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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 behavioral side effects of phenobarbital and carbamazepine in children with epilepsy in Bangladesh, the two most commonly used antiepileptic drugs. Design prospective randomized controlled single center study. Location Dhaka Children’s Hospital, Bangladesh. Subjects 108 children aged 2-15 years with generalized tonic-clonic seizures (n = 51) or those with localized secondary generalized episodes (n = 57). The main outcome measure was epilepsy control and behavioral side effects. Results 91 cases were followed up for 12 months. 6 cases need to switch to other antiepileptic drugs. The drug side effects of 85 children were compared. One year after drug treatment and follow-up, 71 patients had no seizures at the last quarter of follow-up. After randomization, phenobarbital 32 patients 102 days, carbamazepine 39 patients 74 days without seizures. Behavioral problems increased in 10 children, 4 of which were unacceptable (1 in phenobarbital and 3 in carbamazepine). However, independent t test showed no significant difference between the two groups of experimental drugs. Conclusion Phenobarbital does not cause excessive behavioral side effects in children with epilepsy in resource-poor countries. Clinical trial registration number NCT00381537 [ClinicalTrials.gov].