The effects of a course of intranasal oxytocin on social behaviors in youth diagnosed with autism spectrum disorders: a randomized controlled trial
The effects of a course of intranasal oxytocin on social behaviors in youth diagnosed with autism spectrum disorders: a randomized controlled trial
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DOI：
10.1111/jcpp.12305
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发表时间：
2015-04-01
影响因子：
7.6
通讯作者：
Einfeld, Stewart L.
中科院分区：
文献类型：
--
作者：
Guastella, Adam J.;Gray, Kylie M.;Einfeld, Stewart L.
背景催产素作为治疗自闭症谱系障碍（ASD）的社会缺陷的一种治疗方法，越来越受到关注。本研究的目的是调查一个疗程的催产素鼻腔喷雾剂对改善患有ASD的青少年的社会行为的功效。方法在2009年2月至2012年1月期间在两所澳大利亚大学进行的双盲、安慰剂对照试验中，50名年龄在12至18岁之间的患有自闭症或自闭症障碍的男性参与者，随机接受催产素（n=26）或安慰剂（n=24）鼻喷雾剂（18或24国际单位），每天两次，持续8周。参与者在基线、治疗4周和8周后以及3个月随访时进行评估。主要结果是在完成的社会反应量表和临床总印象改善量表的临床医生评分总分的变化。次要评估包括照顾者报告的重复和其他发展行为和社会认知。临床试验注册：澳大利亚新西兰临床试验注册ACTRN12609000513213。结果接受催产素治疗的参与者在治疗后的主要或次要结局方面没有表现出任何益处。然而，与相信孩子接受安慰剂的照顾者相比，相信孩子接受催产素的照顾者报告了更大的改善。鼻腔喷雾剂的耐受性良好，并没有证据表明催产素administration.ConclusionsThis增加的副作用是第一次评估的一个过程中的催产素治疗的青少年ASD的疗效。虽然结果并没有表明临床疗效，需要进一步的研究，以探索替代交付方法，早期干预，照顾者的期望对治疗反应的影响。
BackgroundThere is increasing interest in oxytocin as a therapeutic to treat social deficits in autism spectrum disorders (ASD). The aim of this study was to investigate the efficacy of a course of oxytocin nasal spray to improve social behavior in youth with ASD.MethodsIn a double-blind, placebo-controlled trial across two Australian university sites between February 2009 and January 2012, 50 male participants aged between 12 and 18years, with Autistic or Asperger's Disorder, were randomized to receive either oxytocin (n=26) or placebo (n=24) nasal sprays (either 18 or 24 International Units), administered twice-daily for 8weeks. Participants were assessed at baseline, after 4- and 8-weeks of treatment, and at 3-month follow-up. Primary outcomes were change in total scores on the caregiver-completed Social Responsiveness Scale and clinician-ratings on the Clinical Global Impressions-Improvement scale. Secondary assessments included caregiver reports of repetitive and other developmental behaviors and social cognition. Clinical trial registration: Australian New Zealand Clinical Trials Registry ACTRN12609000513213.ResultsParticipants who received oxytocin showed no benefit following treatment on primary or secondary outcomes. However, caregivers who believed their children received oxytocin reported greater improvements compared to caregivers who believed their child received placebo. Nasal sprays were well tolerated and there was no evidence of increased side effects resulting from oxytocin administration.ConclusionsThis is the first evaluation of the efficacy for a course of oxytocin treatment for youth with ASD. Although results did not suggest clinical efficacy, further research is needed to explore alternative delivery methods, earlier age of intervention, and the influence of caregiver expectation on treatment response.