儿童抗癫痫药物超说明书用药调查分析

A survey of off-label use of antiepileptic drugs in children

目的:了解抗癫痫药物在儿童患者中超说明书用药的情况,并分析原因,为儿童抗癫痫药物的合理使用提供参考。方法:分层随机抽取2012年9月—2013年8月的抗癫痫药物门诊处方,参照药品说明书的内容,判断使用抗癫痫药物的处方是否存在超说明书用药,统计分析超说明书用药的类型,计算超说明书用药发生率。结果:2 400张处方中,超说明书用药共955张,占所有处方的39.79%,主要是超适应证和超年龄用药。抗癫痫药物超说明书用药比例由高到低分别是:唑尼沙胺片(100%)、左乙拉西坦片(95.19%)、拉莫三嗪片(48.08%)、丙戊酸钠片(43.33%)等。结论:抗癫痫药在儿童癫痫患者中超说明书用药的发生率较高,尤其是唑尼沙胺和左乙拉西坦。其中大部分超适应证用药是有循证医学依据的,并非医师盲目用药。儿童用药的特殊性也是造成超说明书用药的重要原因。应尽可能规范超说明书用药行为,促进临床合理用药。

OBJECTIVE To investigate the situations of the off-label use of antiepileptic drugs in children and to analyze the reasons,and provide references for promoting safe medication in children.METHODS Antiepileptic prescriptions were randomly selected from September 2012 to August 2013 for a statistical analysis regarding general information of pediatric patients,status of drug use and off-label use.RESULTS Of 2 400 prescriptions,955（39.79%）involved off-label use.The topfour antiepileptic drugs with off-label use were zonisamide tablets（100%）,levetiracetam tablets（95.19%）,lamotrigine tablets（48.08%）and sodium valproate tablets（43.33%）.CONCLUSION The off-label use of antiepileptic drugs is widespread in children,especially zonisamide and levetiracetam.However,the majority of prescriptions are based on evidences.It is necessary to perform evidence-based evaluation by laws,regulations and guidelines to avoid off-label drug use,and promote clinical rational medicatoin.