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[L-乙酰肉碱临床对照研究的方法学]

[Methodology of a clinical controlled study of L-acetylcarnitine].

作者信息

Neri M, Cortelloni C, De Vreese L

机构信息

Cattedra di Gerontologia e Geriatria, Università degli Studi di Modena.

出版信息

Clin Ter. 1990 Mar 31;132(6 Suppl):457-68.

PMID:2140970
Abstract

A multicentre study was planned and executed to evaluate the effect of psychopharmacological treatment in cognitive decline, while also monitoring the influence of pivotal variables. Using 42 health centres, whose comparability of methodology was ensured through a training seminar and an instructional booklet on the psychometric battery of tests employed, 469 Ss (60 years and over older) were enrolled using strict selection criteria. The treatment was run in four phases over 150 days. The first and the last phases consisted of 30-days placebo treatment, whereas the second and third consisted of 45-days treatment with 1,500 mg of acetyl-L-carnitine. A psychometric evaluation followed each phase. Using this plan it was possible to evaluate the placebo effects, make cross-study comparisons and isolate the effects of the drug treatment.

摘要

一项多中心研究被规划并实施,以评估心理药物治疗对认知衰退的影响,同时监测关键变量的影响。该研究使用了42个健康中心,通过一场培训研讨会和一本关于所采用的心理测量测试组合的指导手册确保了方法的可比性,按照严格的选择标准招募了469名受试者(60岁及以上老年人)。治疗分四个阶段进行,为期150天。第一阶段和最后阶段为30天的安慰剂治疗,而第二阶段和第三阶段为45天的1500毫克乙酰左旋肉碱治疗。每个阶段之后都进行一次心理测量评估。通过这个方案,可以评估安慰剂效应,进行跨研究比较,并分离出药物治疗的效果。

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