目的 了解我国一个儿童癫痫三级诊疗中心住院患儿口服抗癫痫药物(AEDs)超说明书用药的现状,为将来制定超说明书用药政策提供基线数据.方法 收集北京大学第一医院2016年4月1日至9月30日28 d～ 18岁癫痫患儿住院期间AEDs用药医嘱及患儿基本信息,对超说明书用药发生率及类型进行描述性分析,应用单因素x2检验、多因素Logistic回归分析对年龄、性别、用药种数、发作类型、癫痫持续状态5个相关危险因素进行统计学分析.结果 共收集291人次、749条医嘱,涉及12种口服AEDs.按医嘱、患者人次计,超说明书用药发生率分别为35.11％(263/749条)及66.32％(193/291人次).超说明书用药类型包括超发作类型38.40％(101/263条)、超剂量10.27％ (27/263条)、超单药/添加9.89％(26/263条)、超疾病范围0.76％(2/263条)、超年龄72.62％(191/263条),其中30.03％(79/263条)同时存在≥2种类型超说明书用药.各种药物超说明书用药发生率及类型不同,硝西泮、氨己烯酸、氯巴占、唑尼沙胺超说明书用药发生率均为100％,丙戊酸超说明书用药发生率较低,为1.78％(3/169条).氯硝西泮、苯巴比妥无超说明书用药情况发生.超说明书用药与年龄、发作类型相关,婴幼儿组及学龄前期组较学龄期及青春期组超说明书用药发生率更高,仅有局灶性发作的患儿超说明书发生率较低.结论 国内儿童癫痫三级诊疗中心住院患儿AEDs超说明书用药现象常见,且年龄越小,超说明书用药发生率越高,局灶性发作患儿超说明书用药发生率相对较低.%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.
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