Efficacy And Safety Of Perampanel Addition Therapy In 2～12 Year-old Chinese Han Children With Drug-resistant Epilepsy

Objective: To investigate the efficacy and safety of Perampanel in the additive treatment of medication-refractory epilepsy in children aged 2 to 12 years.Methods: Collected in January 2020 to July 2020 in Fujian medical university union hospital of pediatrics department for Perampanel add treatment group comply with the conditions of the clinical data of 20 cases of children with refractory epilepsy.On the basis of the routine use of antiepileptic drugs,Perampanel was added for oral treatment,and follow-up was performed at 3 and 6months after the medication to evaluate the effectiveness and safety of the treatment.Seizure classification and diagnosis of epilepsy syndrome refer to the2017 International Anti-Epilepsy Alliance epilepsy classification and diagnostic criteria.Results: 1.General information: A total of 20 children with drug-refractory epilepsy aged 2 to 12 years were included,including 14 males and 6 females,with an average age of(5.82±2.39)years,an average onset age of(3.41±1.96)years,and an average course of disease of(2.40±1.48)years.Among the 20 children,1 case had focal seizures without impaired perception(5%,1/20),7 cases had focal seizures with impaired perception(35%,7/20),and 1 case had generalized seizures(5%,1/20),6 cases(30%,6/20)who failed to clarify the type of seizure,and 5cases with epilepsy syndrome(25%,5/20).2.Efficacy evaluation of Perampanel addition treatment after 3 months: 4 cases(20%,4/20)with seizure control,8 cases(40%,8/20)with seizure frequency reduction ≥50%,2 cases(10%,2/20)seizure duration decreased,1 case(5%,1/20)with reduced severity of seizures.5 cases were discontinued due to lack of efficacy(25%,5/20).3.Efficacy evaluation of Perampanel addition treatment after 6 months: 20 cases of Perampanel addition treatment with 6 months as the follow-up end point,seizure control in 7 cases(35%,7/20),seizure frequency reduction ≥50 % In 2 cases(10%,2/20),and 1 case each(10%,2/20)with reduced duration and severity of seizures.8 cases(40%,8/20)were discontinued due to lack of efficacy(including no change in seizures,increased frequency,and aggravation),and 1 case of drug withdrawal after surgical treatment.4.Overall curative effect: With the reduction of seizure frequency ≥50% as the effective standard,the effective rate of Perampanel for 3 months is 60%(12/20),and the effective rate is 45%(9/20)for 6 months.The Fisher’s exact probability method was used to compare the efficacy of 3 months and 6 months after the addition of Perampanel,and the difference were not statistically significant(P=0.527).The effective rates of children under 6 years old were 54.5%(3 months of treatment,6/11)and 36.4%(6 months of treatment,4/11),and the effective rates of children 6-12 years old were 66.7%(3 months of treatment,6/9)and 55.6%(6 months of treatment,5/9),the difference was not statistically significant(P=0.67 for 3 months,P=0.65 for 6 months).5.Safety assessment: The overall retention rate of Perampanel addition treatment for 3 months was 75%(15/20),and the overall retention rate for 6 months was 55%(11/20).3 cases(15%,3/20)of the parents reported adverse events during the observation period,1 case of dizziness and drowsiness(5%,1/20)in the initial stage of treatment;1 case was irritable(5%,1/20),all disappeared after 1 to 2 weeks of medication;1 case(5%,1/20)was irritable,the number of attacks increased,and the drug had been stopped.Three cases in our group had adverse events reported after medication.Except for one case,the onset of seizure aggravation,the other two cases only developed dizziness,lethargy or irritability at the initial stage of treatment.There were no abnormalities in blood routine and blood biochemical monitoring.The concentration of the drug was monitored in 13 cases,and no significant effect on the concentration of the combined drug was found.Conclusions: 1.Perampanel can effectively reduce the frequency of epileptic seizures and is effective for various types of epileptic seizures in the treatment of drug-resistant epilepsy in children of Chinese Han nationality between 2 and 12 years old.2.The main adverse reactions of Perampanel in the treatment of drug-refractory epilepsy in Chinese Han children aged 2-12 years are drowsiness,dizziness,etc.The symptoms can disappear spontaneously with the prolonged medication time.Combined with a variety of anti-epileptic drugs,it does not interfere with the blood concentration of other drugs and has good safety.