PDF(Pubmed)
Abstract：
We present the secondary-analysis of neurocognitive tests in the \'Bumetanide in Autism Medication and Biomarker\' (BAMBI;EUDRA-CT-2014-001560-35) study, a randomized double-blind placebo-controlled (1:1) trial testing 3-months bumetanide treatment (≤ 1 mg twice-daily) in unmedicated children 7-15 years with ASD. Children with IQ ≥ 70 were analyzed for baseline deficits and treatment-effects on the intention-to-treat-population with generalized-linear-models, principal component analysis and network analysis. Ninety-two children were allocated to treatment and 83 eligible for analyses. Heterogeneous neurocognitive impairments were found that were unaffected by bumetanide treatment. Network analysis showed higher modularity after treatment (mean difference:-0.165, 95%CI:-0.317 to - 0.013,p = .034) and changes in the relative importance of response inhibition in the neurocognitive network (mean difference:-0.037, 95%CI:-0.073 to - 0.001,p = .042). This study offers perspectives to include neurocognitive tests in ASD trials.
摘要：
我们提出了“布美他尼在自闭症药物治疗和生物标志物”（BAMBI;EUDRA-CT-2014-001560-35）研究中神经认知测试的二次分析，一项随机双盲安慰剂对照(1:1)试验,对未用药的7-15岁ASD儿童进行3个月布美他尼治疗(≤1mg,每日2次).使用广义线性模型分析智商≥70的儿童对意向治疗人群的基线缺陷和治疗效果，主成分分析和网络分析。92名儿童被分配接受治疗，83名儿童有资格接受分析。发现不均匀的神经认知障碍不受布美他尼治疗的影响。网络分析显示治疗后更高的模块化（平均差异：-0.165，95CI：-0.317至-0.013，p=.034）和神经认知网络中反应抑制的相对重要性的变化（平均差异：-0.037，95CI：-0.073至-0.001，p=.042）。这项研究提供了将神经认知测试纳入ASD试验的观点。
