166例门诊癫痫患儿抗癫痫药超说明书使用情况及影响因素分析

Analysis of Off-Label Use of Antiepileptic Drugs and its Influencing Factors in 166 Outpatient Children with Epilepsy

目的:了解门诊癫痫患儿抗癫痫药超说明书使用情况,探讨其影响因素,为儿科抗癫痫药的合理使用提供参考。方法:总结2019年1月至2020年11月中国人民解放军总医院儿科门诊癫痫患儿病例,参照药品说明书的内容,判断使用抗癫痫药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、各品种抗癫痫药超说明书使用情况,并通过单因素分析探讨超说明书用药的影响因素。结果:共收集193例癫痫患儿,其中使用抗癫痫药治疗的有166例,共使用抗癫痫药249例次。3种主要的超说明书用药类型分别为超年龄给药(85例次,占34.1%)、超单药/添加给药(49例次,占19.7%)和超发作类型给药(41例次,占16.5%)。抗癫痫药各品种中,超年龄给药占比较高的药品为托吡酯片(78.4%,40/51)和左乙拉西坦片(58.8%,30/51),超剂量给药占比最高的为左乙拉西坦片(9.8%,5/51),超频次给药占比最高的药品为氯硝西泮片(13.6%,3/22),超发作类型给药占比最高的药品为左乙拉西坦片(51.0%,26/51),超单药/添加给药占比最高的药品为左乙拉西坦片(62.7%,32/51)。结论:抗癫痫药超说明书使用情况在儿科门诊普遍存在,尤其以超年龄使用最为突出,主要涉及的药品为左乙拉西坦片剂和托吡酯片;年龄、是否为基础用药影响儿科抗癫痫药超说明书使用。

OBJECTIVE: To investigate the off-label use of antiepileptic drugs in outpatient children with epilepsy,and to explore its influencing factors,so as to provide reference for rational use of antiepileptic drugs in children.METHODS: The cases of children with epilepsy in pediatric outpatient department of Chinese PLA General Hospital from Jan.2019 to Nov.2020 were summarized,and whether there was off-label drug use in the prescription of antiepileptic drugs was judged according to the contents of drug instructions.The types of off-label drug use and the offlabel use of various antiepileptic drugs were analyzed statistically,and the influencing factors of off-label drug use were discussed by univariate analysis.RESULTS: A total of 193 children with epilepsy were enrolled,of which 166 children were treated with antiepileptic drugs,totally 249 case-times of antiepileptic drugs.The three main types of off-label drug use were off-label age administration( 85 case-times,34. 1%),over single drug/additive administration( 49 casetimes,19. 7%),and off-label attack types( 41 case-times,16. 5%). Among various antiepileptic drugs,Topiramate tablets( 78. 4%,40/51) and Leveethracetam tablets( 58. 8%,30/51) accounted for a higher proportion of drugs with off-label age administration. Levetiracetam tablets( 9. 8%,5/51) accounted for the highest proportion of over-dose administration,and Clonazepam tablets( 13. 6%,3/22) accounted for the highest proportion of over-frequency administration.Levetiracetam tablets( 51. 0%,26/51) took the lead of off-label attack types,and Levetiracetam tablets( 62. 7%,32/51) accounted for the highest proportion of over single drug/additive administration.CONCLUSIONS:Off-label use of antiepileptic drugs is common in pediatric outpatient department, especially off-label age administration,among which Levetiracetam tablets and Topiramate are the most prominent.Age and basic drugs affect the use of pediatric antiepileptic drugs in our hospital.