Pal D K, Das T, Chaudhury G, Johnson A L, Neville B G
Neurosciences Unit, University College London, UK.
Lancet. 1998 Jan 3;351(9095):19-23. doi: 10.1016/S0140-6736(97)06250-8.
The use of phenobarbital for childhood epilepsy is controversial because of reported behavioural side-effects; however, whether this research can validly be extrapolated to developing countries is not clear. We undertook a randomised comparison of phenobarbital and phenytoin to assess the acceptability and efficacy of phenobarbital as monotherapy for childhood epilepsy in rural India.
Between August, 1995, and February, 1996, 109 unselected children aged 2-18 years with partial and generalised tonic-clonic epilepsy were identified by population screening. 15 families declined to take part. 94 children were randomly allocated treatment with phenobarbital (1.5 mg/kg daily for 2 weeks; maintenance dose 3.0 mg/kg daily; n = 47) or phenytoin (2.5 mg/kg daily then 5.0 mg/kg daily; n = 47). Children were followed up for 12 months. The primary outcome measure was the frequency of behavioural side-effects; behaviour was assessed by the Conners parent rating scale for children aged 6 years and older, and by the preschool behaviour screening questionnaire (BSQ) for those aged 2-5 years, at 12 months or at withdrawal from treatment. Analysis was by intention to treat.
The mean log-transformed scores on the behaviour rating scales did not differ significantly between the phenobarbital and phenytoin groups (Conners 2.64 [SD 0.71] vs 2.65 [0.89], p = 0.97; n = 32 in each group: BSQ 2.12 [1.31] vs 2.18 [1.02], p = 0.94; n = 4 vs 3). The odds ratio for behavioural problems (phenobarbital vs phenytoin) was 0.51 (95% CI 0.16-1.59). There was no excess in parental reports of side-effects for phenobarbital. We found no difference in efficacy between the study drugs (adjusted hazard ratio for time to first seizure from randomisation 0.97 [0.28-3.30]).
This evidence supports the acceptability of phenobarbital as a first-line drug for childhood epilepsy in rural settings in developing countries.
由于有报道称苯巴比妥存在行为副作用，因此其在儿童癫痫治疗中的应用存在争议；然而，这项研究是否能有效地外推至发展中国家尚不清楚。我们对苯巴比妥和苯妥英进行了随机对照研究，以评估苯巴比妥作为印度农村地区儿童癫痫单一疗法的可接受性和疗效。
1995年8月至1996年2月期间，通过人群筛查确定了109名年龄在2至18岁之间、患有部分性和全身性强直阵挛性癫痫的未筛选儿童。15个家庭拒绝参与。94名儿童被随机分配接受苯巴比妥治疗（每日1.5mg/kg，持续2周；维持剂量为每日3.0mg/kg；n = 47）或苯妥英治疗（每日2.5mg/kg，然后每日5.0mg/kg；n = 47）。对儿童进行了12个月的随访。主要结局指标是行为副作用的发生频率；在12个月或治疗结束时，对于6岁及以上儿童，通过康纳斯父母评定量表评估行为，对于2至5岁儿童，通过学龄前行为筛查问卷（BSQ）评估行为。分析采用意向性分析。
苯巴比妥组和苯妥英组在行为评定量表上的平均对数转换得分无显著差异（康纳斯量表：2.64 [标准差0.71] 对2.65 [0.89]，p = 0.97；每组n = 32：BSQ量表：2.12 [1.31] 对2.18 [1.02]，p = 0.94；n = 4对3）。行为问题的比值比（苯巴比妥对苯妥英）为0.51（95%可信区间0.16 - 1.59）。父母报告的苯巴比妥副作用并无过多情况。我们发现研究药物在疗效上无差异（从随机分组到首次癫痫发作时间的调整风险比为0.97 [0.28 - 3.30]）。
该证据支持苯巴比妥作为发展中国家农村地区儿童癫痫一线药物具有可接受性。
