Ravindran A V, Judge R, Hunter B N, Bray J, Morton N H
Department of Psychiatry and Pharmacology, University of Ottawa, Ontario, Canada.
J Clin Psychiatry. 1997 Mar;58(3):112-8. doi: 10.4088/jcp.v58n0305.
60%-90% of patients with a primary diagnosis of depression also experience symptoms of anxiety, and such patients have a poorer prognosis than those with uncomplicated depression. The serotonin selective reuptake inhibitors have demonstrated efficacy in the treatment of both depression and certain anxiety states. Furthermore, in a metaanalysis of the paroxetine clinical trial database of 2963 patients in whom depression predominated, there was a concomitant reduction in the Hamilton Rating Scale for Depression anxiety factor. The purpose of the present study was to prospectively compare the efficacy of paroxetine and clomipramine in patients specifically selected for coexisting depression and anxiety.
This was a 12-week, double-blind, parallel-group trial comparing paroxetine 20-40 mg/day with clomipramine 75-150 mg/day in 1002 patients with a Montgomery-Asberg Depression Rating Scale (MADRS) score > or = 20 and a Clinical Anxiety Score (CAS) > or = 11 after a 3-7 day placebo run-in period.
Both paroxetine and clomipramine reduced the MADRS and CAS ratings at 2, 6, and 12 weeks and at endpoint, with no significant differences between treatment groups at any time point. CGI severity of illness and global improvement ratings were also similar throughout the trial; however, there was a statistically significant difference in the CGI efficacy index at 6 weeks and at endpoint, favoring paroxetine (p = .015 and p = .015, respectively). Paroxetine resulted in fewer treatment-emergent adverse experiences and related withdrawals than clomipramine (p = .025 and p = .008, respectively). The number of serious adverse experiences was not significantly different in the paroxetine group compared with the clomipramine group (14 [2.8%] vs. 27 [5.4%]), but did approach statistical significance (p = .056). Anticholinergic-emergent adverse experiences were reported twice as frequently by patients in the clomipramine group as in the paroxetine group (36.1% vs. 18.6%).
There was no evidence of any significant difference in efficacy between paroxetine and clomipramine in patients with coexisting depression and anxiety. However, paroxetine was better tolerated as shown by total treatment-emergent adverse experiences, anticholinergic adverse experiences, and withdrawals due to adverse experiences.
初步诊断为抑郁症的患者中，60%-90%也有焦虑症状，且这类患者的预后比单纯抑郁症患者更差。血清素选择性再摄取抑制剂已证明对抑郁症和某些焦虑状态均有治疗效果。此外，在一项对2963例以抑郁症为主的患者的帕罗西汀临床试验数据库的荟萃分析中，汉密尔顿抑郁焦虑因子评分也随之降低。本研究的目的是前瞻性比较帕罗西汀和氯米帕明对同时患有抑郁症和焦虑症患者的疗效。
这是一项为期12周的双盲平行组试验，在1002例患者中，将每天20-40毫克的帕罗西汀与每天75-150毫克的氯米帕明进行比较。这些患者在经过3-7天的安慰剂导入期后，蒙哥马利-阿斯伯格抑郁评定量表（MADRS）评分≥20分且临床焦虑评分（CAS）≥11分。
帕罗西汀和氯米帕明在第2、6和12周以及试验终点时均降低了MADRS和CAS评分，各治疗组在任何时间点均无显著差异。在整个试验过程中，CGI疾病严重程度和总体改善评分也相似；然而，在第6周和试验终点时，CGI疗效指数存在统计学显著差异，帕罗西汀更具优势（分别为p = .015和p = .015）。与氯米帕明相比，帕罗西汀导致的治疗中出现的不良事件和相关停药较少（分别为p = .025和p = .008）。帕罗西汀组与氯米帕明组严重不良事件的数量无显著差异（14例[2.8%]对27例[5.4%]），但接近统计学显著性（p = .056）。氯米帕明组患者报告的抗胆碱能相关不良事件的频率是帕罗西汀组的两倍（36.1%对18.6%）
没有证据表明帕罗西汀和氯米帕明对同时患有抑郁症和焦虑症的患者在疗效上有任何显著差异。然而从总的治疗中出现不良事件、抗胆碱能不良事件以及因不良事件导致的停药情况来看，帕罗西汀的耐受性更好。
