以泮托拉唑为基础的三联和四联疗法根除幽门螺杆菌疗效比较——一项单中心、随机、开放、平行对照研究

背景：近年质子泵抑制剂（PPI）＋阿莫西林＋克拉霉素标准三联疗法对幽门螺杆菌（H.pylori）的根除率有所降低,PPI＋铋剂＋甲硝唑＋四环素的四联疗法能否成为一线治疗的首选以及适当延长疗程能否提高根除率尚有待明确。目的：比较以泮托拉唑为基础的7d标准三联疗法与7d、10d四联疗法根除H.pylori的疗效。方法：133例非溃疡性消化不良的H.pylori感染患者随机分配至7d三联组（45例,泮托拉唑40mgbid＋阿莫西林1.0gbid＋克拉霉素500mgbid,PAC方案）以及7d、10d四联组（43例和45例,泮托拉唑40mgbid＋枸橼酸铋钾220mgbid＋甲硝唑400mgtid＋四环素750mgbid,PBMT方案）。治疗结束后至少间隔4周行13C-尿素呼气试验复查H.pylori,评估治疗结果。结果：共129例患者按方案完成治疗。三组H.pylori根除率按意图治疗（ITT）分析分别为73.3%、79.1%和88.9%,按方案（PP）分析分别为75.0%、82.9%和90.9%。7dPAC方案的PP根除率显著低于10dPBMT方案（P〈0.05）。除四联组中有2例患者分别因头晕和腹泻而未完成治疗外,其余患者的不良反应相似且均能耐受。结论：在7d标准三联疗法H.pylori根除疗效降低的情况下,含泮托拉唑、铋剂、甲硝唑和四环素的10d四联疗法可考虑作为根除治疗的首选方案。

Comparison of the Efficacy of Pantoprazole-based Triple Therapy Versus Quadruple Therapy in the Treatment of Helicobacter pylori Infection: A Single-center, Randomized, Open and Parallel-controlled Study

Background： The efficacy of standard triple therapy proton pump inhibitor （PPI） ＋ amoxicillin ＋ clarithromycin] in the eradication of Helicobacter pylori （H. pylori） has been decreasing recently. It is not clear whether the quadruple regimen （PPI ＋ bismuth ＋ metronidazole ＋ tetracycline） can be used as the first choice in the treatment of H. pylori infection, or the eradication rate can increase if the course of the treatment is prolonged. Aims： To observe the efficacy of H. pylori eradication with pantoprazole-based 7-day standard triple therapy versus 7-day or 10-day quadruple therapy. Methods： A total of 133 patients with non-ulcer dyspepsia who were H. pylori positive were included and randomly assigned into three groups. Forty-five patients were administered with 7-day triple therapy including pantoprazole 40 mg bid, amoxicillin 1.0 g bid and clarithromycin 500 mg bid （PAC）. Forty-three patients received 7-day quadruple therapy combining pantoprazole 40 mg bid, colloidal bismuth subcitrate 220 mg bid, metronidazole 400 mg tid and tetracycline 750 mg bid （PBMT） and 45 patients received the same quadruple therapy for 10 days. The eradication rate was evaluated by ^13C-urea breath test at least 4 weeks after the completion of treatment. Results： A total of 129 patients completed the study. The H. pylori eradication rates by intention-to-treat （ITT） analysis in 7-day PAC group, 7-day and 10-day PBMT groups were 73.3%, 79.1% and 88.9%, respectively; by per protocol （PP） analysis were 75.0%, 82.9% and 90.9%, respectively. The eradication rate in 7-day PAC group by PP analysis was significantly lower than that in 10-day PBMT group （P〈0.05）. Except two patients in PBMT groups could not complete the course of treatment because of dizziness and diarrhea, respectively, other patients in the three groups had similar side effects and were well tolerant. Conclusions： 10- day quadruple regimen containing pantoprazole, bismuth, metronidazole and tetracycline can be considered as the first-line therapy for H. pylori infection when the efficacy of 7-day standard triple therapy is decreased.