Off-label oral-antiepileptic drugs use in inpatients of a tertiary pediatric epileptic center in China: a cross sectional study / 中华实用儿科临床杂志

ABSTRACT

Objective To determine the extent of off-label antiepileptic drugs (AEDs) use in a tertiary pediatric epileptic center in China,so as to provide baseline data for getting acquainted with the extent of off-label AEDs use for the future.Methods Collected demographic information and prescriptions related to AEDs of all hospitalized children diagnosed with epilepsy from April 1st to September 30th 2016 were collected in Peking University First Hospital.According to person-time,prescriptions,different AEDs,various categories of off-label use,the incidence of off-label AEDs use was calculated respectively.Risk factors (age,gender,number of drug use,type of seizure and status epilepticus) were analyzed through the methods of single factor chi-square and muhi-factor Logistic regression analysis.Results A total of 291 person-times,749 prescriptions and involving 12 kinds of AEDs were collected.The rates of off-label drug use were 35.11％ (263/749 items) and 66.32％ (193/291 person-times) in prescriptions and person-times respectively.The main categories of off-label drug use were seizure types (38.40％,101/263 items),dosage (10.27％,27/263 items),mono/multidrug therapy (9.89％,26/263 items),scope of disease (0.76％,2/263 items) and age (72.62％,191/263 items),while 30.30％ (79/263 items) prescriptions were equal or more than 2 different categories of off-label drug use.The incidences of different drugs were different,with 100％ in Nitrazepam,Vigabatrin,Clobazam,Zonisamide,1.78％ (3/169 items) in Valproate but 0 in Clonazepam,Phenobarbital.According to the results of single factor chi-square and multi-factor Logistic regression,ages and seizure types were correlated with off-label AEDs use.The groups of infants and preschoolers had higher incidences of off-label AEDs use than the group of school and adolescence.The group of focal seizures only had lower incidences of off-label AEDs use.Conclusions Off-label AEDs use in the tertiary pediatric epileptic center in China is common.Younger patients (infant and preschool) have higher incidences of off-label AEDs use,while patients with focal seizures have lower incidences of off-label AEDs use.