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简化挽救治疗的根除率和安全性:14 天 vonoprazan 和阿莫西林双联方案作为补救治疗,用于治疗中国既往治疗失败的幽门螺杆菌感染:一项真实世界、回顾性临床研究。

Eradication rate and safety of a "simplified rescue therapy": 14-day vonoprazan and amoxicillin dual regimen as rescue therapy on treatment of Helicobacter pylori infection previously failed in eradication: A real-world, retrospective clinical study in China.

机构信息

GI Department, Peking University First Hospital, Beijing, China.

出版信息

Helicobacter. 2022 Oct;27(5):e12918. doi: 10.1111/hel.12918. Epub 2022 Jul 25.

Abstract

BACKGROUND

The currently recommended quadruple regimens as rescue therapy on Helicobacter pylori infection were not as effective as being supposed, especially in those who had failed two or more times. Dual regimen composed of vonoprazan (a potassium-competitive acid blocker) and amoxicillin might be an option since it's effective in eradication therapy as first-line treatment.

OBJECTIVE

As a real-world retrospective study, data were collected to evaluate the efficacy and safety of vonoprazan and amoxicillin dual regimen as rescue therapy in Helicobacter pylori positive patients who had failed one or more times in their previous treatment.

METHODS

From May 2020 to June 2021, the clinical data of patients who had failed in Helicobacter pylori infection treatment were collected in GI department of Peking University First Hospital, Beijing, China. Patients were given vonoprazan 20 mg or 40 mg per day and amoxicillin 3000 mg per day (VA dual therapy) for 14 days as rescue treatment. Helicobacter pylori status was evaluated by C-urease breath test 6 weeks after treatment. All adverse effects during treatment were recorded.

RESULTS

A total of 186 patients were enrolled, including 67 males and 119 females. All of them had failed for 1 ~ 7 times in their previous treatment. Successful eradication was achieved in 172 patients (92.5%, 172/186). The adverse effects (referring to skin rash, abdominal pain, diarrhea, and headache), mainly mild and did not cause quit of treatment, occurred in 14 patients (7.5%, 14/186) and all symptoms relieved spontaneously.

CONCLUSIONS

Dual regimen composed of vonoprazan and amoxicillin for 14 days was effective and safe as rescue therapy in Helicobacter pylori infection treatment. It could be chosen as a "simplified rescue therapy" with relatively high eradication rate no matter how many times the patients had failed and what regimens they had used previously.

摘要

背景

目前推荐的四联方案作为幽门螺杆菌感染的补救治疗,其效果并不像预期的那样好,尤其是在那些已经失败两次或以上的患者中。由沃诺拉赞(一种钾竞争型酸阻滞剂)和阿莫西林组成的双联方案可能是一种选择,因为它在一线治疗中的根除治疗中是有效的。

目的

作为一项真实世界的回顾性研究,本研究收集数据评估沃诺拉赞和阿莫西林双联方案作为补救治疗在先前治疗失败一次或以上的幽门螺杆菌阳性患者中的疗效和安全性。

方法

2020 年 5 月至 2021 年 6 月,收集北京大学第一医院消化科因幽门螺杆菌感染治疗失败的患者的临床资料。患者给予沃诺拉赞 20mg 或 40mg 每天和阿莫西林 3000mg 每天(VA 双联治疗),疗程 14 天。治疗结束后 6 周通过 C-尿素呼气试验评估幽门螺杆菌状态。记录所有治疗期间的不良反应。

结果

共纳入 186 例患者,其中男 67 例,女 119 例。所有患者在之前的治疗中均失败 1~7 次。172 例(92.5%,172/186)患者成功根除。不良反应(主要为皮疹、腹痛、腹泻和头痛)主要为轻度,未导致停药,发生在 14 例(7.5%,14/186)患者中,所有症状均自行缓解。

结论

沃诺拉赞和阿莫西林双联方案治疗 14 天作为幽门螺杆菌感染补救治疗是有效且安全的。无论患者失败多少次,以及之前使用何种方案,它都可以作为一种“简化的补救治疗”选择,具有较高的根除率。

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