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174例轻度至中度阿尔茨海默病患者的ω-3脂肪酸治疗:OmegAD研究:一项随机双盲试验。

Omega-3 fatty acid treatment in 174 patients with mild to moderate Alzheimer disease: OmegAD study: a randomized double-blind trial.

作者信息

Freund-Levi Yvonne, Eriksdotter-Jönhagen Maria, Cederholm Tommy, Basun Hans, Faxén-Irving Gerd, Garlind Anita, Vedin Inger, Vessby Bengt, Wahlund Lars-Olof, Palmblad Jan

机构信息

Department of Neurobiology, Caring Sciences and Society, Section of Clinical Geriatrics, Karolinska University Hospital Huddinge, Stockholm.

出版信息

Arch Neurol. 2006 Oct;63(10):1402-8. doi: 10.1001/archneur.63.10.1402.

DOI:10.1001/archneur.63.10.1402
PMID:17030655
Abstract

BACKGROUND

Epidemiologic and animal studies have suggested that dietary fish or fish oil rich in omega-3 fatty acids, for example, docosahexaenoic acid and eicosapentaenoic acid, may prevent Alzheimer disease (AD).

OBJECTIVE

To determine effects of dietary omega-3 fatty acid supplementation on cognitive functions in patients with mild to moderate AD.

DESIGN

Randomized, double-blind, placebo-controlled clinical trial.

PARTICIPANTS

Two hundred four patients with AD (age range [mean +/- SD], 74 +/- 9 years) whose conditions were stable while receiving acetylcholine esterase inhibitor treatment and who had a Mini-Mental State Examination (MMSE) score of 15 points or more were randomized to daily intake of 1.7 g of docosahexaenoic acid and 0.6 g of eicosapentaenoic acid (omega-3 fatty acid-treated group) or placebo for 6 months, after which all received omega-3 fatty acid supplementation for 6 months more.

MAIN OUTCOME MEASURES

The primary outcome was cognition measured with the MMSE and the cognitive portion of the Alzheimer Disease Assessment Scale. The secondary outcome was global function as assessed with the Clinical Dementia Rating Scale; safety and tolerability of omega-3 fatty acid supplementation; and blood pressure determinations.

RESULTS

One hundred seventy-four patients fulfilled the trial. At baseline, mean values for the Clinical Dementia Rating Scale, MMSE, and cognitive portion of the Alzheimer Disease Assessment Scale in the 2 randomized groups were similar. At 6 months, the decline in cognitive functions as assessed by the latter 2 scales did not differ between the groups. However, in a subgroup (n = 32) with very mild cognitive dysfunction (MMSE >27 points), a significant (P<.05) reduction in MMSE decline rate was observed in the omega-3 fatty acid-treated group compared with the placebo group. A similar arrest in decline rate was observed between 6 and 12 months in this placebo subgroup when receiving omega-3 fatty acid supplementation. The omega-3 fatty acid treatment was safe and well tolerated.

CONCLUSIONS

Administration of omega-3 fatty acid in patients with mild to moderate AD did not delay the rate of cognitive decline according to the MMSE or the cognitive portion of the Alzheimer Disease Assessment Scale. However, positive effects were observed in a small group of patients with very mild AD (MMSE >27 points).

摘要

背景

流行病学和动物研究表明,富含ω-3脂肪酸(如二十二碳六烯酸和二十碳五烯酸)的膳食鱼类或鱼油可能预防阿尔茨海默病(AD)。

目的

确定膳食补充ω-3脂肪酸对轻至中度AD患者认知功能的影响。

设计

随机、双盲、安慰剂对照临床试验。

参与者

204例AD患者(年龄范围[均值±标准差],74±9岁),在接受乙酰胆碱酯酶抑制剂治疗时病情稳定,简易精神状态检查表(MMSE)评分15分及以上,被随机分为每日摄入1.7g二十二碳六烯酸和0.6g二十碳五烯酸组(ω-3脂肪酸治疗组)或安慰剂组,为期6个月,之后所有患者再接受6个月的ω-3脂肪酸补充。

主要观察指标

主要结局是用MMSE和阿尔茨海默病评估量表的认知部分测量的认知情况。次要结局是用临床痴呆评定量表评估的整体功能;ω-3脂肪酸补充的安全性和耐受性;以及血压测定。

结果

174例患者完成试验。基线时,2个随机分组的临床痴呆评定量表、MMSE和阿尔茨海默病评估量表认知部分的均值相似。6个月时,后2个量表评估的认知功能下降在两组间无差异。然而,在一个认知功能非常轻微受损(MMSE>27分)的亚组(n =

32)中,与安慰剂组相比,ω-3脂肪酸治疗组的MMSE下降率显著降低(P<0.05)。在该安慰剂亚组接受ω-3脂肪酸补充期间,6至12个月时观察到类似的下降率停滞情况。ω-3脂肪酸治疗安全且耐受性良好。

结论

根据MMSE或阿尔茨海默病评估量表的认知部分,对轻至中度AD患者给予ω-3脂肪酸并未延缓认知下降速度。然而,在一小部分认知功能非常轻微受损(MMSE>27分)的AD患者中观察到了积极效果。

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