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乙酰左旋肉碱治疗阿尔茨海默病患者的双盲平行设计试点研究。

Double-blind parallel design pilot study of acetyl levocarnitine in patients with Alzheimer's disease.

作者信息

Sano M, Bell K, Cote L, Dooneief G, Lawton A, Legler L, Marder K, Naini A, Stern Y, Mayeux R

机构信息

Department of Neurology, Columbia University, College of Physicians and Surgeons, New York, NY.

出版信息

Arch Neurol. 1992 Nov;49(11):1137-41. doi: 10.1001/archneur.1992.00530350051019.

Abstract

Acetyl levocarnitine hydrochloride has been reported to retard dementia in patients with Alzheimer's disease. In a double-blind, parallel design, placebo-controlled pilot study of 30 mild to moderately demented patients with probable Alzheimer's disease, tests of memory, attention, language, visuospatial, and constructional abilities were administered, and the level of acetyl levocarnitine was measured in the cerebrospinal fluid. Patients were then randomly assigned to receive acetyl levocarnitine hydrochloride (2.5 g/d for 3 months followed by 3 g/d for 3 months) or placebo. After 6 months, the acetyl levocarnitine group demonstrated significantly less deterioration in timed cancellation tasks and Digit Span (forward) and a trend toward less deterioration in a timed verbal fluency task. No differences were found in any other neuropsychological test results. A subgroup with the lowest baseline scores, receiving acetyl levocarnitine, had significantly less deterioration on the verbal memory test and a significant increase in cerebrospinal fluid acetyl levocarnitine levels compared with those receiving placebo. These results suggest that acetyl levocarnitine may retard the deterioration in some cognitive areas in patients with Alzheimer's disease and stress the need for a larger study of this drug.

摘要

据报道,盐酸乙酰左旋肉碱可延缓阿尔茨海默病患者的痴呆进程。在一项针对30名轻度至中度痴呆的可能患有阿尔茨海默病患者的双盲、平行设计、安慰剂对照的试点研究中,进行了记忆、注意力、语言、视觉空间和构建能力测试,并测量了脑脊液中乙酰左旋肉碱的水平。然后将患者随机分配接受盐酸乙酰左旋肉碱(2.5克/天,持续3个月,随后3克/天,持续3个月)或安慰剂。6个月后,乙酰左旋肉碱组在定时划消任务和数字广度(顺背)方面的恶化明显较少,在定时语言流畅性任务方面有恶化较少的趋势。在任何其他神经心理学测试结果中均未发现差异。与接受安慰剂的患者相比,基线分数最低且接受乙酰左旋肉碱的亚组在言语记忆测试中的恶化明显较少,脑脊液中乙酰左旋肉碱水平显著升高。这些结果表明,乙酰左旋肉碱可能会延缓阿尔茨海默病患者某些认知领域的恶化,并强调需要对这种药物进行更大规模的研究。

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