Initial severity and efficacy of risperidone in autism: Results from the RUPP trial.
Initial severity and efficacy of risperidone in autism: Results from the RUPP trial.
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利培酮治疗自闭症的初始严重程度和疗效：RUPP 试验的结果。
DOI：
10.1016/j.eurpsy.2015.11.004
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发表时间：
2016
期刊：
影响因子：
--
通讯作者：
Leucht,S
中科院分区：
文献类型：
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作者：
Levine,SZ;Kodesh,A;Goldberg,Y;Reichenberg,A;Furukawa,TA;Kolevzon,A;Leucht,S
研究背景利培酮是治疗自闭症谱系障碍（ASD）易激惹的常用精神药物.利培酮在初始症状严重程度范围内的有效性尚不明确。本研究的目的是研究基线的严重程度对利培酮在治疗ASD的疗效的影响。MethodsParticipants是从NIMH资助的RUPP多地点，随机，双盲试验，比较利培酮与安慰剂治疗自闭症严重发脾气，侵略，或自伤。参与者年龄在5到17岁之间，随机分配到利培酮组（n = 49）或安慰剂组（n = 52）。基线和变化的分数计算与异常行为检查表（ABC）家长评估量表与易怒作为主要结果，以及临床医生评估的ABC易怒子量表，和临床总体印象scale.ResultsThe基线严重程度和变化分数之间的关系，利培酮和安慰剂组进行了检查与8个竞争的三层次的混合效应模型重复测量模型。仅在父母的ABC易怒和嗜睡评分中观察到治疗和基线严重程度之间的显著（P <0.01）相互作用。从中度至极重度基线严重程度的易怒和嗜睡，观察到利培酮和安慰剂之间的差异幅度更大。初始严重度值超过约30对症状变化有很强的影响[易激惹：效应量（ES）= 1.9，需要治疗的人数（NNT）= 2，嗜睡ES = 0.9，NNT = 5].结论父母可能期望利培酮对中度至重度ASD症状的易激惹和嗜睡有益。term = NCT 00005014 &rank = 1，2000年3月31日注册。
BackgroundRisperidone is a common psychopharmacological treatment for irritability in autism spectrum disorder (ASD). It is not well-established how effective risperidone is across the initial symptom severity range. This study aims to examine the influence of baseline severity on the efficacy of risperidone in the treatment of ASD.MethodsParticipants were from the NIMH funded RUPP multisite, randomized, double-blind trial that compared risperidone to placebo to treat autistic disorder with severe tantrums, aggression, or self-injury. Participants were aged 5 to 17, and randomly assigned to risperidone (n = 49) or placebo (n = 52). Baseline and change scores were computed with the Aberrant Behavior Checklist (ABC) parent assessed scales with irritability as the primary outcome, as well as the clinician assessed ABC Irritability subscale, and Clinical Global Impression Scale.ResultsThe relationship between baseline severity and change scores for the risperdone and placebo groups was examined with eight competing three-level mixed-effects models for repeated measure models. Significant (P < 0.01) interactions between treatment and baseline severity were observed for parent ABC ratings of irritability and lethargy only. Greater magnitudes of the differences between risperidone and placebo were observed from moderate to very severe baseline severity on irritability and lethargy. Initial severity values over approximately 30 had a strong effect on symptom change [irritability: effect size (ES) = 1.9, number needed to treat (NNT) = 2, lethargy ES = 0.9, NNT = 5].ConclusionsParents may expect benefits of risperidone on irritability and lethargy with moderate to severe symptoms of ASD.Trial registrationRegistry name: ClinicalTrials.gov, trial identifier: NCT00005014, URL: http://www.clinicaltrials.gov/ct2/show/NCT00005014?term=NCT00005014&rank=1, registered on March 31, 2000.