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阿普唑仑与地昔帕明治疗中度严重抑郁症的安全性及疗效比较。

A comparison of the safety and efficacy of alprazolam and desipramine in moderately severe depression.

作者信息

Remick R A, Fleming J A, Buchanan R A, Keller F D, Hamilton P, Loomer F, Miles J E

出版信息

Can J Psychiatry. 1985 Dec;30(8):597-601. doi: 10.1177/070674378503000808.

Abstract

Fifty-four patients (34 outpatients, 20 inpatients) fulfilling Research Diagnostic Criteria for Definite Major Depressive Disorder were enrolled in a double-blind study comparing the antidepressant effects of alprazolam versus desipramine. The mean daily dose of alprazolam and desipramine at study termination was 3.78 mg and 208 mg respectively. As there were no significant demographic or clinical differences between outpatients and inpatients, both groups were combined in data analysis. Using the Hamilton Depression Rating Scale (HAM-D) both drug groups showed highly significant improvement beginning with the first week of active drug treatment. HAM-D scores continued to decrease through study termination (six weeks of active drug). There were no significant differences when comparing alprazolam and desipramine (outpatients, inpatients, or both groups combined) on any of the subjective or objective psychometrics used in this study. Clinically, only twelve of thirty-four outpatients (35.3%) were felt to be "markedly or moderately" improved, suggesting that neither the outpatient alprazolam nor desipramine patients did particularly well with drug treatment. In terms of drug safety there was no difference between the alprazolam and desipramine in the number of excessive or serious drug side effects. However, five of twenty-nine alprazolam patients had to discontinue therapy because of excessive drowsiness, and two of the alprazolam outpatients had motor vehicle accidents directly related to this adverse event. Alprazolam appeared as effective as desipramine in the pharmacotherapy of this group of depressed outpatient and inpatients. Alprazolam appeared well-tolerated by most subjects although drowsiness was a common--and at times serious--medication side effect.

摘要

54例符合确诊为重度抑郁症研究诊断标准的患者(34例门诊患者,20例住院患者)参与了一项双盲研究,比较阿普唑仑与地昔帕明的抗抑郁效果。研究结束时,阿普唑仑和地昔帕明的日均剂量分别为3.78毫克和208毫克。由于门诊患者和住院患者在人口统计学或临床方面无显著差异,因此在数据分析中将两组合并。使用汉密尔顿抑郁量表(HAM-D),两个药物组从积极药物治疗的第一周开始均显示出高度显著的改善。HAM-D评分在整个研究结束时(六周的积极药物治疗)持续下降。在本研究中使用的任何主观或客观心理测量指标上,比较阿普唑仑和地昔帕明(门诊患者、住院患者或两组合并)时均无显著差异。临床上,34例门诊患者中只有12例(35.3%)被认为“显著或中度”改善,这表明门诊使用阿普唑仑或地昔帕明的患者药物治疗效果均不太理想。在药物安全性方面,阿普唑仑和地昔帕明在药物不良反应或严重药物副作用的数量上没有差异。然而,29例使用阿普唑仑的患者中有5例因过度嗜睡而不得不停止治疗,2例使用阿普唑仑的门诊患者发生了与该不良事件直接相关的机动车事故。在这组抑郁门诊患者和住院患者的药物治疗中,阿普唑仑似乎与地昔帕明一样有效。尽管嗜睡是一种常见且有时严重的药物副作用,但大多数受试者对阿普唑仑的耐受性良好。

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