Nista Enrico C, Candelli Marcello, Zocco Maria A, Cremonini Filippo, Ojetti Veronica, Finizio Rosalba, Spada Cristiano, Cammarota Giovanni, Gasbarrini Giovanni, Gasbarrini Antonio
Department of Internal Medicine, Catholic University, Rome, Italy.
Am J Gastroenterol. 2006 Sep;101(9):1985-90. doi: 10.1111/j.1572-0241.2006.00716.x.
The standard first-line therapies for Helicobacter pylori eradication are based on clarithromycin and amoxicillin or metronidazole. Recent studies suggested levofloxacin as an alternative option for both first-and second-line H. pylori eradication treatment.
To compare efficacy and tolerability of two different 7-day standard triple therapies versus 7-day levofloxacin-based triple therapy in first-line treatment for H. pylori infection.
Three hundred consecutive H. pylori positive patients were randomized to receive: clarithromycin, amoxicillin, esomeprazole (Group A: N = 100); clarithromycin, metronidazole, esomeprazole (Group B: N = 100); or clarithromycin, levofloxacin, esomeprazole (Group C: N = 100). H. pylori status was rechecked by (13)C urea breath test 6 wk after the end of therapy.
Sixteen out of 300 patients discontinued treatment because of the occurrence of side effects (Group A, 5; Group B, 7; Group C, 4). The eradication rates in intention to treat (ITT) and per protocol (PP) analyses were: Group A, 75% and 79%; Group B, 72% and 77.4%; and Group C, 87% and 90.6%. The eradication rate achieved with levofloxacin-based triple therapy was significantly higher than that with standard therapies in either ITT (87%vs 75%, p <0.05; 87%vs 72%, p <0.01;) or PP analysis (90.6%vs 79%, p <0.05; 90.6 vs 77.4, p <0.05). No difference was found between standard triple therapies. The incidence of side effects was similar among groups.
A 7-day levofloxacin-based triple therapy can achieve higher H. pylori eradication rates than standard regimens. These data suggest levofloxacin-based regimens can be the most effective in first-line anti-H. pylori therapy, at least in the Italian population.
根除幽门螺杆菌的标准一线治疗方案是以克拉霉素和阿莫西林或甲硝唑为基础的。最近的研究表明左氧氟沙星可作为一线和二线幽门螺杆菌根除治疗的替代选择。
比较两种不同的7天标准三联疗法与7天左氧氟沙星三联疗法在幽门螺杆菌感染一线治疗中的疗效和耐受性。
连续纳入300例幽门螺杆菌阳性患者，随机分为三组：克拉霉素、阿莫西林、埃索美拉唑（A组：N = 100）；克拉霉素、甲硝唑、埃索美拉唑（B组：N = 100）；或克拉霉素、左氧氟沙星、埃索美拉唑（C组：N = 100）。治疗结束6周后通过¹³C尿素呼气试验复查幽门螺杆菌感染情况。
300例患者中有16例因出现副作用而停药（A组5例；B组7例；C组4例）。意向性分析（ITT）和符合方案分析（PP）中的根除率分别为：A组75%和79%；B组72%和77.4%；C组87%和90.6%。在ITT分析（87%对75%，p <0.05；87%对72%，p <0.01）或PP分析（90.6%对79%，p <0.05；90.6对77.4，p <0.05）中，基于左氧氟沙星的三联疗法的根除率显著高于标准疗法。标准三联疗法之间未发现差异。各组间副作用发生率相似。
7天左氧氟沙星三联疗法的幽门螺杆菌根除率高于标准方案。这些数据表明，至少在意大利人群中，基于左氧氟沙星的方案可能是一线抗幽门螺杆菌治疗中最有效的方案。
