Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine, 1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo, 101-8309, Japan.
Department of Gastroenterology, Yuri Kumiai General Hospital, Akita, Japan.
J Gastroenterol. 2020 Oct;55(10):969-976. doi: 10.1007/s00535-020-01709-4. Epub 2020 Jul 14.
Although 7-day triple therapy, consisting of vonoprazan, amoxicillin (AMO), and clarithromycin (CLA), is recommended for Helicobacter pylori (H. pylori) eradication in adults. However, the importance of reducing antibiotic use in pediatric patients is well recognized. Therefore, our aim was to compare the effectiveness and safety of vonoprazan and AMO (VA) dual therapy to vonoprazan-based (VAC) triple therapy for H. pylori eradication in a cohort of treatment-naïve junior high school students in Japan.
This was a prospective observational study of second-year junior high-school students in Yurihonjo and Nikaho Cities, Japan. Between 2015 and 2017, 161 students were treated with VAC-triple therapy (20 mg vonoprazan, 750 mg AMO, and 200 mg CLA, twice a day for 7 days), while 60 students were treated with VA-dual therapy (20 mg vonoprazan and 750 mg AMO, twice a day for 7 days) since 2018. The success rate of H. pylori eradication and drug-related adverse events were compared between the two therapy groups. Intention-to-treat (ITT) and per-protocol (PP) analyses were performed.
Groups were comparable at baseline. The ITT and PP eradication rates were 85.0% (95% confidence interval [CI] 75.8-94.2%) and 86.4% (95% CI 77.4-95.5%), respectively, with VA-dual therapy and 82.0% (95% CI 76.0%-87.9%) and 84.1% (95% CI 78.3-89.8%), respectively, with VAC-triple therapy. VA-dual therapy was non-inferior to VAC-triple therapy (ITT, p = 0.018; PP, p = 0.020). The adverse event rate was 10.0% with VA-dual therapy and 19.8% with VAC-triple therapy (p = 0.108).
The effectiveness of VA-dual therapy was comparable to that of VAC-triple therapy in H. pylori treatment-naïve junior high school students, while reducing the use of antibiotics.
虽然含 vonoprazan、阿莫西林（AMO）和克拉霉素（CLA）的 7 天三联疗法被推荐用于成人幽门螺杆菌（H. pylori）的根除，但减少儿科患者抗生素使用的重要性已得到充分认识。因此，我们旨在比较 vonoprazan 和 AMO（VA）双联疗法与基于 vonoprazan 的（VAC）三联疗法在日本一批未经治疗的初中生中的 H. pylori 根除的疗效和安全性。
这是一项在日本由由屈町市和仁贺保市的初中生参与的前瞻性观察性研究。在 2015 年至 2017 年期间，161 名学生接受了 VAC 三联疗法（20mg vonoprazan、750mg AMO 和 200mg CLA，每日 2 次，共 7 天）治疗，而自 2018 年以来，有 60 名学生接受了 VA 双联疗法（20mg vonoprazan 和 750mg AMO，每日 2 次，共 7 天）治疗。比较两组 H. pylori 根除的成功率和与药物相关的不良事件。进行了意向治疗（ITT）和符合方案（PP）分析。
两组在基线时具有可比性。VA 双联疗法的 ITT 和 PP 根除率分别为 85.0%（95%置信区间 [CI] 75.8%-94.2%）和 86.4%（95% CI 77.4%-95.5%），VAC 三联疗法的相应根除率分别为 82.0%（95% CI 76.0%-87.9%）和 84.1%（95% CI 78.3%-89.8%）。VA 双联疗法不劣于 VAC 三联疗法（ITT，p=0.018；PP，p=0.020）。VA 双联疗法的不良事件发生率为 10.0%，VAC 三联疗法为 19.8%（p=0.108）。
在未经治疗的初中生中，VA 双联疗法的疗效与 VAC 三联疗法相当，同时减少了抗生素的使用。
