Feighner J P, Gardner E A, Johnston J A, Batey S R, Khayrallah M A, Ascher J A, Lineberry C G
Feighner Research Institute, San Diego, Calif.
J Clin Psychiatry. 1991 Aug;52(8):329-35.
This study was undertaken to compare the efficacy and safety of bupropion and fluoxetine.
Moderately to severely depressed outpatients who fulfilled the DSM-III-R criteria for nonpsychotic major depressive disorder and had a score of 20 or more on the Hamilton Rating Scale for Depression (21 item) participated in this two-center study. Following a 1-week placebo phase, patients were randomly assigned to receive either bupropion or fluoxetine for 6 weeks of double-blind treatment. Weekly efficacy assessments included Hamilton Rating Scale for Depression, Hamilton Rating Scale for Anxiety, Clinical Global Impressions-Severity, and Clinical Global Impressions-Improvement. Vital signs and adverse experiences were also assessed weekly.
A total of 61 patients were randomly assigned to receive bupropion (225-450 mg/day) and 62 were randomly assigned to receive fluoxetine (20-80 mg/day). The mean daily dose at the end of the study was 382 mg/day for the bupropion treatment group and 38 mg/day for the fluoxetine treatment group. There were no statistically significant differences between treatments on any of the efficacy variables. On the basis of a 50% or greater reduction in the HAM-D scores, 63% (N = 37) of the bupropion-treated and 58% (N = 35) of the fluoxetine-treated patients were categorized as responders, and on the basis of CGI scores, 68% (N = 40) of the bupropion-treated and 58% (N = 35) of the fluoxetine-treated patients were rated as much or very much improved. HAM-A scores decreased by 59% for both treatment groups. The incidence of treatment-emergent adverse events was low with no statistically significant differences between treatments. Twenty-six percent (N = 16) of the bupropion-treated and 29% (N = 18) of the fluoxetine-treated patients prematurely discontinued treatment.
Both bupropion and fluoxetine demonstrated similar efficacy in relieving depression and accompanying symptoms of anxiety, and both exhibited a similar, favorable safety profile.
本研究旨在比较安非他酮和氟西汀的疗效与安全性。
符合DSM-III-R非精神病性重度抑郁症标准且汉密尔顿抑郁量表（21项）评分达20分及以上的中度至重度抑郁门诊患者参与了这项双中心研究。经过1周的安慰剂阶段后，患者被随机分配接受安非他酮或氟西汀进行为期6周的双盲治疗。每周的疗效评估包括汉密尔顿抑郁量表、汉密尔顿焦虑量表、临床总体印象-严重程度和临床总体印象-改善情况。生命体征和不良经历也每周进行评估。
共有61例患者被随机分配接受安非他酮（225 - 450毫克/天）治疗，62例被随机分配接受氟西汀（20 - 80毫克/天）治疗。研究结束时，安非他酮治疗组的日均剂量为382毫克/天，氟西汀治疗组为38毫克/天。在任何疗效变量上，治疗组之间均无统计学显著差异。基于汉密尔顿抑郁量表评分降低50%或更多，63%（N = 37）接受安非他酮治疗的患者和58%（N = 35）接受氟西汀治疗的患者被归类为有反应者；基于临床总体印象评分，68%（N = 40）接受安非他酮治疗的患者和58%（N = 35）接受氟西汀治疗的患者被评为改善很多或非常多。两个治疗组的汉密尔顿焦虑量表评分均下降了59%。治疗中出现的不良事件发生率较低，治疗组之间无统计学显著差异。26%（N = 16）接受安非他酮治疗的患者和29%（N = 18）接受氟西汀治疗的患者提前终止了治疗。
安非他酮和氟西汀在缓解抑郁及伴随的焦虑症状方面疗效相似，且安全性方面表现类似，均良好。
