Tegoprazan-Amoxicillin Dual Therapy for Helicobacter pylori Eradication: A Prospective, Randomized, Multicenter Study in Fujian, China

IF 4.3 2区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Helicobacter Pub Date : 2024-11-10 DOI:10.1111/hel.13151

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

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引用次数: 0

Abstract

Introduction

Few studies have investigated the efficacy and safety of tegoprazan-amoxicillin (TA) dual therapy for Helicobacter pylori eradication. We aim to evaluate the effectiveness and safety of different dosages of TA dual therapy for H. pylori eradication.

Methods

This prospective, randomized, open-label, multicenter study was conducted at four centers in Fujian, China. H. pylori-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.

Results

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 p = 0.012; BQT vs. TA-bid, 95% CI −8.50% to 10.36%, noninferiority p = 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 p = 0.006; BQT vs. TA-bid, 95% CI −5.62% to 9.48%, noninferiority p < 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 p = 0.006; BQT vs. TA-bid, 95% CI 4.46% to 10.46%, noninferiority p < 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; p = 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 (p < 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.

Conclusion

Both TA dual therapies provided satisfactory eradication rates of > 90% for eradicating H. pylori, fewer adverse reactions, and greater clinical symptom relief compared to BQT, with a mild, reversible impact on gut microbiota. In addition, the TA dual therapy with low doses of tegoprazan showed better cost-effectiveness.

Trial Registration

Chinese Clinical Trial Register and registration No.: ChiCTR2300071997

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替戈普拉赞-阿莫西林双重疗法根除幽门螺旋杆菌：中国福建的一项前瞻性、随机、多中心研究。

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。

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来源期刊

Helicobacter 医学-微生物学

CiteScore

8.40

自引率

9.10%

发文量

审稿时长

2 months

期刊介绍： Helicobacter is edited by Professor David Y Graham. The editorial and peer review process is an independent process. Whenever there is a conflict of interest, the editor and editorial board will declare their interests and affiliations. Helicobacter recognises the critical role that has been established for Helicobacter pylori in peptic ulcer, gastric adenocarcinoma, and primary gastric lymphoma. As new helicobacter species are now regularly being discovered, Helicobacter covers the entire range of helicobacter research, increasing communication among the fields of gastroenterology; microbiology; vaccine development; laboratory animal science.