title: Randomized Clinical Trial: Esomeprazole, Bismuth, Levofloxacin, and Amoxicillin or Cefuroxime as First-Line Eradication Regimens for Helicobacter pylori Infection.
abstract: The eradication of Helicobacter pylori infection remains a challenge, especially in the patients unsuitable to take penicillin. Cephalosporin has the potential to replace amoxicillin for H. pylori eradication.
  
  
  
  To compare the effectiveness, safety, and compliance of amoxicillin- and cefuroxime-containing quadruple regimens in treatment-naïve patients.
  
  
  
  In this open-label randomized control study, 400 patients with H. pylori infection were divided into amoxicillin-containing (esomeprazole 20 mg twice/day, amoxicillin 1000 mg twice/day, levofloxacin 500 mg once/day, and bismuth 220 mg twice/day for 14 days) or cefuroxime-containing (esomeprazole 20 mg twice/day, cefuroxime 500 mg twice/day, levofloxacin 500 mg once/day, and bismuth 220 mg twice/day for 14 days) quadruple therapy groups. The safety and compliance were assessed 1-3 days after eradication. Urea breath test was performed 8-12 weeks after eradication to determine treatment outcome.
  
  
  
  The baseline data including antibiotic resistance were well matched between the two groups. The eradication rates between amoxicillin- and cefuroxime-containing quadruple therapy groups were not significantly different [intention-to-treat analysis: 83.5% (95% confidence interval 78.3-88.7%) vs. 81.0% (75.5-86.5%), P = 0.513; modified intention-to-treat analysis: 90.3% (86.0-94.6%) vs. 88.5% (83.9-93.2%), P = 0.586; per-protocol analysis: 91.6% (87.5-95.7%) vs. 89.8% (85.3-94.3%), P = 0.560]. The incidence of adverse effects (18.4 vs. 20.1%, P = 0.678) and compliance (94.7 vs. 94.2%, P = 0.813) were also similar. Variate analyses showed that antibiotic resistance and poor compliance were the independent risk factors for eradication failure.
  
  
  
  Esomeprazole, bismuth, levofloxacin, and amoxicillin or cefuroxime achieved similar and relatively satisfactory cure rates, safety, and compliance in first-line H. pylori eradication. Cefuroxime may be a good alternative medicine for eradication instead of amoxicillin for the patients unsuitable to take penicillin.
authors.affiliation: Department of Gastroenterology, Peking University Third Hospital, No 49, North Garden Road, Haidian District, Beijing, 100191, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Fu
authors.affiliation: Department of Gastroenterology, Peking University Third Hospital, No 49, North Garden Road, Haidian District, Beijing, 100191, China.
authors.forename: Zhiqiang
authors.initials: Z
authors.lastname: Song
authors.affiliation: Department of Gastroenterology, Peking University Third Hospital, No 49, North Garden Road, Haidian District, Beijing, 100191, China. zhouliya123456@163.com.
authors.forename: Liya
authors.initials: L
authors.lastname: Zhou
authors.affiliation: Department of Gastroenterology, Peking University Third Hospital, No 49, North Garden Road, Haidian District, Beijing, 100191, China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Xue
authors.affiliation: Department of Gastroenterology, Peking University Third Hospital, No 49, North Garden Road, Haidian District, Beijing, 100191, China.
authors.forename: Yu
authors.initials: Y
authors.lastname: Ding
authors.affiliation: Department of Gastroenterology, Peking University Third Hospital, No 49, North Garden Road, Haidian District, Beijing, 100191, China.
authors.forename: Baojun
authors.initials: B
authors.lastname: Suo
authors.affiliation: Department of Gastroenterology, Peking University Third Hospital, No 49, North Garden Road, Haidian District, Beijing, 100191, China.
authors.forename: Xueli
authors.initials: X
authors.lastname: Tian
authors.affiliation: Department of Gastroenterology, Peking University Third Hospital, No 49, North Garden Road, Haidian District, Beijing, 100191, China.
authors.forename: Li
authors.initials: L
authors.lastname: Wang
mesh_terms: D000328:Adult; D000658:Amoxicillin / Q000627:therapeutic use; D000863:Antacids / Q000009:adverse effects / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001729:Bismuth / Q000009:adverse effects / Q000627:therapeutic use*; D001944:Breath Tests; D002444:Cefuroxime / Q000627:therapeutic use; D024881:Drug Resistance, Bacterial; D004359:Drug Therapy, Combination / Q000009:adverse effects; D064098:Esomeprazole / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D057194:Intention to Treat Analysis; D064704:Levofloxacin / Q000627:therapeutic use; D008297:Male; D055118:Medication Adherence; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D054328:Proton Pump Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D017211:Treatment Failure; D014508:Urea / Q000032:analysis
chemical_list: D000863:Antacids; D000900:Anti-Bacterial Agents; D054328:Proton Pump Inhibitors; D064704:Levofloxacin; D000658:Amoxicillin; D014508:Urea; D064098:Esomeprazole; D002444:Cefuroxime; D001729:Bismuth
keywords: Amoxicillin; Cefuroxime; Compliance; Eradication; Helicobacter pylori; Safety