A Study on clinical efficacy of ulinastatin in severe sepsis patients and its mechanism of action

ObjectiveTo evaluate the efficacy and safety of ulinastatin in patients with severe sepsis and investigate its mechanisms of action.MethodsFifty-six patients were randomly divided into ulinastatin treatment group (group U) and control group (group C).Patients in group U received ulinastatin 200 000 units intravenous twice a day for 5 days,while those in group C received equal quantity of normal saline as placebo.Before treatment and at 24 th 、48 th 、120 th hour after start of treatment,APACHEⅡ scores were recorded.The blood concentration of tumor necrosis factor-α(TNF-α),interleukin-1β (IL-1β),interleukin-6 (IL-6),interleukin-4 (IL-4),interleukin-10 (IL-10) were determined.Mortality rate was compared at 28 days after treatment between the two groups.ResultsThe APACHEⅡ scores in both groups decreased during the treatment,and there was significant difference between the two groups on 5 th day of treatment.The APACHEⅡscores of group U was lower than that of group C.The 28-day mortality rate was 28.6%(8/28) in group U,while that of group C was 57.1%(16/28),there was a significant difference between the two groups.No severe adverse reaction in group U was observed.The concentration of TNF-α in group U patients decreased more markedly than that in group C of 24 to 48 hours after treatment as well as IL-6 at 48 hours.However,blood concentration of TNF-α and IL-10 increased more markedly in group U than that in group C,blood level of IL-4 between the two groups were not significantly different during treatment.ConclusionsUlinastatin improves patient’s condition and reducing 28-day mortality of severe sepsis patients.Ulinastatin can decrease the blood concentration of TNF-α and IL-6 and increase the blood level of IL-10 in patients with severe sepsis.It is a safe and affordable drug for the treatment of severe sepsis.