Corya Sara A, Perlis Roy H, Keck Paul E, Lin Daniel Y, Case Michael G, Williamson Doug J, Tohen Mauricio F
Lilly Research Laboratories, Indianapolis, Ind, USA.
J Clin Psychiatry. 2006 May;67(5):798-806. doi: 10.4088/jcp.v67n0514.
Olanzapine-fluoxetine combination has shown efficacy in the acute treatment of depressive episodes in patients with bipolar I disorder. The present analyses examined the efficacy and safety of longer term treatment with olanzapine-fluoxetine combination or olanzapine monotherapy in a 6-month open-label extension study.
376 patients with DSM-IV bipolar I disorder, depressed, who completed an acute trial entered the open-label study and received 1 week of olanzapine monotherapy (5-20 mg/day). At all subsequent visits, patients could choose between olanzapine monotherapy or olanzapine-fluoxetine combination (6/25, 6/50, or 12/50 mg/day). Three treatment groups were defined retrospectively according to the medication course taken from week 1: olanzapine, olanzapine-fluoxetine combination, or switched. The efficacy measures were the Montgomery-Asberg Depression Rating Scale (MADRS), Clinical Global Impressions-Bipolar Version, and Young Mania Rating Scale. The study was conducted from July 2000 to May 2002.
Among patients who started in remission, MADRS total scores did not change significantly from baseline to endpoint in the olanzapine-fluoxetine combination (0.8) or olanzapine (0.3) groups, but increased slightly in the switched (2.3, p = .02) group. For patients who started in nonremission, MADRS total scores decreased significantly in all groups (olanzapine-fluoxetine combination: -5.7, p = .001; olanzapine: -11.6, p = .004; switched: -6.4, p = .015). The majority of patients who entered the study in nonremission achieved remission (MADRS total score < or = 12) during the trial (olanzapine-fluoxetine combination: 66.7%, olanzapine: 64.7%, switched: 62.5%). The overall rate of depressive relapse was 27.4%, and the overall incidence of mania emergence was 5.9%.
The present findings suggest that long-term treatment with olanzapine-fluoxetine combination may be a useful option for the management of depressive symptoms and carries a low risk of mania emergence.
奥氮平-氟西汀联合用药已显示出对双相I型障碍患者抑郁发作急性期治疗的有效性。本分析在一项为期6个月的开放标签扩展研究中，考察了奥氮平-氟西汀联合用药或奥氮平单药长期治疗的有效性和安全性。
376名符合DSM-IV双相I型障碍且处于抑郁发作期、完成了急性期试验的患者进入开放标签研究，接受为期1周的奥氮平单药治疗（5-20毫克/天）。在所有后续访视中，患者可在奥氮平单药治疗或奥氮平-氟西汀联合用药（6/25、6/50或12/50毫克/天）之间进行选择。根据从第1周开始的用药疗程，回顾性地定义了三个治疗组：奥氮平组、奥氮平-氟西汀联合用药组或换药组。疗效指标为蒙哥马利-阿斯伯格抑郁评定量表（MADRS）、临床总体印象-双相版和杨氏躁狂评定量表。该研究于2000年7月至2002年5月进行。
在起始时处于缓解状态的患者中，奥氮平-氟西汀联合用药组（0.8）和奥氮平组（0.3）从基线到终点的MADRS总分无显著变化，但换药组（2.3，p = 0.02）略有增加。对于起始时未缓解的患者，所有组的MADRS总分均显著下降（奥氮平-氟西汀联合用药组：-5.7，p = 0.001；奥氮平组：-11.6，p = 0.004；换药组：-6.4，p = 0.015）。大多数起始时未缓解而进入研究的患者在试验期间实现了缓解（MADRS总分≤12）（奥氮平-氟西汀联合用药组：66.7%，奥氮平组：64.7%，换药组：62.5%）。抑郁复发的总体发生率为27.4%，躁狂发作的总体发生率为5.9%。
目前的研究结果表明，奥氮平-氟西汀联合用药长期治疗可能是管理抑郁症状的一个有用选择，且出现躁狂的风险较低。
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