[Effect of Xuebijing injection treatment on acute respiratory distress syndrome: a multicenter prospective randomized control clinical trial].

OBJECTIVE: To assess the therapeutic effect of Xuebijing injection on adult patients with acute respiratory distress syndrome (ARDS). METHODS: A multicenter prospective randomized control study was conducted at 10 intensive care units in Jiangsu province. A total of 172 early ARDS patients were randomly divided into Xuebijing treatment and control groups. All patients received routine therapy of ARDS while additional Xuebijing injection 100 ml was administered in the treatment group intravenously for 7 days. Lung injury score, acute physiology and chronic health evaluation II (APACHE II) score, multiple organ dysfunction score (MODS) and PaO2/FiO2 of the patients was recorded before and after treatment. Mortality at 28 days and the duration of mechanical ventilation were compared between two groups. RESULTS: Ninety-one patients were assigned to receive Xuebijing injection and 81 patients as control; Mortality at Days 28 and 90, the duration of mechanical ventilation and ventilation free days showed no difference between two groups (P > 0.05). PaO2/FiO2 improved after randomization versus pre-treatment in all patients. There was no significant difference between two groups. Murray scores were not significantly different between two groups. In a subgroup analysis of patients with pulmonary infection, pulmonary contusion and extra-pulmonary cause, two groups had no difference in mortality at Day 28, mortality at Day 90, the duration of mechanical ventilation, ventilation free days and days of ICU stay (P > 0.05). CONCLUSION: The treatment of Xuebijing injection early in course of ARDS does not improve the mortality of ARDS patients. But it may improve lung function and oxygenation. Further studies are warranted.

[A prospective randomized control clinical study of the effect of Xuebijing injection on prognosis of acute respiratory distress syndrome patients].

OBJECTIVE: To study the effect of Xuebijing injection on prognosis, immune function, adrenal function and inflammatory reaction during the treatment of acute respiratory distress syndrome (ARDS). METHODS: From January 2008 through December 2008, a clinical study was conducted on consecutive adult patients with ARDS in intensive care unit (ICU). The patients were divided into Xuebijing group (31 patients) and control group (30 patients). Both groups were treated with the routine therapy of ARDS, and in addition, Xuebijing injection was used in a dose of 100 ml twice a day for 7 days in Xuebijing group. Duration of mechanical ventilation (MV) and ICU length of stay, 28-day mortality, acute physiology and chronic health evaluation II (APACHE II), Murray and Marshall scores were recorded in both groups. Every patient was given one injection of corticotrophin 250 microg intravenously before and after treatment, and plasma cortisol level was detected by radio-immunoassay before the injection (T0) and 30 minutes (T30) and 60 minutes (T60) after the injection. The ratio of adrenal insufficiency was evaluated according to diagnostic criteria of relative adrenal insufficiency, which was defined as the difference between T0 and the highest value of T30 or T60 (Delta Tmax)< or =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) micromol/L], IL-10 [(1.5+/-0.8) micromol/L] in the Xuebijing group were decreased significantly after the use of Xuebijing compared with control group [4.3+/-3.1, 6.3+/-4.1, (8.9+/-10.2) micromol/L, (4.2+/-4.8) micromol/L, respectively, all P<0.01], while the values of HLA-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 Xuebijing group (45.2%) was lower than that of control group (83.3%), while that of Delta Tmax [(328.4+/-278.3) micromol/L] was higher than that of control group [(172.8+/-110.8) micromol/L, both P<0.01]. MV duration [(4.0+/-3.3) days] and ICU length of stay [(8.4+/-4.2) days] were less than those of control group [(5.9+/-3.8) days, (12.0+/-7.6) days, both P<0.05], and 28-day mortality in Xuebijing 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: Xuebijing injection 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.