Botte L, Evrard J L, Gilles C, Stenier P, Wolfrum C
Centre Hospitalier Universitaire de Tivoli, La Louvière.
Acta Psychiatr Belg. 1992;92(6):355-69.
Moclobemide was compared to placebo in two parallel groups of depressed patients, in a multicenter randomized, double-blind study of six weeks treatment duration. Forty seven patients participated in the study: 23 received moclobemide (flexible dose 300-600 mg/day) and 24 placebo. They were evaluated weekly for efficacy and tolerability. Moclobemide was more efficacious than placebo as judged by analysis on the total score on the Hamilton depression scale (p < 0.05) and by the overall assessment of efficacy (p < 0.01). Moclobemide was also more effective than placebo in the subgroup with neurotic depression (p < 0.05). In addition, the number of patients prematurely terminating treatment for inefficacy, was higher in the placebo than in the moclobemide group (12 versus 2, p < 0.01). The number and the severity of side-effects tended to be slightly greater in the moclobemide than in the placebo group, but this did not reach a level of significance. Cardiovascular tolerability was good in both treatment groups. No hypertensive crisis was reported. Hematology, clinical chemistry and urine analysis were not affected by the treatment in any clinically significant fashion.
在一项为期六周的多中心随机双盲研究中，将两组抑郁症患者进行平行对照，一组服用吗氯贝胺，另一组服用安慰剂。47名患者参与了该研究：23名患者服用吗氯贝胺（灵活剂量为300 - 600毫克/天），24名患者服用安慰剂。每周对他们进行疗效和耐受性评估。根据汉密尔顿抑郁量表总分分析（p < 0.05）以及疗效的总体评估（p < 0.01）判断，吗氯贝胺比安慰剂更有效。在神经症性抑郁症亚组中，吗氯贝胺也比安慰剂更有效（p < 0.05）。此外，因疗效不佳而提前终止治疗的患者数量，安慰剂组高于吗氯贝胺组（12例对2例，p < 0.01）。吗氯贝胺组副作用的数量和严重程度往往比安慰剂组略高，但未达到显著水平。两个治疗组的心血管耐受性都良好。未报告有高血压危象。血液学、临床化学和尿液分析在临床上均未受到治疗的显著影响。
