Analysis of Vancomycin serum concentration and adverse reaction in 213 neonates

Objective To investigate the relationship of Vancomycin serum concentration and drug adverse reactions(ADRs) in neonates. Methods Two hundred and thirteen neonates who were treated by Vancomycin and had their serum concentration monitored were recruited.The number of cases which had liver, kidney and hearing damage after treatment was calculated.The correlation between 3 different serum concentrations( 10 mg/L)and ADRs were analyzed. Results The mean level of Vancomycin in serum was (4.36±4.99) mg/L.The total incidence of ADRs was 17.8%(38/213 cases). The main ADRs were liver damage and hearing impairment, whose incidences were 9.9% (21/213 cases) and 7.5% (16/213 cases), respectively, and they were were significantly higher than kidney damage (0.5%, 1/213 cases) (χ2=19.172, P=0.000; χ2=13.785, P=0.000). There was no significant difference between the inidence ratio of liver damage and that of the hearing impairment (χ2=0.330, P=0.566). The ADRs ratio among 3 different serum concentrations was 17.0% (24/141 cases), 17.6% (9/51 cases) and 23.8% (5/21 cases). There was no significant difference between the ADRs ratios and distribution of different serum concentrations (χ2=0.576, P=0.750). Moreover, the ADRs rates didn't increase along with the serum concentrations (Z=0.648, P=0.517). Except for aspartate transaminase, the indicators of liver and kidney function varied significantly after vancomycin treatment (P 0.05). Conclusions Neonates treated by Vancomycin had relatively high ratio of the liver damage and the hearing impairment.There is no significant correlation between Vancomycin serum concentration and ADRs in neonates. Key words: Neonate; Vancomycin; Serum concentration; Adverse reaction