Joliat Melissa J, Schmidt Mark E, Fava Maurizio, Zhang Shuyu, Michelson David, Trapp Nancy J, Miner Cherri M
Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.
J Clin Psychiatry. 2004 Mar;65(3):373-8. doi: 10.4088/jcp.v65n0313.
Severity of anxiety does not appear to influence the antidepressant response to fluoxetine during acute treatment of major depressive disorder (MDD). We report a retrospective pooled analysis of 2 studies to assess the effect of associated anxiety on the efficacy of fluoxetine in the continuation treatment phase of MDD.
Patients whose MDD remitted (study 1) or responded (study 2) after approximately 12 to 13 weeks of open-label treatment with fluoxetine 20 mg daily were randomly assigned in double-blind fashion to placebo, continued treatment with fluoxetine 20 mg daily, or, in study 2 only, treatment with enteric-coated fluoxetine 90 mg once weekly, for at least 25 weeks. Both studies included male and female outpatients who met criteria for MDD as assessed by DSM-III-R (study 1) or DSM-IV (study 2). Patients were categorized into high anxiety (> or = 7) or low anxiety (< 7) subgroups based on baseline Hamilton Rating Scale for Depression (HAM-D) anxiety/somatization subfactor scores. Subgroups were compared by therapy for time from randomization to relapse and change in efficacy scores.
No significant differences in time to relapse were observed between anxiety subgroups in either active treatment group. However, in patients switched to placebo for continuation treatment, the high anxiety subgroup had a significantly higher risk of relapse than those with low anxiety (risk ratio = 1.63, p =.013). Significant differences between anxiety groups were seen in change in HAM-D anxiety/somatization subfactor scores in the fluoxetine 20 mg and placebo treatment groups, and in change in HAM-D-17 scores in the placebo treatment group (p <.05).
Although high baseline anxiety does not appear to impact the benefit of continuation therapy with fluoxetine, it does appear to predict increased risk of relapse in individuals who do not remain on antidepressant therapy for the duration of continuation treatment.
在重度抑郁症（MDD）的急性治疗期间，焦虑的严重程度似乎不会影响对氟西汀的抗抑郁反应。我们报告了两项研究的回顾性汇总分析，以评估伴发焦虑对氟西汀在MDD维持治疗阶段疗效的影响。
在接受每日20mg氟西汀开放标签治疗约12至13周后MDD缓解（研究1）或有反应（研究2）的患者，以双盲方式随机分配至安慰剂组、继续每日服用20mg氟西汀治疗组，或仅在研究2中，每周一次服用90mg肠溶氟西汀治疗组，持续至少25周。两项研究均纳入了根据DSM-III-R（研究1）或DSM-IV（研究2）评估符合MDD标准的男性和女性门诊患者。根据基线汉密尔顿抑郁量表（HAM-D）焦虑/躯体化子因子评分，将患者分为高焦虑（≥7）或低焦虑（<7）亚组。通过治疗比较亚组从随机分组到复发的时间以及疗效评分的变化。
在任何一个活性治疗组中，焦虑亚组之间复发时间均未观察到显著差异。然而，在转为安慰剂进行维持治疗的患者中，高焦虑亚组的复发风险显著高于低焦虑亚组（风险比=1.63，p=0.013）。在氟西汀20mg和安慰剂治疗组中，焦虑组之间在HAM-D焦虑/躯体化子因子评分变化方面存在显著差异，在安慰剂治疗组中HAM-D-17评分变化方面也存在显著差异（p<0.05）。
尽管高基线焦虑似乎不会影响氟西汀维持治疗的益处，但它似乎确实预示着在维持治疗期间未持续接受抗抑郁治疗的个体复发风险增加。
