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米那普明(200毫克/天)与安慰剂治疗记忆丧失的随机双盲对照研究

[Randomized double-blind comparative study of minaprine (200mg/j) and of placebo on memory loss].

作者信息

Allain H, Belliard S, Lieury A, Menard G, Patat A, Le Coz F, Gandon J M

机构信息

Laboratoire de Pharmacologie Expérimentale et Clinique, Faculté de Médecine, Rennes, France.

出版信息

Therapie. 1996 Mar-Apr;51(2):155-62.

PMID:8763050
Abstract

Thirty five subjects (age: 45-69 years) with subjective memory loss, without any other neuropsychiatric or somatic disease, were recruited in a phase II study. This double blind randomized versus placebo controlled study compared the effects of minaprine (200 mg/d) with placebo, in two parallel groups, during 2 months, on memory, attention and vigilance. Three psychometric tests were the main criteria of assessment: a standardized battery of memory tests (SM 5), the dual-coding test, the analysis of choice reaction times (CRT) and the critical flicker fusion point (CFF). A positive effect of minaprine was detected on words delayed recall (p = 0.028) and immediate recognition of words (p = 0.049). The global clinical tests (CGI, MacNair scale) were not statistically modified. Tolerability of minaprine and placebo were comparable. A positive pharmacodynamic activity on mnemonic performance is thus demonstrated in favour of minaprine (200 mg/d) in this specific population characterized by a memory complaint. These results would lead to a phase III study in which the main criteria would be global scales in order to confirm the clinical reliability of the present results.

摘要

35名主观记忆减退、无其他神经精神或躯体疾病的受试者(年龄:45 - 69岁)被纳入一项II期研究。这项双盲随机对照安慰剂研究在两个月内,将两个平行组中米那普明(200毫克/天)与安慰剂的效果进行比较,观察对记忆、注意力和警觉性的影响。三项心理测量测试为主要评估标准:一组标准化记忆测试(SM 5)、双重编码测试、选择反应时间(CRT)分析和临界闪烁融合点(CFF)。在单词延迟回忆(p = 0.028)和单词即时识别(p = 0.049)方面检测到米那普明有积极作用。整体临床测试(CGI,麦克奈尔量表)无统计学改变。米那普明和安慰剂的耐受性相当。因此,在这个以记忆障碍为特征的特定人群中,已证明米那普明(200毫克/天)对记忆表现有积极的药效学活性。这些结果将促成一项III期研究,其中主要标准将是整体量表,以确认当前结果的临床可靠性。

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