Calabrese J R, Keck P E, McElroy S L, Shelton M D
Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.
J Clin Psychopharmacol. 2001 Jun;21(3):340-2. doi: 10.1097/00004714-200106000-00015.
This small-scale pilot study was performed to grossly document safety and any evidence of efficacy of topiramate in bipolar disorder. Ten patients hospitalized for acute mania were given open-label topiramate monotherapy for up to 28 days. The mean Young Mania Rating Scale (YMRS) score decreased from 32 (range, 26-40) at baseline to 22 (range, 2-40) at the end of the study. Five patients exhibited evidence of moderate to marked improvement, three subjects had at least a 50% reduction in YMRS scores, and the other two patients experienced an improvement of 25% to 49% on the YMRS. The preliminary findings of this small series suggest that topiramate may be effective in acute mania. Double-blind controlled trials are now needed to further investigate the efficacy and safety of topiramate in bipolar disorder.
开展这项小规模试点研究的目的是,粗略记录托吡酯治疗双相情感障碍的安全性及任何疗效证据。10名因急性躁狂住院的患者接受了为期28天的开放标签托吡酯单药治疗。青年躁狂评定量表(YMRS)的平均得分从基线时的32分(范围为26 - 40分)降至研究结束时的22分(范围为2 - 40分)。5名患者表现出中度至显著改善的迹象,3名受试者的YMRS得分至少降低了50%,另外两名患者的YMRS得分改善了25%至49%。这个小系列的初步研究结果表明,托吡酯可能对急性躁狂有效。现在需要进行双盲对照试验,以进一步研究托吡酯治疗双相情感障碍的疗效和安全性。