Lecrubier Y, Pedarriosse A M, Payan C, Schmid-Burgk W, Stabl M
Unité INSERM 302, Hôpital Salpétrière Paris, France.
Acta Psychiatr Scand. 1995 Oct;92(4):260-5. doi: 10.1111/j.1600-0447.1995.tb09580.x.
The efficacy and the safety of moclobemide (400-600 mg/day), a reversible and selective inhibitor of monoamine oxidase-A (RIMA) and of clomipramine (100-150 mg/day) were compared respectively in 98 and 93 nonmelancholic, nonpsychotic out-patients with a DSM-III major depressive episode over 6 weeks and up to 3 months, in a multi-center double-blind trial. No statistically significant difference between the treatments was found on the number of responders, at 6 weeks and 3 months, to the Hamilton Depression Rating Scale (HDRS), which was the main criterion for efficacy. The sample size was sufficient to detect a difference of approximatively 20% in response rates. Reduction of the total scores on HDRS and Covi anxiety scale was comparable for both treatments, but the reduction on the Retardation Depressive Scale (RDS) was significantly higher with moclobemide at the 1- and 2-week assessments. According to the RDS as well as the global impression of both patient and physician, a somewhat earlier onset of antidepressant action was evident in the moclobemide group. Tolerance was significantly better in the moclobemide group, mainly due to a lower frequency of weight gain, sedation and anticholinergic effects.
在一项多中心双盲试验中,对98例和93例非抑郁性、非精神病性的门诊患者(均患有DSM-III重度抑郁发作)分别比较了吗氯贝胺(400 - 600毫克/天,一种可逆性单胺氧化酶-A选择性抑制剂,即RIMA)和氯米帕明(100 - 150毫克/天)的疗效与安全性,治疗时间长达6周乃至3个月。在6周和3个月时,以汉密尔顿抑郁量表(HDRS)作为主要疗效标准,两种治疗方法在有效应答者数量上未发现统计学显著差异。样本量足以检测出应答率约20%的差异。两种治疗方法在降低HDRS总分和科维焦虑量表得分方面相当,但在第1周和第2周评估时,吗氯贝胺在降低迟缓性抑郁量表(RDS)得分方面显著更高。根据RDS以及患者和医生的整体印象,吗氯贝胺组的抗抑郁作用起效稍早。吗氯贝胺组的耐受性显著更好,主要是因为体重增加、镇静和抗胆碱能效应的发生率较低。