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基于 vonoprazan 的三联疗法对幽门螺杆菌的根除是有效的,而不论克拉霉素的敏感性如何。

Vonoprazan-based triple therapy is effective for Helicobacter pylori eradication irrespective of clarithromycin susceptibility.

机构信息

Division of Gastroenterology and Hepatology, National Center for Global Health and Medicine, 1-21-1 Toyama, Shinjuku, Tokyo, 162-8655, Japan.

出版信息

J Gastroenterol. 2020 Nov;55(11):1054-1061. doi: 10.1007/s00535-020-01723-6. Epub 2020 Sep 15.

Abstract

BACKGROUND

Helicobacter pylori causes peptic ulcers and accounts for over 90% of gastric cancers; however, eradication rates have been declining due to antimicrobial resistance. Vonoprazan (VPZ), a potassium-competitive acid blocker, produces rapid and profound gastric acid suppression and has shown promising effects in the improvement of H. pylori eradication rates. The efficacy and safety of VPZ-based triple therapy as a first-line regimen for H. pylori eradication and its relationship with clarithromycin (CAM) susceptibility were evaluated.

METHODS

From May 2015 to September 2017, H. pylori-infected patients who underwent esophagogastroduodenoscopy with CAM susceptibility testing were prospectively enrolled. Patients received a 7-day triple therapy regimen (VAC) of VPZ (20 mg), amoxicillin (750 mg), and CAM (200 mg) twice daily. Eradication rates, demographics, CAM susceptibility, and safety profiles were assessed.

RESULTS

VAC was administered to 146 patients (median age: 63, range: 22-85 years) (60% of whom were females) who underwent CAM susceptibility testing, and 131 patients underwent C-urea breath testing to evaluate eradication success. The prevalence of CAM resistance was 34.2%. The overall eradication rates of VAC in per protocol (PP) and "intention to treat" (ITT) analyses were 90.8% (n = 131) and 81.5% (n = 146), respectively. In PP analysis for CAM susceptibility, the eradication rates of VAC were comparable between CAM-sensitive (91.6%, n = 83) and CAM-resistant (89.4%, n = 47) strains. The corresponding rates from the ITT analysis were 80.0% (n = 95) and 84.0% (n = 50), respectively. No adverse events requiring discontinuation of VAC were observed.

CONCLUSIONS

CAM-resistant H. pylori was prevalent in one-third of patients in the Tokyo metropolitan area. VPZ-based triple therapy was highly effective and well-tolerated irrespective of CAM susceptibility. Therefore, it could be a valuable first-line treatment regimen for H. pylori infection.

摘要

背景

幽门螺杆菌可导致消化性溃疡,并导致超过 90%的胃癌;然而,由于抗生素耐药性的出现,根除率一直在下降。沃诺拉赞(VPZ)是一种钾竞争性酸阻滞剂,可迅速且深度抑制胃酸分泌,在提高幽门螺杆菌根除率方面显示出良好的效果。本文评估了 VPZ 三联疗法作为幽门螺杆菌根除的一线治疗方案的疗效和安全性及其与克拉霉素(CAM)敏感性的关系。

方法

从 2015 年 5 月至 2017 年 9 月,前瞻性地纳入了接受过伴有 CAM 药敏试验的食管胃十二指肠镜检查的幽门螺杆菌感染患者。患者接受 VPZ(20mg)、阿莫西林(750mg)和 CAM(200mg)的 7 天三联疗法(VAC),每日 2 次。评估了根除率、人口统计学特征、CAM 敏感性和安全性特征。

结果

对 146 例(中位年龄 63 岁,范围 22-85 岁)(60%为女性)接受 CAM 药敏试验的患者进行了 VAC 治疗,其中 131 例接受了 C-尿素呼气试验以评估根除效果。CAM 耐药率为 34.2%。VAC 在按方案(PP)和“意向治疗”(ITT)分析中的总体根除率分别为 90.8%(n=131)和 81.5%(n=146)。在 CAM 敏感性的 PP 分析中,VAC 对 CAM 敏感(91.6%,n=83)和 CAM 耐药(89.4%,n=47)菌株的根除率相当。相应的 ITT 分析率分别为 80.0%(n=95)和 84.0%(n=50)。未观察到需要停止 VAC 的不良事件。

结论

在东京都地区的患者中,三分之一的患者存在 CAM 耐药的幽门螺杆菌。VPZ 三联疗法无论 CAM 敏感性如何,均具有高度疗效和良好的耐受性。因此,它可能是治疗幽门螺杆菌感染的一种有价值的一线治疗方案。

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