title: Efficacy of 1st-line bismuth-containing quadruple therapies with levofloxacin or clarithromycin for the eradication of Helicobacter pylori infection: A 1-week, open-label, randomized trial.
abstract: BACKGROUND
  The aim of the present open-label, randomized control trial was to determine the clinical efficacy and safety of two 1-week bismuth-containing quadruple regimens and 1 levofloxacin-based triple regimen for the eradication of Helicobacter pylori infection in treatment-naive patients. The influence of susceptibility and host CYP2C19 polymorphisms on the efficacy was also evaluated.
  
  
  METHODS
  Eligible patients were randomly to receive esomeprazole and colloidal bismuth pectin along with clarithromycin and amoxicillin (EBCA), esomeprazole and colloidal bismuth pectin along with levofloxacin and amoxicillin (EBLA), or esomeprazole along levofloxacin and amoxicillin (ELA) for 1 week. The primary outcome was the eradication rate in the intention-to-treat (ITT) and per-protocol (PP) analyses.
  
  
  RESULTS
  Overall, 270 patients were randomized. The eradication rates in the above 3 groups were 80.25%, 89.66%, and 81.93% in PP analysis and 72.22%, 86.66%, and 75.56% in ITT analysis, respectively. The eradication rate of EBLA was significantly higher than that of EBCA (P = 0.016) in ITT analysis. No significant differences were found among these groups in terms of adverse effects and compliance. The efficacy was significantly affected by levofloxacin resistance for EBLA (P = 0.01) and ELA (P = 0.04), but not by polymorphisms of CYP2C19 gene for any of the 3 groups.
  
  
  CONCLUSIONS
  All 1-week bismuth-containing quadruple therapies and levofloxacin-based triple therapy can obtain an acceptable eradication rate, and levofloxacin-based quadruple regimen exhibits the highest eradication rate. The antibiotic resistant rate of levofloxacin was associated with the eradication rate.
authors.affiliation: Department of Gastroenterology, First Affiliated Hospital of Nanjing Medical University, Nanjing Department of Gastroenterology, XuZhou Central Hospital, Xuzhou, China First Clinical Medical College of Nanjing Medical University, Nanjing, China.
authors.forename: Jing
authors.initials: J
authors.lastname: Su
authors.forename: Xiaoying
authors.initials: X
authors.lastname: Zhou
authors.forename: Han
authors.initials: H
authors.lastname: Chen
authors.forename: Bo
authors.initials: B
authors.lastname: Hao
authors.forename: Weifeng
authors.initials: W
authors.lastname: Zhang
authors.forename: Guoxin
authors.initials: G
authors.lastname: Zhang
mesh_terms: D000328:Adult; D000863:Antacids / Q000008:administration & dosage* / Q000009:adverse effects; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001729:Bismuth / Q000008:administration & dosage* / Q000009:adverse effects; D017291:Clarithromycin / Q000008:administration & dosage; D065731:Cytochrome P-450 CYP2C19 / Q000235:genetics; D024881:Drug Resistance, Bacterial; D004359:Drug Therapy, Combination; D064098:Esomeprazole / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000235:genetics; D016480:Helicobacter pylori; D006801:Humans; D064704:Levofloxacin / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D054328:Proton Pump Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000863:Antacids; D000900:Anti-Bacterial Agents; D054328:Proton Pump Inhibitors; D064704:Levofloxacin; C045793:CYP2C19 protein, human; D065731:Cytochrome P-450 CYP2C19; D017291:Clarithromycin; D064098:Esomeprazole; D001729:Bismuth