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比较米那普明和丙咪嗪治疗心境恶劣障碍疗效及安全性的多中心双盲研究。

Multicentric double-blind study comparing efficacy and safety of minaprine and imipramine in dysthymic disorders.

作者信息

Salzmann E, Robin J L

机构信息

Department of Clinical Research, Sanofi Recherche, Gentilly, France.

出版信息

Neuropsychobiology. 1995;31(2):68-75. doi: 10.1159/000119175.

Abstract

This multicentre study compares the therapeutic efficacy and safety of minaprine (200 mg) to that of imipramine (50, 75, 100 mg) in the treatment of patients over 40 years suffering from dysthymic disorders as diagnosed according to DSM III. After 4-7 days on placebo, 67 patients were randomly assigned to receive either drug for a period of 6 weeks in a double-blind manner. As rated by the Hamilton Depression Rating Scale and evaluated by exploratory statistics, minaprine showed similar efficacy to imipramine in these patients. Minaprine was better tolerated than imipramine according to the physicians' tolerance rating (p < 0.05) and produced significantly fewer symptoms of the autonomic nervous system as compared to imipramine (p < 0.01).

摘要

这项多中心研究比较了米那普明(200毫克)与丙咪嗪(50、75、100毫克)对40岁以上根据《精神疾病诊断与统计手册》第三版诊断为心境恶劣障碍患者的治疗效果和安全性。在服用安慰剂4至7天后,67名患者被随机分配以双盲方式接受其中一种药物治疗6周。根据汉密尔顿抑郁量表评分并经探索性统计评估,米那普明在这些患者中显示出与丙咪嗪相似的疗效。根据医生的耐受性评级,米那普明的耐受性优于丙咪嗪(p<0.05),与丙咪嗪相比,其自主神经系统症状明显更少(p<0.01)。

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