内酯类药物的患者（66.7% vs. 7.5%, p < 0.001）。在意向治疗（ITT）、改良意向治疗（MITT）和每个方案（PP）分析中，定制治疗组的根除率高于经验治疗组(ITT, 86.0% vs. 75.6%；MITT， 94.2%对80.3%；PP, 94.2% vs. 85.1%)。结论先前使用DUR系统识别的大环内酯暴露与较高的CLR耐药率相关。与经验治疗相比，基于大环内酯暴露史的量身定制治疗导致更高的根除率。
{"title":"Effect of Macrolide Exposure on Tailored Helicobacter pylori Eradication Therapy and Antibiotic Resistance Profiles: A Prospective Study Using the Drug Utilization Review System","authors":"Jin Hee Noh, Kee Don Choi, Hee Kyong Na, Ji Yong Ahn, Jeong Hoon Lee, Kee Wook Jung, Do Hoon Kim, Ho June Song, Gin Hyug Lee, Hwoon-Yong Jung","doi":"10.1111/hel.70003","DOIUrl":"https://doi.org/10.1111/hel.70003","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background/Aims</h3>\u0000 \u0000 <p>Determining antibiotic use history accurately is challenging due to its reliance on patient recall. By determining macrolide exposure using the Korean drug utilization review (DUR) system, we analyzed the impact of previous macrolide use on antibiotic resistance profiles and compared the eradication rate between tailored therapy based on macrolide exposure history and empirical therapy.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Patients with confirmed <i>Helicobacter pylori</i> (<i>H. pylori</i>) infection who agreed to access prescription information using the Health Insurance Review and Assessment Service DUR system were enrolled between 2021 and 2023. Patients received tailored therapy, which was clarithromycin (CLR)-based triple therapy in cases without macrolide exposure and bismuth quadruple (BQ) therapy in cases with macrolide exposure. The empirical therapy group was prospectively recruited at the same time to compare the eradication rate.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A total of 418 patients (tailored therapy group, <i>n</i> = 57; empirical therapy group, <i>n</i> = 361) were analyzed. Among the tailored therapy group, 24.6% took macrolide antibiotics for the past 5 years. CLR resistance rates were higher in patients with previous macrolide use than in those without (66.7% vs. 7.5%, <i>p</i> < 0.001). The tailored therapy group showed a higher eradication rate than the empirical therapy group for intention-to-treat (ITT), modified intention-to-treat (MITT), and per-protocol (PP) analyses (ITT, 86.0% vs. 75.6%; MITT, 94.2% vs. 80.3%; PP, 94.2% vs. 85.1%).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Previous macrolide exposure identified using the DUR system was associated with a higher rate of CLR resistance. Tailored therapy based on macrolide exposure history led to higher eradication rates compared to empirical therapy.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"29 6","pages":""},"PeriodicalIF":4.3,"publicationDate":"2024-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142764097","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}
Helicobacter pylori infection is usually acquired during childhood and represents one of the most common infections in humans. It is well known that H. pylori has belonged to humankind for hundreds of thousands of years and it accompanied the human migration from Africa. The adult international guidelines recommend treating all infected patients as H. pylori was classified among the first-class human carcinogens by the WHO in 1994 and it is one of the main factors involved in the development of gastric cancer. Conversely, the pediatric international guidelines are more restrictive in recommending the eradication of the infection in children. Although many studies have shown evidence regarding the pathological role of H. pylori regardless of the age of the infected patients, many others have highlighted its protective/positive role in several extra-gastric diseases in children. In this review, both points of view regarding the eradication in children are critically analyzed.
{"title":"Helicobacter pylori Infection in Children: To Eradicate or Not to Eradicate?","authors":"Marco Manfredi, Madhur Ravikumara","doi":"10.1111/hel.70002","DOIUrl":"https://doi.org/10.1111/hel.70002","url":null,"abstract":"<div>\u0000 \u0000 <p><i>Helicobacter pylori</i> infection is usually acquired during childhood and represents one of the most common infections in humans. It is well known that <i>H. pylori</i> has belonged to humankind for hundreds of thousands of years and it accompanied the human migration from Africa. The adult international guidelines recommend treating all infected patients as <i>H. pylori</i> was classified among the first-class human carcinogens by the WHO in 1994 and it is one of the main factors involved in the development of gastric cancer. Conversely, the pediatric international guidelines are more restrictive in recommending the eradication of the infection in children. Although many studies have shown evidence regarding the pathological role of <i>H. pylori</i> regardless of the age of the infected patients, many others have highlighted its protective/positive role in several extra-gastric diseases in children. In this review, both points of view regarding the eradication in children are critically analyzed.</p>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"29 6","pages":""},"PeriodicalIF":4.3,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142685296","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}
Qing Liu, Omid Sadr-Azodi, Lars Engstrand, Katja Fall, Nele Brusselaers
Background
Helicobacter pylori (H. pylori) is an established gastric carcinogen, also associated with an increased risk of colorectal cancer. Therefore, we suspected that H. pylori eradication lowers the risk of colorectal cancer.
Material and Methods
We assessed if H. pylori eradication therapy is associated with a reduced risk of colorectal adenocarcinoma in a population-based nationwide cohort study. This study included all Swedish adults with at least one recorded H. pylori eradication episode between July 2005 and December 2012, based on the high-quality Swedish health registries. Colorectal adenocarcinoma risks were compared to the Swedish background population, presented as standardized incidence ratios (SIRs) and 95% confidence intervals (CIs), accounting for age, sex, calendar period, tumor location (left or right sided), stage, and number of eradication episodes, from 1 year after eradication and onward.
Results
Among 80,381 individuals receiving H. pylori eradication therapy (average follow-up 4.1 years), 282 were diagnosed with colorectal cancer (97.2% adenocarcinoma). Overall, H. pylori eradication was associated with an elevated risk of colorectal adenocarcinoma (SIR 1.27, 95% CI: 1.12–1.43). The colorectal adenocarcinoma risk was increased 1–2 years after eradication (SIR 1.42, 95% CI: 1.17–1.72), then decreased 2–4 years (SIR 0.80, 95% CI: 0.65–0.98) and 4–6 years (SIR 0.76, 95% CI: 0.57–0.99), yet not ≥ 6 years (SIR 1.36, 95% CI: 0.78–2.21) after eradication compared to the general population. Overall, right-sided (SIR 1.47, 95% CI: 1.21–1.76) and left-sided (SIR 1.35, 95% CI: 1.09–1.67) colon adenocarcinomas risks were higher among eradicated individuals than the general population.
Conclusion
H. pylori eradication was not associated with a clear and consistent reduction of colorectal cancer in our Swedish cohort.
{"title":"Helicobacter pylori Eradication Therapy and the Risk of Colorectal Cancer: A Population-Based Nationwide Cohort Study in Sweden","authors":"Qing Liu, Omid Sadr-Azodi, Lars Engstrand, Katja Fall, Nele Brusselaers","doi":"10.1111/hel.70001","DOIUrl":"https://doi.org/10.1111/hel.70001","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p><i>Helicobacter pylori</i> (<i>H. pylori</i>) is an established gastric carcinogen, also associated with an increased risk of colorectal cancer. Therefore, we suspected that <i>H. pylori</i> eradication lowers the risk of colorectal cancer.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Material and Methods</h3>\u0000 \u0000 <p>We assessed if <i>H. pylori</i> eradication therapy is associated with a reduced risk of colorectal adenocarcinoma in a population-based nationwide cohort study. This study included all Swedish adults with at least one recorded <i>H. pylori</i> eradication episode between July 2005 and December 2012, based on the high-quality Swedish health registries. Colorectal adenocarcinoma risks were compared to the Swedish background population, presented as standardized incidence ratios (SIRs) and 95% confidence intervals (CIs), accounting for age, sex, calendar period, tumor location (left or right sided), stage, and number of eradication episodes, from 1 year after eradication and onward.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Among 80,381 individuals receiving <i>H. pylori</i> eradication therapy (average follow-up 4.1 years), 282 were diagnosed with colorectal cancer (97.2% adenocarcinoma). Overall, <i>H. pylori</i> eradication was associated with an elevated risk of colorectal adenocarcinoma (SIR 1.27, 95% CI: 1.12–1.43). The colorectal adenocarcinoma risk was increased 1–2 years after eradication (SIR 1.42, 95% CI: 1.17–1.72), then decreased 2–4 years (SIR 0.80, 95% CI: 0.65–0.98) and 4–6 years (SIR 0.76, 95% CI: 0.57–0.99), yet not ≥ 6 years (SIR 1.36, 95% CI: 0.78–2.21) after eradication compared to the general population. Overall, right-sided (SIR 1.47, 95% CI: 1.21–1.76) and left-sided (SIR 1.35, 95% CI: 1.09–1.67) colon adenocarcinomas risks were higher among eradicated individuals than the general population.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p><i>H. pylori</i> eradication was not associated with a clear and consistent reduction of colorectal cancer in our Swedish cohort.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"29 6","pages":""},"PeriodicalIF":4.3,"publicationDate":"2024-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/hel.70001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142674230","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}
{"title":"LCI's Diagnostic Performance for Gastric Cancer: A New Solution to Screening?","authors":"Guilherme Nobre Nogueira","doi":"10.1111/hel.70000","DOIUrl":"10.1111/hel.70000","url":null,"abstract":"","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"29 6","pages":""},"PeriodicalIF":4.3,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142619334","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}
Helicobacter pylori infects over 50% of the global population, prompting the issuance of guidelines for effective diagnosis and treatment. However, research on guideline dissemination and adherence is limited. Therefore, we assessed the nationwide status of H. pylori eradication therapies in Korea before and after guideline updates.
Methods
Using data from the Korean National Health Insurance Service, this retrospective cohort study analyzed changes in H. pylori eradication therapies across three periods: Phase I (2006–2007), Phase II (2014–2015), and Phase III (2021–2022). It examined therapy regimens, confirmation tests, and retreatment rates.
Results
Among 1,657,746 patients included, the number undergoing eradication therapy increased across the phases (Phase I: 234,365; Phase II: 493,889; Phase III: 929,492). The use of conventional triple therapy declined from 96.1% in Phase I to 88.3% in Phase III, while non-bismuth and bismuth quadruple therapies increased to 6.8% and 3.3%, respectively, in Phase III. The proportion of patients following a 1-week regimen of conventional triple therapy decreased from 90.3% in Phase I to 54.2% in Phase III, while a 2-week regimen increased to 36.1% in Phase III. Confirmation testing within 1 year of therapy increased from 21.3% in Phase I to 43.0% in Phase III, whereas retreatment rates increased from 3.8% in Phase I to 8.8% in Phase III.
Conclusions
Guideline updates have influenced H. pylori eradication practices in Korea, leading to increased use of quadruple therapies with longer treatment durations. However, further improvements in confirmatory tests and retreatment following failed initial therapy are required.
{"title":"Nationwide Trends in Helicobacter pylori Eradication Therapies in Korea: Impact of Guideline Updates on Treatment Practices","authors":"Byung Wook Jung, Yun Jin Kim, Chan Hyuk Park","doi":"10.1111/hel.13152","DOIUrl":"10.1111/hel.13152","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p><i>Helicobacter pylori</i> infects over 50% of the global population, prompting the issuance of guidelines for effective diagnosis and treatment. However, research on guideline dissemination and adherence is limited. Therefore, we assessed the nationwide status of <i>H. pylori</i> eradication therapies in Korea before and after guideline updates.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Using data from the Korean National Health Insurance Service, this retrospective cohort study analyzed changes in <i>H. pylori</i> eradication therapies across three periods: Phase I (2006–2007), Phase II (2014–2015), and Phase III (2021–2022). It examined therapy regimens, confirmation tests, and retreatment rates.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Among 1,657,746 patients included, the number undergoing eradication therapy increased across the phases (Phase I: 234,365; Phase II: 493,889; Phase III: 929,492). The use of conventional triple therapy declined from 96.1% in Phase I to 88.3% in Phase III, while non-bismuth and bismuth quadruple therapies increased to 6.8% and 3.3%, respectively, in Phase III. The proportion of patients following a 1-week regimen of conventional triple therapy decreased from 90.3% in Phase I to 54.2% in Phase III, while a 2-week regimen increased to 36.1% in Phase III. Confirmation testing within 1 year of therapy increased from 21.3% in Phase I to 43.0% in Phase III, whereas retreatment rates increased from 3.8% in Phase I to 8.8% in Phase III.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Guideline updates have influenced <i>H. pylori</i> eradication practices in Korea, leading to increased use of quadruple therapies with longer treatment durations. However, further improvements in confirmatory tests and retreatment following failed initial therapy are required.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"29 6","pages":""},"PeriodicalIF":4.3,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142619338","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}
Although Helicobacter pylori infection (H. pylori) prevalence in Africa has declined in the last decade, it remains concerningly high. H. pylori is asymptomatic in the majority of patients but is associated with significant morbidity and mortality in 10%–20%.
Materials and Methods
We conducted an online survey of 21 African countries, with the link distributed to members of the African Helicobacter Microbiota Study Group. The survey was completed by 562 respondents; the majority were from Nigeria (27.2%), South Africa (18.1%), Tanzania (17.6%), Egypt (16.9%), and Cameroon (14.2%).
Results
The most common reason for H. pylori testing was dyspepsia in 83.9% of the cases. Abnormal findings at gastroscopy (62.3%) and heartburn (61.7%) were also common indications. Stool antigen testing and histological examination of gastric biopsies using Giemsa were the two most used methods for H. pylori testing at 62.3% and 50.3%, respectively. Most respondents reported the use of standard clarithromycin-based triple therapy as first-line treatment for H. pylori infection.
Conclusion
This survey has demonstrated the diversity of practice and resource availability within the African continent. Several international guidelines exist on the management of H. pylori, but little data is available in Africa on how this condition is managed in every day clinical practice. There is an urgent need to formulate evidence-based and locally relevant practice guidelines on the African continent. In this context, the African Helicobacter and Microbiota study group was formed to coordinate efforts across the continent on H. pylori research to provide guidance on its management. This paper, therefore, aimed to evaluate the practice of H. pylori diagnostics and management, as well as related resources in representative countries in Africa, to facilitate the development of such guidelines.
{"title":"Helicobacter pylori Management in Africa: A Survey of Diagnostic, Treatment, and Related Resources","authors":"Setshedi Mashiko, Stella Ifeanyi Smith, Ugiagbe Rose, Otegbayo Jesse Abiodun, Hyasinta Jaka, Onyekwere Charles, Nashidengo Abdulrashid, Kayamba Violet, Tshibangu-Kabamba Evariste, Ndububa Dennis, Gunturu Revathi, Lahbabi-Amrani Naima, Ajayi Abraham, Tolulope Funbi Jolaiya, Dieye Yakhya, Alboraie Mohamed, Ndip Roland","doi":"10.1111/hel.13153","DOIUrl":"10.1111/hel.13153","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Although <i>Helicobacter pylori</i> infection (<i>H. pylori</i>) prevalence in Africa has declined in the last decade, it remains concerningly high. <i>H. pylori</i> is asymptomatic in the majority of patients but is associated with significant morbidity and mortality in 10%–20%.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Materials and Methods</h3>\u0000 \u0000 <p>We conducted an online survey of 21 African countries, with the link distributed to members of the African Helicobacter Microbiota Study Group. The survey was completed by 562 respondents; the majority were from Nigeria (27.2%), South Africa (18.1%), Tanzania (17.6%), Egypt (16.9%), and Cameroon (14.2%).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The most common reason for <i>H. pylori</i> testing was dyspepsia in 83.9% of the cases. Abnormal findings at gastroscopy (62.3%) and heartburn (61.7%) were also common indications. Stool antigen testing and histological examination of gastric biopsies using Giemsa were the two most used methods for <i>H. pylori</i> testing at 62.3% and 50.3%, respectively. Most respondents reported the use of standard clarithromycin-based triple therapy as first-line treatment for <i>H. pylori</i> infection.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>This survey has demonstrated the diversity of practice and resource availability within the African continent. Several international guidelines exist on the management of <i>H. pylori</i>, but little data is available in Africa on how this condition is managed in every day clinical practice. There is an urgent need to formulate evidence-based and locally relevant practice guidelines on the African continent. In this context, the African Helicobacter and Microbiota study group was formed to coordinate efforts across the continent on <i>H. pylori</i> research to provide guidance on its management. This paper, therefore, aimed to evaluate the practice of <i>H. pylori</i> diagnostics and management, as well as related resources in representative countries in Africa, to facilitate the development of such guidelines.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"29 6","pages":""},"PeriodicalIF":4.3,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142619331","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}
Belén Martínez Benito, Olga P. Nyssen, Javier P. Gisbert
Background
The efficacy of Helicobacter pylori (H. pylori) eradication therapies encompassing one or more antibiotics and a proton pump inhibitor (PPI) has lately decreased. Vonoprazan (VPZ), a potassium-competitive acid blocker, provides higher gastric acid suppression than PPIs. We performed a meta-analysis evaluating the efficacy and safety of VPZ in H. pylori eradication therapies.
Methods
Studies were searched in PubMed, Embase, and the Cochrane Library up to June 2023. Efficacy was evaluated by intention-to-treat analysis. Data were combined by meta-analyzing risk differences (RD). Heterogeneity was evaluated by subgrouping.
Results
Seventy-seven studies (24 randomized clinical trials) evaluated 44,162 patients (22,297 receiving VPZ and 21,865 PPIs). Overall VPZ efficacy was 88% (95% CI = 87%–90%): 86%, 88%, and 94% for dual/triple/quadruple-VPZ-containing therapies. VPZ efficacy was 87% (86%–89%) in first-line and 90% (87%–93%) in rescue therapy. VPZ performed better than PPIs in treatment-naïve patients (87% vs. 70%; RD = 0.13, 95% CI = 0.11–0.15) and when using triple regimens. No significant differences were observed in rescue and quadruple therapies. In patients with clarithromycin-resistant infection, VPZ-based therapies demonstrated an 81% efficacy (76%–85%), surpassing PPIs (76% vs. 40%; RD = 0.33, 95% CI = 0.24–0.43). For clarithromycin-susceptible strains, VPZ efficacy was 92% (89%–95%), similar to PPIs. VPZ adverse events rate was 19% (16%–21%), comparable to PPI-based regimens (18% vs. 13%, respectively; RD = 0.00, 95% CI = −0.01 to 0.02, p = 0.57).
Conclusions
The efficacy of VPZ-based regimens was over 85% in all treatment combinations. In treatment-naïve and clarithromycin-resistant patients, VPZ performed better than PPIs. In rescue therapy, in clarithromycin-susceptible patients or when quadruple regimens were prescribed, this advantage was not confirmed. Tolerability was similar in both regimens.
背景：幽门螺杆菌（H. pylori）根除疗法包括一种或多种抗生素和一种质子泵抑制剂（PPI），其疗效近来有所下降。与 PPIs 相比，钾竞争性胃酸阻滞剂 Vonoprazan（VPZ）能提供更强的胃酸抑制作用。我们进行了一项荟萃分析，评估了 VPZ 在根除幽门螺杆菌疗法中的有效性和安全性：我们在 PubMed、Embase 和 Cochrane 图书馆中检索了截至 2023 年 6 月的研究。通过意向治疗分析评估疗效。通过荟萃分析风险差异（RD）合并数据。通过分组对异质性进行评估：77项研究（24项随机临床试验）评估了44,162名患者（22,297人接受VPZ治疗，21,865人接受PPIs治疗）。VPZ的总体疗效为88%（95% CI = 87%-90%）：含 VPZ 的双重/三重/四重疗法的疗效分别为 86%、88% 和 94%。VPZ在一线治疗中的有效率为87%（86%-89%），在抢救治疗中的有效率为90%（87%-93%）。VPZ 在治疗新患者（87% 对 70%；RD = 0.13，95% CI = 0.11-0.15）和使用三联疗法时的疗效优于 PPIs。在抢救疗法和四联疗法中未观察到明显差异。在克拉霉素耐药感染患者中，VPZ疗法的有效率为81%（76%-85%），超过了PPIs疗法（76% vs. 40%；RD = 0.33，95% CI = 0.24-0.43）。对于克拉霉素易感菌株，VPZ 的有效率为 92%（89%-95%），与 PPIs 相似。VPZ的不良反应率为19%（16%-21%），与基于PPI的治疗方案相当（分别为18% vs. 13%；RD = 0.00，95% CI = -0.01 to 0.02，p = 0.57）：结论：以VPZ为基础的治疗方案在所有治疗组合中的有效率均超过85%。结论：在所有治疗组合中，以 VPZ 为基础的治疗方案的有效率超过 85%。在治疗无效和对克拉霉素耐药的患者中，VPZ 的疗效优于 PPIs。在抢救治疗、对克拉霉素敏感的患者或使用四联疗法时，这一优势并未得到证实。两种方案的耐受性相似。
{"title":"Efficacy and Safety of Vonoprazan in Dual/Triple/Quadruple Regimens Both in First-Line and Rescue Therapy for Helicobacter pylori Eradication: A Systematic Review With Meta-Analysis","authors":"Belén Martínez Benito, Olga P. Nyssen, Javier P. Gisbert","doi":"10.1111/hel.13148","DOIUrl":"10.1111/hel.13148","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>The efficacy of <i>Helicobacter pylori</i> (<i>H. pylori</i>) eradication therapies encompassing one or more antibiotics and a proton pump inhibitor (PPI) has lately decreased. Vonoprazan (VPZ), a potassium-competitive acid blocker, provides higher gastric acid suppression than PPIs. We performed a meta-analysis evaluating the efficacy and safety of VPZ in <i>H. pylori</i> eradication therapies.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Studies were searched in PubMed, Embase, and the Cochrane Library up to June 2023. Efficacy was evaluated by intention-to-treat analysis. Data were combined by meta-analyzing risk differences (RD). Heterogeneity was evaluated by subgrouping.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Seventy-seven studies (24 randomized clinical trials) evaluated 44,162 patients (22,297 receiving VPZ and 21,865 PPIs). Overall VPZ efficacy was 88% (95% CI = 87%–90%): 86%, 88%, and 94% for dual/triple/quadruple-VPZ-containing therapies. VPZ efficacy was 87% (86%–89%) in first-line and 90% (87%–93%) in rescue therapy. VPZ performed better than PPIs in treatment-naïve patients (87% vs. 70%; RD = 0.13, 95% CI = 0.11–0.15) and when using triple regimens. No significant differences were observed in rescue and quadruple therapies. In patients with clarithromycin-resistant infection, VPZ-based therapies demonstrated an 81% efficacy (76%–85%), surpassing PPIs (76% vs. 40%; RD = 0.33, 95% CI = 0.24–0.43). For clarithromycin-susceptible strains, VPZ efficacy was 92% (89%–95%), similar to PPIs. VPZ adverse events rate was 19% (16%–21%), comparable to PPI-based regimens (18% vs. 13%, respectively; RD = 0.00, 95% CI = −0.01 to 0.02, <i>p</i> = 0.57).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>The efficacy of VPZ-based regimens was over 85% in all treatment combinations. In treatment-naïve and clarithromycin-resistant patients, VPZ performed better than PPIs. In rescue therapy, in clarithromycin-susceptible patients or when quadruple regimens were prescribed, this advantage was not confirmed. Tolerability was similar in both regimens.</p>\u0000 </section>\u0000 </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"29 6","pages":""},"PeriodicalIF":4.3,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142619314","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}
<div> <section> <h3> Introduction</h3> <p>Few studies have investigated the efficacy and safety of tegoprazan-amoxicillin (TA) dual therapy for <i>Helicobacter pylori</i> eradication. We aim to evaluate the effectiveness and safety of different dosages of TA dual therapy for <i>H. pylori</i> eradication.</p> </section> <section> <h3> Methods</h3> <p>This prospective, randomized, open-label, multicenter study was conducted at four centers in Fujian, China. <i>H. pylori-</i>infective patients were randomized 1:1:1 to receive one of the following treatments: bismuth quadruple therapy (BQT, esomeprazole 20 mg twice daily + potassium bismuth citrate 240 mg twice daily + amoxicillin 1 g twice daily + clarithromycin 500 mg twice daily), tegoprazan-amoxicillin dual therapies (TA-qd, tegoprazan 50 mg once daily + amoxicillin 1 g thrice daily; TA-bid, tegoprazan 50 mg twice daily + amoxicillin 1 g thrice daily) for 14 days. The primary outcome was noninferiority in eradication rates of the different TA groups compared to the BQT group. Secondary outcomes encompassed an assessment of adverse reactions and clinical symptom relief. Additionally, exploratory outcomes were focused on the shifts in gut microbiota and a cost-effectiveness analysis.</p> </section> <section> <h3> Results</h3> <p>A total of 321 patients were enrolled. The eradication rates in the BQT group, TA-qd group, and TA-bid group were 85.05% (91/107), 85.98% (92/107), and 85.98% (92/107) in the intention-to-treat analysis (ITT) (BQT vs. TA-qd, 95% CI −8.50% to 10.36%, noninferiority <i>p</i> = 0.012; BQT vs. TA-bid, 95% CI −8.50% to 10.36%, noninferiority <i>p</i> = 0.012); 91.00% (91/100), 91.09% (92/101), and 92.93% (92/99) in the modified intention-to-treat analysis (mITT) (BQT vs. TA-qd, 95% CI −7.81% to 7.98%, noninferiority <i>p</i> = 0.006; BQT vs. TA-bid, 95% CI −5.62% to 9.48%, noninferiority <i>p</i> < 0.001); 90.81% (89/98), 91.00% (91/100), and 93.81% (91/97) in the per-protocol analysis (PP) (BQT vs. TA-qd, 95% CI −7.83% to 8.19%, noninferiority <i>p</i> = 0.006; BQT vs. TA-bid, 95% CI 4.46% to 10.46%, noninferiority <i>p</i> < 0.001). The incidence of adverse reactions in the TA-qd and TA-bid groups was significantly lower than in the BQT group (13.33%, 14.56%, and 27.18%, respectively; <i>p</i> = 0.017). The complete remissions of clinical symptoms for BQT, TA-qd, and TA-bid were 36.89%, 65.71%, and 68.93%, respectively, had significant differences (<i>p</i> < 0.001). Two weeks of TA therapy altered gut microbiota diversity and composition, but that recovered 4 weeks after discontinuation. The cost-effectiveness ratios (CERs) for BQT, TA-qd, and TA-bid were 1.85 CNY, 2.08 CNY, and 3.69 CNY, respectively.</p> </section>
简介：很少有研究探讨替戈普拉唑-阿莫西林（TA）双重疗法根除幽门螺杆菌的有效性和安全性。我们旨在评估不同剂量的替戈普拉唑-阿莫西林双重疗法根除幽门螺杆菌的有效性和安全性：这项前瞻性、随机、开放标签的多中心研究在中国福建的四个中心进行。H. 幽门螺杆菌感染患者按 1:1:1 的比例随机接受以下疗法之一：铋剂四联疗法（BQT，埃索美拉唑 20 毫克，每日两次；枸橼酸铋钾 240 毫克，每日两次；阿莫西林 1 克，每日两次；克拉霉素 500 毫克，每日两次）、替戈普拉赞-阿莫西林双联疗法（TA-qd，替戈普拉赞 50 毫克，每日一次；阿莫西林 1 克，每日三次；TA-bid，替戈普拉赞 50 毫克，每日两次；阿莫西林 1 克，每日三次），疗程 14 天。主要结果是不同TA组的根除率与BQT组相比无劣效。次要结果包括对不良反应和临床症状缓解情况的评估。此外，探索性结果侧重于肠道微生物群的变化和成本效益分析：结果：共有 321 名患者接受了治疗。在意向治疗分析（ITT）中，BQT 组、TA-qd 组和 TA-bid 组的根除率分别为 85.05%（91/107）、85.98%（92/107）和 85.98%（92/107）（BQT vs. TA-qd，95% CI -8.50% to 10.36%，非劣效性 p = 0.012；BQT vs. TA-bid，95% CI -8.50% to 10.36%，非劣效性 p = 0.012）；在修正意向治疗分析（mITT）中，分别为 91.00%（91/100）、91.09%（92/101）和 92.93%（92/99）（BQT vs. TA-qd，95% CI -7.81% to 7.98%，非劣效性 p = 0.006；BQT vs. TA-bid，95% CI -5.62% to 9.48%，非劣效性 p 结论：与BQT相比，两种TA双重疗法的幽门螺杆菌根除率均大于90%，不良反应更少，临床症状缓解程度更高，对肠道微生物群的影响轻微且可逆。此外，TA与小剂量替戈普拉赞的双重疗法显示出更好的成本效益：试验注册：中国临床试验注册中心，注册号：ChiCTR2300071997。
{"title":"Tegoprazan-Amoxicillin Dual Therapy for Helicobacter pylori Eradication: A Prospective, Randomized, Multicenter Study in Fujian, China","authors":"Xueyan Lin, Huping Huang, Yijuan Liu, Yanling Zeng, Shiyun Lu, Xuefeng Xu, Yun Lin, Feng Qiu, Fangfang Cai, Jie Pan, Shaozhong Huang, Shaowei Lin, Aiping Lin, Zhihui Lin, Xueping Huang","doi":"10.1111/hel.13151","DOIUrl":"10.1111/hel.13151","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Few studies have investigated the efficacy and safety of tegoprazan-amoxicillin (TA) dual therapy for <i>Helicobacter pylori</i> eradication. We aim to evaluate the effectiveness and safety of different dosages of TA dual therapy for <i>H. pylori</i> eradication.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This prospective, randomized, open-label, multicenter study was conducted at four centers in Fujian, China. <i>H. pylori-</i>infective patients were randomized 1:1:1 to receive one of the following treatments: bismuth quadruple therapy (BQT, esomeprazole 20 mg twice daily + potassium bismuth citrate 240 mg twice daily + amoxicillin 1 g twice daily + clarithromycin 500 mg twice daily), tegoprazan-amoxicillin dual therapies (TA-qd, tegoprazan 50 mg once daily + amoxicillin 1 g thrice daily; TA-bid, tegoprazan 50 mg twice daily + amoxicillin 1 g thrice daily) for 14 days. The primary outcome was noninferiority in eradication rates of the different TA groups compared to the BQT group. Secondary outcomes encompassed an assessment of adverse reactions and clinical symptom relief. Additionally, exploratory outcomes were focused on the shifts in gut microbiota and a cost-effectiveness analysis.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A total of 321 patients were enrolled. The eradication rates in the BQT group, TA-qd group, and TA-bid group were 85.05% (91/107), 85.98% (92/107), and 85.98% (92/107) in the intention-to-treat analysis (ITT) (BQT vs. TA-qd, 95% CI −8.50% to 10.36%, noninferiority <i>p</i> = 0.012; BQT vs. TA-bid, 95% CI −8.50% to 10.36%, noninferiority <i>p</i> = 0.012); 91.00% (91/100), 91.09% (92/101), and 92.93% (92/99) in the modified intention-to-treat analysis (mITT) (BQT vs. TA-qd, 95% CI −7.81% to 7.98%, noninferiority <i>p</i> = 0.006; BQT vs. TA-bid, 95% CI −5.62% to 9.48%, noninferiority <i>p</i> < 0.001); 90.81% (89/98), 91.00% (91/100), and 93.81% (91/97) in the per-protocol analysis (PP) (BQT vs. TA-qd, 95% CI −7.83% to 8.19%, noninferiority <i>p</i> = 0.006; BQT vs. TA-bid, 95% CI 4.46% to 10.46%, noninferiority <i>p</i> < 0.001). The incidence of adverse reactions in the TA-qd and TA-bid groups was significantly lower than in the BQT group (13.33%, 14.56%, and 27.18%, respectively; <i>p</i> = 0.017). The complete remissions of clinical symptoms for BQT, TA-qd, and TA-bid were 36.89%, 65.71%, and 68.93%, respectively, had significant differences (<i>p</i> < 0.001). Two weeks of TA therapy altered gut microbiota diversity and composition, but that recovered 4 weeks after discontinuation. The cost-effectiveness ratios (CERs) for BQT, TA-qd, and TA-bid were 1.85 CNY, 2.08 CNY, and 3.69 CNY, respectively.</p>\u0000 </section>\u0000 ","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"29 6","pages":""},"PeriodicalIF":4.3,"publicationDate":"2024-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142619344","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}
扫码关注我们
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号