Gastroenterology and Digestive Endoscopy, Nuovo Regina Margherita Hospital, Rome, Italy.
Clin Res Hepatol Gastroenterol. 2013 Dec;37(6):647-50. doi: 10.1016/j.clinre.2013.04.003. Epub 2013 Jun 6.
Since the efficacy of the standard triple therapies for Helicobacter pylori eradication has decreased, novel antibiotic regimens have been introduced, including concomitant, sequential, and hybrid therapies. We aimed to compare the cure rates achieved by these new therapy regimens.
This was a multicenter, open-label, pilot study enrolling consecutive non-ulcer dyspepsia patients with H. pylori infection never previously treated for the infection. Patients were randomized to receive one of the following treatments: (a) concomitant therapy: omeprazole 20mg, amoxicillin 1g, clarithromycin 500 mg, and tinidazole 500 mg for 5 days; (b) sequential therapy: omeprazole 20mg and amoxicillin 1g for 5 days followed by omeprazole 20mg, clarithromycin 500 mg, and tinidazole 500 mg for 5 days; (c) hybrid therapy: omeprazole 20mg, and amoxicillin 1g for 7 days followed by omeprazole 20mg, amoxicillin 1g, clarithromycin 500 mg, and tinidazole 500 mg, for 7 days. All drugs were administered twice daily. Bacterial eradication was checked 6 weeks after treatment by using a (13)C-urea breath test. A 10-day, second-line therapy with omeprazole 20mg, levofloxacin 250 mg, and amoxicillin 1g, all given twice daily, was offered to the eradication failure patients.
Overall, 270 patients were enrolled, but 13 patients early interrupted treatment due to side effects. At intention-to-treat (ITT) and per-protocol analysis (PP), the eradication rates were 85.5% and 91.6% with the concomitant regimen, 91.1% and 92.1% with the sequential therapy, and 80% and 85.7% with the hybrid regimen. Differences were not statistically significant. H. pylori infection was cured in 10 (55.6%) patients with the second-line regimen.
In our study, both concomitant and sequential therapy, but not hybrid therapy, reached high eradication rates. The success rate of second-line levofloxacin-based triple therapy is decreasing.
由于标准三联疗法根除幽门螺杆菌的疗效下降，已引入新的抗生素方案，包括同时、序贯和混合疗法。我们旨在比较这些新疗法的治愈率。
这是一项多中心、开放标签、试点研究，纳入了从未接受过感染治疗的非溃疡性消化不良患者。患者随机接受以下治疗之一：（a）同时疗法：奥美拉唑 20mg、阿莫西林 1g、克拉霉素 500mg 和替硝唑 500mg，连用 5 天；（b）序贯疗法：奥美拉唑 20mg 和阿莫西林 1g 连用 5 天，然后奥美拉唑 20mg、克拉霉素 500mg 和替硝唑 500mg 连用 5 天；（c）混合疗法：奥美拉唑 20mg 和阿莫西林 1g 连用 7 天，然后奥美拉唑 20mg、阿莫西林 1g、克拉霉素 500mg 和替硝唑 500mg 连用 7 天。所有药物均每日 2 次给药。治疗后 6 周通过 13C-尿素呼气试验检查细菌清除情况。对治疗失败的患者提供为期 10 天的二线治疗，包括奥美拉唑 20mg、左氧氟沙星 250mg 和阿莫西林 1g，每日 2 次。
总体而言，共纳入 270 例患者，但 13 例患者因副作用提前中断治疗。意向治疗（ITT）和方案分析（PP）的根除率分别为同时疗法组 85.5%和 91.6%，序贯疗法组 91.1%和 92.1%，混合疗法组 80%和 85.7%。差异无统计学意义。二线方案治愈了 10 例（55.6%）患者的 H. pylori 感染。
在我们的研究中，同时和序贯疗法均达到了较高的根除率，但混合疗法没有。基于左氧氟沙星的二线三联疗法的成功率正在下降。
