10天伏诺拉生-阿莫西林双联疗法与14天埃索美拉唑-阿莫西林双联疗法用于一线根除治疗：一项前瞻性多中心随机对照试验。
Ten-day vonoprazan-amoxicillin dual therapy versus 14-day esomeprazole-amoxicillin dual therapy for first-line eradication: a prospective multicenter randomized controlled trial.
作者信息
Zhou Ben-Gang, Guo Ming-Wen, Zhang Li-Juan, Liu Zhi-Dong, Liu Chun-Hua, Li Xue-Feng, Li Shun-Song, Xiao Peng, Bao Bing, Ai Yao-Wei, Ding Yan-Bing
机构信息
Dalian Medical University, Dalian, Liaoning, China.
Department of Gastroenterology, Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, Jiangsu, China.
出版信息
Therap Adv Gastroenterol. 2024 Dec 27;17:17562848241309870. doi: 10.1177/17562848241309870. eCollection 2024.
BACKGROUND
The efficacy of the 14-day esomeprazole-amoxicillin (EA) dual therapy in eradicating () has been widely discussed previously. Vonoprazan, a novel potassium-competitive acid blocker, presents rapid, potent, and long-lasting acid inhibitory effects compared to esomeprazole. However, there is currently a scarcity of direct comparisons between the 10-day vonoprazan-amoxicillin (VA) and the 14-day EA dual therapy for eradication.
OBJECTIVES
This study aimed to compare the efficacy and safety of the 10-day VA and the 14-day EA dual therapy for first-line eradication.
DESIGN
This study was a prospective, multicenter, open-label, randomized controlled trial.
METHODS
The study was conducted at 10 hospitals in China. In total, 570 newly diagnosed -infected patients were recruited from April 2023 to February 2024. These patients were randomly assigned to either the 10-day VA group (vonoprazan 20 mg twice daily + amoxicillin 1000 mg three times daily) or the 14-day EA group (esomeprazole 20 mg four times daily + amoxicillin 750 mg four times daily). The primary outcome was the eradication rate, with secondary outcomes including adverse events and compliance.
RESULTS
The 10-day VA regimen outperformed the 14-day EA regimen in terms of eradication rates in intention-to-treat (ITT) analysis (85.4% vs 76.7%, = 0.008), modified ITT analysis (90.7% vs 84.8%, = 0.036), and per-protocol (PP) analysis (91.1% versus 85.5%, = 0.047). The non-inferiority -values in all three analyses were less than 0.001. No statistically significant difference was observed in the incidence of adverse events between the two groups (9.1% vs 11.7%, = 0.308). The 10-day VA regimen demonstrated higher compliance compared to the 14-day EA regimen ( = 0.006).
CONCLUSION
The 10-day VA dual therapy showed a satisfactory eradication rate of 91.1% (PP analysis), demonstrating good safety and better compliance compared to the 14-day EA dual therapy as the first-line eradication.
TRIAL REGISTRATION
This trial was registered in the Chinese Clinical Trial Registry (registration number: ChiCTR2300070475) on April 12, 2023.
背景
14天的埃索美拉唑-阿莫西林（EA）双联疗法根除（）的疗效此前已被广泛讨论。沃克拉唑是一种新型钾离子竞争性酸阻滞剂，与埃索美拉唑相比，具有快速、强效和持久的酸抑制作用。然而，目前对于10天的沃克拉唑-阿莫西林（VA）双联疗法与14天的EA双联疗法在根除方面缺乏直接比较。
目的
本研究旨在比较10天的VA和14天的EA双联疗法一线根除的疗效和安全性。
设计
本研究是一项前瞻性、多中心、开放标签、随机对照试验。
方法
该研究在中国的10家医院进行。2023年4月至2024年2月共招募了570例新诊断的（）感染患者。这些患者被随机分配到10天的VA组（沃克拉唑20mg每日两次 + 阿莫西林1000mg每日三次）或14天的EA组（埃索美拉唑20mg每日四次 + 阿莫西林750mg每日四次）。主要结局是根除率，次要结局包括不良事件和依从性。
结果
在意向性分析（ITT）中，10天的VA方案在根除率方面优于14天的EA方案（85.4% 对76.7%， = 0.008），在改良ITT分析中（90.7% 对84.8%， = 0.036），以及在符合方案（PP）分析中（91.1% 对85.5%， = 0.047）。三项分析中的非劣效性值均小于0.001。两组之间不良事件的发生率未观察到统计学上的显著差异（9.1% 对11.7%， = 0.308）。10天的VA方案与14天的EA方案相比显示出更高的依从性（ = 0.006）。
结论
10天的VA双联疗法显示出令人满意的根除率，为91.1%（PP分析），作为一线根除疗法，与14天的EA双联疗法相比，具有良好的安全性和更好的依从性。
试验注册
本试验于2023年4月12日在中国临床试验注册中心注册（注册号：ChiCTR2300070475）。
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