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首页> 外文期刊>Pediatric drugs >A Review of the Safety, Efficacy and Mechanisms of Delivery of Nasal Oxytocin in Children: Therapeutic Potential for Autism and Prader-Willi Syndrome, and Recommendations for Future Research
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A Review of the Safety, Efficacy and Mechanisms of Delivery of Nasal Oxytocin in Children: Therapeutic Potential for Autism and Prader-Willi Syndrome, and Recommendations for Future Research

机译：审查儿童鼻催产素的安全性，疗效和机制：自闭症和PRADER-WILLI综合征的治疗潜力，以及未来研究的建议

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摘要

Abstract In this article, we conduct a comprehensive review of?existing evidence for the?safety and therapeutic potential of intranasal oxytocin in pediatric populations. Unique considerations for dosing and delivery of oxytocin to the nasal passageway in pediatric populations and methods to promote adherence are reviewed. Intranasal oxytocin has been administered to 261 children in three open-label studies and eight randomized controlled trials. To date, the only published results in pediatric populations have focused on autism spectrum disorder (ASD) and Prader-Willi syndrome (PWS). Results regarding efficacy for improving social impairment in ASD are equivocal, partially due to mixed methodological designs, dosing regimens, and outcome measures. At present, there is no randomized controlled evidence that oxytocin provides benefit to individuals with PWS. There is no clear evidence of a link between oxytocin administration and any specific adverse event. Adverse events have been assessed using medical interviews, open reports, checklists, and physiological assessments. Adverse events reports have been largely classified as mild ( n ?=?93), with few moderate ( n ?=?9) or severe ( n ?=?3) events reported. There were 35 additional adverse events reported, without severity ratings. Severe events, hyperactivity and irritability, occurred at first administration in both placebo and oxytocin groups, and subsided subsequent to discontinuation. We note that adverse event monitoring is inconsistent and often lacking, and reporting of its relationship to the study drug is poor. Only one study reported adherence data to suggest high adherence. Recommendations are then?provided for the delivery of nasal sprays to the nasal passageway, monitoring, and reporting of efficacy, safety, and adherence for oxytocin nasal spray trials in pediatric populations.
机译：摘要在本文中，我们进行了全面的审查？现有证据？鼻内催产素在儿科群体中的安全和治疗潜力。综述了对儿科群体和促进遵守方法的鼻孔给鼻孔给药和催产素的唯一考虑因素。鼻内催产素已在三项开放标签研究中给予261名儿童，并进行了8项随机对照试验。迄今为止，儿科人群的唯一公布结果集中在自闭症谱系障碍（ASD）和PRADER-WILLI综合征（PWS）上。关于改善ASD社会障碍的疗效的结果是等离异性的，部分是由于混合方法设计，给药方案和结果措施。目前，没有随机对照证据，即催产素为具有PWS的个体提供益处。催产素给药与任何特定不良事件之间的联系没有明确的证据。使用医疗访谈，公开报告，清单和生理学评估进行了不良事件。不良事件报告已经大大归类为轻度（n？= 93），几个中等（n？=？9）或严重（n？=？3）事件报告。报告了35例其他不良事件，没有严重程度的评级。严重的事件，多动和烦躁，在安慰剂和催产素基团中进行首次给药，并在停止之后潜伏。我们注意到不良事件监测不一致，往往缺乏，并报告其与研究药物的关系差。只有一项研究报告依从性数据建议高依从性。然后是建议书？为鼻孔，监测和报告进行鼻孔，安全性和粘附在儿科群体中的鼻孔，安全性和依从性的鼻腔喷雾提供的推荐。

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  • 来源
    《Pediatric drugs》 |2017年第5期|共20页
  • 作者

    Marilena M. DeMayo; Yun Ju C. Song; Ian B. Hickie; Adam J. Guastella;

  • 作者单位

    Autism Clinic for Translational Research Brain and Mind Centre Central Clinical School Sydney;

    Autism Clinic for Translational Research Brain and Mind Centre Central Clinical School Sydney;

    Autism Clinic for Translational Research Brain and Mind Centre Central Clinical School Sydney;

    Autism Clinic for Translational Research Brain and Mind Centre Central Clinical School Sydney;

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  • 正文语种 eng
  • 中图分类 药学;
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