Carbamazepine in aggressive children with conduct disorder: A double-blind and placebo-controlled study
Carbamazepine in aggressive children with conduct disorder: A double-blind and placebo-controlled study
复制标题
DOI：
10.1097/00004583-199604000-00014
复制
发表时间：
1996-04-01
影响因子：
13.3
通讯作者：
Campbell, M
中科院分区：
文献类型：
--
作者：
Cueva, JE;Overall, JE;Campbell, M
目的：评价卡马西平在减少被诊断为品行障碍的儿童攻击性方面的短期疗效和安全性。方法：受试者是5至12岁的儿童，他们因治疗抵抗性攻击性和爆发性而住院，并被诊断为行为障碍。本研究采用平行组设计，为双盲、安慰剂对照研究。经过2周的安慰剂基线期后，符合攻击标准的儿童被随机分配接受6周的治疗;研究以治疗后一周的安慰剂期结束。多名评分员在四种情况下使用多个评分量表独立地对儿童进行评分。主要结果测量包括外显攻击量表、总体临床判断（共识）量表和儿童精神病评定量表。结果：22名儿童，年龄5.33至11.7岁，完成了研究。卡马西平在最佳日剂量范围为400 - 800 mg，平均683 mg，血清浓度为4.98 - 9.1 μ g/mL时并不上级安慰剂。与卡马西平给药相关的不良反应很常见。结论：在这一适度的儿童样本中，卡马西平在减少攻击性行为方面优于安慰剂，这一点并未得到证实。
Objective: To assess critically the short-term efficacy and safety of carbamazepine in the reduction of aggressiveness in children with diagnosed conduct disorder. Method: Subjects were children aged 5 to 12 years who were hospitalized for treatment-resistant aggressiveness and explosiveness and who had diagnosed conduct disorder. The study was double-blind and placebo-controlled, using a parallel-groups design. Following a 2-week placebo baseline period, children who met the aggression criteria were randomly assigned to treatments for 6 weeks; the study ended with a I-week posttreatment placebo period. Multiple raters rated the children independently, using multiple rating scales under four conditions. The main outcome measures included the Overt Aggression Scale, the Global Clinical Judgments (Consensus) Scale, and the Children's Psychiatric Rating Scale. Results: Twenty-two children, aged 5.33 to 11.7 years, completed the study. Carbamazepine was not superior to placebo at optimal daily doses ranging from 400 to 800 mg, mean 683 mg, at serum levels of 4.98 to 9.1 mu g/mL. Untoward effects associated with administration of carbamazepine were common. Conclusions: In this modest sample of children, the superiority of carbamazepine over placebo in reducing aggressive behavior was not demonstrated.