RANDOMISED CLINICAL TRIALS
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
Version of Record online: 28 FEB 2012
© 2012 Blackwell Publishing Ltd
Alimentary Pharmacology & Therapeutics
Volume 35, Issue 8, pages 894–903, April 2012
How to Cite
Chen, C.-C., Lee, J.-Y., Fang, Y.-J., Hsu, S.-J., Han, M.-l., Tseng, P.-H., Liou, J.-M., Hu, F.-C., Lin, T.-l., Wu, M.-S., Wang, H.-P. and Lin, J.-T. (2012), 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. Alimentary Pharmacology & Therapeutics, 35: 894–903. doi: 10.1111/j.1365-2036.2012.05047.x
- Issue online: 21 MAR 2012
- Version of Record online: 28 FEB 2012
- Manuscript Accepted: 6 FEB 2012
- Manuscript Revised: 24 JAN 2012
- Manuscript Revised: 30 DEC 2011
- Manuscript Received: 7 DEC 2011
- National Taiwan University Hospital. Grant Number: NTUHYL 97-S003
- National Clinical Trial Center, National Taiwan University Hospital. Grant Number: 100-2325-B-002-063
The optimal dosage of intravenous proton pump inhibitors (PPIs) for the prevention of peptic ulcer rebleeding remains unclear.
To compare the rebleeding rate of high-dose and standard-dose PPI use after endoscopic haemostasis.
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.
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).
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).