title: Randomised clinical trial: high-dose vs. standard-dose proton pump inhibitors for the prevention of recurrent haemorrhage after combined endoscopic haemostasis of bleeding peptic ulcers.
abstract: BACKGROUND
  The optimal dosage of intravenous proton pump inhibitors (PPIs) for the prevention of peptic ulcer rebleeding remains unclear.
  
  
  OBJECTIVE
  To compare the rebleeding rate of high-dose and standard-dose PPI use after endoscopic haemostasis.
  
  
  METHODS
  A total of 201 patients with bleeding ulcers undergoing endoscopic treatment with epinephrine injection and heater probe thermocoagulation were randomised to receive a high-dose regimen (80 mg bolus, followed by pantoprazole 8 mg/h infusion, n = 100) or a standard-dose regimen (pantoprazole 40 mg bolus daily, n = 101). After 72 h, all patients were given 40 mg pantoprazole daily orally for 27 days.
  
  
  RESULTS
  There were no statistical differences in mean units of blood transfused, length of hospitalisation ≦5 days, surgical or radiological interventions and mortality within 30 days between two groups. Bleeding recurred within 30 days in six patients [6.2%, 95% confidence interval (CI) 1.3-11.1%] in the high-dose group, as compared to five patients (5.2%, 95% CI 0.6-9.7%) in the standard-dose group (P = 0.77). The stepwise Cox regression analysis showed end-stage renal disease, haematemesis, chronic obstructive pulmonary disease (hazard ratio: 37.15, 10.07, 9.12, 95% CI: 6.76-204.14, 2.07-49.01, 1.66-50.00 respectively) were independent risk factors for rebleeding and Helicobacter pylori infection was associated with lower risk of rebleeding (hazard ratio: 0.20, 95% CI: 0.04-0.94).
  
  
  CONCLUSIONS
  Following combined endoscopic haemostasis of bleeding ulcers, co-morbidities, haematemesis and H. pylori Status, but not PPI dosage, are associated with rebleeding (http://www.Clinical Trials.gov.ID: NCT00709046).
authors.affiliation: Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, Douliou, Taiwan.
authors.forename: C-C
authors.initials: CC
authors.lastname: Chen
authors.forename: J-Y
authors.initials: JY
authors.lastname: Lee
authors.forename: Y-J
authors.initials: YJ
authors.lastname: Fang
authors.forename: S-J
authors.initials: SJ
authors.lastname: Hsu
authors.forename: M-L
authors.initials: ML
authors.lastname: Han
authors.forename: P-H
authors.initials: PH
authors.lastname: Tseng
authors.forename: J-M
authors.initials: JM
authors.lastname: Liou
authors.forename: F-C
authors.initials: FC
authors.lastname: Hu
authors.forename: T-l
authors.initials: TL
authors.lastname: Lin
authors.forename: M-S
authors.initials: MS
authors.lastname: Wu
authors.forename: H-P
authors.initials: HP
authors.lastname: Wang
authors.forename: J-T
authors.initials: JT
authors.lastname: Lin
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000008:administration & dosage*; D000368:Aged; D000369:Aged, 80 and over; D004305:Dose-Response Relationship, Drug; D004564:Electrocoagulation / Q000379:methods; D004837:Epinephrine / Q000627:therapeutic use; D005260:Female; D016481:Helicobacter Infections / Q000150:complications; D016480:Helicobacter pylori / Q000302:isolation & purification; D016558:Hemostasis, Endoscopic / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077402:Pantoprazole; D010438:Peptic Ulcer Hemorrhage / Q000517:prevention & control* / Q000628:therapy; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000008:administration & dosage*; D012044:Regression Analysis; D012307:Risk Factors; D055502:Secondary Prevention; D014662:Vasoconstrictor Agents / Q000627:therapeutic use*
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D054328:Proton Pump Inhibitors; D014662:Vasoconstrictor Agents; D000077402:Pantoprazole; D004837:Epinephrine