Goldberg Joseph F, Kelley Mary E, Rosenquist Klara J, Hsu Douglas J, Filkowski Megan M, Nassir Ghaemi S
Affective Disorders Program, Silver Hill Hospital, New Canaan, CT 06840, United States.
J Affect Disord. 2008 Jan;105(1-3):305-10. doi: 10.1016/j.jad.2007.04.023. Epub 2007 Jun 5.
The authors examined long-term effectiveness and study retention during open-label quetiapine treatment for rapid cycling bipolar disorder.
An open-label, nonrandomized trial was conducted in 41 patients with rapid-cycling bipolar disorder (type I=33, type II=7, NOS=1) who received flexibly dosed quetiapine monotherapy (n=19) or add-on therapy (n=22) for up to one year. Linear growth curves were calculated to assess longitudinal changes in depression and mania.
Linear growth curves demonstrated highly significant reductions in manic (p<.0001) and depressive (p<.0001) symptoms. Effect sizes were large against manic symptoms (add-on therapy: Cohen's d=0.66; monotherapy: Cohen's d=0.75) but small-to-moderate against depression (monotherapy: d=0.29; add-on therapy: d=0.40). Most patients (68%) prematurely terminated the protocol (mean duration: 18.0+/-16.9 weeks, mean dose: 195.6+/-196.1 mg/day), most often because of the need for additional psychotropic treatments.
The study protocol involved an open label design with no placebo or active comparator group. The sample size provided adequate statistical power to detect large but not medium or small within-group effects. Premature dropout during the first six months precluded inferences about longer-term treatment outcome.
These observational findings provisionally suggest some benefit with quetiapine for both manic and depressive symptoms in rapid cycling bipolar disorder, at dosages somewhat lower than previously described either for mania or bipolar depression. The relatively high dropout rate underscores the complexity of rapid cycling bipolar disorder and likely necessity for pharmacotherapy adjustments over time.
作者研究了开放标签的喹硫平治疗快速循环型双相情感障碍的长期疗效及研究保留率。
对41例快速循环型双相情感障碍患者（I型=33例，II型=7例，未特定型=1例）进行了一项开放标签、非随机试验，这些患者接受了灵活剂量的喹硫平单药治疗（n=19）或联合治疗（n=22），为期一年。计算线性生长曲线以评估抑郁和躁狂症状的纵向变化。
线性生长曲线显示躁狂（p<0.0001）和抑郁（p<0.0001）症状有极显著降低。针对躁狂症状的效应量较大（联合治疗：Cohen's d=0.66；单药治疗：Cohen's d=0.75），但针对抑郁症状的效应量为小到中等（单药治疗：d=0.29；联合治疗：d=0.40）。大多数患者（68%）提前终止了方案（平均持续时间：18.0±16.9周，平均剂量：195.6±196.1毫克/天），最常见的原因是需要额外的精神药物治疗。
该研究方案采用开放标签设计，没有安慰剂或活性对照基团。样本量提供了足够的统计效力来检测组内大的效应，但无法检测中等或小的效应。前六个月的提前退出妨碍了对长期治疗结果的推断。
这些观察结果初步表明，喹硫平对快速循环型双相情感障碍的躁狂和抑郁症状均有一定益处，其剂量略低于先前描述的治疗躁狂或双相抑郁的剂量。相对较高的退出率突出了快速循环型双相情感障碍的复杂性以及随着时间推移调整药物治疗的必要性。
