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欧洲幽门螺杆菌管理登记处(Hp-EuReg):以色列一线治疗方案。

European Registry on Helicobacter pylori management (Hp-EuReg): First-line Therapy in Israel.

机构信息

Division of Gastroenterology, Rabin Medical Center (Beilinson Campus), Petah Tikva, Israel.

Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

出版信息

Isr Med Assoc J. 2021 Jan;23(1):38-42.

Abstract

BACKGROUND

The antibiotic resistance profile of Helicobacter pylori (H. pylori) is constantly changing. Up-to-date and reliable data for the effectiveness of first-line H. pylori treatment protocols are necessary to provide evidence-based best-practice guidelines.

OBJECTIVES

To determine the effectiveness, compliance and safety of first-line treatment for H. pylori in Israel.

METHODS

An observational, prospective, multicenter study was conducted in tertiary referral centers in Israel, as part of the European registry on H. pylori management (Hp-EuReg). H. pylori-infected patients were included from 2013 to March 2020. Data collected included demographics, clinical data, diagnostic tests, previous eradication attempts, current treatment, compliance, adverse events, and treatment outcome result.

RESULTS

In total, 242 patients were registered, including 121 (50%) who received first-line therapy, 41% of these individuals received clarithromycin based triple therapy and 58.9% received a four-drug regimen. The overall effectiveness of first-line therapy was 85% and 86% by modified intention-to-treat and per protocol analyses, respectively. The effectiveness of both sequential and concomitant therapies was 100% while clarithromycin-based triple therapy achieved an eradication rate of 79%. Treatment eradication was higher among patients who received high dose proton pump inhibitor (PPI) compared to those treated with low dose PPI (100% vs. 81.5% respectively, P < 0.01). No difference in treatment effectiveness was found between 7-, 10-, and 14-day treatment.

CONCLUSIONS

The effectiveness of clarithromycin-based triple therapy is suboptimal. First-line treatment of H. pylori infection should consist of four drugs, including high dose PPI, according to international guidelines.

摘要

背景

幽门螺杆菌(H. pylori)的抗生素耐药谱不断变化。为了提供循证最佳实践指南,有必要获得最新和可靠的一线 H. pylori 治疗方案有效性数据。

目的

确定以色列一线治疗 H. pylori 的疗效、依从性和安全性。

方法

在以色列的三级转诊中心进行了一项观察性、前瞻性、多中心研究,作为幽门螺杆菌管理欧洲登记处(Hp-EuReg)的一部分。从 2013 年到 2020 年 3 月,招募了感染 H. pylori 的患者。收集的数据包括人口统计学、临床数据、诊断试验、先前的根除尝试、当前的治疗、依从性、不良事件和治疗结果。

结果

共登记了 242 名患者,其中 121 名(50%)接受了一线治疗,其中 41%接受了基于克拉霉素的三联疗法,58.9%接受了四联方案。根据修改后的意向治疗和方案分析,一线治疗的总体有效率分别为 85%和 86%。序贯和伴随疗法的有效性均为 100%,而基于克拉霉素的三联疗法的根除率为 79%。接受高剂量质子泵抑制剂(PPI)治疗的患者的治疗根除率高于接受低剂量 PPI 治疗的患者(分别为 100%和 81.5%,P<0.01)。7 天、10 天和 14 天治疗的疗效无差异。

结论

基于克拉霉素的三联疗法的疗效不理想。根据国际指南,H. pylori 感染的一线治疗应包括四种药物,包括高剂量 PPI。

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