Med Princ Pract. 2017;26(6):523-529. doi: 10.1159/000484930. Epub 2017 Nov 3.
The aim of this study was to compare the efficacy and safety of 2-week levofloxacin-containing triple therapy, levofloxacin-containing bismuth quadruple therapy, and standard bismuth-containing quadruple therapy as a first-line regimen for the eradication of Helicobacter pylori.
A total of 329 patients with H. pylori infection were randomly divided into 3 groups to receive one of the following regimens: (a) levofloxacin-containing bismuth quadruple therapy, RBAL (rabeprazole 20 mg, b.i.d., bismuth subsalicylate 562 mg, b.i.d., amoxicillin 1 g, b.i.d, levofloxacin 500 mg, once daily), (b) standard bismuth quadruple therapy, RBMT (rabeprazole 20 mg, b.i.d, subsalicylate 562 mg, b.i.d., metronidazole 500 mg, t.i.d, tetracycline 500 mg, q.i.d), or (c) levofloxacin-containing triple therapy, RAL (rabeprazole 20 mg, b.i.d., amoxicillin 1 g, b.i.d, levofloxacin 500 mg, once daily). The primary outcome was the eradication rate in the intention-to-treat (ITT) and per protocol (PP) analysis.
The eradication rates of the above 3 groups using ITT analysis were RBAL 83.8%, RBMT 88.3%, and RAL 74.8% compared with 91.2, 92.5, and 79.2%, respectively, using PP analysis. The eradication rate using RBMT was significantly higher than that of RAL (p = 0.029 in ITT analysis and p = 0.017 in PP analysis). Several side effects occurred in 156 patients (54.1%) in the RBAL group, 215 (52.3%) in the RBMT group, and 56 (26.2%) in the RAL group (p > 0.05, RBAL vs. RBMT; p < 0.001, RBMT vs. RAL; p < 0.001, RBAL vs. RAL).
All bismuth-containing quadruple therapies had acceptable eradication rates, but levofloxacin-containing triple therapy was not as good as quadruple therapies. Hence, quadruple therapies should be considered the preferred first-line therapy for H. pylori infections.
本研究旨在比较含左氧氟沙星的 2 周三联疗法、含左氧氟沙星的铋四联疗法和标准铋四联疗法作为幽门螺杆菌根除的一线方案的疗效和安全性。
共 329 例幽门螺杆菌感染患者随机分为 3 组,分别接受以下方案之一:(a)含左氧氟沙星的铋四联疗法,RBAL(雷贝拉唑 20mg,bid,次水杨酸铋 562mg,bid,阿莫西林 1g,bid,左氧氟沙星 500mg,qd),(b)标准铋四联疗法,RBMT(雷贝拉唑 20mg,bid,次水杨酸铋 562mg,bid,甲硝唑 500mg,tid,四环素 500mg,qid),或(c)含左氧氟沙星的三联疗法,RAL(雷贝拉唑 20mg,bid,阿莫西林 1g,bid,左氧氟沙星 500mg,qd)。主要结局是意向治疗(ITT)和方案(PP)分析中的根除率。
3 组的 ITT 分析根除率分别为 RBAL83.8%、RBMT88.3%和 RAL74.8%,PP 分析分别为 91.2%、92.5%和 79.2%。RBMT 的根除率明显高于 RAL(ITT 分析中 p=0.029,PP 分析中 p=0.017)。RBAL 组 156 例(54.1%)、RBMT 组 215 例(52.3%)和 RAL 组 56 例(26.2%)出现不良反应(p>0.05,RBAL 与 RBMT;p<0.001,RBMT 与 RAL;p<0.001,RBAL 与 RAL)。
所有铋四联疗法的根除率均可接受,但含左氧氟沙星的三联疗法不如四联疗法。因此,四联疗法应被视为幽门螺杆菌感染的首选一线治疗。