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首页> 外文期刊>Journal of clinical psychopharmacology >Effectiveness and safety of the combination of fluoxetine and olanzapine in outpatients with bipolar depression: an open-label, randomized, flexible-dose study in Puerto Rico.
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Effectiveness and safety of the combination of fluoxetine and olanzapine in outpatients with bipolar depression: an open-label, randomized, flexible-dose study in Puerto Rico.

机译：氟西汀和奥氮平联用在门诊双相抑郁患者中的有效性和安全性：在波多黎各进行的一项开放标签，随机，灵活剂量研究。

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We studied the effectiveness of olanzapine/fluoxetine combination (OFC) treatment of bipolar depressive episode (7 weeks, study period 1 [SP1]). Study period 1 responders (mean modal daily OFC dosage, 10.8/27.8 mg) were randomized to OFC continuation treatment or olanzapine (OLZ) monotherapy starting at 10 mg (12 weeks, SP2). Seventy-three percent of the 114 patients who entered into SP2 completed the trial. The Montgomery-Asberg Depression Rating Scale total score changes from baseline in SP1 (primary outcome) were significant (-20 +/- 10, P < 0.001) and, during SP2, worsened for patients in the OLZ group (OFC vs OLZ, -0.4 +/- 7.55 vs +8.2 +/- 14.1, respectively; P < 0.001). During SP1, 69% responded and 59% remitted. During SP2, significantly more patients in the OFC group maintained response (31.3% vs 12.5%) and remission (71.4% vs 39.6%) than patients in the OLZ group. Treatment-emergent adverse events with OFC (SP1 and SP2) included increased appetite, increased weight, somnolence, anxiety, insomnia, and depressed mood. Since visit 1, the mean weight increases (in pounds) were 4.8 +/- 6.8 for SP1 (P < 0.001) and 6.3 +/- 10.3 (OFC) or 10.7 +/- 11.3 (OLZ) for SP2; 50% (OLZ) and 33% (OFC) of the patients had a 7% or higher weight increase. For cholesterol, triglycerides, and low-density lipoprotein levels and some hepatic enzymes, there were statistically and clinically significant changes in both study periods but no differences between the SP2 groups. Study limitations included the open-label design and exclusion of the SP1 nonresponders from SP2. These study results suggest that improvements resulting from 7 weeks of acute OFC treatment of a bipolar depressive episode are maintained in responders for an additional 12 weeks with OFC, but switching to OLZ alone may result in symptom worsening.
机译：我们研究了奥氮平/氟西汀组合（OFC）治疗双相性抑郁发作（7周，研究期1 [SP1]）的有效性。研究阶段1的应答者（平均每日OFC剂量，10.8 / 27.8 mg）被随机分配至以10 mg（12周，SP2）开始的OFC持续治疗或奥氮平（OLZ）单一疗法。参加SP2的114名患者中有73％完成了试验。 SP1的蒙哥马利-阿斯伯格抑郁量表总分变化（主要结果）显着（-20 +/- 10，P <0.001），在SP2期间，OLZ组患者的病情恶化（OFC vs OLZ，-分别为0.4 +/- 7.55和+8.2 +/- 14.1; P <0.001）。在SP1期间，有69％的人做出了回应，有59％的人提出了汇款。在SP2期间，与OLZ组相比，OFC组中维持缓解（31.3％vs. 12.5％）和缓解（71.4％vs 39.6％）的患者多得多。用OFC（SP1和SP2）治疗时出现的不良事件包括食欲增加，体重增加，嗜睡，焦虑，失眠和情绪低落。自第1次访问以来，SP1的平均体重增加（磅）为4.8 +/- 6.8（P <0.001）和SP2的平均体重增加为6.3 +/- 10.3（OFC）或10.7 +/- 11.3（OLZ）; 50％（OLZ）和33％（OFC）的患者体重增加了7％或更高。对于胆固醇，甘油三酸酯，低密度脂蛋白水平和某些肝酶，在两个研究期间都有统计学和临床​​上的显着变化，但SP2组之间没有差异。研究的局限性包括开放标签设计和将SP1无反应者从SP2中排除。这些研究结果表明，使用OFC可使应答者的急性OFC治疗7周（对双相抑郁发作）持续改善达12周，但仅改用OLZ可能会导致症状恶化。

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