Department of Gastroenterology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Helicobacter. 2023 Feb;28(1):e12940. doi: 10.1111/hel.12940. Epub 2022 Dec 1.
Although vonoprazan has been proven to be a highly potent drug for Helicobacter pylori eradication, there have been no randomized trials comparing the effectiveness of regimens containing vonoprazan 20 mg daily with alternative standard strategies. We aimed to assess the efficacy, tolerance, and cost-effectiveness of quadruple therapy with vonoprazan 20 mg daily as a first-line therapy for H. pylori eradication.
We conducted a single-center, open-label, noninferiority, randomized controlled study in Zhejiang, China. Treatment-naive H. pylori-positive participants (n = 234) were randomly assigned to three groups in a 1:1:1 ratio: vonoprazan 20 mg daily with amoxicillin 1000 mg, furazolidone 100 mg and colloidal bismuth 200 mg each given twice a day for 10 days (V10) or 14 days (V14), or esomeprazole 20 mg with amoxicillin 1000 mg, furazolidone 100 mg and colloidal bismuth 200 mg each given twice a day for 14 days (E14). The primary endpoint was the eradication rates in each group. The secondary endpoints were the incidence of adverse events (AEs) and compliance.
The eradication rates in the V10, V14 and E14 groups were 96.2% (89.2-99.2%), 94.9% (87.4-98.6%), and 93.6% (85.7-97.9%) in the intention-to-treat analysis, and 98.6% (92.7-100.0%), 97.4% (90.8-99.7%), and 94.8% (87.2-98.6%) in the per-protocol analysis, respectively. Quadruple therapy with vonoprazan 20 mg daily was noninferior to the esomeprazole-based regimen (Farrington and Manning test: margin 10%, significance level 2.5%). The adverse event rates were 12.8% versus 3.8% versus 6.4% in the V10, V14, and E14 groups, respectively. All regimens were well tolerated without significant differences (p = 0.096). The cost-effectiveness ratio was 1.32, 1.88, and 3.06 for the V10, V14, and E14 groups in the intention-to-treat analysis, respectively. (NCT04907747).
Vonoprazan (20 mg daily) was as effective as esomeprazole (20 mg twice a day) in quadruple therapies for the eradication of H. pylori, was more economical, and was well tolerated. In addition, the 10-day regimen of vonoprazan (20 mg daily) was comparable to the 14-day regimen.
沃诺拉赞已被证明是一种高效的幽门螺杆菌根除药物，但尚无随机试验比较含沃诺拉赞 20mg 每日剂量的方案与替代标准策略的疗效。我们旨在评估沃诺拉赞 20mg 每日剂量作为幽门螺杆菌根除的一线治疗的疗效、耐受性和成本效益。
我们在中国浙江进行了一项单中心、开放标签、非劣效性、随机对照研究。未经治疗的幽门螺杆菌阳性参与者（n=234）以 1:1:1 的比例随机分为三组：沃诺拉赞 20mg 每日剂量联合阿莫西林 1000mg、呋喃唑酮 100mg 和胶体次枸橼酸铋 200mg，每日两次，持续 10 天（V10）或 14 天（V14），或埃索美拉唑 20mg 联合阿莫西林 1000mg、呋喃唑酮 100mg 和胶体次枸橼酸铋 200mg，每日两次，持续 14 天（E14）。主要终点是每组的根除率。次要终点是不良事件（AE）发生率和依从性。
V10、V14 和 E14 组的根除率在意向治疗分析中分别为 96.2%（89.2-99.2%）、94.9%（87.4-98.6%）和 93.6%（85.7-97.9%），在符合方案分析中分别为 98.6%（92.7-100.0%）、97.4%（90.8-99.7%）和 94.8%（87.2-98.6%）。沃诺拉赞 20mg 每日剂量的四联疗法与埃索美拉唑为基础的方案无差异（法林顿和曼宁检验：差值 10%，显著性水平 2.5%）。V10、V14 和 E14 组的不良事件发生率分别为 12.8%、3.8%和 6.4%。所有方案均耐受良好，无显著差异（p=0.096）。在意向治疗分析中，V10、V14 和 E14 组的成本效益比分别为 1.32、1.88 和 3.06。（NCT04907747）。
沃诺拉赞（每日 20mg）与埃索美拉唑（每日 2 次 20mg）在四联疗法根除幽门螺杆菌方面同样有效，且更经济，耐受性更好。此外，沃诺拉赞（每日 20mg）的 10 天疗程与 14 天疗程相当。
