Dodrill C B, Arnett J L, Sommerville K W, Sussman N M
Department of Neurological Surgery, University of Washington School of Medicine, Seattle.
Neurology. 1993 Dec;43(12):2501-7. doi: 10.1212/wnl.43.12.2501.
We evaluated the psychological effects of the antiepilepsy drug vigabatrin in a randomized multicenter double-blind placebo-controlled parallel group study that compared 3 grams oral vigabatrin with placebo as daily add-on therapy in patients with focal epilepsy whose complex partial seizures were difficult to control. Testing at baseline and after 12 weeks of vigabatrin (n = 83) or placebo (n = 85) used eight measures of cognitive abilities and three of mood and adjustment. The vigabatrin and placebo groups were highly similar at entry into the study. At the end of the study, there were no differences between the vigabatrin and placebo groups on any cognitive variable or on any measure of mood and adjustment. Analysis of the results related to relief from seizures demonstrated only chance findings. In a similar manner, there were no relationships between vigabatrin serum levels at the end of the study and changes on measures of abilities and adjustment. Vigabatrin appears to be a useful antiepilepsy drug with little impact upon tests of either cognitive abilities or quality of life.
我们在一项随机、多中心、双盲、安慰剂对照的平行组研究中,评估了抗癫痫药物氨己烯酸的心理效应。该研究比较了3克口服氨己烯酸与安慰剂作为每日附加治疗,用于治疗局灶性癫痫且复杂部分性发作难以控制的患者。在基线以及接受氨己烯酸治疗12周后(n = 83)或安慰剂治疗12周后(n = 85)进行测试,使用了八项认知能力测量指标以及三项情绪和适应能力测量指标。氨己烯酸组和安慰剂组在进入研究时高度相似。在研究结束时,氨己烯酸组和安慰剂组在任何认知变量、任何情绪和适应能力测量指标上均无差异。对与癫痫发作缓解相关的结果分析仅显示出偶然结果。同样,研究结束时氨己烯酸血清水平与能力和适应能力测量指标的变化之间也没有关联。氨己烯酸似乎是一种有用的抗癫痫药物,对认知能力测试或生活质量几乎没有影响。