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沃诺拉赞与阿莫西林双联疗法与沃诺拉赞、阿莫西林和克拉霉素三联疗法根除幽门螺杆菌的疗效相当。

Dual Therapy with Vonoprazan and Amoxicillin Is as Effective as Triple Therapy with Vonoprazan, Amoxicillin and Clarithromycin for Eradication of Helicobacter pylori.

机构信息

Center for Clinical Research, Hamamatsu University School of Medicine, Hamamatsu, Japan,

First Department of Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.

出版信息

Digestion. 2020;101(6):743-751. doi: 10.1159/000502287. Epub 2019 Aug 21.

DOI:10.1159/000502287
PMID:31434101
Abstract

BACKGROUNDS/AIMS: Vonoprazan (VPZ) is the first clinically available potassium competitive acid blocker. This class of agents provides faster and more potent acid inhibition than proton pump inhibitors. Most strains of Helicobacter pylori are sensitive to amoxicillin. We hypothesized that dual therapy with VPZ and amoxicillin would provide the sufficient eradication rate for H. pylori infection. To evaluate this, we compared the eradication rate by the dual VPZ/amoxicillin therapy with that by the standard triple VPZ/amoxicillin/clarithromycin therapy.

METHODS

Non-inferiority of the eradication rate of H. pylori by the dual therapy with VPZ 20 mg twice daily (bid) and amoxicillin 500 mg 3 times daily (tid) for 1 week to that by the triple therapy with VPZ 20 mg bid, amoxicillin 750 mg bid and clarithromycin 200 mg bid for 1 week was retrospectively studied. Propensity score matching was performed to improve comparability between 2 regimen groups. Successful eradication was diagnosed using the [13C]-urea breath test at 1-2 months after the end of eradication therapy.

RESULTS

The intention-to-treat analysis demonstrated that the eradication rate by the dual therapy (92.9%; 95% CI 82.7-98.0%, 52/56) was not inferior to that of the triple therapy (91.9%; 95% CI 80.4-97.0%, 51/56; OR 1.275, 95% CI 0.324-5.017%, p = 0.728). There were no statistically significant differences in incidences of adverse events between 2 regimens.

CONCLUSION

VPZ-based dual therapy (VPZ 20 mg bid and amoxicillin 500 mg tid for 1 week) provides an acceptable eradication rate of H. pylori infection without the need for second antimicrobial agents, such as clarithromycin.

摘要

背景/目的:沃诺拉赞(VPZ)是首个临床可用的钾竞争性酸阻滞剂。这类药物比质子泵抑制剂能更快、更有效地抑制胃酸。大多数幽门螺杆菌菌株对阿莫西林敏感。我们假设 VPZ 和阿莫西林的双联疗法将为幽门螺杆菌感染提供足够的根除率。为了评估这一点,我们比较了 VPZ/阿莫西林双联疗法和 VPZ/阿莫西林/克拉霉素三联标准疗法的根除率。

方法

回顾性研究了 VPZ 20mg 每日 2 次(bid)和阿莫西林 500mg 每日 3 次(tid)双联治疗 1 周与 VPZ 20mg bid、阿莫西林 750mg bid 和克拉霉素 200mg bid 三联治疗 1 周对幽门螺杆菌根除率的非劣效性。采用倾向评分匹配来提高两组方案的可比性。在根除治疗结束后 1-2 个月,采用 [13C]-尿素呼气试验诊断根除成功。

结果

意向治疗分析显示,双联疗法的根除率(92.9%;95%CI 82.7-98.0%,52/56)不劣于三联疗法(91.9%;95%CI 80.4-97.0%,51/56;OR 1.275,95%CI 0.324-5.017%,p=0.728)。两组方案的不良反应发生率无统计学差异。

结论

VPZ 为基础的双联疗法(VPZ 20mg bid 和阿莫西林 500mg tid 连用 1 周)无需使用克拉霉素等第二种抗菌药物,即可为幽门螺杆菌感染提供可接受的根除率。

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