新型与传统抗癫■药物对新诊断癫■患儿的疗效及安全性分析

Efficacy and safety of new and traditional antiepileptic drugs on children with newly diagnosed epilepsy

目的比较新型与传统抗癫■药物对新诊断癫■患儿的疗效及安全性。方法选取2017年6月至2019年6月在湖南省人民医院治疗的新诊断部分性癫■患儿96例,应用随机数字表法分为传统抗癫■药物卡马西平组和新型抗癫■药物拉莫三嗪组、奥卡西平组,各32例,均连续治疗6个月。比较3组患儿治疗6个月后的临床疗效和脑电图癫■样放电改善效果,治疗前及治疗3、6个月后的认知功能、骨代谢指标水平和生长激素水平变化情况,以及治疗期间的药物安全性。结果治疗6个月后,3组临床疗效比较差异均无统计学意义(均P> 0. 05),拉莫三嗪组、奥卡西平组的脑电图癫■样放电总好转率均显著高于卡马西平组[90. 6%(29/32)、84. 4%(27/32)比62. 5%(20/32)](均P <0. 05)。治疗3、6个月后,拉莫三嗪组、奥卡西平组的言语智商、操作智商、总智商评分均显著高于治疗前,且均显著高于同时点卡马西平组(均P <0. 05),卡马西平组治疗6个月后血清碱性磷酸酶、β胶原降解产物水平均高于治疗前和治疗3个月后,且高于拉莫三嗪组和奥卡西平组同时点,N端骨钙素、总Ⅰ型胶原氨基端肽水平均低于治疗前和治疗3个月后,且低于拉莫三嗪组和奥卡西平组同时点(均P <0. 05);治疗3、6个月后,3组血清生长激素水平与治疗前比较以及3组间比较差异均无统计学意义(均P> 0. 05)。治疗期间拉莫三嗪组、奥卡西平组不良反应总发生率显著低于卡马西平组[6. 2%(2/32)、12. 5%(4/32)比37. 5%(12/32)](χ2=9. 143、5. 333,P=0. 002、0. 021)。结论新型抗癫■药物拉莫三嗪和奥卡西平对新诊断部分性癫■患儿的疗效与传统抗癫■药物卡马西平相当,改善患儿脑电图癫■样放电和认知功能的效果优于卡马西平,且对患儿骨代谢水平和生长激素水平无显著影响,临床应用安全性高于卡马西平。

Objective To compare the efficacy and safety of new and traditional antiepileptic drugs on children with newly diagnosed epilepsy.Methods Ninety-six children patients with newly diagnosed partial epilepsy admitted to Hunan Provincial People's Hospital from June 2017 to June 2019 were selected.The patients were randomly divided into carbamazepine group,lamotrigine group and oxcarbazepine group according to the random number table method,with 32 cases in each group.The patients were consecutively treated for 6 months.The clinical efficacy and improvement effects of electroencephalogram(EEG)epileptiform discharge after 6 months of treatment,cognitive function,bone metabolism indexes and growth hormone before treatment and after 3 and 6 months of treatment and drug safety during treatment were compared among the three groups.Results After 6 months of treatment,there were no significant differences in the clinical efficacy among the three groups(all P>0.05),and the EEG epileptiform discharge in lamotrigine group and oxcarbazepine group were better than that in carbamazepine group,and the improvement rates were significantly higher than that in carbamazepine group[90.6%(29/32),84.4%(27/32)vs 62.5%(20/32)](all P<0.05),After 3 and 6 months of treatment,the scores of verbal intelligence quotient(VIQ),performance intelligence quotient(PIQ)and full intelligence quotient(FIQ)in lamotrigine group and oxcarbazepine group were significantly higher than those before treatment(all P<0.05)and were significantly higher than those in carbamazepine group at the same time point(all P<0.05).After 6 months of treatment the levels of serum alkaline phosphatase and type I collagen carboxy1-terminal peptide in carbamazepine group were higher than those before treatment and those after 3 months of treatment,and were higher than those in lamotrigine group and oxcarbazepine group at the same time point,and the levels of N-terminal osteocalcin and total procollagen I N-terminal propeptide were lower than those before treatment and after 3 months of treatment,and lower than those in lamotrigine group and oxcarbazepine group at the same time point(all P<0.05).After 3 and 6 months of treatment,there were no significant differences in serum growth hormones levels within the groups compared with those before treatment and among the three groups(all P>0.05).The total incidences of adverse reactions in lamotrigine group and oxcarbazepine group were significantly lower than that in carbamazepine group during treatment[6.2%(2/32),12.5%(4/32)vs 37.5%(12/32)](χ2=9.143,5.333,P=0.002,0.021).Conclusions New antiepileptic drugs lamotrigine and oxcarbazepine have similar efficacy with traditional antiepileptic drug carbamazepine in treating children with newly diagnosed partial epilepsy.The improvement effects of EEG epileptiform discharge and cognitive function are better than those of carbamazepine.And they have no negative effects on the bone metabolism and growth hormones,and their clinical application safety is better than carbamazepine.