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台湾地区基于埃索美拉唑和雷贝拉唑的 14 天高剂量双联疗法一线根除幽门螺杆菌的多中心真实世界疗效报告。

The multicenter real-world report of the efficacies of 14-day esomeprazole-based and rabeprazole-based high-dose dual therapy in first-line Helicobacter pylori eradication in Taiwan.

机构信息

Division of Hepatogastroenterology, Kaohsiung Chang Gung Memorial Hospital, Taiwan; Chang Gung University College of Medicine, Taiwan.

Division of Gastroenterology, Department of Medicine, An Nan Hospital, China Medical University, Tainan, Taiwan.

出版信息

J Microbiol Immunol Infect. 2024 Aug;57(4):601-608. doi: 10.1016/j.jmii.2024.02.009. Epub 2024 Mar 4.

DOI:10.1016/j.jmii.2024.02.009
PMID:38461114
Abstract

BACKGROUND

High-dose dual therapy (HDDT) using proton-pump inhibitors (PPI) and amoxicillin attracted attention for its simplicity and lower adverse event profile. Besides, vonoprazan is not available worldwide. This real-world study aims to compare the efficacy of esomeprazole-based and rabeprazole-based HDDT regimens and to identify clinical factors influencing outcomes.

METHODS

A retrospective study enrolled 346 Helicobacter pylori-infected naïve patients from January 2016 to August 2023. Patients were assigned to either a 14-day esomeprazole-based HDDT (EA-14; esomeprazole 40 mg t.i.d. and amoxicillin 750 mg q.i.d. for 14 days, n = 173) or a 14-day rabeprazole-based HDDT (RA-14; rabeprazole 20 mg and amoxicillin 750 mg q.i.d. for 14 days, n = 173).

RESULTS

Five patients from the EA-14 group and 10 from the RA-14 group were lost to follow-up, resulting in 168 and 163 patients for the per-protocol (PP) analysis, respectively. Eradication rates for the EA-14 and RA-14 groups were 90.2% and 80.9% (P = 0.014) in intention-to-treat (ITT) analysis; and 92.9% and 85.9% (P = 0.039) in PP analysis. Adverse event rates were similar between the two groups (11.9% vs 11.7%, P = 0.944). In multiple logistic regression analysis, age≧60 was associated with eradication failure (P = 0.046) and a trend of significance for smoking (P = 0.060) in the EA-14 group but not in the RA-14 group. A trend of significance was also observed for eradication regimens (EA-14 vs RA-14) (P = 0.071). The antibiotic resistance rates were amoxicillin (2.3%), clarithromycin (14.7%), metronidazole (40.3%), and dual resistance to clarithromycin and metronidazole (7.0%).

CONCLUSIONS

Esomeprazole-based HDDT achieved over 90% eradication rates but rabeprazole-based HDDT, which failed.

摘要

背景

质子泵抑制剂(PPI)和阿莫西林的高剂量双联疗法(HDDT)因其简单性和较低的不良事件谱而受到关注。此外,沃诺拉赞尚未在全球范围内上市。本回顾性研究旨在比较埃索美拉唑和雷贝拉唑为基础的 HDDT 方案的疗效,并确定影响疗效的临床因素。

方法

一项回顾性研究纳入了 2016 年 1 月至 2023 年 8 月期间的 346 例未经治疗的幽门螺杆菌感染患者。患者被分为 14 天埃索美拉唑为基础的 HDDT(EA-14;埃索美拉唑 40mg,tid,阿莫西林 750mg,qid,共 14 天,n=173)或 14 天雷贝拉唑为基础的 HDDT(RA-14;雷贝拉唑 20mg,阿莫西林 750mg,qid,共 14 天,n=173)。

结果

EA-14 组有 5 例和 RA-14 组有 10 例患者失访,因此意向治疗(ITT)分析中分别有 168 例和 163 例患者符合方案(PP)分析。EA-14 组和 RA-14 组的根除率在 ITT 分析中分别为 90.2%和 80.9%(P=0.014);在 PP 分析中分别为 92.9%和 85.9%(P=0.039)。两组不良反应发生率相似(11.9% vs 11.7%,P=0.944)。多因素 logistic 回归分析显示,年龄≥60 岁与 EA-14 组的根除失败相关(P=0.046),与吸烟呈显著趋势相关(P=0.060),但在 RA-14 组无此相关性。此外,还观察到根除方案(EA-14 与 RA-14)有显著趋势(P=0.071)。抗生素耐药率分别为阿莫西林(2.3%)、克拉霉素(14.7%)、甲硝唑(40.3%)和克拉霉素与甲硝唑双重耐药(7.0%)。

结论

埃索美拉唑为基础的 HDDT 根除率超过 90%,但雷贝拉唑为基础的 HDDT 根除失败。

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