Fung Lawrence K, Mahajan Rajneesh, Nozzolillo Alixandra, Bernal Pilar, Krasner Aaron, Jo Booil, Coury Daniel, Whitaker Agnes, Veenstra-Vanderweele Jeremy, Hardan Antonio Y
Department of Psychiatry & Behavioral Sciences, Stanford University, Stanford, California;
Kennedy Krieger Institute and Johns Hopkins University School of Medicine, Baltimore, Maryland;
Pediatrics. 2016 Feb;137 Suppl 2:S124-35. doi: 10.1542/peds.2015-2851K.
Autism spectrum disorder (ASD) is increasingly recognized as a public health issue. Irritability and aggression (IA) often negatively affect the lives of people with ASD and their families. Although many medications have been tested for IA in ASDs in randomized controlled trials (RCTs), critical quantitative analyses of these trials are lacking in the literature.
To systematically review and quantitatively analyze the efficacy and safety of pharmacologic treatments for IA in youth with ASD.
Studies were identified from Medline, PsycINFO, Embase, and review articles.
Original articles on placebo-controlled RCTs of pharmacologic treatments of IA in youth age 2 to 17 years with ASD were included. Data items included study design, study goals, details of study participants, details of intervention, study results, statistical methods, side effects, and risks of bias. The primary study outcome measure was the effect size of reduction in the Aberrant Behavioral Checklist-Irritability (ABC-I) scores in the medication group, as compared with placebo, in RCTs using parallel groups design.
Forty-six RCTs were identified. Compared with placebo, 3 compounds resulted in significant improvement in ABC-I at the end of treatment. Risperidone and aripiprazole were found to be the most effective, with the largest effect sizes. Sedation, extrapyramidal sides effects, and weight gain were assessed quantitatively.
Although risperidone and aripiprazole have the strongest evidence in reducing ABC-I in youth with ASD, a few other compounds also showed significant efficacy with fewer potential side effects and adverse reactions in single studies.
自闭症谱系障碍（ASD）日益被视为一个公共卫生问题。易激惹和攻击行为（IA）常常对自闭症患者及其家人的生活产生负面影响。尽管在随机对照试验（RCT）中已经对许多药物用于自闭症患者的IA进行了测试，但文献中缺乏对这些试验的关键定量分析。
系统评价和定量分析药物治疗对患有ASD的青少年IA的疗效和安全性。
从医学数据库（Medline）、心理学文摘数据库（PsycINFO）、荷兰医学文摘数据库（Embase）及综述文章中检索相关研究。
纳入关于2至17岁患有ASD的青少年IA药物治疗的安慰剂对照RCT的原始文章。数据项目包括研究设计、研究目标、研究参与者的详细信息、干预细节、研究结果、统计方法、副作用和偏倚风险。主要研究结局指标是在采用平行组设计的RCT中，与安慰剂相比，药物治疗组异常行为检查表-易激惹性（ABC-I）评分降低的效应量。
共确定了46项RCT。与安慰剂相比，3种化合物在治疗结束时使ABC-I有显著改善。发现利培酮和阿立哌唑最有效，效应量最大。对镇静、锥体外系副作用和体重增加进行了定量评估。
尽管利培酮和阿立哌唑在降低患有ASD的青少年的ABC-I方面有最有力的证据，但在单项研究中，其他一些化合物也显示出显著疗效，且潜在副作用和不良反应较少。
