Abstract：
The efficacy of bumetanide (oral liquid formulation 0.5 mg bid) as a treatment for the core symptoms of autism spectrum disorders in children and adolescents aged 7-17 years is being investigated in an international, randomised, double-blind, placebo-controlled phase III study. The primary endpoint is the change in Childhood Autism Rating Scale 2 (CARS2) total raw score after 6 months of treatment. At baseline, the 211 participants analysed are broadly representative of autistic subjects in this age range: mean (SD) age, 10.4 (3.0) years; 82.5% male; 47.7% with intelligence quotient ≥ 70. Mean CARS2 score was 40.1 (4.9) and mean Social Responsiveness Scale score was 116.7 (23.4). Final study results will provide data on efficacy and safety of bumetanide in autistic children and adolescents.
摘要：
国际上正在研究布美他尼（口服液体制剂0.5mgbid）作为治疗7-17岁儿童和青少年自闭症谱系障碍核心症状的疗效，随机化，双盲,安慰剂对照III期研究。主要终点是治疗6个月后儿童自闭症评定量表2（CARS2）总原始评分的变化。在基线,分析的211名参与者广泛代表了这个年龄段的自闭症受试者：平均(SD)年龄，10.4（3.0）岁；男性占82.5%；智商≥70的占47.7%。平均CARS2评分为40.1（4.9），平均社会反应量表评分为116.7（23.4）。最终的研究结果将提供布美他尼在自闭症儿童和青少年中的疗效和安全性的数据。
