托吡酯与氟哌啶醇治疗Tourette综合征疗效的对照研究

A compared study of treating Tourette's syndrome with topiramate

目的 探讨托吡酯单一治疗Tourette综合征(TS)的疗效和安全性。方法 将53例TS患者按病例编号分为研究组(35例)和对照组(18例)。研究组予托吡酯(50-150 mg/d)治疗;对照组予氟哌啶醇(1.5-6 mg/d),共治疗24周。研究组3例脱落,对照组2例脱落。采用耶鲁抽动症整体严重度量表(YGTSS)、治疗中需处理的不良反应症状量表(TESS)于治疗前、治疗第8,24周末对两组进行评估。结果(1)治疗第8周末研究组有效率为72％,高于对照组(38％;Z=-3.284,P=0.001)。研究组YGTSS总分[(28.06±14.45)分]低于对照组[(40.00±20.90)分;P<0.05];减分率[(48.10±22.80)％]高于对照组[(33.17±31.90)％;但P>0.05]。治疗第24周末,研究组有效率为81％,高于对照组(56％;Z=-4.808,P<0.001)。研究组YGTSS总分[(24.96±16.28)分]低于对照组[(36.50±21.08)分;P<0.05];减分率[(52.90±24.49)％]高于对照组[(34.63±32.58)％;P<0.05]。(2)第8周末研究组TESS分[(2.69±3.02)分]低于对照组[(6.25±4.06)分;P<0.01];第24周末研究组TESS分[(1.69±1.79)分]低于对照组[(2.69±3.02)分;P<0.01]。结论 托吡酯能有效改善TS的运动、发声抽动和综合损伤效应,副作用相对较轻。

Objective The aim of this study was to determine the efficacy and safety of topiramate in treating Tourette's syndrome (TS). Methods An open-labeled control study was carried out. Fifty-three patients met the DSV-Ⅳ criteria for TS were involved in the study. Subjects were given 24-week topiramate (50-150 mg/d;35 cases) or haloperidol medication (1.5-6 mg/d;18 cases). The efficacy was assessed with the Yale Global Tic Severity Scale (YGTSS) and the safety with the Treatment Emergent Symptom Scale (TESS) at baseline and at the end of 8th, 24th week of the study. Results Forty-eight subjects completed the study, with 3 in topiramate group and 2 in haloperidol group dropped out. The efficacy in the topiramate group was significantly better than that in control group, with response rates of 72% and 38% respectively after 8-week treatment, and the YGTSS total score was significantly lower in topiramate group compared to haloperidol group (P<0. 05). After 24-week treatment, there were more higher response rate (81% vs. 56% ), lower YGTSS total score, and higher reduction rate of YGTSS score in topiramate group than in haloperidol group (all P <0. 05). The adverse reactions in the topiramate group were milder than that in haloperidol both at the end of 8-week and 24-week treatment (P < 0. 01). Conclusion It is effective and safe of topiramate in treating Tourette's syndrome.