舒噻嗪治疗癫痫强直-阵挛发作随机对照多中心临床研究

A randomized controlled multicenter clinical study on sulthiame in the treatment of GTCS

目的 评价舒噻嗪治疗癫痫强直 -阵挛发作 (GTCS)的疗效和安全性。方法 对 146例 GTCS患者采取随机分组、开放试验、苯妥英钠对照多中心的临床研究。其中舒噻嗪研究组 32例 ,开放组 82例 ,苯妥英钠对照组 32例。结果 舒噻嗪研究组对 GTCS总有效率 90 .6 % ,苯妥英钠对照组总有效率 81.3% ,两组间无显著差别 (P>0 .0 5 ) ;舒噻嗪对患者血常规、肝肾功能、心电图均无明显影响 ;舒噻嗪引起的不良反应发生率为 2 6 .3% ,苯妥英钠组为 2 5 .0 % ,两组相比无显著差异 (P>0 .0 5 ) ,舒噻嗪所致不良反应极大多数轻微且不需特别处理。结论 舒噻嗪是治疗

Objective To investigate the curative effect and safety of sulthiame in the treatment of GTCS.Methods A randomized dividing group,open trial,phenytoin sodium controlled multicenter clinical study was made in 146 patients with GTCS. In the study, 32 patients were enrolled in sulthiame group, 32 patients were assessable for phenytoin group, and the rest were enrolled in open labelled group.Results The total effective rates were 90.6% for sulthiame group, 81.3% for phenytoin group, and there was no remarkable diffe rence between the two groups ( P >0 05);There was no obvious effect on the whole blood routine test, hepatonephric function and the electrocardiogram with sulthiame; The incidence of adverse reaction were 26.3% for the sulthiame group, 25.0% for the phenytoin group, and there was no remarkable difference in the two groups ( P >0 05), and the adverse reaction for sulthiame was mild and no necessary to cure.Conclusion It is effective and safe in the treatment for GTCS with sulthiame.