Pylaeva O A, Petrukhin A S, Voronkova K V
Zh Nevrol Psikhiatr Im S S Korsakova. 2004;104(8):61-5.
The study aimed at a comparative analysis of safety and efficacy of valproic acid (valproate) and barbiturates in the treatment of epilepsy in children. Two hundred and forty children were treated with valproate, 94% being assigned to depakine and depakine chrono, and 210 children received barbiturates. Therapeutic effect (a decrease of seizures frequency by 2 and more times or remission) was detected in 82 of 127 (65 +/- 8.53%) patients for valproate monotherapy and only in 26 of 89 (30 +/- 9.45%) for barbiturates monotherapy. An efficacy of antiepileptic therapy in children was significantly higher (p<0.05) for valproates as compared to barbiturates. A drug withdrawal due to poor tolerability was recorded in 6 of 127 (5 +/- 3.7%) patients treated with valproate in monotherapy and in 14 of 210 (7 +/- 3.45%)--in polytherapy; in 53 of 89 (59 +/- 10.2%) patients treated with barbiturates in monotherapy and in 78 of 121 (65 +/- 8.53%) patients treated with barbiturates in polytherapy. Therefore, adverse effects occurred more often in barbiturates than in valproate treatment both for mono- and polytherapy (p<0.05). The results of the study confirmed the high efficacy and safety of valproates, specifically depakine chrono, in the treatment of epilepsy in children. depakine chrono in-take is associated with lower frequency of adverse effects; side-effects are mostly of dose-dependent character and do not result in the drug withdrawal. The authors do not recommend using barbiturates in the first-line treatment in children, because of the lower efficacy, high frequency of medical complications that might result in the drug withdrawal and reducing of the efficacy of other antiepileptic medications.
该研究旨在对比分析丙戊酸（丙戊酸盐）和巴比妥类药物治疗儿童癫痫的安全性和有效性。240名儿童接受丙戊酸盐治疗，其中94%使用德巴金和德巴金缓释片，210名儿童接受巴比妥类药物治疗。丙戊酸单药治疗的127名患者中有82名（65±8.53%）出现治疗效果（癫痫发作频率降低2次及以上或缓解），而巴比妥类药物单药治疗的89名患者中只有26名（30±9.45%）出现治疗效果。与巴比妥类药物相比，丙戊酸盐治疗儿童癫痫的疗效显著更高（p<0.05）。丙戊酸单药治疗的127名患者中有6名（5±3.7%）因耐受性差而停药，丙戊酸联合治疗的210名患者中有14名（7±3.45%）停药；巴比妥类药物单药治疗的89名患者中有53名（59±10.2%）停药，巴比妥类药物联合治疗的121名患者中有78名（65±8.53%）停药。因此，无论是单药治疗还是联合治疗，巴比妥类药物的不良反应发生率均高于丙戊酸治疗（p<0.05）。研究结果证实丙戊酸盐，特别是德巴金缓释片，在治疗儿童癫痫方面具有高效性和安全性。服用德巴金缓释片的不良反应发生率较低；副作用大多具有剂量依赖性，不会导致停药。由于疗效较低、医疗并发症发生率高，可能导致停药以及降低其他抗癫痫药物的疗效，作者不建议将巴比妥类药物用于儿童的一线治疗。
