Program for Pharmacy, Faculty of Health Sciences, Oslo Metropolitan University, Pilestredet 50, 0167 Oslo, Norway.
Section for Clinical Pharmacology, The National Center for Epilepsy (SSE), Dept of Pharmacology, Oslo University Hospital, G.F. Henriksens vei 23, 1300 Sandvika, Norway.
Epilepsy Res. 2022 Mar;181:106872. doi: 10.1016/j.eplepsyres.2022.106872. Epub 2022 Feb 5.
The use of antiseizure medications (ASMs) in the pediatric population is poorly studied. The purpose of this study was to investigate changes in the use of ASMs in children and adolescents compared to adults, and to elucidate safety considerations of certain drugs.
In this population-based pharmacoepidemiological study we used the Norwegian Prescription Database (NorPD), 2009-2018. The use of ASMs is presented as 1-year prevalence per 1000: number of ASM users in a year * 1000 / number of inhabitants that year. Variables included predetermined 5-year age groups, gender, ASMs, diagnosis-specific reimbursement codes, user, and population numbers. Selected ASMs used for specific indications or subgroups included ethosuximide, sulthiame, rufinamide, stiripentol, and clobazam. Gender differences in the use of valproate was examined due to safety considerations in girls/women.
The total number of ASM users (all indications) for the age groups 0-19 and 20-59 years was 5807 and 47,481 respectively in 2009, and 5906 and 61,447 respectively in 2018. The 1-year prevalence for children/adolescents (0-19 years) using ASMs in epilepsy remained stable from 2008 to 2018, 4.3-4.2/1000 inhabitants, as compared to 8.2-7.6/1000 in adults (20-59 years). Valproate, lamotrigine, and levetiracetam were the three most used ASMs in epilepsy in children/adolescents, similar to adults. The selected ASMs were mainly used in children/ adolescents, accounting for 0.74/1000 in 2018 versus 0.17/1000 in adults. A significant increase was seen for sulthiame (8-fold), ethosuximide (4-fold), clobazam (3-fold), and stiripentol (2-fold). The use of ASMs in non-epilepsy indications was limited and stable (17% in 2018); mainly lamotrigine in psychiatry in adolescents (15-19 years). This finding was in contrast to extensive non-epilepsy use in adults (71% in 2018).
Changes in the use of ASMs in children/adolescents differ as compared to adults, most notably extensive and increasing use of selected ASMs and limited non-epilepsy. This is an important part of pharmacovigilance and patient safety evaluations.
抗癫痫药物（ASMs）在儿科人群中的使用情况研究甚少。本研究旨在调查儿童和青少年使用 ASMs 的变化情况，并阐明某些药物的安全性考虑因素。
在这项基于人群的药物流行病学研究中，我们使用了挪威处方数据库（NorPD），时间范围为 2009 年至 2018 年。ASM 的使用情况以每 1000 人中有多少人在一年内使用（当年使用 ASM 的人数 * 1000 /当年的居民人数）来表示。变量包括预定的 5 岁年龄组、性别、ASM、特定诊断报销代码、使用者和人口数量。用于特定适应症或亚组的选定 ASM 包括乙琥胺、噻加宾、鲁非酰胺、司替戊醇和氯巴占。由于女孩/妇女的安全性考虑，对丙戊酸的性别差异进行了检查。
2009 年，0-19 岁和 20-59 岁年龄组的所有适应症 ASM 使用者总数分别为 5807 人和 47481 人，2018 年分别为 5906 人和 61447 人。2008 年至 2018 年，儿童/青少年（0-19 岁）癫痫患者使用 ASM 的年患病率保持稳定，为 4.3-4.2/1000 居民，而成年人（20-59 岁）为 8.2-7.6/1000。丙戊酸、拉莫三嗪和左乙拉西坦是儿童/青少年癫痫患者中使用最多的三种 ASM，与成年人相似。选定的 ASM 主要用于儿童/青少年，2018 年为 0.74/1000，而成年人为 0.17/1000。硫加宾（增加 8 倍）、乙琥胺（增加 4 倍）、氯巴占（增加 3 倍）和司替戊醇（增加 2 倍）的使用显著增加。非癫痫适应症的 ASM 使用量有限且稳定（2018 年为 17%）；主要是青少年（15-19 岁）精神病学中的拉莫三嗪。这一发现与成年人广泛的非癫痫用途（2018 年为 71%）形成鲜明对比。
儿童/青少年 ASM 使用情况的变化与成年人不同，最显著的是选定 ASM 的广泛和不断增加的使用以及有限的非癫痫用途。这是药物警戒和患者安全评估的重要组成部分。
