唑尼沙胺辅助治疗难治性部分性癫痫：一项欧洲双盲试验。

Zonisamide for add-on treatment of refractory partial epilepsy: a European double-blind trial.

作者信息

Schmidt D, Jacob R, Loiseau P, Deisenhammer E, Klinger D, Despland A, Egli M, Bauer G, Stenzel E, Blankenhorn V

机构信息

Epilepsy Research Group, Universitätsklinikum Rudolf Virchow, Berlin, Germany.

出版信息

Epilepsy Res. 1993 May;15(1):67-73. doi: 10.1016/0920-1211(93)90011-u.

DOI:10.1016/0920-1211(93)90011-u

PMID:8325280

Abstract

The new antiepileptic drug zonisamide was evaluated in a European multicenter parallel-group double-blind trial as add-on treatment for 139 patients with refractory partial epilepsy. During treatment with zonisamide complex partial seizures decreased by 27.7% compared to placebo (P < 0.05) and the median rate dropped from 12/month to 7.1/month with no changes in the placebo group (P < 0.007). During the 12-week double-blind phase a 50% reduction of all seizures was recorded in 29.9% of the patients treated with zonisamide vs. 9.4% during placebo. Complete remission was observed during treatment with zonisamide in 6.2%. The plasma concentrations of the concomitant antiepileptic drugs did not change markedly when zonisamide was added. Adverse events, mostly fatigue, somnolence, dizziness and ataxia, occurred in 59.2% of the patients compared to 27.9% during placebo. Zonisamide was withdrawn in two patients due to adverse events. Kidney stones were not observed nor any relevant clinical chemistry or hematological changes. Zonisamide is an effective antiepileptic drug for add-on treatment of refractory partial epilepsy.

摘要

新型抗癫痫药物唑尼沙胺在一项欧洲多中心平行组双盲试验中，作为139例难治性部分性癫痫患者的附加治疗药物进行了评估。在使用唑尼沙胺治疗期间，复杂部分性发作与安慰剂相比减少了27.7%（P < 0.05），中位数发作率从每月12次降至7.1次，而安慰剂组无变化（P < 0.007）。在12周的双盲阶段，接受唑尼沙胺治疗的患者中有29.9%的患者所有发作减少了50%，而安慰剂组为9.4%。在使用唑尼沙胺治疗期间，有6.2%的患者出现完全缓解。添加唑尼沙胺后，同时服用的抗癫痫药物的血浆浓度没有明显变化。不良事件大多为疲劳、嗜睡、头晕和共济失调，59.2%的患者出现不良事件，而安慰剂组为27.9%。两名患者因不良事件停用唑尼沙胺。未观察到肾结石，也未发现任何相关的临床化学或血液学变化。唑尼沙胺是难治性部分性癫痫附加治疗的有效抗癫痫药物。