[Clinical study on effects of ulinastatin on patients with systemic inflammatory response syndrome]

To evaluate the value of ulinastatin in hindering systemic inflammatory response syndrome (SIRS) to proceed to multiple organ dysfunction syndrome (MODS).

Sixty patients were randomly divided into routine treatment group (n=30) and ulinastatin treatment group (n=30). Both groups were given routine treatment, while the patients of the ulinastatin treatment group were given ulinastatin (100 kU intravenously drip, once every 8 hours, and continued for 5 days) in addition. Additionally, 15 healthy persons were enrolled as normal control group. Temperature (T), heart rate (HR), respiration rate (RR) and white blood cell (WBC) count were observed everyday. The duration of SIRS, the number of organ dysfunction, and mortality were also compared. Serum C reactive protein(CRP), tumor necrosis factor-alpha (TNF-alpha), interleukin-6(IL-6) and IL-10 levels were measured before treatment and 5 days after in ulinastatin treatment group, routine treatment group, and in normal control group at the time of health examination.

All of the SIRS markers were not different both in ulinastatin group and routine treatment group before treatment. T, RR, HR and WBC were reduced significantly after 3 days in ulinastatin groups(P<0.05 or P<0.01), but HR was not lowered significantly after 5 days and WBC after 7 days of treatment in regular treatment group (P<0.05 or P<0.01). All of the cytokines in ulinastatin treatment group and routine treatment group were higher than normal control group before treatment. Serum CRP, TNF-alpha and IL-6 levels were reduced significantly after 5 days of treatment in both ulinastatin treatment group and routine treatment group(P<0.01), but in ulinastatin treatment group the reduction was faster than routine treatment group(both P<0.01). IL-10 level was elevated significantly after treatment in ulinastatin treatment group(P<0.01), but it showed no significant change in routine treatment groups(P>0.05). The number of patients with duration of SIRS longer than 3 days were fewer and the incidence of MODS was lower in ulinastatin treatment group than those in routine treatment group(10.00% vs. 36.67%, P<0.05), and the fatality rate was reduced significantly with ulinastatin(3.33% vs. 20.00%, P<0.05).

Ulinastatin significantly improves the inflammatory symptom and signs of SIRS, such as T, HR, RR, and WBC, inhibits the production of inflammatory cytokines, and enhance the anti-inflammatory cytokines in the treatment of SIRS. It can effectively prevent SIRS to proceed to MODS.