Effect of raloxifene on prevention of dementia and cognitive impairment in older women: The multiple outcomes of raloxifene evaluation (MORE) randomized trial
Effect of raloxifene on prevention of dementia and cognitive impairment in older women: The multiple outcomes of raloxifene evaluation (MORE) randomized trial
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DOI：
10.1176/appi.ajp.162.4.683
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发表时间：
2005-04-01
影响因子：
17.7
通讯作者：
Grady, D
中科院分区：
文献类型：
--
作者：
Yaffe, K;Krueger, K;Grady, D
目的：这项调查研究雷洛昔芬，选择性雌激素受体调节剂，是否会影响阿尔茨海默病的风险。方法：雷洛昔芬评价的多个结果是一个随机的，安慰剂对照试验绝经后妇女骨质疏松症。雷洛昔芬（60或120 mg/天）对椎体骨折的影响是主要结局。轻度认知障碍和痴呆的发展是次要结局。妇女在基线和每年进行临床和认知评估。3年后，在参与研究的5，386名女性中，那些有痴呆临床症状或在认知筛查中得分最低的第10百分位的女性由盲态痴呆专家进行评估，并进行脑部扫描和实验室检查以评估痴呆病因。痴呆症的诊断是由一个盲目的裁定committee.Results：5,386名妇女，5,153（95.7%）被归类为认知正常，181（3.4%）有轻度认知障碍，52（1.0%）有痴呆症，36阿尔茨海默氏病。与服用安慰剂的女性相比，服用120 mg/天雷洛昔芬的女性发生轻度认知障碍的风险降低33（相对危险度，0.67; 95%置信区间[CI]，0.46 - 0.98），患阿尔茨海默病的风险略低（相对危险度= 0.52，95% CI = 0.22 - 1.21）和任何认知损害（相对危险度= 0.73，95% CI = 0.53 - 1.01）。轻度认知功能障碍，阿尔茨海默病，和任何损害的风险没有显着差异，在组服用60毫克/天的雷洛昔芬。结论：雷洛昔芬在剂量为120毫克/天，但不是60毫克/天，导致认知功能障碍的风险降低绝经后妇女。
Objective: This investigation examined whether raloxifene, a selective estrogen receptor modulator, affects the risk for Alzheimer's disease.Method: The Multiple Outcomes of Raloxifene Evaluation was a randomized, placebo-controlled trial among postmenopausal women with osteoporosis. The effect of raloxifene ( 60 or 120 mg/day) on vertebral fractures was the primary outcome. Development of mild cognitive impairment and dementia was a secondary outcome. Women were given clinical and cognitive evaluations at baseline and annually. After 3 years, among the 5,386 women enrolled at participating sites, those who had clinical symptoms of dementia or scored in the lowest 10th percentile on cognitive screening were evaluated by a blinded dementia specialist and had brain scans and laboratory tests to evaluate dementia etiology. Dementia was diagnosed by a blinded adjudication committee.Results: Of the 5,386 women, 5,153 (95.7%) were classified as cognitively normal, 181 (3.4%) had mild cognitive impairment, and 52 (1.0%) had dementia, 36 with Alzheimer's disease. Compared to those taking placebo, women receiving 120 mg/day of raloxifene had a 33% lower risk of mild cognitive impairment ( relative risk, 0.67; 95% confidence interval [CI], 0.46 - 0.98) and somewhat lower risks of Alzheimer's disease ( relative risk = 0.52, 95% CI = 0.22 - 1.21) and any cognitive impairment ( relative risk = 0.73, 95% CI = 0.53 - 1.01). Risks of mild cognitive impairment, Alzheimer's disease, and any impairment were not significantly different in the group taking 60 mg/day of raloxifene.Conclusions: Raloxifene at a dose of 120 mg/day, but not 60 mg/day, resulted in reduced risk of cognitive impairment in postmenopausal women.