Division of Gastroenterology and Hepatology, Department of Medicine, Rajavithi Hospital, College of Medicine, Rangsit University, Bangkok, Thailand.
J Gastroenterol Hepatol. 2021 Dec;36(12):3308-3313. doi: 10.1111/jgh.15700. Epub 2021 Oct 13.
Vonoprazan has more potent and sustained acid inhibitory effects than proton pump inhibitors; therefore, Helicobacter pylori eradication rates are expected to improve with the use of vonoprazan-based regimens. To date, no randomized trial has compared the efficacy of 7-day vonoprazan-based triple therapy (7-VAC) with 14-day omeprazole-based triple therapy (14-OAC). This study aimed to compare the H. pylori eradication rates of 7-VAC and 14-OAC.
This randomized clinical trial was performed at a tertiary hospital in Bangkok. Patients with active H. pylori infection who were naive to treatment were included and randomized (1:1) into either a 7-VAC group (vonoprazan 20 mg bid. pc., amoxicillin 1000 mg bid. pc., and clarithromycin 500 mg bid. pc.) or a 14-OAC group (omeprazole 20 mg bid. ac., amoxicillin 1000 mg bid. pc., and clarithromycin 500 mg bid. pc.). Eradication success was evaluated by urea breath test 4-6 weeks after completion of treatment.
A total of 122 subjects were randomized to receive 7-VAC (n = 61) or 14-OAC (n = 61). The H. pylori eradication rates of the 7-VAC and 14-OAC groups were 96.7% and 88.5% (P = 0.083), respectively, by intention-to-treat analysis and 98.3% and 93.1% (P = 0.159), respectively, by per-protocol analysis. All treatment-related adverse events were mild and not significantly different between the two groups. Common side effects included bitter taste, nausea, and dizziness.
The 7-VAC regimen was well tolerated and achieved similar eradication rates and side effects to those of 14-OAC; therefore, 7-VAC may be considered an alternative regimen for H. pylori treatment with the benefit of shorter duration.
沃诺拉赞具有比质子泵抑制剂更强且持续的抑酸作用；因此，预计使用沃诺拉赞为基础的治疗方案可提高幽门螺杆菌的根除率。迄今为止，尚无随机试验比较 7 天沃诺拉赞三联疗法（7-VAC）与 14 天奥美拉唑三联疗法（14-OAC）的疗效。本研究旨在比较 7-VAC 和 14-OAC 的幽门螺杆菌根除率。
本随机临床试验在曼谷的一家三级医院进行。纳入初治的幽门螺杆菌感染活动期患者，并按 1:1 比例随机分为 7-VAC 组（沃诺拉赞 20mg，bid. pc.，阿莫西林 1000mg，bid. pc.，克拉霉素 500mg，bid. pc.）或 14-OAC 组（奥美拉唑 20mg，bid. ac.，阿莫西林 1000mg，bid. pc.，克拉霉素 500mg，bid. pc.）。治疗结束后 4-6 周通过尿素呼气试验评估根除成功。
共有 122 名患者被随机分配接受 7-VAC（n=61）或 14-OAC（n=61）治疗。意向治疗分析显示，7-VAC 组和 14-OAC 组的幽门螺杆菌根除率分别为 96.7%和 88.5%（P=0.083），按方案分析分别为 98.3%和 93.1%（P=0.159）。所有与治疗相关的不良事件均为轻度，两组间无显著差异。常见的副作用包括口苦、恶心和头晕。
7-VAC 方案耐受性良好，其根除率和副作用与 14-OAC 相当；因此，7-VAC 可能是一种替代幽门螺杆菌治疗方案，具有较短疗程的优势。
