Clinical effect of ulinastatin

In Japan, It is clinically used to treat endoscopic retrograde cholangiopancreatography (ERCP). Studies in Japan have documented a reduction in the incidence of ERCP-induced pancreatitis with the use of ulinastatin. In one study, the incidence of hyperenzymemia and pancreatitis was significantly lower in the ulinastatin group than in the placebo group.In another study, ulinastatin reduced serum, drain amylase, and the incidence of postoperative pancreatitis following pancreaticoduodenectomy.

A study conducted in India found that mortality from all causes over 22 days in subjects with severe pancreatitis was lower among those receiving ulinastatin than those receiving placebo (2.8% versus 18.8%; p=0.048), resulting in a 16% absolute reduction in the risk of death and a relative reduction of 85%. The results indicated that in this population, one life would be saved for every 6.25 subjects treated with ulinastatin. New organ dysfunction was seen in 12 subjects with severe pancreatitis on ulinastatin and 29 on placebo (p=0.0026).