Silverstone P H, Salinas E
Department of Psychiatry, University of Alberta, Edmonton, Canada.
J Clin Psychiatry. 2001 Jul;62(7):523-9. doi: 10.4088/jcp.v62n07a04.
A subset of patients with comorbid major depressive disorder and generalized anxiety disorder (GAD) was examined from a double-blind. placebo-controlled study comparing the efficacy and safety of venlafaxine extended release (XR) and fluoxetine.
From a total of 368 patients, 92 patients meeting DSM-IV criteria for major depressive disorder who also had comorbid GAD were identified. The comparison group comprised 276 evaluable noncomorbid patients. Patients received venlafaxine XR (75-225 mg/day), fluoxetine (20-60 mg/day), or placebo for 12 weeks. Efficacy evaluations included Hamilton Rating Scale for Depression (HAM-D), Hamilton Rating Scale for Anxiety (HAM-A), and Clinical Global Impressions (CGI) scale.
By the final assessment at week 12, comorbid patients in the venlafaxine XR group, but not in the fluoxetine group, showed a significantly greater decrease than those in the placebo group in the primary efficacy variables of mean HAM-D and HAM-A total scores (p < .05, pairwise comparison). In comorbid patients, significant pairwise differences were noted between venlafaxine XR and placebo at week 12 for the secondary variables of HAM-D anxiety-somatization and retardation factors, HAM-D depressed mood item. HAM-A psychic anxiety factor, the Hospital Anxiety and Depression scale (HAD) anxiety subscale score, and the Covi Anxiety Scale score. Fluoxetine was significantly different from placebo only on the HAD depression subscale score. Response, defined as > or = 50% decrease in symptoms score, was achieved in 66% and 59% of the comorbid patients for HAM-D and HAM-A, respectively, in the venlafaxine XR group at week 12. This response was higher than that seen with fluoxetine (52% and 45%) or placebo (36% and 24%). Onset of efficacy appeared to be slower in comorbid than in noncomorbid patients.
This is the first evidence from a controlled study of the effectiveness of pharmacotherapy in patients with comorbid major depressive disorder and GAD. The delayed improvement in comorbid patients compared with noncomorbid patients suggests that a longer treatment period may be necessary in comorbid patients.
对患有重度抑郁症和广泛性焦虑症（GAD）共病的一部分患者进行了一项双盲、安慰剂对照研究，比较了文拉法辛缓释剂（XR）和氟西汀的疗效及安全性。
从368名患者中，确定了92名符合DSM-IV重度抑郁症标准且患有共病GAD的患者。对照组包括276名可评估的无共病患者。患者接受文拉法辛XR（75 - 225毫克/天）、氟西汀（20 - 60毫克/天）或安慰剂治疗12周。疗效评估包括汉密尔顿抑郁评定量表（HAM-D）、汉密尔顿焦虑评定量表（HAM-A）和临床总体印象（CGI）量表。
在第12周的最终评估中，文拉法辛XR组的共病患者（而非氟西汀组）在平均HAM-D和HAM-A总分的主要疗效变量方面，比安慰剂组有显著更大程度的下降（p < 0.05，两两比较）。在共病患者中，第12周时，文拉法辛XR与安慰剂在HAM-D焦虑 - 躯体化和迟缓因子、HAM-D抑郁情绪项目、HAM-A精神性焦虑因子、医院焦虑抑郁量表（HAD）焦虑分量表得分以及科维焦虑量表得分等次要变量上存在显著的两两差异。氟西汀仅在HAD抑郁分量表得分上与安慰剂有显著差异。在第12周时，文拉法辛XR组共病患者中，分别有66%和59%的患者在HAM-D和HAM-A方面达到了症状评分降低≥50%的缓解标准。这一缓解率高于氟西汀组（52%和45%）或安慰剂组（36%和24%）。共病患者的疗效起效似乎比无共病患者更慢。
这是来自一项对照研究的首个证据，证明了药物治疗对患有重度抑郁症和GAD共病患者的有效性。与无共病患者相比，共病患者改善延迟表明共病患者可能需要更长的治疗期。
