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Clinical trial of gabexate in the prophylaxis of post-endoscopic retrograde cholangiopancreatography pancreatitis.

Abstract
The objective of the present study was to determine the efficacy of prophylactic administration of gabexate for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis, hyperamylasemia and pancreatic pain. Patients scheduled for ERCP were randomized into two groups in a double-blind manner: the patients in the gabexate group were treated with continuous intravenous infusion of 300 mg gabexate dissolved in 500 mL Ringer's solution at 111 mL/h, starting 30 min before the endoscopic maneuvers and continuing up to 4 h after them; placebo group patients were treated only with Ringer's solution also starting 30 min before the endoscopic maneuvers and continuing up to 4 h. Data for 193 patients were analyzed. The incidence of post-ERCP pancreatitis was 3 patients (3.1%) in the gabexate group and 10 (10.5%) in the placebo group (P = 0.040). The incidence of hyperamylasemia was 33 patients (33.7%) in the gabexate group and 42 (43.7%) in the placebo group (P = 0.133). The incidence of pancreatic pain was 15 patients (15.3%) in the gabexate group and 28 (29.5%) in the placebo group (P = 0.018). The results suggest that a 4.5-h infusion of gabexate (for a total of 300 mg) could prevent post-ERCP pancreatitis and pancreatic pain.
AuthorsG-S Xiong, S-M Wu, X-W Zhang, Z-Z Ge
JournalBrazilian journal of medical and biological research = Revista brasileira de pesquisas médicas e biológicas / Sociedade Brasileira de Biofísica ... [et al.] (Braz J Med Biol Res) Vol. 39 Issue 1 Pg. 85-90 (Jan 2006) ISSN: 0100-879X [Print] Brazil
PMID16400468 (Publication Type: Journal Article, Randomized Controlled Trial)
Chemical References
  • Serine Proteinase Inhibitors
  • Gabexate
Topics
  • Abdominal Pain (etiology, prevention & control)
  • Acute Disease
  • Cholangiopancreatography, Endoscopic Retrograde (adverse effects, methods)
  • Double-Blind Method
  • Female
  • Gabexate (administration & dosage)
  • Humans
  • Hyperamylasemia (etiology, prevention & control)
  • Male
  • Middle Aged
  • Pancreatitis (etiology, prevention & control)
  • Prospective Studies
  • Serine Proteinase Inhibitors (administration & dosage)

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