中国临床药学杂志

目的 探讨癫痫患儿左乙拉西坦血药浓度影响因素。方法 纳入2021年10月到2023年7月接受治疗的106例癫痫患儿作为研究对象，采用高效液相色谱法(HPLC)检测患儿左乙拉西坦血药浓度。根据患儿左乙拉西坦血药浓度水平分为4～8μg·mL^-1组、8～12μg·mL^-1组和12～46μg·mL^-1组，比较3组的治疗总有效率。同时收集患儿相关临床资料，分析影响左乙拉西坦血药浓度的因素，确定左乙拉西坦有效血药浓度参考区间。比较左乙拉西坦单药治疗和联合用药引起的药物不良反应发生情况。结果 12～46μg·mL^-1组、8～12μg·mL^-1组和4～8μg·mL^-1组总有效率比较差异有统计学意义(P<0.05),12～46μg·m L^-1组总有效率最高(88.24%)。身体质量指数(BMI)、血红蛋白(Hb)、丙氨酸氨基转移酶(ALT)、天冬氨酸氨基转移酶(AST)、血尿素氮(BUN)、肌酐(Cr)、每日给药剂量、用药情况不同的患儿左乙拉西坦血药浓度比较差异有统计学意义(P<0.05)。多元线性回归分析结果显示，每日给药剂量、合并丙戊酸钠是癫痫患儿左乙拉西坦血药浓度的影响因素(P<0.05)。癫痫患儿左乙拉西坦有效血药浓度参考区间为4.45～14.78μg·mL^-1。106例患儿中有12例发生不良反应，其中仅2例为左乙拉西坦单药治疗引起，联合用药患儿的不良反应发生率高于单药治疗患儿(P<0.05)。结论 每日给药剂量和联用丙戊酸钠是癫痫患儿左乙拉西坦血药浓度的影响因素，癫痫患儿左乙拉西坦有效血药浓度范围为4.45～14.78μg·mL^-1，单用的安全性高于与其他药物联合使用。

AIM To investigate the influencing factors of blood concentrations of levetiracetam in pediatric patientswith epilepsy. METHODS A total of 106 pediatric epilepsy patients treated at the hospital between October 2021 andJuly 2023 were enrolled as research subjects. The blood concentrations of levetiracetam in the pediatric patients weredetermined using high-performance liquid chromatography(HPLC). Based on the effective blood concentrations range of levetiracetam, the pediatric patients were categorized into groups with concentrations of 4-8 μg·mL^-1, 8-12 μg·mL^-1, and12-46 μg·mL^-1. The total effective rates of different groups were compared. Clinical data relevant to the pediatric patientswere collected to identify the factors influencing blood concentrations of levetiracetam in pediatric patients. A referencerange of effective blood concentrations was determined. Concurrently, adverse drug reactions induced by levetiracetammonotherapy and combination therapy were monitored. RESULTS The total effective rates in the 12-46 μg·mL^-1 and8-12 μg·mL^-1 groups were statistically significantly higher than that in the 4-8 μg·mL^-1 group(P < 0.05). The highest totaleffective rate, at 88.24%, was observed in the 12-46 μg·mL^-1 group. There were statistically significant differences in theblood concentrations of levetiracetam between pediatric patients grouped based on body mass index(BMI), hemoglobin(Hb), alanine aminotransferase(ALT), aspartate aminotransferase(AST), blood urea nitrogen(BUN), creatinine(Cr), dosage, andmedication(P < 0.05). Multiple linear regression analysis results showed that dosage and combination of sodium valproatewere factors influencing the blood concentrations of levetiracetam in pediatric patients with epilepsy(P < 0.05). Accordingto the effective blood concentrations range, the reference range for effective blood concentrations of levetiracetam in pediatric patients with epilepsy was 4.45-14.78 μg·mL^-1. Of the 106 pediatric cases, 12 cases of adverse reactions werereported, with only 2 attributed to monotherapy. The incidence of adverse reactions was significantly higher in patientsreceiving combination therapy compared to monotherapy(P < 0.05). CONCLUSION The dosage and co-administrationof sodium valproate are factors influencing the blood concentrations of levetiracetam in pediatric patients with epilepsy.The effective blood concentrations range of levetiracetam in pediatric patients with epilepsy is 4.45-14.78 μg·mL^-1. Levetiracetam monotherapy demonstrates a superior safety profile compared to its use in polytherapy regimens.