小剂量雷贝拉唑、铋、阿莫西林和四环素组成的10天四联疗法是治疗高耐药人群幽门螺杆菌感染的有效和安全的一线治疗:一项前瞻性、多中心、随机、平行对照临床试验。

PubMed ID
发表日期 2018年09月

原始出处 抗菌药物与化疗
Antimicrobial agents and chemotherapy
作者 Xie  Yong  Zhu  Zhenhua  Wang  Jiangbin  Zhang  Lingxia  Zhang  Zhenyu  Lu  Hong  Zeng  Zhirong  Chen  Shiyao  Liu  Dongsheng  Lv  Nonghua 

文献标题 小剂量雷贝拉唑、铋、阿莫西林和四环素组成的10天四联疗法是治疗高耐药人群幽门螺杆菌感染的有效和安全的一线治疗:一项前瞻性、多中心、随机、平行对照临床试验。
Ten-Day Quadruple Therapy Comprising Low-Dose Rabeprazole, Bismuth, Amoxicillin, and Tetracycline Is an Effective and Safe First-Line Treatment for Helicobacter pylori Infection in a Population with High Antibiotic Resistance: a Prospective, Multicenter, Randomized, Parallel-Controlled Clinical Trial in China.

文献摘要

本研究的目的是探讨10天铋四联疗法联合阿莫西林、四环素、克拉霉素和不同剂量的雷贝拉唑一线治疗幽门螺杆菌感染的疗效和安全性。这项多中心、随机、平行对照临床试验于2013年3月至2014年8月进行。431例幽门螺杆菌感染的十二指肠溃疡患者被随机分为4个治疗组(1:1:1),共10天:(i)一组接受小剂量的雷贝拉唑,每天两次(b.i.d.)(LR剂量)加铋、阿莫西林和克拉霉素(LR-BAC);(ii)一组接受LR加铋,阿莫西林和四环素(LR-BAT);(iii)一组接受高剂量的雷贝拉唑20毫克每日一次(HR剂量)加铋、阿莫西林和克拉霉素(HR-BAC);(iv)一组接受HR-BAT。用Etest法测定药物敏感性。主要结果是治疗后4周根除幽门螺杆菌。LR-BAC、LR-BAT、HR-BAC和HR-BAT组的按方案(PP)根除率分别为94.1%、91.9%、94.8%和91.9%,而这些组的意向治疗(ITT)根除率分别为87.2%、87.2%、87.7%和86%。在PP分析(P=0.799)和ITT分析(P=0.985)中,四组之间没有显著差异。四种治疗方法的疗效均不受抗生素耐药性的影响。四个治疗组的不良事件相似;中枢神经系统(CNS)和胃肠道症状是最常见的报告。含铋四联疗法联合小剂量雷贝拉唑、阿莫西林和四环素是高耐药人群幽门螺杆菌感染一线治疗的良好选择。(本研究在中国临床试验注册处注册[www.chictr.org.cn]编号为ChiCTR1800014832)。


The objective of this study was to investigate the efficacy and safety of 10-day bismuth quadruple therapy with amoxicillin, tetracycline, or clarithromycin and different doses of rabeprazole for first-line treatment of Helicobacter pylori infection. This multicenter, randomized, parallel-controlled clinical trial was conducted between March 2013 and August 2014. A total of 431 H. pylori-infected patients with duodenal ulcers were enrolled and randomized into four treatment groups (1:1:1:1) for 10 days, as follows: (i) a group receiving a low dose of rabeprazole of 10 mg twice a day (b.i.d.) (LR dose) plus bismuth, amoxicillin, and clarithromycin (LR-BAC); (ii) a group receiving LR plus bismuth, amoxicillin, and tetracycline (LR-BAT); (iii) a group receiving a high dose of rabeprazole of 20 mg b.i.d. (HR dose) plus bismuth, amoxicillin, and clarithromycin (HR-BAC); and (iv) a group receiving HR-BAT. Antimicrobial susceptibility was assessed by the Etest method. The primary outcome was H. pylori eradication at 4 weeks after the treatment. The per-protocol (PP) eradication rates in the LR-BAC, LR-BAT, HR-BAC, and HR-BAT groups were 94.1%, 91.9%, 94.8%, and 91.9%, respectively, while the intention-to-treat (ITT) eradication rates in those groups were 87.2%, 87.2%, 87.7%, and 86%, respectively. There was no significant difference between the four groups in PP analysis (P = 0.799) and ITT analysis (P = 0.985). The efficacies of four-treatment therapy were not affected by antibiotic resistance. The adverse events in the four treatment groups were similar; central nervous system (CNS) and gastrointestinal symptoms were the most common reported. Bismuth-containing quadruple therapy with low-dose rabeprazole, amoxicillin, and tetracycline is a good option for first-line treatment of H. pylori infection in a population with high antibiotic resistance. (This study is registered at Chinese Clinical Trials Registry [www.chictr.org.cn] under number ChiCTR1800014832.).


获取全文 10.1128/AAC.00432-18