University of Brasilia, Brasilia, DF 70904-970, Brazil.
J Affect Disord. 2013 Apr 25;146(3):310-8. doi: 10.1016/j.jad.2012.11.001. Epub 2012 Dec 4.
Olanzapine plus fluoxetine combination (OFC) is one of the current approaches for treating the depressive phase of bipolar disorder. Our objective was to synthesize the evidence on the efficacy of OFC therapy in bipolar depressed patients.
We searched for randomized controlled trials (RCTs) on MEDLINE, Embase and other databases. Independent researchers selected the studies and extracted the data. The GRADE approach was used to assess the quality of the evidence. The Mantel-Haenszel random effect model was used to perform the meta-analyses.
From 627 unique records retrieved, four RCTs were included (1330 patients). OFC improved the response compared to olanzapine (relative risk [RR]=1.58; 95% confidence interval [95% CI]: 1.27, 1.97) and to placebo (RR=1.99; 95% CI: 1.49, 2.65) but not to lamotrigine (low-quality evidence). Similar results were found for remission and relapse rates. No differences were identified for levels of depression and mania symptoms (low-quality evidence) and incidence of mania (moderate-quality evidence). Adverse effects were more common in patients treated with OFC than in those treated with lamotrigine (RR=1.13; 95% CI: 1.04, 1.23), but no difference was found relative to the patients treated with olanzapine (low-quality evidence).
Despite the totality of the evidence included, there are few RCTs available regarding the efficacy of OFC therapy for bipolar depression. The risk of attrition and reporting bias is also a concern.
OFC therapy improved the response, remission, and relapse rates among other outcomes. However, a worse profile of adverse reactions was observed in some comparisons. These data clarify the therapeutic use of OFC as an option to olanzapine in bipolar depression. The quality of the evidence could be improved by additional comparisons and higher rates of treatment adherence.
奥氮平联合氟西汀（OFC）是目前治疗双相情感障碍抑郁期的方法之一。我们的目的是综合评估 OFC 治疗双相抑郁患者的疗效证据。
我们在 MEDLINE、Embase 和其他数据库中搜索随机对照试验（RCT）。独立研究者选择研究并提取数据。采用 GRADE 方法评估证据质量。采用 Mantel-Haenszel 随机效应模型进行荟萃分析。
从 627 条独特的记录中，纳入了 4 项 RCT（1330 例患者）。与奥氮平相比，OFC 改善了应答率（相对风险 [RR]=1.58；95%置信区间 [95%CI]：1.27，1.97）和安慰剂（RR=1.99；95%CI：1.49，2.65），但与拉莫三嗪无差异（低质量证据）。缓解率和复发率也有类似结果。在抑郁和躁狂症状水平（低质量证据）和躁狂发生率（中等质量证据）方面，两组无差异。与拉莫三嗪相比，OFC 治疗组的不良反应更常见（RR=1.13；95%CI：1.04，1.23），但与奥氮平治疗组无差异（低质量证据）。
尽管纳入了全部证据，但关于 OFC 治疗双相抑郁疗效的 RCT 数量较少。也存在失访和报告偏倚的风险。
OFC 治疗改善了应答、缓解和复发率等其他结局。然而，在某些比较中观察到不良反应谱更差。这些数据阐明了 OFC 作为双相抑郁治疗中奥氮平的替代选择的治疗用途。通过更多的比较和更高的治疗依从性，可以提高证据质量。
