可乐定透皮贴片治疗儿童中重度抽动障碍的临床研究

Efficacy of clonidine transdermal patch in treatment of moderate to severe tic disorders in children

摘要:

目的 观察可乐定透皮贴片与氟哌啶醇片治疗中重度儿童抽动障碍的疗效差异。方法 将134例耶鲁大体抽动严重程度量表（YGTSS）总评分25分以上的中重度抽动障碍患儿随机分为可乐定组（70例）和氟哌啶醇组（64例）。可乐定组给予可乐定透皮贴片治疗，氟哌啶醇组给予氟哌啶醇治疗，疗程均为8周。采用YGTSS进行治疗前后症状评价，并记录治疗中的不良反应。结果 氟哌啶醇组治疗1周的疗效高于可乐定组（P < 0.05）；治疗后3周、5周、8周的疗效差异无统计学意义（P > 0.05）。在运动抽动积分、发声抽动积分、功能受损积分和总评分方面，治疗1周后可乐定组的YGTSS减分率均低于氟哌啶醇组（P  < 0.05）；治疗3周、5周、8周时，两组的YGTSS减分率差异无统计学意义（P > 0.05）。可乐定组总不良反应发生率为8%，低于氟哌啶醇组（37%）（P  < 0.01）。结论 可乐定透皮贴剂和氟哌啶醇均是治疗儿童中重度抽动障碍的有效药物，可乐定起效速度较慢，但疗效与氟哌啶醇相当，且不良反应低于氟哌啶醇。

Abstract:

Objective To investigate the difference in the efficacy between clonidine transdermal patch and haloperidol tablets in the treatment of moderate to severe tic disorders in children. Methods A total of 134 children with moderate to severe tic disorders were randomly divided into clonidine group (n=70) and haloperidol group (n=64). The clonidine and haloperidol groups were treated with clonidine transdermal patch and haloperidol tablets respectively, and the treatment lasted for 8 weeks in both groups. The Yale Global Tic Severity Scale (YGTSS) was used to evaluate the conditions of the children before and after treatment, and the adverse events during the treatment were recorded. Results The haloperidol group had a signifcantly better treatment outcome than the clonidine group after one week of treatment (P < 0.05); the treatment outcome showed no signifcant difference between the two groups after 3, 5, and 8 weeks of treatment (P > 0.05). The clonidine group had signifcantly less reductions in the motor tics, vocal tics, and function impairment scores and total score of YGTSS than the haloperidol group after one week of treatment (P < 0.05); there were no signifcant differences in YGTSS score reductions between the two groups after 3, 5, and 8 weeks of treatment (P > 0.05). The clonidine group had a signifcantly lower overall incidence of adverse events than the haloperidol group (8% vs 37%; P < 0.01). Conclusions Clonidine transdermal patch and haloperidol are both effective in the treatment of moderate to severe tic disorders in children. The clonidine transdermal patch, despite slow action, has comparable effcacy and fewer adverse effects compared with haloperidol.