Control clinical study of the effect of Ulinastatin on prognosis of acute respiratory distress syndrome patients

Abstract

Objective To study the effect of Ulinastatin on prognosis,immune function,adrenal function and inflammatory reaction during the treatment of acute respiratory distress syndrome (ARDS). Methods From December 2004 to November 2009, a clinical study was conducted on consecutive adult patients with ARDS in intensive care unit (ICU). The patients were divided into Ulinastatin group ( 30 patients) and control group (30 patients). Both groups were treated with the routine therapy of ARDS and in addition, Ulinastatin was used in a dose of 500,000 U twice a day for 7 ays in Ulinastatin group. Duration of mechanical ventilation (MV)and ICU length of stay,28-day mortality, acute physiology and chronic health evaluation I(APACHE Ⅱ ), Murray and Marshall scores were recorded in both groups. Every patient was given one of corticotrophin 250 μg intravenously before and after treatment and plasma contisol level was detected by radio-immunoassay before the (TO) and 30 minutes (T30)and 60 minutes (T60)after the, The ratio of adrenal insufficiency was evaluated according to diagnostic criteria of ralative adrenal insufficiency, which was defined as the diffenence between TO and the highest value of T30 or T60( △ Tmax) ≤248. 4 nmol/L. Human leukocyte antigen-DR( HLA-DR), subpopulations of T lymphocyte ( CD4 +/CD8 + ), interleukin-6 ( IL-6 ), IL-10 in peripheral blood was also determined. Results Murray ( 1.5 ± 1.5 ) and Marshall score (2.9 ± 2.7 ) and the level of IL-6 (( 3.4 ± 1.9) μmol/L,IL-10( (1.5 ± 0.8 ) μmol/Lin the Ulinastatin group were decreased significantly after the use of Ulinastatin compared with control group4.3 ± 3.1,6.3 ± 4.1, ( 8.9 ± 10.2) μmol/L, (4.2 ± 4.8 ) μmol/L, respectively, all P ＜ 0. 01, while the values ofHLA-DR(41.1 ± 10.1 ), CD4 + (58.0 ± 10.7), CD4 +/CD8 + ( 1.9 ± 0.3 ) were increased compared with control group(30.6 ± 15.0,50.5 ± 16.2,1.4 ±0.7,respectively,P ＜0.05 or P ＜0.01.The ratio of adrenal insufficiency in Ulinastatin group(45.2% )was lower than that of control group( 83.3% ),while that of ATmax( 328.4 ± 278.3 )/μmol/Lwas higher than that of control group( 172.8 ± 110.8 )/μmol/L ,both P ＜ 0.01. MV duration (4.0 ± 3.3 ) daysand ICU length of stay ( 8.4 ± 4. 2) dayswere less than those of control group (5.9 ± 3.8 ) days, ( 12.0 ± 7.6 ) days, both P ＜ 0.053, and 28-day mortality in Ulinastatin group was 35.5% ,which was 11.2% less than that of control group(46.7% ) ,but there was no statistically significant difference between two groups ( P ＞ 0.05 ). Conclusion Ulinastatin improves organ function, decreases MV duration and ICU length of stay in ARDS patients. The underlying mechanism may involve modulation of the immune function, decrease in the degree of adrenal insufficiency, and modulation of regulating inflammatory reaction. Key words: Ulinastatin; Acute respiratory distress syndrome; Prognosis