Ting Jin, Wei Wu, Lei Zhang, Han Xuan, Haixiang Zhang, Li Zhong
{"title":"Vonoprazan和Tegoprazan根除幽门螺杆菌的有效性和安全性：一项随机对照试验的综合系统评价和荟萃分析。","authors":"Ting Jin, Wei Wu, Lei Zhang, Han Xuan, Haixiang Zhang, Li Zhong","doi":"10.1177/17562848251314801","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Potassium-competitive acid blocker (P-CAB)-based therapies are emerging as promising alternatives for eradicating <i>Helicobacter pylori</i> infection. However, the comparative efficacy of P-CAB-based therapy versus proton-pump inhibitor (PPI)-based therapy in treating <i>H. pylori</i> infection remains uncertain.</p><p><strong>Objectives: </strong>This meta-analysis evaluated the efficacy and safety of P-CAB-based therapies, including Vonoprazan (VPZ) and Tegoprazan (TPZ), compared to PPI-based therapies for <i>H. pylori</i> infection. Subgroup analysis assessed the influence of drug history, experimental drug, treatment duration, combination therapies, and geographic regions on treatment outcomes.</p><p><strong>Design: </strong>Meta-analysis.</p><p><strong>Data sources and methods: </strong>Comprehensive searches were conducted in major databases, including PubMed, Embase, the Cochrane Library, and Web of Science, up to January 1, 2024. The primary outcome was the eradication rate, analyzed by intention-to-treat (ITT). Secondary outcomes included adverse events. Heterogeneity among studies was assessed using the χ<sup>2</sup> test and the <i>I</i> <sup>2</sup> test. <i>I</i> <sup>2</sup> > 50% or <i>p</i> < 0.05 indicated significant heterogeneity.</p><p><strong>Results: </strong>The analysis totally included 28 randomized controlled trials (RCTs) comprising 37 studies and 8818 patients diagnosed with <i>H. pylori</i> infection. Of these, 14 RCTs, including 20 studies and 4286 patients, compared P-CAB-based therapy with 14-day bismuth-based quadruple therapy (BQT). P-CAB-based therapy exhibited superior eradication rates compared to both 14-day BQT and PPI-based therapy (ITT analysis: 87.0% vs 79.8%, risk ratio (RR) = 1.08, 95% CI: 1.04-1.12, <i>p</i> < 0.0001; and 85.6% vs 77.8%, RR = 1.09, 95% CI: 1.05-1.12, <i>p</i> < 0.00001, respectively). This enhanced efficacy was particularly pronounced in patients with clarithromycin-resistant infections (73.7% vs 41.5%, RR = 1.53, 95% CI: 1.07-2.20, <i>p</i> = 0.02). Subgroup analysis demonstrated higher eradication rates with P-CAB-based therapy in treatment-naïve participants, VPZ recipients, and those receiving 7- or 14-day regimens (dual, triple, or quadruple therapy). However, no significant differences were observed in treatment-experienced subgroups, TPZ recipients, or those on 10-day regimens. In addition, P-CAB-based therapy showed a lower incidence of adverse events than PPI-based treatments (RR = 0.73, 95% CI: 0.63-0.86, <i>p</i> < 0.0001).</p><p><strong>Conclusion: </strong>P-CAB-based therapies are more effective than traditional PPI-based treatments for eradicating <i>H. pylori</i> infection, with a reduced incidence of adverse events.</p><p><strong>Prospero registration: </strong>CRD42024503665.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251314801"},"PeriodicalIF":3.9000,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11783504/pdf/","citationCount":"0","resultStr":"{\"title\":\"The efficacy and safety of Vonoprazan and Tegoprazan in <i>Helicobacter pylori</i> eradication: a comprehensive systematic review and meta-analysis of randomized controlled trials.\",\"authors\":\"Ting Jin, Wei Wu, Lei Zhang, Han Xuan, Haixiang Zhang, Li Zhong\",\"doi\":\"10.1177/17562848251314801\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Potassium-competitive acid blocker (P-CAB)-based therapies are emerging as promising alternatives for eradicating <i>Helicobacter pylori</i> infection. However, the comparative efficacy of P-CAB-based therapy versus proton-pump inhibitor (PPI)-based therapy in treating <i>H. pylori</i> infection remains uncertain.</p><p><strong>Objectives: </strong>This meta-analysis evaluated the efficacy and safety of P-CAB-based therapies, including Vonoprazan (VPZ) and Tegoprazan (TPZ), compared to PPI-based therapies for <i>H. pylori</i> infection. Subgroup analysis assessed the influence of drug history, experimental drug, treatment duration, combination therapies, and geographic regions on treatment outcomes.</p><p><strong>Design: </strong>Meta-analysis.</p><p><strong>Data sources and methods: </strong>Comprehensive searches were conducted in major databases, including PubMed, Embase, the Cochrane Library, and Web of Science, up to January 1, 2024. The primary outcome was the eradication rate, analyzed by intention-to-treat (ITT). Secondary outcomes included adverse events. Heterogeneity among studies was assessed using the χ<sup>2</sup> test and the <i>I</i> <sup>2</sup> test. <i>I</i> <sup>2</sup> > 50% or <i>p</i> < 0.05 indicated significant heterogeneity.</p><p><strong>Results: </strong>The analysis totally included 28 randomized controlled trials (RCTs) comprising 37 studies and 8818 patients diagnosed with <i>H. pylori</i> infection. Of these, 14 RCTs, including 20 studies and 4286 patients, compared P-CAB-based therapy with 14-day bismuth-based quadruple therapy (BQT). P-CAB-based therapy exhibited superior eradication rates compared to both 14-day BQT and PPI-based therapy (ITT analysis: 87.0% vs 79.8%, risk ratio (RR) = 1.08, 95% CI: 1.04-1.12, <i>p</i> < 0.0001; and 85.6% vs 77.8%, RR = 1.09, 95% CI: 1.05-1.12, <i>p</i> < 0.00001, respectively). This enhanced efficacy was particularly pronounced in patients with clarithromycin-resistant infections (73.7% vs 41.5%, RR = 1.53, 95% CI: 1.07-2.20, <i>p</i> = 0.02). Subgroup analysis demonstrated higher eradication rates with P-CAB-based therapy in treatment-naïve participants, VPZ recipients, and those receiving 7- or 14-day regimens (dual, triple, or quadruple therapy). However, no significant differences were observed in treatment-experienced subgroups, TPZ recipients, or those on 10-day regimens. In addition, P-CAB-based therapy showed a lower incidence of adverse events than PPI-based treatments (RR = 0.73, 95% CI: 0.63-0.86, <i>p</i> < 0.0001).</p><p><strong>Conclusion: </strong>P-CAB-based therapies are more effective than traditional PPI-based treatments for eradicating <i>H. pylori</i> infection, with a reduced incidence of adverse events.</p><p><strong>Prospero registration: </strong>CRD42024503665.</p>\",\"PeriodicalId\":48770,\"journal\":{\"name\":\"Therapeutic Advances in Gastroenterology\",\"volume\":\"18 \",\"pages\":\"17562848251314801\"},\"PeriodicalIF\":3.9000,\"publicationDate\":\"2025-01-31\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11783504/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Therapeutic Advances in Gastroenterology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/17562848251314801\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic Advances in Gastroenterology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/17562848251314801","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
背景：以钾竞争酸阻滞剂（P-CAB）为基础的治疗方法正在成为根除幽门螺杆菌感染的有希望的替代方法。然而，以p - cab为基础的治疗与以质子泵抑制剂（PPI）为基础的治疗幽门螺杆菌感染的比较疗效仍不确定。目的：本荟萃分析评估了基于p - cab的治疗方法，包括Vonoprazan （VPZ）和Tegoprazan (TPZ)，与基于ppi的治疗方法相比，治疗幽门螺杆菌感染的有效性和安全性。亚组分析评估了药物史、实验药物、治疗时间、联合治疗和地理区域对治疗结果的影响。设计:荟萃分析。数据来源和方法：综合检索PubMed、Embase、Cochrane Library、Web of Science等主要数据库，检索时间截止到2024年1月1日。主要终点是根除率，通过意向治疗（ITT）进行分析。次要结局包括不良事件。采用χ2检验和I 2检验评价各研究间的异质性。结果：该分析共纳入28项随机对照试验（RCTs），包括37项研究和8818例诊断为幽门螺杆菌感染的患者。其中，14项随机对照试验，包括20项研究和4286名患者，比较了基于p - cab的治疗和14天基于铋的四联治疗（BQT）。与14天BQT和基于ppi的治疗相比，基于p - cab的治疗显示出更高的根除率（ITT分析：87.0% vs 79.8%，风险比(RR) = 1.08, 95% CI: 1.04-1.12, p p p = 0.02）。亚组分析表明，在treatment-naïve参与者、VPZ接受者和接受7天或14天方案（双、三联或四联治疗）的患者中，p - cab为基础的治疗根除率更高。然而，在治疗经历亚组，TPZ接受者或10天方案中没有观察到显着差异。此外，p - cab为基础治疗的不良事件发生率低于ppi为基础治疗（RR = 0.73, 95% CI: 0.63-0.86, p）。结论：p - cab为基础治疗在根除幽门螺杆菌感染方面比传统的ppi为基础治疗更有效，不良事件发生率降低。普洛斯彼罗注册：CRD42024503665。
The efficacy and safety of Vonoprazan and Tegoprazan in Helicobacter pylori eradication: a comprehensive systematic review and meta-analysis of randomized controlled trials.
Background: Potassium-competitive acid blocker (P-CAB)-based therapies are emerging as promising alternatives for eradicating Helicobacter pylori infection. However, the comparative efficacy of P-CAB-based therapy versus proton-pump inhibitor (PPI)-based therapy in treating H. pylori infection remains uncertain.
Objectives: This meta-analysis evaluated the efficacy and safety of P-CAB-based therapies, including Vonoprazan (VPZ) and Tegoprazan (TPZ), compared to PPI-based therapies for H. pylori infection. Subgroup analysis assessed the influence of drug history, experimental drug, treatment duration, combination therapies, and geographic regions on treatment outcomes.
Design: Meta-analysis.
Data sources and methods: Comprehensive searches were conducted in major databases, including PubMed, Embase, the Cochrane Library, and Web of Science, up to January 1, 2024. The primary outcome was the eradication rate, analyzed by intention-to-treat (ITT). Secondary outcomes included adverse events. Heterogeneity among studies was assessed using the χ2 test and the I2 test. I2 > 50% or p < 0.05 indicated significant heterogeneity.
Results: The analysis totally included 28 randomized controlled trials (RCTs) comprising 37 studies and 8818 patients diagnosed with H. pylori infection. Of these, 14 RCTs, including 20 studies and 4286 patients, compared P-CAB-based therapy with 14-day bismuth-based quadruple therapy (BQT). P-CAB-based therapy exhibited superior eradication rates compared to both 14-day BQT and PPI-based therapy (ITT analysis: 87.0% vs 79.8%, risk ratio (RR) = 1.08, 95% CI: 1.04-1.12, p < 0.0001; and 85.6% vs 77.8%, RR = 1.09, 95% CI: 1.05-1.12, p < 0.00001, respectively). This enhanced efficacy was particularly pronounced in patients with clarithromycin-resistant infections (73.7% vs 41.5%, RR = 1.53, 95% CI: 1.07-2.20, p = 0.02). Subgroup analysis demonstrated higher eradication rates with P-CAB-based therapy in treatment-naïve participants, VPZ recipients, and those receiving 7- or 14-day regimens (dual, triple, or quadruple therapy). However, no significant differences were observed in treatment-experienced subgroups, TPZ recipients, or those on 10-day regimens. In addition, P-CAB-based therapy showed a lower incidence of adverse events than PPI-based treatments (RR = 0.73, 95% CI: 0.63-0.86, p < 0.0001).
Conclusion: P-CAB-based therapies are more effective than traditional PPI-based treatments for eradicating H. pylori infection, with a reduced incidence of adverse events.
期刊介绍：
Therapeutic Advances in Gastroenterology is an open access journal which delivers the highest quality peer-reviewed original research articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of gastrointestinal and hepatic disorders. The journal has a strong clinical and pharmacological focus and is aimed at an international audience of clinicians and researchers in gastroenterology and related disciplines, providing an online forum for rapid dissemination of recent research and perspectives in this area.
The editors welcome original research articles across all areas of gastroenterology and hepatology.
The journal publishes original research articles and review articles primarily. Original research manuscripts may include laboratory, animal or human/clinical studies – all phases. Letters to the Editor and Case Reports will also be considered.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
