苯巴比妥和卡马西平应用于儿童期癫痫的副作用:随机对照研究  

Side effects of phenobarbital and carbamazepine in childhood epilepsy:randomised controlled trial

作　　者：Selina H Banu Moshrat Jahan Umme Kulsum Koli Saadia Ferdousi Naila Z Khan Brian Neville 魏研萍 

机构地区：[1]clinical neurophysiologist and paediatric neurologist [2]primary care physician trained in childhood epilepsy [3]child psychologist [4]professor of child development and neurology [5]Prince of Wales's professor of childhood epilepsy

出　　处：《英国医学杂志中文版》2007年第5期272-275,共4页The BMJ Chinese Edition

摘　　要：目的比较两种最常用的抗癫痫药物——苯巴比妥和卡马西平在孟加拉儿童癫痫患者中应用时的行为学副作用。设计前瞻性随机对照单中心研究。地点孟加拉 Dhaka 儿童专科医院。对象 108例2～15岁全身性强直-阵挛发作(51例)或局限性继发全身性发作(57例)的患儿。主要结局评估指标癫痫控制和行为学副作用。结果 91例患儿随访12个月。6例需改用其他抗癫痫药物。比较了85例患儿的药物副作用。药物治疗和随访1年,在随访中的后1/4时间,71例患儿未再癫痫发作。随机分组后,苯巴比妥组32例102天、卡马西平组39例74天未再癫痫发作。10例患儿行为学问题增多,其中4例不能接受(苯巴比妥组1例,卡马西平组3例)。但独立 t 检验显示,两组试验药物间没有显著性差异。结论在资源缺乏的国家,苯巴比妥不引起癫痫儿童过多的行为学副作用。临床试验注册号 NCT00381537[ClinicalTrials.gov]。Objectives To compare the behavioural side effects associated with two commonly used antiepilepsy drugs--phenobarbital and carbamazepine--in children in Bangladesh. Design Prospective randomised controlled single centre trial. Setting Specialist children＇s hospital in Dhaka, Bangladesh. Participants 108 children aged 2-15 with generalised tonic-clonic （ n = 51 ） or partial and secondary generalised seizures （ n = 57）. Main outcome measures Seizure control and behavioural side effects. Results 91 children were followed up for 12 months. Six required a change of antiepilepsy drug. Side effects were compared in 85 children. In the last quarter of the 12 month follow-up, 71 children were seizure free after one year＇s treatment. Thirty two in the phenobarbital group and 39 in the earbamazepine group had no seizures in 74 and 102 days after randomisation, respectively. Ten children had increased behavioural problems, which were unacceptable in four （one in the phenobarbital group and three in the carbamazepine group）. Independent t tests, however, showed no difference between the two trial drugs. Conclusion There was no excess in behavioural side effects with phenobarbital in children with epilepsy in a country with limited resources. Trial registration NCTO0381537 [ClinicalTrials. gov].

关 键 词：药物副作用 随机对照研究 儿童期癫痫 苯巴比妥 卡马西平 强直一阵挛发作 抗癫痫药物 全身性发作 

分 类 号：R742.1[医药卫生—神经病学与精神病学]