Department of Gastroenterology, Digestive Disease Hospital, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, China.
Department of Surgery, The Chinese University of Hong Kong, Shatin, China.
Helicobacter. 2024 Jan-Feb;29(1):e13045. doi: 10.1111/hel.13045.
We previously optimized the duration and dose of vonoprazan and amoxicillin dual therapy in China. The efficacy of vonoprazan with b.i.d. amoxicillin in comparison with vonoprazan-containing quadruple therapy as the first-line treatment of Helicobacter pylori infection has not been adequately evaluated.
In a non-inferiority, randomized clinical trial, H. pylori infected and treatment-naïve patients were randomly assigned to receive 14 days of either vonoprazan dual (vonoprazan 20 mg and amoxicillin 1 g twice daily) or quadruple therapy (vonoprazan 20 mg + amoxicillin 1 g + furazolidone 100 mg + bismuth potassium citrate 600 mg twice daily). H. pylori status was confirmed using C-urea breath tests or fecal antigen test. The primary outcome was the H. pylori eradication rate following vonoprazan dual and quadruple therapy at 4-12 weeks. We also compared drug compliance to either regimen and documented their side effect.
A total of 190 subjects were randomized. The eradication rate of vonoprazan dual and quadruple therapy were 87.4% and 92.6% (p = 0.23) by intention-to-treat analysis, respectively, and 96.5% and 97.7% (p = 0.63) by per-protocol analysis, respectively. The efficacy of vonoprazan dual therapy was non-inferior to vonoprazan-containing quadruple therapy in per-protocol analysis (p < 0.001; difference: -1.2%; 90% confidence interval: -5.4% to 3.0%).
Vonoprazan with b.i.d. amoxicillin for 14 days provided similar satisfactory efficacy with vonoprazan-containing quadruple therapy as a first-line H. pylori treatment in China.
我们之前在中国优化了沃诺拉赞和阿莫西林双联疗法的疗程和剂量。沃诺拉赞联合每日 2 次阿莫西林与包含沃诺拉赞的四联疗法作为幽门螺杆菌感染的一线治疗相比，其疗效尚未得到充分评估。
在一项非劣效性、随机临床试验中，感染幽门螺杆菌且未经治疗的患者被随机分配接受 14 天的沃诺拉赞双联（沃诺拉赞 20mg 和阿莫西林 1g 每日 2 次）或四联疗法（沃诺拉赞 20mg+阿莫西林 1g+呋喃唑酮 100mg+枸橼酸铋钾 600mg 每日 2 次）治疗。使用 C-尿素呼气试验或粪便抗原试验确认幽门螺杆菌状态。主要结局是 4-12 周后沃诺拉赞双联和四联疗法的幽门螺杆菌根除率。我们还比较了两种方案的药物依从性，并记录了它们的副作用。
共有 190 名受试者被随机分配。意向治疗分析中，沃诺拉赞双联和四联疗法的根除率分别为 87.4%和 92.6%（p=0.23），按方案分析分别为 96.5%和 97.7%（p=0.63）。按方案分析，沃诺拉赞双联疗法的疗效不劣于含沃诺拉赞的四联疗法（p<0.001；差值：-1.2%；90%置信区间：-5.4%至 3.0%）。
沃诺拉赞联合每日 2 次阿莫西林治疗 14 天与包含沃诺拉赞的四联疗法作为中国幽门螺杆菌感染的一线治疗方案，疗效相似，令人满意。
