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氟西汀与氯米帕明治疗重度抑郁症的临床疗效与安全性双盲对照研究

Double-blind controlled study on the clinical efficacy and safety of fluoxetine vs clomipramine in the treatment of major depressive disorders.

作者信息

Manna V, Martucci N, Agnoli A

机构信息

Italian Institute of Neurotraumatology, Rome, Italy.

出版信息

Int Clin Psychopharmacol. 1989 Jan;4 Suppl 1:81-8.

PMID:2644342
Abstract

In the present double-blind controlled study the efficacy and safety of fluoxetine 20 mg/day versus clomipramine 75 mg/day was evaluated during 5 weeks of treatment in 30 hospitalized patients. The sample was selected according to DSM III criteria for major depressive disorders with a score of at least 18 on the first 17 items of the Hamilton Rating Scale for Depression (HRSD). Therapeutic efficacy was evaluated weekly by using HRSD, Zung Self Rating Scale for Depression, Montgomery-Asberg Scale for Depression, Clinical Global Impression for severity and improvement of depressive symptoms. Safety was monitored weekly by recording body weight, blood pressure, pulse rate, temperature, physical conditions, laboratory tests, adverse experiences and concomitant medication. The results confirm the effectiveness and good tolerability of fluoxetine in the treatment of depressive disorders.

摘要

在本双盲对照研究中,对30例住院患者进行了为期5周的治疗,评估了每日20毫克氟西汀与每日75毫克氯米帕明的疗效和安全性。样本根据精神疾病诊断与统计手册第三版(DSM III)中重度抑郁症的标准选取,汉密尔顿抑郁评定量表(HRSD)前17项得分至少为18分。每周使用HRSD、zung抑郁自评量表、蒙哥马利-阿斯伯格抑郁量表、临床总体印象量表评估抑郁症状的严重程度和改善情况,以此来评价治疗效果。通过记录体重、血压、脉搏率、体温、身体状况、实验室检查、不良反应和伴随用药情况,每周监测安全性。结果证实了氟西汀治疗抑郁症的有效性和良好耐受性。

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