一项比较左氧氟沙星、奥美拉唑、硝唑尼特和强力霉素与三联疗法用于幽门螺杆菌根除治疗的随机研究

Objectives:Resistance to standard Helicobacter pylori (HP) treatment regimens has led to unsatisfactory cure rates in HP-infected patients. This study was designed to evaluate a novel four-drug regimen (three antibiotics and a proton pump inhibitor (PPI)) for eradication of HP infection in treatment-naive patients. Methods:Patients with a diagnosis of HP gastritis or peptic ulcer disease confirmed using endoscopy and stool antigen testing were eligible for inclusion in this study. All patients underwent a washout period of 6weeks from any prior antibiotic or PPI usage. Patients were then randomized to either levofloxacin, omeprazole, nitazoxanide, and doxycycline (LOAD) therapy for 7days (LOAD-7) or 10days (LOAD-10), including levofloxacin 250mg with breakfast, omeprazole 40mg before breakfast, nitazoxanide (Alina) 500mg twice daily with meals and doxycycline 100mg at dinner, or lansoprozole, amoxicillin, and clarithromycin (LAC) therapy for 10days, which included lansoprozole 30mg, amoxicillin 1g with breakfast and dinner, and clarithromycin 500mg with breakfast and dinner. HP eradication was confirmed by stool antigen testing at least 4weeks after cessation of therapy. Results:Intention-to-treat analysis revealed significant differences (P<0.05) in the respective eradication rates of the LOAD therapies (88.9% (80/90) LOAD-10, 90% (81/90) LOAD-7, 89.4% (161/180) for combined LOAD) compared with those receiving LAC, 73.3% (66/90). There were no differences in adverse effects between the groups. Conclusions:This open-label, prospective trial demonstrates that LOAD is a highly active regimen for the treatment of HP in treatment-naive patients. A large randomized controlled trial is warranted to further evaluate the efficacy of this regimen (Fig 1). Figure 1: Comparative efficacy, intent-to-treat analysis. ∗LAC vs. all LOAD, P=0.0001; LAC vs. LOAD-7, P=0.006; LAC vs. LOAD-10, P=0.013. There was no difference between the LOAD regimens as compared with each other. LAC, lansoprozole 30mg, amoxicillin 1g with breakfast and dinner, and clarithromycin 500mg with breakfast and dinner; LOAD, levofloxacin 250mg with breakfast, omeprazole 40mg before breakfast, nitazoxanide (Alina®) 500mg twice daily with meals and doxycycline 100mg at dinner. (Reprinted from Basu PP, Rayapudi K, Pacana T, et al. A randomized study comparing levofloxacin, omeprazole, nitazoxanide, and doxycycline versus triple therapy for the eradication of Helicobacter pylori. Am J Gastroenterol. 2011;106:1970-1975. Reprinted by permission from Macmillan Publishers Ltd: American Journal of Gastroenterology.