Department of Gastroenterology, The Affiliated Changzhou No. 2 People's Hospital of Nanjing Medical University, 29 Xinglong Lane, Tianning District, Changzhou, Jiangsu Province, 213000, China.
Graduate School, Dalian Medical University, 9 West Section of Lushun South Road, Lvshunkou District, Dalian, Liaoning Province, 116000, China.
BMC Gastroenterol. 2024 Nov 26;24(1):430. doi: 10.1186/s12876-024-03524-0.
Currently, Vonoprazan (VPZ) and amoxicillin dual regimen (VA-dual) has not achieved satisfied efficacy as the first-line treatment for Helicobacter pylori (H. pylori) infection in China. Thus, we aimed to determine the effect of VA-dual plus Saccharomyces boulardii (S. boulardii) on H. pylori eradication rate.
Naive H. pylori-infected patients were randomly allocated to the ECAB group [20-mg esomeprazole, 500-mg clarithromycin, 1000-mg amoxicillin, and 220-mg bismuth twice/day for 14 days] or the VAS group [20-mg VPZ twice/day, 750-mg amoxicillin three times/day, and 250-mg S. boulardii twice/day for 10 days]. Factors associated with eradication success were explored, and cost-effectiveness analyses were also performed.
Herein, 126 patients were finally included and randomly assigned to the two groups in a 1:1 ratio. The H. pylori eradication rates of VAS and ECAB groups by intention-to-treat analysis were 87.3% and 88.9% (P = 1.000) and by per-protocol analysis were 87.3% and 91.8% (P = 0.560), respectively. The ECAB group had a significantly higher incidence of adverse events than the VAS group. Superior H. pylori eradication in the VAS group was related to small body surface area and being a non-smoker. The cost-effectiveness ratio of the VAS group was less than that of the ECAB group.
Addition of S. boulardii to VA-dual for 10 days is as effective as the 14-days bismuth-based quadruple regimen while ensuring fewer adverse events and lesser cost. This regimen is particularly suitable for low-BSA patients or non-smokers.
Chinese Clinical trial Registry No. ChiCTR2100055101 31/12/2021.
目前，沃诺拉赞（VPZ）和阿莫西林双联方案（VA-双联）在中国尚未作为幽门螺杆菌（H. pylori）感染的一线治疗达到满意的疗效。因此，我们旨在确定 VA-双联加布拉氏酵母菌（S. boulardii）对 H. pylori 根除率的影响。
将未经治疗的 H. pylori 感染患者随机分配至 ECAB 组[20mg 埃索美拉唑、500mg 克拉霉素、1000mg 阿莫西林和 220mg 次水杨酸铋每日 2 次，连用 14 天]或 VAS 组[20mg VPZ 每日 2 次、750mg 阿莫西林每日 3 次和 250mg S. boulardii 每日 2 次，连用 10 天]。探索与根除成功相关的因素，并进行成本效益分析。
共有 126 例患者最终被纳入研究并按 1:1 比例随机分配至两组。意向治疗分析中 VAS 组和 ECAB 组的 H. pylori 根除率分别为 87.3%和 88.9%（P=1.000），按方案分析分别为 87.3%和 91.8%（P=0.560）。ECAB 组不良反应发生率明显高于 VAS 组。VAS 组 H. pylori 根除率较高与较小的体表面积和不吸烟有关。VAS 组的成本效益比低于 ECAB 组。
VA-双联加用布拉氏酵母菌 10 天与 14 天铋剂四联方案同样有效，同时可减少不良反应和降低成本。该方案特别适用于低体表面积患者或不吸烟者。
中国临床试验注册中心，ChiCTR2100055101，31/12/2021。
