title: [Ilaprazole based bismuth-containing quadruple regimen for the first-line treatment of Helicobacter pylori infection: a multicenter, randomized, controlled clinical study].
abstract: OBJECTIVE
  To explore the effects of 7-day quadruple regimen as the first-line therapy strategy for Helicobacter pylori(H. pylori)infection and compare the eradication rate of ilaprazole versus esoprazole-based regimen.
  
  
  METHODS
  A total of 440 patients with H. pylori infection, who had never received H. pylori eradication treatment, were enrolled from 10 domestic hospitals from October 2010 to July 2011. Diagnosed as chronic gastritis or duodenal ulcer according to their endoscopic examination results, they were randomized into ilaprazole and(or) esoprazole-based bismuth-containing quadruple regimen group with amoxicillin and clarithromycin (n = 110 each). After a 7-day eradication treatment, all patients with duodenal ulcer received PPI (ilaprazole and(or) esoprazole) treatment for 14 days and (13)C urea breath test was performed at least 28 days after the end of therapy. The patients with failed eradication treatment underwent endoscopy examination and biopsy. H. pylori culture and detection of antibiotic-resistant genes were also performed.
  
  
  RESULTS
  In gastritis patients, the eradication rate (per-protocol, PP value) were 78.2% (79/101) and 82.0% (82/100) in ilaprazole and esoprazole groups (P = 0.50) while the (intention-to-treat) ITT value of eradication rate were 71.8% (79/110) and 74.5% (82/110) in ilaprazole and esoprazole groups respectively (P = 0.65). And there was no statistical difference (P > 0.05). In duodenal patients, the eradication rate (PP) were 92.1% (93/101) and 91.4% (96/105) in ilaprazole and esoprazole group (P = 0.86) while the ITT value of eradication rate were 84.5% (93/110) and 87.3% (96/110) in ilaprazole and esoprazole groups respectively (P = 0.56). And no significant difference existed between two groups in gastritis and duodenal ulcer patients (P > 0.05). In total, the eradication rate was 80.1% (161/201) (PP) and 73.2% (161/220) (ITT), 91.7% (189/206) (PP) and 85.9% (189/220) (ITT) in chronic gastritis and duodenal ulcer patients respectively. The symptomatic improvements of stomachache, burning, belching and nausea remained almost unchanged. No severe side effect was observed. The point mutations for clarithromycin resistance were detected in all 53 H. pylori strains (100%) isolated from the patients with failed eradication treatment.
  
  
  CONCLUSIONS
  The eradication rate of PPI based bismuth-containing quadruple regimen as the first-line treatment is satisfactory in chronic gastritis and duodenal ulcer patients. No significant difference exists between the effects of ilaprazole and esoprazole-based groups. And the treatment failure may be attributed mainly to the clarithromycin resistance of H. pylori.
authors.affiliation: Department of Gastroenterology, Peking University First Hospital, Beijing 100034, China.
authors.forename: Wen
authors.initials: W
authors.lastname: Gao
authors.forename: Hong
authors.initials: H
authors.lastname: Cheng
authors.forename: Fu-lian
authors.initials: FL
authors.lastname: Hu
authors.forename: Nong-hua
authors.initials: NH
authors.lastname: Lü
authors.forename: Yong
authors.initials: Y
authors.lastname: Xie
authors.forename: Jian-qiu
authors.initials: JQ
authors.lastname: Sheng
authors.forename: Jian-ming
authors.initials: JM
authors.lastname: Xu
authors.forename: Ling-xia
authors.initials: LX
authors.lastname: Zhang
authors.forename: Li
authors.initials: L
authors.lastname: Zhang
authors.forename: Ye
authors.initials: Y
authors.lastname: Chen
authors.forename: Zhen-yu
authors.initials: ZY
authors.lastname: Zhang
authors.forename: Guo-xin
authors.initials: GX
authors.lastname: Zhang
authors.forename: Mei-hua
authors.initials: MH
authors.lastname: Cui
authors.forename: Gui-bin
authors.initials: GB
authors.lastname: Yang
authors.forename: Heng-jun
authors.initials: HJ
authors.lastname: Gao
authors.forename: Li
authors.initials: L
authors.lastname: Yang
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002681:China; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; C119615:ilaprazole; D009853:Omeprazole