质子泵抑制剂四联疗法作为幽门螺杆菌根除治疗一线方案的临床研究

A Clinical Study of Proton Pump Inhibitor-containing Quadruple Regimen as First-line Therapy for Helicobacter pylori Eradication

背景:随着幽门螺杆菌(H.pylori)对抗生素耐药率的上升,传统一线治疗方案质子泵抑制剂(PPI)三联疗法的根除率逐渐下降。临床上需要新的一线治疗方案以提高H.pylori感染的初治成功率。目的:评价PPI四联1周疗法作为H.pylori根除治疗一线方案的疗效和安全性。方法:符合入选标准的H.pylori感染患者随机分为A1组(LCAB方案:兰索拉唑30 mg+克拉霉素250 mg+阿莫西林1.0 g+枸橼酸铋钾220 mg,b.i.d.)、A2组(LCMB方案:兰索拉唑30 mg+克拉霉素250 mg+甲硝唑400 mg+枸橼酸铋钾220 mg,b.i.d.)和B1组(LCA方案:兰索拉唑30 mg+克拉霉素500 mg+阿莫西林1.0g,b.i.d.)、B2组(LCM方案:兰索拉唑30 mg+克拉霉素500 mg+甲硝唑400 mg,b.i.d.)。各组疗程均为1周。记录治疗期间发生的不良反应。疗程结束4周后以快速尿素酶试验、组织学或^(13)C-尿素呼气试验判断H.pylori根除情况。结果:共145例患者纳入研究。A组按方案(PP)分析H.pylori根除率显著高于B组(91.9%对79.2%,P<0.05).意向治疗(ITT)根除率则与B组无显著差异(83.8%对74.0%,P>0.05)。A1组PP和ITT根除率分别为93.8%和85.7%,A2组分别为90.0%和81.8%;B1组分别为79.4%和75.0%,B2组分别为78.9%和73.2%。A1与A2组比较,B1与B2组比较,差异均无统计学意义(P>0.05)。各组均未见明显不良反应。结论:PPI四联1周疗法用于H.pylori感染的初治,疗效明显高于PPI三联1周疗法,是一种可供选择的一线治疗方案。

Background： A triple regimen with combination of proton pump inhibitor （PPI） and two antibiotics is currently the standard first-line anti-Helicobacter pylorl （H. pylori） therapy. Recent studies indicated that this regimen might not achieve satisfactory eradication rate due to the increasing prevalence of antibiotic resistance. An alternative option that can achieve a higher eradication rate of H. pylori for first-line initial treatment is urgently needed in clinical practice. Aims： To appraise the efficacy and safety of a 7-day PPI-containing quadruple regimen as first-line therapy for eradicating H. pylori infection. Methods： Patients with H. pylori-positive peptic ulcer disease or chronic gastritis were randomly allocated to Group A1, A2 and Group B1, B2. Patients in Group A received lansoprazole 30 mg, clarithromycin 250 mg, bismuth potassium citrate 220 mg, and either amoxycillin 1.0 g （A1） or metronidazole 400 mg （A2） twice daily for 7 days. Patients in Group B received lansoprazole 30 mg, clarithromyein 500 mg, and either amoxycillin 1.0 g （B1） or metronidazole 400 mg （B2） twice daily for 7 days. The adverse effects were recorded during the course of treatment. Eradication of H. pylori was determined by rapid urease test, histology or ^13C-urea breath test 4 weeks after completion of treatment. Results： A total of 145 patients were recruited. Per protocol （PP） but not intention-to-treat （ITT） eradication rate in Group A was significantly higher than that in Group B （PP 91.9% vs. 79.2%, P〈0.05; ITT 83.8% vs. 74.0%, P〉0.05）. No significant differences in both PP and ITT eradication rates were found between A1 （PP 93.8%, ITT 85.7%） and A2 （PP 90.0%, ITY 81.8%） groups （P〉0.05）, and B1 （PP 79.4%, ITT 75.0%） and B2 （PP 78.9%, ITF 73.2%） groups （P〉0.05）. No significant adverse effects were found among these groups. Conclusions： The 7-day PPI-containing quadruple regimen used as first-line therapy can achieve a higher eradication rate than the 7-day PPI-eontaining triple regimen in the initial treatment of H. pylori infection.