目的 研究癫痫患儿使用拉考沙胺 (lacosamide,LCM)的临床疗效、血药浓度和安全性,为临床合理用药提供参考。方法 采用超高效液相色谱法测定148例口服LCM的癫痫患儿的稳态血清谷浓度,观察其临床疗效和不良反应,并运用Logistic回归和受试者操作特征曲线分析癫痫患儿血药浓度与临床疗效的相关性。结果 LCM治疗我院癫痫患儿有效率为69%。无效组患儿在全面性发作和混合发作中的患儿比例明显高于有效组(P<0.05)。无效组患儿出现异常脑电图的频率明显高于有效组患儿(P<0.05)。无效组患儿的LCM血药浓度结果和浓度剂量比(ratio of concentration-to-dose,CDR)结果明显高于有效组患儿(P<0.01)。无效组接受LCM和诱导剂治疗的患儿比例明显高于有效组(48%比25%,P<0.01)。LCM临床疗效与CDR结果有较好的相关性(P<0.01)。当LCM血药浓度≥ 3.50 μg·mL-1时,临床疗效会得以更好的保证。49名儿童(33%)至少经历了1次不良反应,最常见的不良反应为头晕、嗜睡、乏力和恶心。结论 癫痫患儿临床使用LCM时,有必要对其进行血药浓度监测,以提高临床疗效和降低不良反应发生率。
Abstract
OBJECTIVE To study the efficacy, serum concentration and safety of lacosamide(LCM) in children with epilepsy, so as to provide reference for rational clinical drug use. METHODS The steady-state serum trough concentration of 148 children with epilepsy who took LCM orally was determined by Ultra high performance liquid chromatography to observe its clinical efficacy and adverse reactions. Logistic regression and subject operation characteristic curve were used to analyze the correlation between serum concentration and clinical efficacy. RESULTS The effective rate of LCM was 69%. The proportion of children with general and mixed seizures was significantly higher in the ineffective group than in the effective group (P<0.05). The frequency of abnormal electroencephalogram in the ineffective group was significantly higher than that in the effective group (P<0.05). The serum concentration of LCM and ratio of concentration-to-dose(CDR) in the ineffective group were significantly higher than those in the effective group (P<0.01). In addition, the proportion of children treated with LCM and inducers was significantly higher in the ineffective group than in the effective group (48% vs 25%, P<0.01). There was a good correlation between the clinical efficacy of LCM and CDR results (P<0.01). When the serum concentration of LCM was ≥3.50 μg·mL-1, the clinical efficacy could be better guaranteed. Forty-nine children (33%) experienced at least one adverse event, with dizziness, drowsiness, fatigue, and nausea being the most common adverse events. CONCLUSION In order to improve the clinical efficacy and reduce the incidence of adverse reactions, it is necessary to monitor the blood concentration of LCM in epileptic children.
关键词
癫痫 /
拉考沙胺 /
血药浓度 /
临床疗效
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Key words
epilepsy /
lacosamide /
serum concentration /
efficacy
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中图分类号：
R969.1
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参考文献
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脚注
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基金
新疆维吾尔自治区药学会科研项目资助(YXH202105)
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