经颅微电流刺激与阿立哌唑治疗儿童抽动障碍的对照研究

A control study of cranial electrotherapy stimulation and aripiprazole treatment for tic disorders in children

目的比较经颅微电流刺激疗法（CES）和阿立哌唑治疗儿童抽动障碍（TD）的临床疗效和安全性。方法本研究采用随机、治疗前与治疗后病例对照的临床试验设计方法,诊断标准符合2000年美国《精神病诊断与统计手册》第4版修订本（DSM-Ⅳ-TR）关于儿童TD中慢性抽动障碍（CTD）或Tourette综合征（TS）诊断标准。共有69例汉族TD患儿入组,其中CTD 38例,TS 31例,年龄在5-16岁。随机分为CES组（n=35例）和阿立哌唑组（n=34例）,分别给予CES与阿立哌唑治疗,观察疗程为4周,采用《耶鲁综合抽动严重程度量表》（YGTSS）、《副反应量表》（TESS）评估疗效及安全性。结果从治疗第2周末起两组YGTSS总分得分均下降,在治疗2周末CES组YGTSS减分率为（17.91±10.44）%,阿立哌唑组YGTSS减分率为（28.60±12.99）%,两组的YGTSS减分率差异有统计学意义（P〈0.01）,CES组下降率明显低于阿立哌唑组;在治疗4周末时CES组的YGTSS减分率[（33.03±19.65）%]也明显低于阿立哌唑组[（52.79±22.87）%]（P〈0.01）。治疗4周后,CES组和阿立哌唑组治疗总体有效率分别为45.71%和76.47%,两组差异具有统计学意义（P〈0.05）。CES组和阿立哌唑组治疗期间不良事件的发生率分别14.29%和11.76%,差异无统计学意义（P〉0.05）,且两组均未见严重不良反应。结论 CES治疗儿童抽动障碍有效,其疗效虽劣于阿立哌唑,但其副反应小,可以作为治疗儿童抽动障碍的一种选择。

Objective To evaluate the clinical efficacy and tolerability of cranial electrotherapy stimulation（CES）and aripiprazole treatment in children with tic disorders. Methods A randomized,case-controlled clinical trial was designed.Samples were all meet the revised fourth edition of Psychiatric Diagnostic and Statistical Manual in 2000（DSM-Ⅳ-TR）diagnostic criteria of chronic tic disorders（CTD）and Tourette＇s syndrome（TS）.Sixty-nine Han Chinese children aged 5to 16 years old with CTD（n=38）or TS（n=31）were randomly assigned to CES group（n=35）and aripiprazole group（n=34）.After 4weeks treatment,the clinical efficacy and safety were assessed by the Yale Global Tic Severity Scale（YGTSS）and the Treatment Emergent Symptom Scale（TESS）respectively. Results There was no significant difference between two groups（P〈0.05）.The YGTSS score in both groups decreased from the second week of treatment.Compared with the aripirazole treatment group,the CES treatment group showed a less decreased YGTSS score[（17.91±10.44）% vs（28.60±12.99）%;P〈0.01]by the second week of treatment.Similarly,the decline rate of YGTSS score in CES treatment group[（33.03±19.65）%]was significantly lower than that in aripirazole treatment group[（52.79±22.87）%]by the forth week of treatment（P〈0.01）.The overall effective rate in the CES and aripiprazole treatment groups was 45.71% and76.47%,respectively,which was significantly different by 4weeks after treatment（P〈0.05）.The incidences of adverse reactions in the CES and aripiprazole groups were separately 14.29% and 11.76%,which had no significant difference（P〈0.05）.There were also no serious adverse reactions in the two groups. Conclusions The efficacy of CES may be less and slower than that of aripiprazole.But CES may be a treatment for children with tic disorders because of its certain efficacy and less tolerability.