| Objective: Levetiracetam(LEV)has been acknowledged as the first-line anti-epileptic drugs(AEDs)for infantile focal epilepsy,while the efficacy and safety of oxcarbazepine(OXC)for this entity remains unclear to date.This study compared the effectiveness and safety of OXC versus LEV for infantile focal epilepsy aiming to optimize the options of AEDs for focal-onset epilepsy in infancy.Methods: A ambispective and observational cohort study was conducted on the patients diagnosed with focal epilepsy,who aged at 2–24months and received OXC or LEV as initial monotherapy in the Children’s Hospital of Chongqing Medical University from February 2015 to April2019.Demographic data,clinical features of seizure semiology,EEG,MRI,findings of genetic testing and neurodevelopmental conditions were collected at the enrollment.All the enrolled cases were followed up at least one year.Seizure frequency over the observational period,AEDs retention rate,establishment of epileptic syndrome and etiologies,AEDs adverse effects(AEs)and AEDs adjustment were all collected during follow-up.The relative efficacy of OXC versus LEV were evaluated using generalized linear regression model and the retention rates were evaluated using Cox proportional hazards model.The potential factors associated with the efficacy of each regimen were explored by subgroup analysis.Results:(1)We enrolled 187 patients in total,and 161 patients completed the study including 83 patients on OXC and 78 on LEV.The median follow-up period was 2 years(IQR 1.8-2.4)and 1.6years(IQR1.4-2.4)for OXC and LEV,respectively.(2)The median onset age of patients was 6 months(IQR 4.3-9.0),85.7%(n=138)of the cohort was at2-12 months.The most common diagnosed epilepsy syndrome and classification was benign nonfamilial(familial)infantile epilepsy(54.7%,88/161),followed by non-syndromic epilepsy(31.1%,50/161)and developmental and epileptic encephalopathies(14.3%,23/161).Regarding the frequency of etiology,unknown cause represented 52.2%(n=84),then genetic causes(34.2%,55/161)and other etiologies(13.7%,22/161)including structural abnormalities,central nervous system infection and metabolic diseases.Among of them,23 patients were identified to have pathogenic genetic variants,including PRRT2、SCN1A、KCNQ2、KCNT1et.al.The baseline data consisting of demographic data,epilepsy syndrome and epilepsy classification as well as etiology between the two groups were comparable.(3)The 12-month seizure freedom rate of OXC and LEV therapy was 73.5%(61/83)and 41.0%(32/78),respectively.OXC achieved significantly higher responses than LEV(RR=1.71,95% CI=1.28–2.73,P<0.001),especially for those patients: the onset age <12 months(RR=2.18,95% CI=1.55–3.30,P<0.001),genetic-related(RR=2.37,95%CI =1.42–4.84,P=0.001)or unknow causes(RR=1.61,95% CI=1.21–2.36,P<0.001),benign nonfamilial(familial)infantile epilepsy(RR=1.90,95%CI=1.42–2.77,P<0.001)or NSE(RR=1.88,95% CI=1.04–5.40,P=0.02).(5)The 12-month retention rates for OXC and LEV were 70.4%(69/98)and51.7%(46/89),respectively.OXC showed a significantly higher probability of retention than LEV(HR=1.84,95% CI=1.15–2.95,P=0.007).(6)There were 11 patients(5.9%,11/187)reported adverse events.Eight(9.6%)patients from OXC group showed rash(n=3),somnolence(n=2),irritation(n=1),vomiting(n=1)and severe adverse effects(SAEs)(n=1)-drug hypersensitivity syndrome.The other three(3.8%)cases were from LEV group,including somnolence(n=1),irritation(n=1)and excitement(n=1).The adverse events related to both OXC and LEV were well-tolerated.Conclusions: OXC could be an alternative to LEV for treating infantile focal epilepsy.OXC monotherapy can be considered as first-line AED for patients aged < 12 months,with genetic-related or unknow causes,and diagnosed as benign nonfamilial(familial)infantile epilepsy or NSE. |
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