Abstract: Objective To investigate the relationship between vancomycin plasma concentration and drug adverse reactions in neonates, provide a basis for the rational use of vancomycin in clinical practice. Methods One hundred and seventy neonates treated with vancomycin were recruited, and their plasma levels were monitored. The number of patients who had liver, kidney and hearing damage after treatment was observed and calculated. The correlations between three different plasma levels (<5 mg·L^-1, 5~10 mg·L^-1 and >10 mg·L^-1) and adverse reactions were analyzed. Results The mean minimum, maximum level of vancomycin in serum was 4.96±2.35 mg·L^-1 and 31.04±10.13 mg·L^-1. The total incidence of adverse reactions was 17.65% (30/170 cases), the main adverse reactions included liver damage (10.00%, 17/170 cases) and hearing impairment (7.06%, 12/170 cases), one case showed renal injury. The incidence of renal injury was significantly lower than that of the liver damage and hearing impairment (χ²=18.162, P=0.000；χ²=12.795, P=0.000). The adverse reaction ratio among three different plasma levels (<5 mg·L^-1, 5~10 mg·L^-1 and >10 mg·L^-1) was 16.81% (19/113 cases), 17.50% (7/40 cases) and 23.53% (4/17 cases), respectively. There was no significant difference between the serum concentrations and adverse reaction ratio (χ²=0.968, P=0.253). Moreover, the adverse reaction rates didn’t increase along with the serum levels of vancomycin (Z=0.941, P=0.226). The parameters of liver and kidney function (alanine transaminase, urea nitrogen, creatinine, uric acid) varied significantly after vancomycin treatment (P<0.05), but there was no clinical significance because the mean values were in normal range. Conclusion Neonates treated with vancomycin have relatively high ratio of the liver damage and hearing impairment, renal injury also takes place possibly. There is no significant correlation between vancomycin plasma level and adverse reactions in neonates.

Key words: vancomycin, neonate, adverse reaction, liver damage, plasma concentration