Baylor College of Medicine, Department of Neurology, Houston, TX 77030, USA.
J Neurol Neurosurg Psychiatry. 2010 Jan;81(1):70-3. doi: 10.1136/jnnp.2009.185348. Epub 2009 Sep 1.
To investigate the effects of topiramate on Tourette syndrome (TS).
Dopamine-receptor-blocking drugs have been traditionally used to control tics in patients with TS, but these neuroleptics are associated with potentially limiting side effects.
This is a randomised, double-blind, placebo-controlled, parallel group study. To be included in the study, subjects required a DSM-IV diagnosis of TS, were 7-65 years of age, had moderate to severe symptoms (Yale Global Tic Severity Scale (YGTSS) > or =19), were markedly impaired as determined by the Clinical Global Impression (CGI) scale severity score of > or =4 and were taking no more than one drug each for tics or TS comorbidities.
There were 29 patients (26 males), mean age 16.5 (SD 9.89) years, randomised, and 20 (69%) completed the double-blind phase of the study. The primary endpoint was Total Tic Score, which improved by 14.29 (10.47) points from baseline to visit 5 (day 70) with topiramate (mean dose 118 mg) compared with a 5.00 (9.88) point change in the placebo group (p = 0.0259). There were statistically significant improvements also in the other components of the YGTSS as well as improvements in various secondary measures, including the CGI and premonitory urge CGI. No differences were observed in the frequency of adverse events between the two treatment groups.
This double-blind, placebo-controlled trial provides evidence that topiramate may have utility in the treatment of moderately severe TS.
研究托吡酯治疗妥瑞氏症（TS）的疗效。
传统上，多巴胺受体阻滞剂被用于控制 TS 患者的抽搐，但这些神经阻滞剂可能存在潜在的限制作用。
这是一项随机、双盲、安慰剂对照、平行组研究。纳入研究的受试者需符合 DSM-IV 妥瑞氏症诊断标准，年龄 7-65 岁，症状中度至重度（耶鲁综合抽动严重程度量表（YGTSS）>或=19），临床整体印象量表严重程度评分>或=4 表明严重受损，且每种抽动或 TS 合并症仅服用一种药物。
共有 29 名患者（26 名男性），平均年龄 16.5（9.89）岁，随机分组，其中 20 名（69%）完成了双盲阶段的研究。主要终点是总抽搐评分，与安慰剂组相比，托吡酯（平均剂量 118mg）组从基线到第 5 次访视（第 70 天）时总抽搐评分改善了 14.29（10.47）分（p=0.0259），而安慰剂组仅改善了 5.00（9.88）分。YGTSS 的其他组成部分以及各种次要指标（包括 CGI 和预感 CGI）也有统计学意义的改善。两组之间不良反应的频率没有差异。
这项双盲、安慰剂对照试验提供了证据，表明托吡酯可能对治疗中度严重的妥瑞氏症有效。
