7-day triple therapy of Helicobacter pylori infection with levofloxacin, amoxicillin, and high-dose esomeprazole in patients with known antimicrobial sensitivity
7-day triple therapy of Helicobacter pylori infection with levofloxacin, amoxicillin, and high-dose esomeprazole in patients with known antimicrobial sensitivity
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DOI：
10.1111/j.0083-8703.2006.00375.x
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发表时间：
2006-02-01
期刊：
影响因子：
4.4
通讯作者：
Bayerdörffer, E
中科院分区：
文献类型：
--
作者：
Antos, D;Schneider-Brachert, W;Bayerdörffer, E
背景和目的：初次抗幽门螺杆菌治疗失败导致高耐药率。这就需要寻找新的疗法来治愈幽门螺杆菌感染。本研究的目的是评估新的左氧氟沙星7天三联疗法的疗效和耐受性，并将其与标准的法国三联疗法进行比较，以治疗对甲硝唑和克拉霉素敏感的幽门螺杆菌。根据马斯特里赫特共识2/2000指南进行幽门螺杆菌治疗，随机分为埃索美拉唑2 x 40 mg、左氧氟沙星2 x 500 mg和阿莫西林2 x 1 g，疗程7天(ELA，n=30)，或埃索美拉唑2 x 20 mg、克拉霉素2 x 500 mg和阿莫西林2 x 1 g，7天(ECA，n=31)。结果：61例患者随机分为两组。ELA组30例患者中有28例可用于按方案(PP)分析，其中26例(92.9%CI：76-99%；意向治疗[ITT]分析86.7%CI：68-96%)Hp阴性，而ECA组31例患者中有26例(83.9%，PP和ITT分析均为66-93%)。ELA组有5例患者表现出CLA耐药，其中3例也表现出MET耐药，5例均获成功治疗。两名对左氧氟沙星耐药的患者被治愈，每组一名。两种方案总体耐受性良好，ELA组15名患者(51.7%)和ECA组13名患者(40.6%)出现轻微不良反应。没有患者因不良事件而过早停止治疗。结论：这项初步研究的数据显示，新的7天左氧氟沙星三联疗法对MET和CLA敏感菌株患者的疗效优于80%，在法国三联疗法的范围内。这些数据表明，新的左氧氟沙星三联疗法也可能是MET和CLA耐药幽门螺杆菌菌株患者的一种选择。
Background and Aims: Failed primary anti-Helicobacter pylori therapy results in a high rate of antimicrobial resistance. This necessitates a search for new regimens to cure H. pylori infection. The aim of this study was to evaluate the efficacy and tolerability of a new levofloxacin-containing 7-day triple therapy and to compare it with that of standard French triple therapy in patients with known H. pylori susceptibility to MET (metronidazole) and CLA (clarithromycin).Patients and Methods: Sixty-one patients with documented antibiotic sensitivity (E-test) and an indication for anti-H. pylori treatment based on the Maastricht Consensus 2/2000 guidelines were randomized to receive either esomeprazole 2 x 40 mg, levofloxacin 2 x 500 mg, and amoxicillin 2 x 1 g for 7 days (ELA, n = 30), or esomeprazole 2 x 20 mg, clarithromycin 2 x 500 mg, and amoxicillin 2 x 1 g for 7 days (ECA, n = 31). A cure check was performed 4-6 weeks after conclusion of therapy.Results: Sixty-one patients were randomized to the two treatment groups. Twenty-eight of 30 patients of the ELA group were available for per-protocol (PP) analysis, of whom 26 (92.9% CI: 76-99%; intention-to-treat [ITT] analysis 86.7% CI: 68-96%) became H. pylori negative compared with 26 of the 31 patients of the ECA group (83.9%, CI: 66-93% both PP and ITT analyses). Five patients of the ELA group showed CLA resistance, three of whom also showed MET resistance, and all five were treated successfully. Two patients with levofloxacin-resistant strains, one in each group, were cured. Both regimens were generally well tolerated with minor adverse events being seen in 15 patients (51.7%) of the ELA group and in 13 (40.6%) of the ECA group. None of the patients discontinued treatment prematurely due to adverse events.Conclusion: The data of this pilot study suggest a better than 80% efficacy of the new 7-day levofloxacin triple therapy, which is within the range of the French triple therapy in patients with MET- and CLA-susceptible strains. The data suggest that the new levofloxacin triple therapy may also be an option in patients with MET- and CLA-resistant H. pylori strains.