Owen Randall, Sikich Linmarie, Marcus Ronald N, Corey-Lisle Patricia, Manos George, McQuade Robert D, Carson William H, Findling Robert L
Bristol-Myers Squibb, 5 Research Parkway, Wallingford, Connecticut 06492, USA.
Pediatrics. 2009 Dec;124(6):1533-40. doi: 10.1542/peds.2008-3782.
The objective of this study was to evaluate short-term efficacy and safety of aripiprazole in the treatment of irritability in children and adolescents with autistic disorder who were manifesting behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these.
This 8-week, double-blind, randomized, placebo-controlled, parallel-group study was conducted of children and adolescents (aged 6-17 years) with autistic disorder. Patients were randomly assigned (1:1) to flexibly dosed aripiprazole (target dosage: 5, 10, or 15 mg/day) or placebo. Efficacy outcome measures included the Aberrant Behavior Checklist irritability subscale and the Clinical Global Impression-Improvement score (CGI-I). Safety and tolerability were also assessed.
Ninety-eight patients were randomly assigned to receive placebo (n = 51) or aripiprazole (n = 47). Mean improvement in Aberrant Behavior Checklist irritability subscale score was significantly greater with aripiprazole than with placebo from week 1 through week 8. Aripiprazole demonstrated significantly greater global improvements than placebo, as assessed by the mean CGI-I score from week 1 through week 8; however, clinically significant residual symptoms may still persist for some patients. Discontinuation rates as a result of adverse events (AEs) were 10.6% for aripiprazole and 5.9% for placebo. Extrapyramidal symptom-related AE rates were 14.9% for aripiprazole and 8.0% for placebo. No serious AEs were reported. Mean weight gain was 2.0 kg on aripiprazole and 0.8 kg on placebo at week 8.
Aripiprazole was efficacious in children and adolescents with irritability associated with autistic disorder and was generally safe and well tolerated.
本研究旨在评估阿立哌唑治疗患有自闭症谱系障碍且表现出如发脾气、攻击行为、自伤行为或这些行为组合的儿童和青少年易怒症状的短期疗效和安全性。
本为期8周的双盲、随机、安慰剂对照、平行组研究针对患有自闭症谱系障碍的儿童和青少年（6至17岁）开展。患者被随机（1:1）分配至灵活剂量的阿立哌唑组（目标剂量：5、10或15毫克/天）或安慰剂组。疗效指标包括异常行为检查表易怒分量表和临床总体印象改善评分（CGI-I）。同时评估安全性和耐受性。
98名患者被随机分配接受安慰剂（n = 51）或阿立哌唑（n = 47）治疗。从第1周到第8周，阿立哌唑组异常行为检查表易怒分量表评分的平均改善程度显著大于安慰剂组。根据第1周到第8周的平均CGI-I评分评估，阿立哌唑组的总体改善程度显著大于安慰剂组；然而，一些患者可能仍存在临床上显著的残留症状。因不良事件（AE）导致的停药率，阿立哌唑组为10.6%，安慰剂组为5.9%。锥体外系症状相关AE发生率，阿立哌唑组为14.9%，安慰剂组为8.0%。未报告严重AE。第8周时，阿立哌唑组平均体重增加2.0千克，安慰剂组平均体重增加0.8千克。
阿立哌唑对患有自闭症谱系障碍相关易怒症状的儿童和青少年有效，且总体安全、耐受性良好。
