Efficacy and safety of intravenous ulinastatin versus placebo along with standard supportive care in subjects with mild or severe acute pancreatitis.

Background: Ulinastatin is reported to inhibit pro-inflammatory markers and also inhibits coagulation and fibrinolysis. The drug is available in East Asia for the treatment of acute pancreatitis.

Aim: To study the effect of addition of ulinastatin to standard care on mortality and morbidity in Indian subjects with acute pancreatitis.

Intravenous administration of ulinastatin (human urinary trypsin inhibitor) in severe sepsis: a multicenter randomized controlled study.

Purpose: Ulinastatin, a serine protease inhibitor, inhibits several pro-inflammatory proteases and decreases inflammatory cytokine levels and mortality in experimental sepsis. We studied the effect of ulinastatin on 28-day all-cause mortality in a double-blind trial in patients with severe sepsis in seven Indian hospitals.

Methods: Patients with sepsis were randomized within 48 h of onset of one or more organ failures to receive intravenous administration of ulinastatin (200,000 IU) or placebo 12 hourly for 5 days.