Tanabe Hiroki, Ando Katsuyoshi, Sato Kiichi, Ito Takahiro, Goto Mitsuru, Sato Tomonobu, Fujinaga Akihiro, Kawamoto Toru, Utsumi Tatsuya, Yanagawa Nobuyuki, Ichiishi Eiichiro, Otake Takaaki, Kohgo Yutaka, Nomura Yoshiki, Ueno Nobuhiro, Sugano Hiroko, Kashima Shin, Moriichi Kentaro, Fujiya Mikihiro, Okumura Toshikatsu
Department of Gastroenterology, Asahikawa Kousei Hospital, 111-3 1-Jodori 24-chome, Asahikawa, Hokkaido, 078-8211, Japan.
Department of Gastroenterology, International University of Health and Welfare Hospital, Tokyo, Japan.
Dig Dis Sci. 2017 Nov;62(11):3069-3076. doi: 10.1007/s10620-017-4664-1. Epub 2017 Jun 29.
Eradication therapies for Helicobacter pylori infection are advancing as new acid inhibitory reagents approved. The aim of this study was to assess the efficacy and safety of vonoprazan-based triple treatment.
Triple therapy with vonoprazan and two antibiotics (amoxicillin and clarithromycin or metronidazole) received focus in this analysis. We performed a multicenter retrospective study of patients who received vonoprazan-based eradication therapy between February 2015 and February 2016 and conducted a review of the literature.
The eradication rate among the 799 patients in our multicenter study was 94.4% (95% confidence interval [CI] 92.6-96.2%) in the per-protocol analysis for first-line treatment (with vonoprazan 20 mg, amoxicillin 750 mg, and clarithromycin 200 or 400 mg, twice a day for 7 days) and 97.1% (95% CI 93.0-101.1%) for second-line treatment (with vonoprazan 20 mg, amoxicillin 750 mg, and metronidazole 250 mg, twice a day for 7 days). The overall incidence of adverse events was 4.4% in an intention-to-treat analysis with no patients hospitalized. In a literature review, six reports, in which 1380 patients received vonoprazan-based first-line eradication therapy, were included and were all reported by Japanese researchers. The eradication success rates in per-protocol analysis were between 85 and 93%, which was roughly the same among the studies.
Vonoprazan-based triple therapy was effective and safe for Helicobacter pylori eradication in real-world experience, confirmed by a multicenter study and a review of the pertinent literature.
随着新型抑酸剂的获批，幽门螺杆菌感染的根除疗法不断进步。本研究旨在评估基于沃克奥美拉唑的三联疗法的疗效和安全性。
本分析聚焦于沃克奥美拉唑与两种抗生素（阿莫西林和克拉霉素或甲硝唑）的三联疗法。我们对2015年2月至2016年2月期间接受基于沃克奥美拉唑的根除疗法的患者进行了多中心回顾性研究，并对文献进行了综述。
在我们的多中心研究中，799例患者在一线治疗的符合方案分析中（使用20毫克沃克奥美拉唑、750毫克阿莫西林和200或400毫克克拉霉素，每日两次，共7天）根除率为94.4%（95%置信区间[CI] 92.6 - 96.2%），二线治疗（使用20毫克沃克奥美拉唑、750毫克阿莫西林和250毫克甲硝唑，每日两次，共7天）根除率为97.1%（95% CI 93.0 - 101.1%）。在意向性分析中，不良事件的总体发生率为4.4%，无患者住院。在文献综述中，纳入了6篇报告，其中1380例患者接受了基于沃克奥美拉唑的一线根除疗法，均由日本研究人员报告。符合方案分析中的根除成功率在85%至93%之间，各研究大致相同。
多中心研究和相关文献综述证实，在实际临床经验中，基于沃克奥美拉唑的三联疗法对根除幽门螺杆菌有效且安全。
