在克拉霉素高耐药地区，克拉霉素与呋喃唑酮用于初治幽门螺杆菌感染患者的比较

Clarithromycin versus furazolidone for naïve Helicobacter pylori infected patients in a high clarithromycin resistance area.

作者信息

Qiao Chen, Li Yueyue, Liu Jing, Ji Chaoran, Qu Junyan, Hu Junnan, Ji Rui, Wan Meng, Lin Boshen, Lin Minjuan, Qi Qingqing, Zuo Xiuli, Li Yanqing

机构信息

Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.

Laboratory of Translational Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.

出版信息

J Gastroenterol Hepatol. 2021 Sep;36(9):2383-2388. doi: 10.1111/jgh.15468. Epub 2021 Mar 10.

DOI:10.1111/jgh.15468

PMID:33691344

Abstract

BACKGROUND AND AIM

The increase in antibiotic resistance makes the eradication of Helicobacter pylori more difficult. Considering the limitations of the application of susceptibility-guided therapy, it is important to find an effective empirical regimen. The aim of the study is to compare the efficacy, safety, and cost-effectiveness of clarithromycin-based bismuth-containing quadruple therapy (C-BQT) and furazolidone-based bismuth-containing quadruple therapy (F-BQT) in naïve H. pylori positive patients.

METHODS

This was an open-label, randomized controlled, crossover trial. The trial comprised two phases. In C-F group, patients received C-BQT in the first phase; those who were still positive for H. pylori infection after the first phase entered the second phase to receive F-BQT as rescue treatment. In F-C group, patients were treated with F-BQT firstly and rescued with C-BQT.

RESULTS

As first-line treatments, the eradication rates of C-BQT and F-BQT were 89.7% (157/175) and 92.0% (161/175) (P = 0.458) in intention-to-treat analysis and 93.4% (156/167) and 95.8% (161/168) (P = 0.327) in per-protocol analysis, respectively. The cumulative eradication rates of the C-F group and the F-C group were both 94.3% in intention-to-treat analysis (P = 1.000). Cost-effectiveness indexes of F-BQT and C-BQT were 0.54 and 1.24 in first-line treatments. Frequencies of adverse events in F-BQT and C-BQT had no differences (36.0% in C-BQT vs 32.6% in F-BQT, P = 0.499).

CONCLUSIONS

Furazolidone-based bismuth-containing quadruple therapy should be preferred for its excellent cost-effectiveness and acceptable safety.

摘要

背景与目的

抗生素耐药性的增加使得根除幽门螺杆菌更加困难。考虑到药敏指导治疗应用的局限性，寻找一种有效的经验性治疗方案很重要。本研究的目的是比较在初治幽门螺杆菌阳性患者中，基于克拉霉素的含铋四联疗法（C-BQT）和基于呋喃唑酮的含铋四联疗法（F-BQT）的疗效、安全性和成本效益。

方法

这是一项开放标签、随机对照、交叉试验。该试验包括两个阶段。在C-F组中，患者在第一阶段接受C-BQT治疗；第一阶段后幽门螺杆菌感染仍为阳性的患者进入第二阶段接受F-BQT作为挽救治疗。在F-C组中，患者首先接受F-BQT治疗，并用C-BQT进行挽救治疗。

结果

在意向性分析中，作为一线治疗，C-BQT和F-BQT的根除率分别为89.7%（157/175）和92.0%（161/175）（P = 0.458），在符合方案分析中分别为93.4%（156/167）和95.8%（161/168）（P = 0.327）。在意向性分析中，C-F组和F-C组的累积根除率均为94.3%（P = 1.000）。在一线治疗中，F-BQT和C-BQT的成本效益指数分别为0.54和1.24。F-BQT和C-BQT的不良事件发生率无差异（C-BQT为36.0%，F-BQT为32.6%，P = 0.499）。