Sveinbjornsdottir S, Sander J W, Patsalos P N, Upton D, Thompson P J, Duncan J S
Epilepsy Research Group, Chalfont Centre for Epilepsy, Gerrards Cross, Bucks, UK.
Seizure. 1994 Mar;3(1):29-35. doi: 10.1016/s1059-1311(05)80160-8.
The neuropsychological effects of the GABA-reuptake blocker, tiagabine-HCl, were tested in an open trial of 22 adult patients with refractory partial epilepsy followed by a double-blind, placebo-controlled, cross-over trial in 12 subjects. Nineteen patients completed the initial open titration and fixed-dose phase of the study and 11 patients completed the double-blind phase. The median daily tiagabine dose was 32 mg during the open fixed dose and 24 mg during the double-blind periods. Neuropsychological evaluation did not show any significant effect on cognitive function in the open or double-blind phases. In this group of patients no statistically significant difference in the frequency of the total number of seizures or complex partial seizures was found in the open or double-blind stages. Seizure severity was significantly less in the open fixed dose than in the baseline period, but was not significantly different between the two double-blind periods. Reported side effects were transient, most commonly aggression/irritability, lethargy, headache and drowsiness. No significant EEG changes were observed.
在一项针对22名难治性部分性癫痫成年患者的开放性试验中，对γ-氨基丁酸（GABA）再摄取阻滞剂盐酸噻加宾的神经心理学效应进行了测试，随后在12名受试者中进行了双盲、安慰剂对照的交叉试验。19名患者完成了研究的初始开放滴定和固定剂量阶段，11名患者完成了双盲阶段。开放固定剂量期间，噻加宾的每日中位剂量为32毫克，双盲期间为24毫克。神经心理学评估在开放或双盲阶段均未显示对认知功能有任何显著影响。在该组患者中，开放或双盲阶段癫痫发作总数或复杂部分性癫痫发作频率均未发现统计学上的显著差异。开放固定剂量时癫痫发作严重程度明显低于基线期，但两个双盲期之间无显著差异。报告的副作用是短暂的，最常见的是攻击性/易怒、嗜睡、头痛和困倦。未观察到脑电图有显著变化。
