经颅交流电刺激治疗原发性失眠及伴发焦虑的疗效及安全性

Efficacy and safety of transcranial alternating current stimulation in the treatment of primary insomnia complicated by anxiety

目的探讨经颅交流电刺激(transcranial alternating-current stimulation,tACS)治疗原发性失眠及伴发焦虑的疗效及安全性。方法62例原发性失眠障碍患者随机分为治疗组和对照组,治疗组给予tACS真刺激治疗,对照组予以tACS伪刺激治疗。2组治疗次数均为20次,治疗部位为前额部、双侧乳突部,频率为77.5 Hz,强度为15mA。采用匹兹堡睡眠质量指数量表(Pittsburgh sleep quality index,PSQI)、汉密尔顿焦虑量表(Hamilton anxiety scale,HAMA)评估患者临床症状,采用副反应量表及开放式记录收集不良反应。评估时间点为基线,治疗结束时(4周),随访时(8周)。结果采用重复测量方差分析比较治疗组和对照组在基线、治疗4周末、随访8周末时PSQI及HAMA评分变化,显示2组PSQI总分及HAMA总分均随治疗及随访时间的延长逐渐降低(P_(时间)<0.05);治疗组降低幅度大于对照组(P_(组间)<0.05),且随观察时间的延长治疗的效应增大(P_(交互)<0.05)。2组HAMA均随治疗及随访时间的延长时间逐渐降低(P_(时间)<0.05);随观察时间的延长治疗的效应增大(P_(交互)<0.05),但组间比较差异无统计学意义(P_(组间)>0.05)。2组均无严重不良事件发生。结论经颅交流电刺激对原发性失眠及伴发的焦虑有效,安全性高,可作为原发性失眠特别是伴发焦虑症状失眠障碍患者治疗的新选择。

Objective To investigate the efficacy and safety of transcranial alternating current stimulation(tACS)in the treatment of primary insomnia complicated by anxiety.Methods Sixty-two patients with primary insomnia were randomly divided into treatment group and control group.The patients in the treatment group received real tACS while the patients in the control group were treated with sham tACS.The treatment session was 20 times in both groups.The treatment site was prefrontal and bilateral mastoid regions,with a frequency of 77.5 Hz and an intensity of 15 mA.Pittsburgh sleep quality index(PSQI)and Hamilton Anxiety Scale(HAMA)were used to evaluate the clinical symptoms at baseline,and at the end of treatment(4 weeks)and follow-up(8 weeks).Adverse reactions were assessed using Treatment Emergent Symptom Scale and recorded.Results The scores of PSQI and HAMA in the treatment group and the control group at baseline,4 weeks after treatment and 8 weeks after follow-up were compared using repeated measurement analysis of variance.The total scores of PSQI and HAMA in the two groups decreased gradually with the extension of treatment and follow-up time(P_(time)<0.05).The decrease in the treatment group was greater than that in the control group(P_(group)<0.05),and the effect of treatment increased with the extension of observation time(P_(interaction)<0.05).The total score of HAMA in both groups decreased gradually with the extension of treatment and follow-up time(P_(time)<0.05),and the effect of treatment increased with the extension of observation time(P_(interaction)<0.05);However,there was no significant difference between two groups(P_(group)>0.05).Conclusion tACS is effective and safe in the treatment of primary insomnia complicated by anxiety.It can be used as a new option for the treatment of primary insomnia,especially for those patients with anxiety.