拉克酰胺治疗部分发作性癫痫的药动学及安全性评价

Pharmacokinetic and safety evaluation of laccase in the treatment of partial seizure

目的观察拉克酰胺治疗部分发作性癫痫的药动学及安全性,为部分发作性癫痫的临床治疗提供参考。方法选择2016年1月—2018年8月济宁医学院附属医院神经内科诊治部目的分发作性癫痫患者96例作为研究对象,按照随机数字表法分为对照组和观察组(再按照年龄不同分为儿童亚组15例和成年亚组33例)各48例。对照组给予安慰剂治疗,观察组给予拉克酰胺治疗,并随访10个月。比较2组患者治疗前后癫痫发作次数、生活质量及认知功能变化,观察2组患者临床疗效及不良反应发生情况。结果观察组患者治疗总有效率为91.67%,高于对照组的52.08%(χ^2/P=18.603/<0.001),脑电图改善优于对照组(χ^2/P=11.253/0.000)。成年亚组患者的AUC0-t、AUC0-∞、Cmax及T1/2水平明显高于儿童亚组,Tmax明显低于儿童亚组(t/P=2.470/0.017、2.615/0.012、4.089/<0.001、3.726/0.000、4.934/<0.001)。与治疗前比较,治疗后观察组QOLIE-31、MMSE评分明显升高,WCST评分降低,且改善程度优于对照组(t/P=5.247/<0.001、4.024/<0.001、3.428/0.000);观察组患者治疗后4周、5~8周、9~12周、13~16周癫痫发作减低次数均明显高于对照组(t/P=3.894/<0.001、5.402/<0.001、9.689/<0.001、11.632/<0.001)。2组不良反应发生率比较差异无统计学意义(P>0.05)。结论拉克酰胺治疗部分发作性癫痫患者,其药动学指标与年龄存在一定相关性,并可以明显改善患者认知功能和生活质量,降低癫痫发作次数,治疗过程中不良反应轻、安全性好,疗效显著,具有较好的临床应用价值。

Objective To observe the pharmacokinetics and safety of laccase in the treatment of partial seizure,and to provide reference for the clinical treatment of partial seizure.Methods From January 2016 to August 2018,96 patients with partial seizure diagnosed and treated in the Department of Neurology,Affiliated Hospital of Jining Medical College were selected as the study objects.According to the random number table method,they were divided into the control group and the observation group(again divided into 15 children's subgroups and 33 adults'subgroups according to different ages)with 48 cases each.The control group was treated with placebo,and the observation group was treated with laccase and followed up for 10 months.The changes of seizure frequency,quality of life and cognitive function were compared before and after treatment in the two groups.Results The total effective rate of the observation group was 91.67%,which was higher than that of the control group 52.08%(χ^2/P=18.603/<0.001).The improvement of EEG was better than that of the control group(χ^2/P=11.253/0.000).The levels of AUC0-t、AUC0-∞、Cmaxand T1/2 in the adult subgroup were significantly higher than those in the child subgroup,and Tmax was significantly lower than that in the child subgroup(t/P=2.470/0.017,t/P=2.615/0.012,t/P=4.089/<0.001,t/P=3.726/0.000,t/P=4.934/<0.001).Compared with that before treatment,QOLIE 31 and MMSE scores of the observation group were significantly higher and WCST scores were lower after treatment,and the improvement degree was better than that of the control group(t/P=5.247/<0.001,t/P=4.024/<0.001,t/P=3.428/0.000).The frequency of epileptic attack reduction in the observation group was significantly higher than that in the control group(t/P=3.894/<0.001,t/P=5.402/<0.001,t/P=9.689/<0.001,t/P=11.632/<0.001).There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05).Conclusion In the treatment of epilepsy,the pharmacokinetic indexes of laccase are related to age,which can improve the cognitive function and quality of life of patients,reduce the number of epileptic seizures.In the process of treatment,the adverse reactions are light,the safety is good,the curative effect is significant,and it has better clinical application value.