To compare the potential efficacy and safety of dual therapy and quadruple therapy with vonoprazan (VPZ) as well as the standard quadruple therapy of proton pump inhibitor (PPI) for the eradication of Helicobacter pylori (Hp) infection in Hainan province. A single-centre, non-blinded, non-inferiority randomized controlled trial was conducted at the outpatient department of gastroenterology at the Second Affiliated Hospital of Hainan Medical University from June 2022 to February 2023. 135 patients aged 18–75 years with Hp infection were enrolled and randomized into three different groups (group V1: VPZ 20 mg twice a day and amoxicillin 1.0 g three times a day for 14 days V2: vonoprazan 20 mg, amoxicillin capsules 1.0 g, furazolidone 0.1 g and bismuth potassiulm citrate 240 mg, twice daily for 14 days;; group V3: ilaprazole 5 mg, Amoxicillin 1.0 g, Furazolidone 100 mg, bismuth potassiulm citrate 240 mg, twice a day for 14 days). Four weeks after the end of treatment, Hp eradication was confirmed by rechecking 13C-urea breath test (UBT). The eradication efficacy of V1 and V3 was non-inferior to that of V2, which is consistent with the results obtained from the Kruskal-Wallis H test. The eradication rate by intentional analysis was 84.4% (38/45, 95%CI 73.4%–95.5%, P>0.05) for all the three groups. If analyzed by per-protocol, the eradication rates were 88.4% (38/43, 95%CI 78.4%–98.4%), 92.7% (38/41, 95%CI 84.4%–101.0%),88.4% (38/43，95%CI 78.4%–98.4%) in groups V1, V2 and V3, respectively, which did not show a significant difference (P > 0.05). The incidence of adverse effects was significantly lower in VPZ dual therapy compared to the other two treatment regimens (P < 0.05). VPZ dual therapy or quadruple therapy was also relatively less costly than standard quadruple therapy. VPZ dual therapy and quadruple therapy shows promise of not being worse than the standard quadruple therapy by a clinically relevant margin. More studies might be needed to definitively determine if the new therapy is equally effective or even superior.

中文翻译：

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海南地区沃诺拉赞双联疗法、四联疗法与标准四联疗法治疗幽门螺杆菌感染的比较：单中心、开放、非劣效性、随机对照试验

比较沃诺拉赞（VPZ）双重疗法和四联疗法以及质子泵抑制剂（PPI）标准四联疗法根除海南省幽门螺杆菌（Hp）感染的潜在疗效和安全性。 2022年6月至2023年2月在海南医科大学第二附属医院消化内科门诊进行的单中心、非盲法、非劣效性随机对照试验，纳入135例年龄18~75岁的Hp感染患者。入组并随机分为三个不同组（V1 组：VPZ 20 mg 每天两次，阿莫西林 1.0 g 每天 3 次，持续 14 天 V2：沃诺拉赞 20 mg、阿莫西林胶囊 1.0 g、呋喃唑酮 0.1 g 和柠檬酸铋钾 240 mg，两次每天一次，持续14天；；V3组：艾普拉唑5mg，阿莫西林1.0g，呋喃唑酮100mg，柠檬酸铋钾240mg，每天两次，持续14天）。治疗结束后 4 周，通过重新检查 13C-尿素呼气试验 (UBT) 确认 Hp 根除。 V1和V3的根除效果不劣于V2，这与Kruskal-Wallis H检验的结果一致。通过意向分析，三组的根除率为84.4%（38/45，95%CI 73.4%–95.5%，P>0.05）。如果按方案分析，根除率为 88.4% (38/43, 95% CI 78.4%–98.4%)、92.7% (38/41, 95% CI 84.4%–101.0%)、88.4% (38/ V1、V2、V3 组分别为 43，95%CI 78.4%–98.4%），差异无显着性（P > 0.05）。与其他两种治疗方案相比，VPZ双重治疗的不良反应发生率显着降低（P < 0.05）。 VPZ 双重疗法或四联疗法的成本也比标准四联疗法相对便宜。 VPZ 双重疗法和四联疗法显示出在临床相关边缘上不会比标准四联疗法更差的前景。可能需要更多的研究来明确确定新疗法是否同样有效甚至更优越。