布美他尼治疗3至6岁孤独症谱系障碍儿童后症状改善:一项随机、双盲、安慰剂对照的临床试验

查看全文 作　　者：[1]戴媛;[1]章玲丽;[1,2]俞珏华;[3]周欣;[1]何华;[1]季忆婷;Kai [1]Wang;[1]杜秀娟;[1]刘欣;[1,4]唐云;[1]邓世宁;Christelle [5]Langley;[6]李伟广;[1]张军;[7]冯建峰;Barbara [1,5,7]J.Sahakian;[1,8]罗强;[1]李斐

机构地区：[1]Department of Developmental and Behavioural Pediatric&Child Primary Care,Brain and Behavioural Research Unit of Shanghai Institute for Pediatric Research and MOE-Shanghai Key Laboratory for Children’s Environmental Health,Xinhua Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200092,China;[2]Centre for Experimental Studies and Research,The First Affiliated Hospital of Kunming Medical University,Kunming 650032,China;[3]Clinical Research Unit,Xinhua Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200092,China;[4]The School of Psychology and Cognitive Science,East China Normal University,Shanghai 200062,China;[5]Department of Psychiatry and the Behavioural and Clinical Neuroscience Institute,University of Cambridge,Cambridge CB21TN,UK;[6]Collaborative Innovation Center for Brain Science,Department of Anatomy and Physiology,Shanghai Jiao Tong University School of Medicine,Shanghai 200025,China;[7]Institute of Science and Technology for Brain-Inspired Intelligence,Ministry of Education-Key Laboratory of Computational Neuroscience and Brain-Inspired Intelligence and Research and Research Institute of Intelligent Complex Systems,Fudan University,Shanghai 200433,China;[8]State Key Laboratory of Medical Neurobiology and Ministry of Education Frontiers Center for Brain Science,Institutes of Brain Science and National Clinical Research Center for Aging and Medicine,Huashan Hospital,Fudan University,Shanghai 200040,China

出　　处：《Science Bulletin》索引2021年第66卷第15期,共9页

基　　金：the Shanghai Municipal Commission of Health and Family Planning(2018BR33,2017EKHWYX-02,and GWV-10.1-XK07);the Shanghai Shenkang Hospital Development Center(16CR2025B);the Shanghai Clinical Key Subject Construction Project(shslczdzk02902);the National Natural Science Foundation of China(81761128035,81930095,81873909,82001771,and 31860306);the Shanghai Committee of Science and Technology(17XD1403200,20ZR1404900,and 19410713500);Xinhua Hospital of Shanghai Jiao Tong University School of Medicine(2018YJRC03);the National Human Genetic Resources Sharing Service Platform(2005DKA21300);the National Key Research and Development Program of China(2018YFC0910503);111 Project(B18015);the Shanghai Municipal Science and Technology Major Project(2018SHZDZX01);Guangdong Key Project in‘‘Development of New Tools for Diagnosis and Treatment of Autism”(2018B030335001);the Science and Technology Department of Yunnan Province(202001AV070010)。 摘　　要：孤独症谱系障碍是一大类婴幼儿期起病、以社交沟通和感知觉障碍为主要特征的神经发育障碍性疾病.目前治疗以康复为主,无有效药物.本研究采用随机、双盲、安慰剂对照临床试验策略,探索布美他尼干预对低龄孤独症患儿的疗效、安全性及潜在的神经生物学机制.研究结果显示,与安慰剂对照组相比,为期3个月的布美他尼药物干预可安全、有效改善低龄孤独症患儿核心症状,药效可能与其调节岛叶皮层GABA功能有关.本研究为目前国际上单站点最大样本量的随机双盲临床试验,研究结果为低龄孤独症患儿提供了潜在的药物治疗方案. 关键词：孤独症谱系障碍安慰剂对照布美他尼药物治疗方案发育障碍性疾病核心症状症状改善临床试验

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布美他尼治疗3至6岁孤独症谱系障碍儿童后症状改善:一项随机、双盲、安慰剂对照的临床试验

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