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氟伏沙明与多塞平治疗老年抑郁症的双盲随机对照研究。

A double-blind, randomised comparison of fluvoxamine with dothiepin in the treatment of depression in elderly patients.

作者信息

Rahman M K, Akhtar M J, Savla N C, Sharma R R, Kellett J M, Ashford J J

机构信息

Bolton General Hospital.

出版信息

Br J Clin Pract. 1991 Winter;45(4):255-8.

PMID:1810358
Abstract

The efficacy and tolerability of the selective 5-HT reuptake inhibitor fluvoxamine were compared with the tricyclic dothiepin in 52 elderly (age greater than 64 years) hospital patients in a multi-centre double-blind randomised trial. Patients met DSM-III criteria for 'major depressive episode' and scored greater than 29 on the Montgomery Asberg Depression Rating Scale (MADRS) after a one-week placebo baseline. Active treatment was for six weeks. The dosage of both drugs was 50 mg nocte for three days, 100 mg nocte for the remainder of the first week, thereafter increasing to a maximum of 200 mg/day according to response/tolerance. MADRS scores improved by 63.5% with fluvoxamine and 60.0% with dothiepin; there were no significant differences between treatments at any assessment. Nausea, dizziness, headache, somnolence and constipation in both groups, plus dry mouth and asthenia in the dothiepin group were more frequent than single reports. Two patients in each group discontinued treatment owing to unwanted effects. There were no clinically significant changes in haematological, biochemical or cardiovascular parameters.

摘要

在一项多中心双盲随机试验中,对52名老年(年龄大于64岁)住院患者比较了选择性5-羟色胺再摄取抑制剂氟伏沙明与三环类药物多塞平的疗效和耐受性。患者符合DSM-III中“重度抑郁发作”的标准,在经过一周的安慰剂基线期后,蒙哥马利-阿斯伯格抑郁评定量表(MADRS)得分超过29分。积极治疗为期六周。两种药物的剂量均为第1至3天每晚50mg,第1周其余时间每晚100mg,此后根据反应/耐受性最多增加至200mg/天。使用氟伏沙明时MADRS得分改善了63.5%,使用多塞平时改善了60.0%;在任何评估中,治疗组之间均无显著差异。两组中恶心、头晕、头痛、嗜睡和便秘,以及多塞平组中的口干和乏力比个别报告更为常见。每组有两名患者因不良反应而停药。血液学、生化或心血管参数均无临床显著变化。

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