| Objective.To evaluate the the clinical efficacy and safety of perampanel(PER)in the adjunctive treatment of Chinese patients with drug-resistant epilepsy(DRE)and its influencing factors,provide some reference for the clinical practice of PER in the treatment of DRE.Methods.A prospective cohort study was used to study adolescent and adult who aged 12 ～ 70 years and diagnosed with DRE,came to First Affiliated Hospital of Nanchang University from October 2020 to September 2021.PER was added to the original anti-epileptic treatment regimen and followed up for 6 months.The overall clinical efficiency,incidence of adverse events(AEs)and retention rates of the study subjects were analyzed.The effects of different age,seizure type,etiology,EEG background activity,previous Anti-seizure medications and combination of Enzyme-inducing anti-seizure medications(EI-ASMs)on clinical outcomes and adverse events were analyzed.Results.A total of 34 patients with drug-resistant epilepsy were included(22 females and 12 males),the mean age was 12 ～ 68(32.8 ± 16.3)years.The age of seizure onset was 6 ～ 66(median: 16 years).Across all the patients,the median number of previous ASMs is 2(2 ～ 5),the median number of concomitant ASMs at baseline was 2(2 ～ 3).58.8%(20/34)of patients were concomitant EI-ASMs,including 15 patients combined with oxcarbazepine and the rest combined with topiramate(2patients),carbamazepine(2 patients),and phenobarbital(1 patient).61.8%(21/34)of the patients had only partial onset seizures,5.9%(2/34)had only generalized onset seizures.The etiology of epilepsy was clearly diagnosed in 47.1%(16/34)of the patients,while the remaining 52.9%(18/34)were of unknown etiology.According to the background activity of electroencephalogram before enrollment,55.9%(19/34)had abnormal electroencephalogram background.At month 3 follow-up,one patient discontinued due to AEs and 33 patients with DRE were maintained on treatment;the median maintenance dose was 4 mg/d(2 ～ 8mg/d).At month 6 follow-up,a total of 6 patients discontinued treatment,and the mean maintenance dose of patients was 4 mg/d(2 ～ 10 mg/d).The average percentage of seizure frequency reduction was 39.6% and 48.3%after 3 and 6 months,respectively.The effective rate was 35.3% and 44.1%,respectively.At the sixth month follow-up,14.7%(5/34)patients were seizure-free for ≥ 3 months,and the duration of seizure-free period was 4 months(3 ～ 6 months).Thirty-three patients had no change in laboratory tests before and after medication(1case was not reviewed because of stopping medication).14(38.2%)patients experienced AEs,which including dizziness(26.5%,9/34),drowsiness(8.8%,3/34)and inattention(5.9%,2/34).78.6%(11/14)were mild to moderate,and 28.6% of AEs did not require treatment,mostly resolved or disappeared with dose reduction and titration slowing.Retention rates at month 3 and 6 were 97.1% and 82.4%,respectively.Three patients(8.8%,3/34)discontinued due to AEs,1 patient discontinued due to concerns about adverse effects,1 patient discontinued due to increased seizures,and 1 patient discontinued due to poor efficacy.Patients with onset of seizures less than 18 years had significantly lower efficiency rate than other age groups(30% vs.71.4%,p = 0.02).Patients with partial onset seizures only had higher efficiency rate than other seizure types(61.9% vs.15.4%,p = 0.009).The symptomatic focal epilepsy one had higher efficiency rate than those with other etiologies and unknown causes(72.7% vs.30.4%,p = 0.03).The incidence of AEs was higher in those with combined oxcarbazepine than in those without(66.7% vs.21.1%,p = 0.009).There was no difference in efficiency rate between those with 2 previous ASMs and those with more than 2.No difference in efficiency or perampanel dose between the EI-ASM group and the non-EI-ASM group.There was no difference in efficiency between those with abnormal electroencephalogram background compared to those with normal.Conclusions.1.PER is effective for both partial seizures and generalized seizures of DRE,the efficiency rate is 44.1%,with better efficacy in patients with symptomatic focal drug-resistant epilepsy.Those with an age of onset less than 18 years were less effective than other age groups.2.The concomitant use of EI-ASMs was not found to affect the efficacy and treatment dose..The electroencephalogram background was not found to affect the efficacy 3.The common adverse events are dizziness,drowsiness,inattention,irritability,depression,mostly resolved or disappeared with dose reduction and titration slowing.4.PER combined with oxcarbazepine for drug-resistant epilepsy increased the incidence of AEs.5.The retention rate of PER treatment DRE at month 6 was 82.4%,and the reasons for discontinuation were mostly adverse events or poor efficacy. |
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