新生儿万古霉素高谷浓度的影响因素分析及安全性观察

摘要

目的 寻找影响新生儿患者万古霉素谷浓度变化的相关因素并观察高谷浓度的安全性.方法 研究对象为2013年1月至2016年12月苏州市立医院使用万古霉素治疗并在住院期间进行常规血药浓度监测(TDM)的新生儿病例.按谷浓度是否大于20进行分组,分为A组和B组.对可能影响谷浓度的指标进行logistic单因素和多因素回归分析,并对连续性变量绘制ROC曲线,筛选切点.结果 在符合纳入标准的119例患儿中,96例患儿的万古霉素血清谷浓度≤20 μg/ml(80.67％,A组),＞20 μg/ml的有23例(19.33％,B组).新生儿万古霉素的谷浓度与矫正孕周、血肌酐水平密切相关,且当血肌酐水平大于36.6 μmol/L或矫正孕周小于32.7周时万古霉素的谷浓度发生明显升高.两组患儿的血肌酐水平用药后均未见升高,差异无统计学意义(P＞0.05).结论 新生儿万古霉素谷浓度的主要影响因素为矫正孕周和血肌酐水平,其中矫正孕周与谷浓度成负相关,血肌酐水平与谷浓度成正相关.万古霉素谷浓度的高低对患儿用药前后的肌酐变化无明显影响.%Objective To investigate the related factors influencing the vancomycin trough concentration in neonates and to observe the safety of high trough concentration.Methods Participants were newborns who were treated with vancomycin at Suzhou Municipal Hospital from January,2013 to December,2016 and received routine therapeutic drug monitoring (TDM) during hospitalization.According to whether the trough concentration was more than 20 or not,they were divided into a high trough concentration group (group A) and a low trough concentration group (group B).Single factor and multiple factor regression analysis were used to analyze the indexes that might affect the trough concentration;and the ROC curve was drawn for the continuous variables;and the tangent points were screened.Results Of the 119 neonates who met the inclusion criteria,96 had vancomycin trough concentration ≤ 20 μg/ml (80.67％,included in group A) and 23 ＞ 20 μg/ml (19.33％,included in group B).The neonatal vancomycin trough concentration was closely related to the corrected gestational weeks and serum creatinine levels;and when the serum creatinine was higher than 36.6 μmol/L or the corrected gestational weeks were fewer than 32.7 weeks,vancomycin trough concentrations significantly increased.The serum creatinine levels in group A and group B did not increase after medication,and there was no statistical difference between the two groups (P ＞ 0.05).Conclusions The main influencing factors of neonatal vancomycin trough concentration are corrected gestational weeks and serum creatinine levels;corrected gestational weeks negatively correlates with serum creatinine concentrations,and serum creatinine levels positively.Vancomycin trough concentration has no significant effect on creatinine changes in neonates before and after medication.