儿童超药品说明书应用抗癫痫药物的调查分析  

Analysis on Off-Label Use of Antiepileptic Drugs in Children

作　　者：刘晓玲 段彦彦[1] 陶兴茹 张胜男 海莉丽[1] LIU Xiao-ling;DUAN Yan-yan;TAO Xing-ru;ZHANG Sheng-nan;HAI Li-li(Department of Pharmacy,Children's Hospital Affiliated to Zhengzhou University,Zhengzhou 450018,China)

机构地区：[1]郑州大学附属儿童医院药学部,郑州450018

出　　处：《中国合理用药探索》2023年第11期49-54,共6页Chinese Journal of Rational Drug Use

基　　金：河南省医学科技攻关计划联合共建项目(LHGJ20200622)。

摘　　要：目的:了解某儿童医院患儿超药品说明书应用抗癫痫药物现状及分析原因,以期促进抗癫痫药物在患儿中的合理使用。方法:抽取该院2022年1~6月抗癫痫药物门诊处方,根据药品说明书内容,判断是否存在超药品说明书用药(OLDU),并对OLDU类型、各年龄段OLDU情况进行统计分析。结果:共纳入5994张处方,含7623条医嘱记录。其中,OLDU处方和医嘱的比例分别为19.65%(1178张)和16.00%(1220条);主要OLDU类型是超单药/添加(52.70%)和超给药年龄用药(24.75%)。OLDU发生率排名前3的药物依次是托吡酯胶囊(60.00%)、左乙拉西坦口服溶液(56.19%)和硝西泮片(50.00%)。各年龄组儿童OLDU发生率按从高到低排序依次是:婴儿组(64.04%)、幼儿组(35.30%)、学龄前组(24.75%)、学龄期组(13.34%)和青春期组(12.40%)。结论:该院癫痫患儿OLDU现象普遍,主要发生在婴幼儿时期,并且以第二代抗癫痫药物为主。大部分OLDU有证可循,医生应尽量规范OLDU行为,促进儿童安全合理用药。Objective:The aim of this study is to investigate the off-label use of antiepileptic drugs in the a children's hospital,and to analyze the rational for this practice.The ultimate goal is to promote the rational use of antiepileptic drugs in children.Methods:Outpatient prescriptions of antiepileptic drugs in the hospital from January to June in 2022 were selected.The presence of off-label drug use(OLDU)was determine based on the contents of drug instructions.The types of OLDU and the corresponding situation at different ages were analyzed statistically.Results:A total of 5994 prescriptions were included,along with 7623 medical order records.The proportion of OLDU prescriptions and medical orders was 19.65%(1178)and 16.00%(1220),respectively.The main types of OLDU were ultra-single drug/addition(52.70%)and over-age drug use(24.75%).The top 3 drugs in the incidence of OLDU were topiramate capsules(60.00%),levetiacetam oral solution(56.19%)and nitrazepam tablets(50.00%).The incidence rate of OLDU in all age groups was in descending order as follows:infant group(64.04%),infant group(35.30%),preschool group(24.75%),school age group(13.34%)and adolescent group(12.40%).Conclusion:OLDU is common in children with epilepsy in the hospital,mainly occurring in infants and young children.Second generation antiepileptic drugs are the main therapeutic drugs.Most OLDU has its own evidence.Physicians should strive to regulate the behavior of OLDU to promote safe and rational drug use in children.

关 键 词：儿童 超药品说明书用药 抗癫痫药物 用药分析 合理用药 

分 类 号：R972.6[医药卫生—药品]