title: [Quadruple regimens using domestically manufactured drugs in gastritis and duodenal ulcer patients for Helicobacter pylori eradication: a perspective, multicenter, randomized controlled trial].
abstract: OBJECTIVE
  To observe the effects and safety of quadruple regimens including domestically manufactured rabeprazole used as first line/initial therapy for Helicobacter pylori(H.pylori) eradication in gastritis and duodenal ulcer patients, and to investigate the effects of extended use of bismuth after the quadruple therapy on eradication of H. pylori.
  
  
  METHODS
  From January to August 2013, 430 patients with chronic gastritis or duodenal ulcer who were confirmed as H. pylori positive in gastroscopy for upper gastrointestinal symptoms were enrolled from 12 centers in China for initial treatment using quadruple regimens for H. pylori eradication. The study was a prospective, multicenter, randomized double-blinded double-dummy parallel-controlled clinical trial. The 310 chronic gastritis patients were divided into 2 groups: group A1 was given quadruple regime (rabeprazole+ amoxicillin+ clarithromycin+ bismuth potassium citrate) for 10 days followed by bismuth-placebo for 21 days; group A2 was given the quadruple regimen for 10 days and then bismuth potassium citrate for 21 days. The duodenal ulcer patients were given the quadruple for 10 days, then rabeprazole for 14 days. All the patients took (13)C urea breath test to detect H. pylori 28 days after medicine withdrawal.
  
  
  RESULTS
  Altogether 428 cases were enrolled and 404 completed the trial. The total eradication rate in the chronic gastritis patients was 85.1% (262/308, intention-to-treat (ITT)analysis), which was 81.7% (125/153, ITT) in the A1 group and 88.4% (137/155, ITT) in the A2 group; the eradication rate in the duodenal ulcer patients was 85.8% (103/120, ITT). No severe adverse effects were reported. The symptoms (pain, burning sensation, reflux, belching, nausea, and vomiting) improvement status was similar among A1 and A2 groups.
  
  
  CONCLUSIONS
  The quadruple regimen using rabeprazole manufactured in China and administered for 10 days as first line/initial therapy in chronic gastritis and duodenal ulcer patients could achieve good H. pylori eradication rate. The extended use of bismuth after 10-day quadruple regimen might further improve the eradication rate. The regimens containing proton-pump inhibitor and bismuth may be well tolerated and safe in clinical application.
authors.affiliation: Department of Gastrointestinal, Peking University First Hospital, Beijing 100034, China.
authors.forename: Wen
authors.initials: W
authors.lastname: Gao
authors.forename: Fulian
authors.initials: F
authors.lastname: Hu
authors.forename: Hong
authors.initials: H
authors.lastname: Cheng
authors.forename: Huahong
authors.initials: H
authors.lastname: Wang
authors.forename: Yunsheng
authors.initials: Y
authors.lastname: Yang
authors.forename: Hao
authors.initials: H
authors.lastname: Liang
authors.forename: Shutian
authors.initials: S
authors.lastname: Zhang
authors.forename: Fandong
authors.initials: F
authors.lastname: Meng
authors.forename: Meihua
authors.initials: M
authors.lastname: Cui
authors.forename: Hong
authors.initials: H
authors.lastname: Wei
authors.forename: Jianqiu
authors.initials: J
authors.lastname: Sheng
authors.forename: Hejuan J
authors.initials: HJ
authors.lastname: An
authors.forename: Bo
authors.initials: B
authors.lastname: Jiang
authors.forename: Ye
authors.initials: Y
authors.lastname: Chen
authors.forename: Yanqing
authors.initials: Y
authors.lastname: Li
authors.forename: Xiuli
authors.initials: X
authors.lastname: Zuo
authors.forename: Jun
authors.initials: J
authors.lastname: Gong
authors.forename: Ping
authors.initials: P
authors.lastname: Zhao
authors.forename: Lei
authors.initials: L
authors.lastname: Dong
authors.forename: Bangmao
authors.initials: B
authors.lastname: Wang
authors.forename: Kai
authors.initials: K
authors.lastname: Jiang
authors.forename: Guiying
authors.initials: G
authors.lastname: Zhang
authors.forename: Jiansheng
authors.initials: J
authors.lastname: Li
authors.forename: Ye
authors.initials: Y
authors.lastname: Zhao
authors.forename: Hengjun
authors.initials: H
authors.lastname: Gao
authors.forename: Li
authors.initials: L
authors.lastname: Yang
mesh_terms: D000658:Amoxicillin; D000863:Antacids; D001729:Bismuth; D001944:Breath Tests; D004359:Drug Therapy, Combination; D004381:Duodenal Ulcer; D005756:Gastritis; D005764:Gastroesophageal Reflux; D005773:Gastroscopy; D016481:Helicobacter Infections; D016480:Helicobacter pylori; D006801:Humans; D009942:Organometallic Compounds; D011446:Prospective Studies; D054328:Proton Pump Inhibitors; D014508:Urea
chemical_list: D000863:Antacids; D009942:Organometallic Compounds; D054328:Proton Pump Inhibitors; D000658:Amoxicillin; D014508:Urea; C002791:bismuth tripotassium dicitrate; D001729:Bismuth