OBJECTIVE: To observe therapeutic efficacy of ulinastatin in the treatment of acute pancreatitis. METHODS: A total of 80 acute pancreatitis patients were randomly divided into control group and observation group, with 40 cases in each group. Control group was given conventional treatment as gastrointestinal decompression, analgesia and spasmolysis, anti-infective treatment, fluid replacement, electrolyte disturbances balance, in vivo microcirculation improvement; observation group was additional given ulinastatin 100 000 U added into 5% Glucose injection 250 ml, ivgtt, bid, on the basis of control group, and then given medicine qd after improving symptoms; finally, stopped taking medicine immediately the symptom disappeared. Both groups was given 8d of treatment. Serum levels of IL-6 and TNF-α were observed in 2 groups before and after treatment, and clinical symptom, the time of sign and lab index improvement were also observed. Clinical efficacy was evaluated. RESULTS: After treatment, serum levels of IL-6 and TNF-α in observation group was significantly lower than in control group; the time of clinical symptom and sign, lab indicator improvement were significantly shorter than in control group, with statistical significance (P<0.01). The effective rate (95.00%) of observation group was significantly higher than that (70.00%) of control group, with statistical significance (P<0.05). CONCLUSIONS: Ulinastatin can significantly reduce acute pancreatitis significantly, improve clinical symptom, promote disease recovery and clinical efficacy.