[Protective effect of the use of Xuebijing injection during laparotomy on perioperative inflammatory response and organ function].

OBJECTIVE: To investigate the role of Xuebijing injection in inhibiting perioperative inflammatory responses and protecting the function of multiple organs.

METHODS: A single-blind, randomized, parallel controlled trial was conducted. 60 patients in the First Affiliated Hospital of Zhejiang University School of Medicine, aged 18 to 80 years, ASA gradeI-III, undergoing elective abdominal surgery, were enrolled. The patients were randomly divided into the control group (n=30) and the treatment group (n=30). In the control group, after induction of anesthesia, a continuous infusion of 0.9% normal saline (NS) 200 mL was given in a speed of 2 mL/min, while a continuous infusion of Xuebijing 2 mL/kg in 100 mL of 0.9% NS was given at 2 mL/min in the treatment group after induction of anesthesia. The blood sample was drawn, and body temperature, routine blood test, C-reactive protein (CRP), liver and kidney function, fasting glucose (Glu), and serum interleukin-6 (IL-6), high mobility group protein B1 (HMGB1) levels were determined in all the patients before anesthesia (T1), at the end of operation (T2), 12 hours after operation (T3), or at 5:00 am on the third day after operation (T4). At the same time the adverse reactions were recorded for evaluation of the safety of Xuebijing.

RESULTS: After using Xuebijing injection, T3 body temperature and the T3-T1 temperature difference in treatment group were significantly lower than those of the control group (36.70±0.37 centigrade vs. 37.38±0.47 centigrade, t=6.199, P=0.000; 0.07±0.50 vs. 0.85±0.58, t=5.598, P=0.000). Postoperative white blood cell count, neutrophil percentage, and CRP were significantly higher than those before the operation, but the differences between two groups were not statistically significant. Compared with the control group, alanine aminotransferase (ALT), aspartate transaminase (AST), total bilirubin (TBil) levels at T3 of treatment group were significantly reduced (ALT: 17.56±9.80 U/L vs. 88.60±179.76 U/L, AST: 27.53±13.12 U/L vs. 84.16±151.14 U/L, TBil: 15.46±9.79 μmol/L vs. 25.63±25.33 μmol/L, all P<0.05). Difference of conjugated bilirubin (CB), blood urea nitrogen (BUN), creatinine (Cr), Glu was not statistically significant between two groups. IL-6 showed an increasing trend after the operation in both groups, and IL-6 level at T2 of the treatment group was significantly lower than that of the control group (41.42±59.74 ng/L vs. 124.84±119.66 ng/L, t=3.405, P=0.001). The HMGB1 level of two groups at T4 were lower than those at T1, but it decreased significantly only in treatment group (22.03±15.73 μg/L vs. 45.09±33.79 μg/L, P<0.05), and there was no significant difference between two groups. No serious adverse events occurred during the clinical trial.

CONCLUSIONS: Application of Xuebijing injection during anesthesia can significantly diminish postoperative inflammatory injury, which plays an important role in the protection of liver function, helps restore organ function and improve prognosis, and it is safe and effective.