| Objective:Lacosamide（LCM）,as a third-generation antiepileptic drug（ASMs）,has few relevant clinical studies and limited clinical efficacy data in China.In this study,we retrospectively analyzed the clinical efficacy of LCM in children with epilepsy with electrical continuity during sleep（ESES）in order to provide a clinical basis for LCM treatment of ESES.Methods:The clinical data and long-range video EEG of 38 children with epilepsy with ESES were retrospectively analyzed,of which 24 cases treated with LCM were set up as LCM group and 14 cases treated with other ASMs or glucocorticoids without LCM were set up as control group.The indexes before the addition of LCM in the LCM group were used as baseline values.The seizure frequency,EEG discharge time during slow-wave sleep,changes in psycho-cognitive function and adverse effects of LCM were analyzed after 3,6 and 9 months of LCM addition in children with ESES to assess the efficacy of LCM addition for the treatment of epilepsy with ESES in children.Results:1.After 3 months of LCM addition treatment,the seizure rate in the LCM group decreased from 66.7% to 25%.Complete control was 75.0%,effective control was12.5%,ineffective was 8.3%,and exacerbation was 4.2%.In the control group,the seizure rate decreased from 100% to 73.7% in 14 children,with 35.7% complete control,42.9% effective control,7.1% ineffective,and 14.3% exacerbation.Seizure frequency was significantly reduced in the LCM group compared with the control Vgroup（P<0.05）,but the overall seizure reduction rate was not significantly different（P>0.05）.2.After 3 months of LCM added treatment,the median change in total discharge time within 30 min of sleep onset in the LCM group was 90（0,450）sec,the median change in SWI was 5%（0%,25%）.The EEG was 0% effective,29.2% effective,50%ineffective,and 20.8% aggravated.In the control group,the median change in total discharge time within 30 min of sleep onset was 360（67.5,585）sec,the median change in SWI was 20%（3.75%,32.5%）。The EEG was 21.4% effective,14.3%effective,50% ineffective,and 14.3% aggravated.8.7% of the LCM group improved in the area of discharge,which was significantly lower than the control group（P<0.05）。SWI,total discharge time within 30 min of sleep onset,background activity,sleep structure,and spike and slow wave morphology were not significantly different compared with the control group（P>0.05）.Because of the higher rate of lost visits after 6 and 9 months of treatment in the control group,no comparative analysis was performed.3.After 3 months of treatment in the LCM group compared with their baseline values: all 24 children in the LCM group completed follow-up with a total clinical efficacy of 87.5% which significantly reduced in seizure frequency compared with their baseline values（P<0.05）.The median total discharge time within 30 min of sleep onset was 1080（742.5,1260）sec,and the median SWI was 60%（41.2%,70%）after 3months of treatment in the LCM addition.Compared to their own baseline values:total discharge time within 30 min of sleep onset was significantly lower（P<0.05）and SWI was not statistically different（P>0.05）.4.LCM group after 6 months of treatment compared with their own baseline values: a total of 15 children completed 6 months of follow-up.The total clinical efficiency of these 15 children is 86.6%,and the frequency of seizures compared with their own baseline values was statistically different（P<0.05）.After 6 months of treatment,the median total discharge time within 30 min of sleep onset of 15 children in the LCM group was 1080（990,1260）sec,with a median SWI of 60%（55%,70%）.The total discharge time and SWI within 30 min after sleep onset in these 15 children VIwere not statistically different from their baseline values（P > 0.05）.5.Comparison of the LCM group with their own baseline values after 9 months of treatment: A total of 10 children completed 9 months of follow-up.The total clinical efficiency of these 10 children was 100%,and the frequency of seizures was statistically different from their own baseline values（P<0.05）sec,with a median SWI of 65%（25%,70%）.The total discharge time and SWI within 30 min after sleep onset in these 10 children were not statistically different compared to their own baseline values（P > 0.05）.6.Mental cognitive profile: children in the LCM group had decreased performance（37.4%）,attention deficit（20.8%）,memory decline（16.7%）,unresponsiveness（8.3%）,mental cognitive abnormalities（8.3%）,decreased calculation power（4.2%）,and language regression（4.2%）before treatment.After 3months of treatment,10% of the LCM group had improved memory decline,10% had improved mental abnormalities,and 10% had decreased memory compared to before,while 14.2% of the control group had disappeared their mental abnormalities.There was no statistically significant difference between the two groups overall（P>0.05）.7.The reduction of other ASMs in the LCM group: 20.8% of the children in the LCM group had reduced 1 other ASM at 3 months of treatment,33.3% of the 15 children at 6 months of treatment and 60% of the 10 children at 9 months of treatment had reduced ≥1 other ASMs.8.After 3 months of treatment,20.8% of children in the LCM group had LCM-related adverse reactions,mainly drowsiness（80%）,dizziness（40%）,abdominal pain（40%）and nausea（25%）.After 6 months of treatment,13.3% of the15 follow-up children still had adverse reactions,and after 9 months of treatment,the adverse reactions basically disappeared in 10 follow-up children.Conclusion:1.LCM add-on therapy in children with epilepsy with ESES may be effective in reducing seizures,and reducing the types of other ASMs used.2.LCM add-on therapy in children with epilepsy with ESES may not have a significant advantage in reducing EEG discharges during slow-wave sleep,and a small number of children may even have increased EEG discharges.3.There is no significant difference in the improvement of psychological cognition between LCM add-on therapy and other ESES treatments in children with epilepsy and ESES.4.Short-term adverse effects such as drowsiness,dizziness,abdominal pain and nausea may occur in children with epilepsy and ESES treated with LCM add-on therapy,which may disappear with prolonged drug administration. |
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