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目的探讨左乙拉西坦在不同孕周、体质量、日龄的新生儿的体内的药代动力学特点。方法纳入该院2014年7月-2015年12月新生儿科癫痫部分性发作的新生儿104例,所有的患者接受了负荷剂量为30mg/kg,在首次给予负荷剂量的8h和第5天的时候检测新生儿肝肾功能及左乙拉西坦药物的浓度,在停止治疗前每周对新生儿复查血药浓度,建立群体的药代动力学模型,计算药代动力学参数,进行相关性分析。结果左乙拉西坦药物的表观分布容积为(0.60±0.15)L/kg;血浆清除率为(17.53±5.41)ml/(kg·h),半衰期为(28.40±7.42)h。内生肌酐清除率相关系数为0.62,血浆清除率的相关系数为0.68,出生后的日龄和孕龄相关系数为0.56,P<0.05,新生儿的出生体质量和表观分布容积相关,相关系数为0.82,P<0.05。结论新生儿左乙拉西坦药物的药代动力学参数与成年人比较有着一定的差异,应该根据新生儿的出生日龄和孕龄进行常规的需要浓度监测调整药物用量。
Objective To investigate the pharmacokinetics of levetiracetam in newborn infants of different gestation, body weight and age. Methods A total of 104 newborns with partial seizures of neonates with epilepsy from July 2014 to December 2015 were enrolled in this study. All patients received a loading dose of 30 mg / kg. On the first loading dose of 8 and 5 days, Neonatal liver and renal function testing and the concentration of levetiracetam drug were measured. The plasma concentration of nevirapine was checked every week before treatment was stopped. Pharmacokinetic models of the population were established. Pharmacokinetic parameters were calculated and analyzed. . Results The apparent volume of distribution of levetiracetam was (0.60 ± 0.15) L / kg. The plasma clearance rate was (17.53 ± 5.41) ml / (kg · h) and the half-life was (28.40 ± 7.42) h. The correlation coefficient of endogenous creatinine clearance was 0.62 and the correlation coefficient of plasma clearance was 0.68. The correlation coefficient between birth day and gestational age was 0.56 (P <0.05). The birth weight and apparent volume of newborns were correlated The coefficient was 0.82, P <0.05. Conclusions The pharmacokinetic parameters of levetiracetam in neonates are different from those in adults. The dosage of drugs should be adjusted according to the routine need of concentration monitoring according to the birth date and gestational age of neonates.