Cheng Jianping, Zhao Xiaolin, Fan Chanjuan, Huang Kun, Cai Yong, Li Zhen, Xie Dongling, Zhai Lili, Zhang Xiaomei, Ding Haiou
Department of Gastroenterology, Civil Aviation General Hospital, Beijing, China.
Department of Gastroenterology and Hepatology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.
Front Med (Lausanne). 2025 Aug 12;12:1629567. doi: 10.3389/fmed.2025.1629567. eCollection 2025.
The identification of novel and effective treatments for () infection remains a critical need. Treatment is indicated for peptic ulcer disease, gastric MALT lymphoma, and gastric cancer prevention, following diagnosis via non-invasive testing or endoscopy. This study aimed to investigate the efficacy and safety of tegoprazan-based regimens compared to bismuth-containing quadruple therapy in eradication.
In a randomized, controlled, treatment-naïve adult patients with confirmed infection were assigned in a 1:1:1 ratio to one of the following 14-day open-label therapies: BQT (rabeprazole 10 mg twice daily, compound bismuth aluminate granules 2.6 g thrice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily), tegoprazan-based therapies (TAD, tegoprazan 50 mg twice daily, amoxicillin 1 g thrice daily; TBQT, tegoprazan 50 mg twice daily, compound bismuth aluminate granules 2.6 g thrice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily). The primary outcome was the eradication rate of . Secondary outcomes included the assessment of adverse events and treatment compliance.
A total of 468 patients were enrolled. The eradication rates for TBQT, TAD and BQT were 86.3, 85.5 and 77.2%, respectively, by intention-to-treat analysis ( = 0.059), and 87.3, 87.2 and 77.7%, respectively, by per-protocol analysis ( = 0.029). The incidence of adverse events was comparable between the BQT and tegoprazan-based therapies ( > 0.05). Treatment compliance was similar across all three groups.
Tegoprazan-based therapies achieved acceptable eradication rates exceeding 85%, outperforming the BQT. Additionally, tegoprazan-amoxicillin dual therapy may serve as an alternative eradication regimen in regions with high clarithromycin resistance.
http://clinicaltrials.gov, Identifier ChiCTR2300077088.
确定针对（）感染的新型有效治疗方法仍然是一项迫切需求。经非侵入性检测或内镜检查确诊后，针对消化性溃疡疾病、胃黏膜相关淋巴组织淋巴瘤和胃癌预防进行治疗。本研究旨在调查与含铋四联疗法相比，替戈拉赞方案在根除（）方面的疗效和安全性。
在一项随机、对照、初治的成年患者研究中，确诊为（）感染的患者按1:1:1比例分配至以下14天开放标签治疗方案之一：BQT（雷贝拉唑10毫克，每日两次；复方铝酸铋颗粒2.6克，每日三次；阿莫西林1克，每日两次；克拉霉素500毫克，每日两次），替戈拉赞方案（TAD，替戈拉赞50毫克，每日两次；阿莫西林1克，每日三次；TBQT，替戈拉赞50毫克，每日两次；复方铝酸铋颗粒2.6克，每日三次；阿莫西林1克，每日两次；克拉霉素500毫克，每日两次）。主要结局是（）的根除率。次要结局包括不良事件评估和治疗依从性。
共纳入468例患者。按意向性分析，TBQT、TAD和BQT的根除率分别为86.3%、85.5%和77.2%（=0.059），按符合方案分析分别为87.3%、87.2%和77.7%（=0.029）。BQT与替戈拉赞方案之间不良事件发生率相当（>0.05）。所有三组的治疗依从性相似。
基于替戈拉赞的治疗方案实现了超过85%的可接受根除率，优于BQT。此外，在克拉霉素耐药率高的地区，替戈拉赞 - 阿莫西林双联疗法可作为替代的（）根除方案。
