Köksal Aydin S, Parlak Erkan, Filik Levent, Yolcu Omer F, Odemiş Bülent, Ulker Aysel, Saşmaz Nurgül, Ozden Ali, Sahin Burhan
Department of Gastroenterology, Türkiye Yüksek Ihtisas Hospital, Ankara, Turkey.
J Gastroenterol Hepatol. 2005 Apr;20(4):637-42. doi: 10.1111/j.1440-1746.2005.03801.x.
Quadruple therapy with a proton pump inhibitor, bismuth, metronidazole and tetracycline is recommended as the optimal second-line therapy of Helicobacter pylori infection in the Maastricht Consensus Report. The aim of the present paper was to evaluate the efficacy of ranitidine bismuth citrate (RBC)-based regimens as second-line therapies after failure of the standard Maastricht triple therapy.
One hundred and sixteen H. pylori-positive patients were given omeprazole 20 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d for 10 days. Patients remaining H. pylori-positive (n = 29) were combined with 27 patients enrolled after an initial eradication failure from proton-pump inhibitor (PPI), amoxicillin and clarithromycin therapy for at least 7 days and were randomly given one of the following second-line 10-day treatments: RBC 400 mg b.d., amoxicillin 1 g b.d and clarithromycin 500 mg b.d. (RAC group, n = 28) and RBC 400 mg b.d., metronidazole 500 mg b.d and tetracycline 500 mg b.d. (RMT group, n = 28). Eradication was assessed by either histology and rapid urease test or (13)C urea breath test 8 weeks after therapy.
The eradication rate of first-line Maastricht therapy was 67% for intention-to-treat analysis (95% confidence interval [CI]: 58-75). Per-protocol and intention-to-treat eradication was achieved in 60.7% of patients (95%CI: 42-79) in the RAC group and in 85.7% of patients (95%CI: 73-98) in the RMT group (P = 0.03). Fifty-three percent of patients in the RAC and 50% of patients in the RMT group experienced at least one slight side-effect (P = 0.6).
RMT is an effective and well-tolerated second-line therapy after H. pylori eradication failure from PPI, amoxicillin, and clarithromycin.
在《马斯特里赫特共识报告》中，质子泵抑制剂、铋剂、甲硝唑和四环素的四联疗法被推荐为幽门螺杆菌感染的最佳二线治疗方案。本文旨在评估以雷尼替丁枸橼酸铋（RBC）为基础的方案作为标准马斯特里赫特三联疗法失败后的二线治疗的疗效。
116例幽门螺杆菌阳性患者接受奥美拉唑20mg，每日2次、克拉霉素500mg，每日2次、阿莫西林1g，每日2次，疗程10天。仍为幽门螺杆菌阳性的患者（n = 29）与27例在质子泵抑制剂（PPI）、阿莫西林和克拉霉素治疗至少7天初始根除失败后入组的患者合并，随机给予以下二线10天治疗方案之一：RBC 400mg，每日2次、阿莫西林1g，每日2次和克拉霉素500mg，每日2次（RAC组，n = 28）以及RBC 400mg，每日2次、甲硝唑500mg，每日2次和四环素500mg，每日2次（RMT组，n = 28）。治疗8周后通过组织学和快速尿素酶试验或（13）C尿素呼气试验评估根除情况。
意向性分析中一线马斯特里赫特疗法的根除率为67%（95%置信区间[CI]：58 - 75）。RAC组60.7%的患者（95%CI：42 - 79）实现了符合方案集和意向性分析的根除，RMT组85.7%的患者（95%CI：73 - 98）实现了根除（P = 0.03）。RAC组53%的患者和RMT组50%的患者经历了至少一种轻微副作用（P = 0.6）。
RMT是PPI、阿莫西林和克拉霉素根除幽门螺杆菌失败后的一种有效且耐受性良好的二线治疗方案。
