Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, South Kargar Street, Tehran, 13337, Iran.
Department of Psychiatry, Razi Hospital, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.
Eur Child Adolesc Psychiatry. 2019 Dec;28(12):1619-1628. doi: 10.1007/s00787-019-01333-5. Epub 2019 Apr 12.
Increasing evidence suggests that the function of the GABAergic system is abnormally low in autism spectrum disorder (ASD). Baclofen, which functions as a selective agonist for GABA receptors, does appear promising for the treatment of ASD. We conducted a 10-week randomized-controlled study aimed at evaluating the potential of baclofen as an adjuvant therapy to enhance the effect of risperidone in children with ASD. Sixty-four children (3-12 years) with moderate-to-severe irritability symptoms of ASD were included. We used the Aberrant Behavior Checklist-Community Edition (ABC-C) for the outcome measures on each of the follow-up visits (weeks 0, 5, and 10). Analysis of the combined data revealed significant improvement for all the ABC subscales (irritability: F = 51.644, df = 1.66, p < 0.001, lethargy: F = 39.734, df = 1.38, p < 0.001, stereotypic behavior: F = 25.495, df = 1.56, p < 0.001, hyperactivity: F = 54.135, df = 1.35, p < 0.001, and inappropriate speech: F = 19.277, df = 1.47, p = 0.004). Combined treatment with baclofen and risperidone exerted a greater effect on improvement of hyperactivity symptoms at both midpoint [Cohen's d, 95% confidence interval (CI) = - 3.14, - 5.56 to - 0.72] and endpoint (d, 95% CI = - 4.45, - 8.74 to - 0.16) when compared with treatment with placebo plus risperidone. The two treatments achieved comparable results for other outcome measures. Our data support safety and efficacy of baclofen as an adjuvant to risperidone for improvement of hyperactivity symptoms in children with ASD.
越来越多的证据表明，在自闭症谱系障碍（ASD）中，GABA 能系统的功能异常低下。巴氯芬作为 GABA 受体的选择性激动剂，似乎有望成为 ASD 的治疗方法。我们进行了一项为期 10 周的随机对照研究，旨在评估巴氯芬作为辅助治疗药物，增强利培酮治疗 ASD 儿童疗效的潜力。纳入了 64 名（3-12 岁）有中度至重度烦躁症状的 ASD 儿童。我们使用异常行为检查表-社区版（ABC-C）作为每个随访（第 0、5 和 10 周）的疗效评估指标。综合数据分析显示，所有 ABC 子量表均有显著改善（烦躁：F=51.644，df=1.66，p<0.001，嗜睡：F=39.734，df=1.38，p<0.001，刻板行为：F=25.495，df=1.56，p<0.001，多动：F=54.135，df=1.35，p<0.001，不适当言语：F=19.277，df=1.47，p=0.004）。巴氯芬和利培酮联合治疗在中点[Cohen's d，95%置信区间（CI）=−3.14，−5.56 至−0.72]和终点（d，95%CI=−4.45，−8.74 至−0.16）时对改善多动症状的效果优于安慰剂加利培酮。两种治疗方法在其他疗效评估指标上均取得了相似的结果。我们的数据支持巴氯芬作为利培酮辅助治疗药物，用于改善 ASD 儿童多动症状的安全性和有效性。
