Ulinastatin in the treatment of acute pancreatitis: A multicenter clinical trial

OBJECTIVE: To assess the effectiveness of Chinese-made ulinastatin in the treatment of patients with acute edematous pancreatitis (AEP) and acute hemorrhagic and necrotic pancreatitis (AHNP). METHODS: A multicenter randomized controlled clinical trial was performed. Stratified by AHNP or AEP, patients were randomly allocated into either the treatment group (with ulinastatin) or the control group (treatment with cabexate or octreotide). Clinical symptoms and signs were scored as none, mild, moderate or severe. Laboratory tests included serum amylase, liver and renal function tests, routine blood tests, serum glucose, calcium, blood pH and PaO2. Clinical results were assessed as cured, significantly effective, effective and non-effective. All adverse effects were recorded. RESULTS: From April to July 2000, a total of 94 patients with acute pancreatitis were enrolled into the study (50 males; 44 females). In this patient group, there were 68 cases of mild pancreatitis and 26 cases of severe pancreatitis. The study showed that the global effective rates of ulinastatin and cabexate in treating AEP were 100%, whereas the cured rate for ulinastatin was 83.3%, which was a little higher than that for cabexate (71.4%), but this difference was not statistically significant. Clinical symptoms, such as abdominal pain and distension, almost disappeared within 3−5 days in both groups for both treatment protocols. The global effective rate of ulinastatin in treating AHNP was similar to that of octreotide (78.6 vs 81.9%; P= 0.840). The main complication in AHNP was pancreatic pseudocyst. Only one case showed increased levels of alanine aminotransferase. No adverse effects, including allergy, skin rash and decreases in the white blood cell count, were noted. No abnormalities in liver and renal function, electrolytes or routine blood tests were noted. CONCLUSIONS: Ulinastatin was shown to be effective in treating AEP and AHNP with few adverse effects.