Department of Psychiatry, Institute for Juvenile Research, University of Illinois at Chicago, USA.
Bipolar Disord. 2010 Sep;12(6):593-605. doi: 10.1111/j.1399-5618.2010.00850.x.
To determine the relative effects of risperidone and divalproex in pediatric mania.
This is a double-blind, randomized, outpatient clinical trial with 66 children and adolescents (mean age= 10.9 ± 3.3 years; age range= 8-18 years) with mania who were randomly assigned to either risperidone (0.5-2 mg/day, n= 33) or divalproex (60-120 μg/mL, n= 33) for a six-week period. Measures included the Young Mania Rating Scale (YMRS) and Child Depression Rating Scale-Revised (CDRS-R).
Mixed-effects regression models, with interaction between time and the active drug as predictors, found that the risperidone group had more rapid improvement than the divalproex group (p < 0.05), although final scores did not differ significantly between groups. Mixed models using only those subjects who completed the six-week study found similar results. The response rate on YMRS was 78.1% for risperidone and 45.5% for divalproex (p < 0.01). The remission rate for risperidone was 62.5%, compared with 33.3% for divalproex (p < 0.05). Improvement on the CDRS-R was significantly higher for the risperidone group relative to the divalproex group (p < 0.05). There were no significant differences between groups in safety, but subject retention was significantly higher at study endpoint in the risperidone group (p < 0.01). Dropout rate was 24% in the risperidone group and 48% in the divalproex group, with increased irritability being the most common reason for dropout in the latter. There was no significant weight gain in either group.
Results suggest that risperidone was associated with more rapid improvement and greater reduction in manic symptoms compared to divalproex. Although the results suggest that both drugs are safe, risperidone's lower attrition rate and lower rate of adverse events may suggest better toleration. Clinical trials with larger samples are required to confirm these preliminary findings.
确定利培酮和丙戊酸钠在儿科躁狂症中的相对疗效。
这是一项双盲、随机、门诊临床试验，纳入 66 名（平均年龄=10.9±3.3 岁；年龄范围 8-18 岁）患有躁狂症的儿童和青少年，他们被随机分配至利培酮（0.5-2mg/天，n=33）或丙戊酸钠（60-120μg/mL，n=33）组，疗程为 6 周。评估指标包括 Young 躁狂评定量表（YMRS）和儿童抑郁评定量表修订版（CDRS-R）。
采用混合效应回归模型，以时间和活性药物之间的交互作用作为预测因子，结果发现利培酮组的改善速度快于丙戊酸钠组（p＜0.05），尽管最终两组评分无显著差异。仅对完成 6 周研究的受试者进行混合模型分析，结果相似。利培酮组的 YMRS 应答率为 78.1%，丙戊酸钠组为 45.5%（p＜0.01）。利培酮组的缓解率为 62.5%，而丙戊酸钠组为 33.3%（p＜0.05）。利培酮组在 CDRS-R 上的改善显著高于丙戊酸钠组（p＜0.05）。两组在安全性方面无显著差异，但利培酮组的研究终点保留率显著高于丙戊酸钠组（p＜0.01）。利培酮组的脱落率为 24%，丙戊酸钠组为 48%，后者最常见的脱落原因为激惹增加。两组均未出现明显的体重增加。
结果表明，与丙戊酸钠相比，利培酮治疗躁狂症起效更快，躁狂症状改善更明显。尽管结果提示两种药物均安全，但利培酮的脱落率较低且不良反应发生率较低，可能提示其更好的耐受性。需要更大样本量的临床试验来证实这些初步发现。
