Intranasal Oxytocin in Children and Adolescents with Autism Spectrum Disorder
Intranasal Oxytocin in Children and Adolescents with Autism Spectrum Disorder
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DOI：
10.1056/nejmoa2103583
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发表时间：
2021-10-14
影响因子：
158.5
通讯作者：
Veenstra-VanderWeele, J.
中科院分区：
文献类型：
--
作者：
Sikich, L.;Kolevzon, A.;Veenstra-VanderWeele, J.
催产素在自闭症谱系障碍中的应用鼻内催产素疗法已被用于改善自闭症谱系障碍的各个方面，这是基于来自小型研究的脆弱结果。在一项随机试验中，涉及290名参与者3至17岁的自闭症谱系障碍，每天使用催产素并没有改善措施的社会交往相比，安慰剂超过一段时间的24 weeks.Background实验研究和小型临床试验表明，鼻内催产素治疗可能会减少社会障碍的自闭症谱系障碍的人。催产素已在临床实践中被用于许多自闭症谱系障碍儿童。方法我们进行了一项为期24周的安慰剂对照的2期临床试验，鼻内催产素治疗3至17岁的自闭症谱系障碍儿童和青少年。参与者以1：1的比例随机分配，根据年龄和语言流畅性分层，接受催产素或安慰剂，鼻内给药，总目标剂量为每天48个国际单位。主要结局是异常行为检查表改良社交退缩子量表（ABC-mSW）较基线的最小二乘平均变化，该量表包括13个项目（评分范围为0 - 39，评分越高表示社交互动越少）。次要结果包括两项额外的社会功能指标和一项简短的智商指标。结果355名儿童和青少年接受筛查，290名入组。共有146名参与者被分配到催产素组，144名被分配到安慰剂组;分别有139名和138名参与者完成了基线和至少一次基线后ABC-mSW评估，并被纳入改良的意向治疗分析。催产素组ABC-mSW评分（主要结局）较基线的最小二乘平均变化为-3.7，安慰剂组为-3.5（最小二乘平均差异为-0.2; 95%置信区间为-1.5至1.0; P=0.61）。试验组之间的次要结局通常没有差异。两组不良事件的发生率和严重程度相似。结论：这项安慰剂对照的试验，鼻内催产素治疗自闭症谱系障碍的儿童和青少年显示，在24周内，社会或认知功能指标较基线的最小二乘平均变化无显著组间差异。（由国家儿童健康和人类发展研究所资助; SOARS-B ClinicalTrials.gov编号，。
Oxytocin in Autism Spectrum Disorder Intranasal oxytocin therapy has been used to improve various aspects of autism spectrum disorder on the basis of tenuous results from small studies. In a randomized trial involving 290 participants 3 to 17 years of age with autism spectrum disorder, daily use of oxytocin did not improve measures of social interaction as compared with placebo over a period of 24 weeks.Background Experimental studies and small clinical trials have suggested that treatment with intranasal oxytocin may reduce social impairment in persons with autism spectrum disorder. Oxytocin has been administered in clinical practice to many children with autism spectrum disorder. Methods We conducted a 24-week, placebo-controlled phase 2 trial of intranasal oxytocin therapy in children and adolescents 3 to 17 years of age with autism spectrum disorder. Participants were randomly assigned in a 1:1 ratio, with stratification according to age and verbal fluency, to receive oxytocin or placebo, administered intranasally, with a total target dose of 48 international units daily. The primary outcome was the least-squares mean change from baseline on the Aberrant Behavior Checklist modified Social Withdrawal subscale (ABC-mSW), which includes 13 items (scores range from 0 to 39, with higher scores indicating less social interaction). Secondary outcomes included two additional measures of social function and an abbreviated measure of IQ. Results Of the 355 children and adolescents who underwent screening, 290 were enrolled. A total of 146 participants were assigned to the oxytocin group and 144 to the placebo group; 139 and 138 participants, respectively, completed both the baseline and at least one postbaseline ABC-mSW assessments and were included in the modified intention-to-treat analyses. The least-squares mean change from baseline in the ABC-mSW score (primary outcome) was -3.7 in the oxytocin group and -3.5 in the placebo group (least-squares mean difference, -0.2; 95% confidence interval, -1.5 to 1.0; P=0.61). Secondary outcomes generally did not differ between the trial groups. The incidence and severity of adverse events were similar in the two groups. Conclusions This placebo-controlled trial of intranasal oxytocin therapy in children and adolescents with autism spectrum disorder showed no significant between-group differences in the least-squares mean change from baseline on measures of social or cognitive functioning over a period of 24 weeks. (Funded by the National Institute of Child Health and Human Development; SOARS-B ClinicalTrials.gov number, .)