可乐定贴片治疗抽动障碍的随机双盲多中心安慰剂对照临床试验。

Randomized double-blind multicentre placebo-controlled clinical trial of the clonidine adhesive patch for the treatment of tic disorders.

作者信息

Du Ya-song, Li Hua-fang, Vance Alasdair, Zhong You-quan, Jiao Fu-yong, Wang Hui-mei, Wang Min-jie, Su Lin-yan, Yu De-li, Ma Shi-wei, Wu Jie-bao

机构信息

Department of Child and Adolescent Psychiatry, Shanghai Mental Health Center, Shanghai Jiao Tong University, Shanghai, China.

出版信息

Aust N Z J Psychiatry. 2008 Sep;42(9):807-13. doi: 10.1080/00048670802277222.

DOI:10.1080/00048670802277222

PMID:18696285

Abstract

OBJECTIVE

The aim of the present study was to evaluate the therapeutic effectiveness and safety of the clonidine adhesive patch in treating tic disorders.

METHOD

A total of 437 patients, who met Chinese Classification of Mental Disorders-third edition diagnostic criteria for transient tic disorder (5%), chronic motor or vocal tic disorder (40%) or Tourette disorder (55%), aged 6-18 years, were divided randomly into an active treatment group and a clinical control group. Participants in the active treatment group were treated with a clonidine adhesive patch and participants in the clinical control group with a placebo adhesive patch for 4 weeks. The dosage of the clonidine adhesive patch was 1.0mg, 1.5mg or 2.0mg per week, depending on each participant's bodyweight. Participants whose Yale Global Tic Severity Scale (YGTSS) score decreased <30% and Clinical Global Impression score was > or =4 by the end of week 3 were withdrawn from the trial.

RESULTS

After 4 weeks of treatment the active treatment group participants' YGTSS score was significantly lower than that of the clinical control group (F=4.63, p=0.03). Further, the active treatment group had a significantly better therapeutic response than the clinical control group (chi(2)=9.15, p=0.003). The response rate in the active treatment group was 68.85% compared to 46.85% in the clinical control group (chi(2)=16.98, p=0.0001). The rate of adverse events was low (active treatment group, 3.08%; clinical control group, 7.21%) and did not differ between the two groups.

CONCLUSIONS

The clonidine adhesive patch is effective and safe for tic disorders.

摘要

目的

本研究旨在评估可乐定贴片治疗抽动障碍的疗效和安全性。

方法

共437例年龄在6至18岁、符合《中国精神障碍分类与诊断标准》第三版中短暂性抽动障碍（5%）、慢性运动或发声抽动障碍（40%）或 Tourette 障碍（55%）诊断标准的患者，被随机分为积极治疗组和临床对照组。积极治疗组患者使用可乐定贴片治疗，临床对照组患者使用安慰剂贴片治疗4周。可乐定贴片的剂量根据每位参与者的体重，为每周1.0mg、1.5mg或2.0mg。在第3周结束时，耶鲁综合抽动严重程度量表（YGTSS）评分降低<30%且临床总体印象评分为>或 =4的参与者退出试验。

结果

治疗4周后，积极治疗组参与者的YGTSS评分显著低于临床对照组（F = 4.63，p = 0.03）。此外，积极治疗组的治疗反应明显优于临床对照组（χ(2)=9.15，p = 0.003）。积极治疗组的有效率为68.85%，而临床对照组为46.85%（χ(2)=16.98，p = 0.0001）。不良事件发生率较低（积极治疗组为3.08%；临床对照组为7.21%），两组之间无差异。