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一项关于辅助使用丁螺环酮治疗自闭症易激惹症状的随机双盲安慰剂对照临床试验。

A randomized double-blind placebo-controlled clinical trial of adjuvant buspirone for irritability in autism.

作者信息

Ghanizadeh Ahmad, Ayoobzadehshirazi Anaheed

机构信息

Research Center for Psychiatry and Behavioral Sciences, Shiraz University of Medical Sciences, Shiraz, Iran; Department of Psychiatry, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran; Department of Neuroscience, School of Advanced Medical Sciences and Technologies, Shiraz University of Medical Sciences, Shiraz, Iran.

Research Center for Psychiatry and Behavioral Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.

出版信息

Pediatr Neurol. 2015 Jan;52(1):77-81. doi: 10.1016/j.pediatrneurol.2014.09.017. Epub 2014 Oct 5.

DOI:10.1016/j.pediatrneurol.2014.09.017
PMID:25451017
Abstract

BACKGROUND

The brain serotonin level is decreased in individuals with autism. Buspirone is a 5-HT(1A) receptor agonist with antiaggressive effects increasing prosocial behaviors.

METHODS

We conducted an 8-week randomized double-blind placebo-controlled clinical trial. Participants included 40 outpatient children and adolescents with autism. The patients took buspirone plus risperidone or risperidone plus placebo during 8 weeks. The patients were assessed at baseline, week 4, and week 8 using the Aberrant Behavior Checklist-Community Rating Scale.

RESULTS

Eighteen patients in the placebo group and 16 patients in the buspirone group completed this trial. The mean dose of buspirone was 6.7 (SD 2.7) mg/day. Irritability subscale score significantly decreased during this trial in both groups (buspirone group: declined from 25.7 [SD 5.7] to 16.3 [SD 8.5]; placebo group: declined from 24.7 [SD 7.6] to 18.2 [SD 7.7]). The Cohen d effect size was .45. Thirteen (81.2%) of 16 patients in the buspirone group and 7 (38.9%) of 18 patients in the placebo group showed a ≥30% decline in irritability score. The relative risk for treatment was 2.1. There were no serious adverse effects. The most common adverse effects in the buspirone group were increased appetite, drowsiness, and fatigue.

CONCLUSION

This clinical trial supports that low dose buspirone plus risperidone is more effective than risperidone plus placebo for treating irritability in individuals with autism.

摘要

背景

自闭症患者的大脑血清素水平降低。丁螺环酮是一种5-HT(1A)受体激动剂,具有抗攻击作用,可增加亲社会行为。

方法

我们进行了一项为期8周的随机双盲安慰剂对照临床试验。参与者包括40名门诊自闭症儿童和青少年。患者在8周内服用丁螺环酮加利培酮或利培酮加安慰剂。在基线、第4周和第8周使用异常行为检查表-社区评定量表对患者进行评估。

结果

安慰剂组的18名患者和丁螺环酮组的16名患者完成了该试验。丁螺环酮的平均剂量为6.7(标准差2.7)毫克/天。在该试验期间,两组的激惹分量表评分均显著下降(丁螺环酮组:从25.7[标准差5.7]降至16.3[标准差8.5];安慰剂组:从24.7[标准差7.6]降至18.2[标准差7.7])。科恩d效应量为0.45。丁螺环酮组16名患者中的13名(81.2%)和安慰剂组18名患者中的7名(38.9%)激惹评分下降≥30%。治疗的相对风险为2.1。没有严重的不良反应。丁螺环酮组最常见的不良反应是食欲增加、嗜睡和疲劳。

结论

该临床试验支持低剂量丁螺环酮加利培酮治疗自闭症患者激惹比利培酮加安慰剂更有效。

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