摘要
目的总结首都儿科研究所附属儿童医院(以下简称"我院")住院癫痫儿童抗癫痫药物使用及超说明书使用情况,分析超说明书用药的原因,为癫痫儿童抗癫痫药物的合理使用提供临床参考。方法收集2011年1月~2015年12月在我院住院癫痫儿童基本信息和临床诊断治疗情况,包括性别、年龄、发作类型和抗癫痫药使用情况等。根据药品使用说明书,判断抗癫痫药物是否超说明书,同时将超说明书使用分为超年龄、超发作类型、超剂量和超单药/添加和超给药频次等,分类统计分析抗癫痫药物超说明书使用情况。结果共收集865例癫痫儿童,其中男500例,女365例,年龄中位数2.3岁,其中724例儿童服用抗癫痫药物治疗,另141例未添加抗癫痫药(包括使用促肾上腺皮质激素、泼尼松和/或甲强龙82例)。抗癫痫药物共使用1120人次,其中服用1种抗癫痫药儿童492例,服用2种抗癫痫药儿童125例,服用3种抗癫痫药儿童55例,服用4种及以上抗癫痫药儿童52例。抗癫痫药超说明书用药类型的占比由高到低分别是超年龄(35.8%)、超单药/添加(19.7%)、超发作类型(14.6%)、超给药剂量(4.5%)和超给药频次(2.3%)。抗癫痫药物超给药年龄占比由高到低分别为托吡酯(72.9%)、左乙拉西坦片剂(67.0%)和奥卡西平口服液(56.7%);抗癫痫药物超发作类型占比由高到低分别为左乙拉西坦口服液(51.9%)、左乙拉西坦片剂(40.8%)、托吡酯(26.3%);抗癫痫药物超单药/添加占比由高到低分别为左乙拉西坦口服液(81.4%)、左乙拉西坦片剂(55.5%)、托吡酯(23.7%)。结论抗癫痫药在儿童癫痫中超说明书用药的发生率是很高的,尤其以超年龄使用最为突出,其中药物以托吡酯和左乙拉西坦为著。儿童用药的特殊性是造成超说明书用药的重要原因。超说明书应用抗癫痫药物时,需评估药物的不良反应和超说明书用药的获益,最终获得药物疗效与安全的最佳平衡,促进临床合理用药。
Objective To summarize the situation of antiepileptic drugs（AEDs） administration and off-label use in epileptic children hospitalized in Children′s Hospital, Capital Institute of Pediatrics（CIP Children Hospital）, and investigate the reason for off-label use, and provide evidence for the appropriate administration of AEDs in epileptic children. Methods Demographic and clinical diagnosis and therapy information of epileptic children, including gender, age,seizure types, AEDs administration and and so on, were collected in CIP Children Hospital from January 2011 to December 2015. Based on the label and instruction of AEDs, whether the AEDs administration was off-label use of which types were categorized into off-age, off-seizure types, off-dosage, off-mono/add-on therapy and off-administration frequency were evaluated, and the situation of off-label use of AED was statistically analyzed. Results Totally 865 epileptic children were collected, including 500 males and 365 females. The median age was 2.3 years old. Among them, 724 epileptic children received AEDs therapy, while the other 141 did not（including 82 children with Adrenocorticotropic Hormone, Prednisone, and/or Methylprednisolone therapy）. 1120 person-times of AEDs were administrated. The numbers of epileptic children who received 1, 2, 3 and ≥4 AEDs were 492, 125, 55 and 52 cases. The percentage rank of types of off-label use was off-age（35.8%）, off-mono/add-on therapy（19.7%）, off-seizure types（14.6%）, off-dosage（4.5%）and off-administration frequency（ 2. 3 %）. Moreover,top 3 percentage of AEDs in off-age were Topiramate（72.9%）, Levetiracetam Tablets（67.0%）, and Oxcarbazepine Liquid（56.7%）; top 3 percentage of AEDs in off-seizure types were Levetiracetam Liqu id（51.9%）,Levetiracetam Tablets（40.8%）, Topiramate（26.3%）; top 3 percentage of AEDs in off-mono/add-on therapy were Levetiracetam Liquid（81.4%）, Levetiracetam Tablets（55.5%）, Topiramate（23.7%）. Conclusion The off-label use of AEDs is widespread in epileptic children, especially in off-age. The most percentage of off-label use in AEDs were Levetiracetam and Topiramate. The main reason for the off-label use in AEDs is the complication of children epileptic therapy. When the administration of AEDs is an off-label use, the adverse effects and benefits should be evaluated, so that get optimal balance of drug efficacy and safety and promote clinical appropriate drug administration.
作者
杨圣海
王珺
王立文
陈金晓
吴欢欢
徐翠娟
YANG Shenghai, WANG Jun ,WANG Liwen ,CHEN Jinxiao ,WU Huanhuan ,XU Cuijuan(Department of Neurology, Children＇s Hospital, Capital Institute of Pediatrics, Beijing 100020, Chin)
出处
《中国医药导报》
CAS
2018年第11期45-48,共4页
China Medical Herald
基金
国家科技支撑计划(2012BAI03B02)
关键词
儿童
癫痫
抗癫痫药
超说明书用药
Children
Epilepsy
Antiepileptie drugs
Off-label use
作者简介
杨圣海（1979．10-），男，硕士，主要从事儿科神经内科疾病诊疗和研究。;王珺（1977．5-），女，硕士，主任医师，主要从事儿科神经内科疾病诊疗和研究。
