Marcus R N, Mendels J
Bristol-Myers Squibb, Wallingford, Conn 06492, USA.
J Clin Psychiatry. 1996;57 Suppl 2:19-23.
The development of a new antidepressant medication is usually accompanied by a concern as to whether or not the compound will be sufficiently effective in clinically important subgroups of patients (e.g., depressed patients with increased severity of symptomatology, patients with melancholic features, and patients whose illness is recurrent). This paper describes results of a pooled analysis of four placebo-controlled studies included in the development program of the antidepressant nefazodone. These studies involved a total of 247 patients receiving nefazodone in a dose of up to 600 mg/day, 251 patients on placebo, and 166 patients receiving imipramine. For purposes of the analysis, patients were defined as being more severely depressed (Clinical Global Impressions scale [CGI] psychopathology score of at least markedly ill), having melancholia using DSM-III-R criteria, or having recurrent major depression (using DSM-III-R criteria). Efficacy was assessed by improvement in the Hamilton Rating Scale for Depression (17 items; HAM-D-17) Total score and CGI scale. Nefazodone (mean dose at endpoint = 379 mg/day) was effective in the management of depressed patients with moderate or severe symptomatology, depressed patients with or without melancholic features, and patients with single or recurrent episodes of depression.
一种新型抗抑郁药物的研发通常伴随着这样一个担忧，即该化合物在临床上重要的患者亚组（例如，症状严重程度增加的抑郁症患者、具有忧郁特征的患者以及病情复发的患者）中是否会有足够的疗效。本文描述了对纳入抗抑郁药奈法唑酮研发项目的四项安慰剂对照研究进行汇总分析的结果。这些研究总共涉及247名接受剂量高达600毫克/天奈法唑酮治疗的患者、251名接受安慰剂治疗的患者以及166名接受丙咪嗪治疗的患者。为了进行分析，患者被定义为患有更严重抑郁症（临床总体印象量表[CGI]精神病理学评分至少为明显患病）、根据《精神疾病诊断与统计手册第三版修订本》（DSM-III-R）标准患有忧郁症或患有复发性重度抑郁症（根据DSM-III-R标准）。通过汉密尔顿抑郁评定量表（17项；HAM-D-17）总分和CGI量表的改善来评估疗效。奈法唑酮（终点时平均剂量 = 379毫克/天）对有中度或重度症状的抑郁症患者、有或没有忧郁特征的抑郁症患者以及有单次或复发性抑郁发作的患者的治疗有效。
