Department Of Gastroenterology, Digestive Disease Hospital, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China.
JiangXi Clinical Research Center for Gastroenterology, Nanchang, Jiangxi, China.
Front Immunol. 2023 Jan 13;13:1049908. doi: 10.3389/fimmu.2022.1049908. eCollection 2022.
We previously reported that vonoprazan-amoxicillin (VA) dual therapy for 7 or 10 days is not satisfactorily efficacious for () eradication. We aimed to explore the efficacy of VA dual therapy for 14 days as a first-line treatment for infection.
This was a single center, prospective, open-labeled, randomized non-inferiority clinical study conducted in China. Treatment naïve infected patients were randomized into two groups: 20 mg vonoprazan (VPZ) b.i.d. in combination with low-dose (1000 mg b.i.d.) or high-dose (1000 mg t.i.d) amoxicillin for 14 days. C-urea breath tests were used to access the cure rate at least 4 weeks after treatment.
A total of 154 patients were assessed and 110 subjects were randomized. The eradication rate of VPZ with b.i.d. amoxicillin or t.i.d. amoxicillin for 14 days was 89.1% and 87.3% by intention-to-treat analysis, respectively, and 94.1% and 95.9% by per-protocol analysis, respectively. The eradication rate and incidence of adverse events were not different between the two groups.
VPZ with b.i.d. or t.i.d. amoxicillin for 14 days provides satisfactory efficacy as a first-line treatment for infection in China.
我们之前报道过，使用沃诺拉赞-阿莫西林（VA）双联疗法治疗 7 天或 10 天，对于 () 根除的疗效并不令人满意。我们旨在探索 VA 双联疗法治疗 14 天作为 () 感染一线治疗的疗效。
这是一项在中国进行的单中心、前瞻性、开放性、随机非劣效性临床研究。治疗初治的 () 感染患者被随机分为两组：每天两次（b.i.d.）20 毫克沃诺拉赞（VPZ）联合低剂量（b.i.d.）或高剂量（t.i.d.）阿莫西林 1000 毫克治疗 14 天。在治疗后至少 4 周，使用 C-尿素呼气试验评估治愈率。
共评估了 154 例患者，其中 110 例患者被随机分组。VPZ 联合 b.i.d.阿莫西林或 t.i.d.阿莫西林治疗 14 天的根除率分别为意向治疗分析的 89.1%和 87.3%，按方案分析分别为 94.1%和 95.9%。两组的根除率和不良反应发生率无差异。
VPZ 联合 b.i.d.或 t.i.d.阿莫西林治疗 14 天，作为中国 () 感染的一线治疗，提供了令人满意的疗效。
