Barzman Drew H, DelBello Melissa P, Adler Caleb M, Stanford Kevin E, Strakowski Stephen M
Division of Bipolar Disorders Research, Department of Psychiatry, University of Cincinnati, Cincinnati, Ohio, USA.
J Child Adolesc Psychopharmacol. 2006 Dec;16(6):665-70. doi: 10.1089/cap.2006.16.665.
The aim of this study was to compare the efficacy and tolerability of quetiapine and divalproex for the treatment of impulsivity and reactive aggression in adolescents with co-occurring bipolar disorder and disruptive behavior disorders.
Patients were included in this post hoc analysis if they scored > or = 14 on the Positive and Negative Syndrome Scale (PANSS) Excited Component (EC) and > or = 4 on at least one of the PANSS EC items, had a current diagnosis of bipolar I disorder, manic or mixed episode, and had a lifetime and/or current diagnosis of a disruptive behavioral disorder (DBD) [conduct disorder (CD) or oppositional defiant disorder (ODD)]. Thirty-three (92%) of the 36 subjects with bipolar disorder and DBD met the PANSS EC inclusion criteria. These thirty-three adolescents were randomized to quetiapine (400-600 mg/day) or divalproex (serum level 80-120 microg/mL) for 28 days in this double-blinded study. The primary efficacy measure was change in PANSS Excited Component (EC) score over the study period and at each time point.
Repeated measures analysis of variance (ANOVA) demonstrated statistically significant within-treatment-group effects for divalproex (baseline = 20.6, end point = 13.3, p < 0.0001) and quetiapine (baseline = 18.8, end point = 10.8, p < 0.0001) for the PANSS EC. There were no statistically significant treatment group differences in PANSS EC changes from baseline to end point scores (p = 0.7, d = 0.14). Mixed regression analyses (comparison of slopes, DAY*TREATMENT) revealed that there was no significant difference in the rate of improvement in the PANSS EC scores between the two treatment groups [F(1,31) = 0.78, p = 0.39, d = 0.28].
Quetiapine and divalproex showed similar efficacy for the treatment of impulsivity and reactive aggression related to co-occurring bipolar and disruptive behavior disorders in adolescents. Quetiapine and divalproex are both useful as monotherapy for the treatment of impulsivity and reactive aggression in adolescents with bipolar and disruptive behavior disorders. Placebo-controlled studies are necessary.
本研究旨在比较喹硫平和丙戊酸二钠治疗共病双相情感障碍和破坏性行为障碍青少年冲动性和反应性攻击行为的疗效和耐受性。
如果患者在阳性和阴性症状量表（PANSS）兴奋分量表（EC）上得分≥14分，且在至少一项PANSS EC项目上得分≥4分，目前诊断为双相I型障碍、躁狂或混合发作，且有终身和/或目前诊断为破坏性行为障碍（DBD）[品行障碍（CD）或对立违抗障碍（ODD）]，则纳入本事后分析。36名双相情感障碍和DBD患者中有33名（92%）符合PANSS EC纳入标准。在这项双盲研究中，这33名青少年被随机分为喹硫平组（400 - 600毫克/天）或丙戊酸二钠组（血清水平80 - 120微克/毫升），为期28天。主要疗效指标是研究期间及每个时间点PANSS兴奋分量表（EC）得分的变化。
重复测量方差分析（ANOVA）显示，丙戊酸二钠（基线 = 20.6，终点 = 13.3，p < 0.0001）和喹硫平（基线 = 18.8，终点 = 10.8，p < 0.0001）在PANSS EC方面有统计学显著的组内效应。从基线到终点得分，PANSS EC变化在治疗组之间无统计学显著差异（p = 0.7，d = 0.14）。混合回归分析（斜率比较，DAY*TREATMENT）显示，两组治疗组在PANSS EC得分改善率上无显著差异[F(1,31) = 0.78，p = 0.39，d = 0.28]。
喹硫平和丙戊酸二钠在治疗与青少年共病双相情感障碍和破坏性行为障碍相关的冲动性和反应性攻击行为方面显示出相似的疗效。喹硫平和丙戊酸二钠均可用作治疗双相情感障碍和破坏性行为障碍青少年冲动性和反应性攻击行为的单一疗法。需要进行安慰剂对照研究。
