The effect of raloxifene on risk of breast cancer in postmenopausal women - Results from the MORE randomized trial
The effect of raloxifene on risk of breast cancer in postmenopausal women - Results from the MORE randomized trial
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DOI：
10.1001/jama.281.23.2189
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发表时间：
1999-06-16
影响因子：
120.7
通讯作者：
Jordan, VC
中科院分区：
文献类型：
--
作者：
Cummings, SR;Eckert, S;Jordan, VC
雷洛昔芬盐酸盐是一种选择性雌激素受体调节剂，对乳腺和子宫内膜组织具有抗雌激素作用，对骨、脂代谢和凝血具有雌激素作用。目的确定服用雷洛昔芬的妇女是否具有较低的浸润性乳腺癌风险。设计与设置雷洛昔芬评价的多结局（MORE），一项多中心、随机、双盲试验，服用雷洛昔芬或安慰剂的妇女随访中位数为40个月（SD，3年），从1994年到1998年，在25个国家，主要是美国和欧洲的180个临床中心，由社区环境和医疗实践组成。年龄小于81岁（平均年龄66.5岁），患有骨质疏松症，定义为存在椎骨骨折或股骨颈或脊柱T评分低于年轻健康女性平均值至少2.5 SD。几乎所有的参与者（96%）都是白色。有乳腺癌病史或正在服用雌激素的妇女被排除。干预雷洛昔芬，60毫克，每日2片;或雷洛昔芬，60毫克，每日1片和1片安慰剂片剂;或2片安慰剂片剂。主要结果测量经组织病理学证实的乳腺癌新病例。经阴道超声检查用于评估雷洛昔芬对1781名妇女子宫内膜的影响。结果雷洛昔芬组5129例中确诊乳腺癌13例，安慰剂组2576例中确诊乳腺癌27例（相对危险度[RR] 0.24; 95%可信区间[CI] 0.13-0.44; P
Context Raloxifene hydrochloride is a selective estrogen receptor modulator that has antiestrogenic effects on breast and endometrial tissue and estrogenic effects on bone, lipid metabolism, and blood clotting.Objective To determine whether women taking raloxifene have a lower risk of invasive breast cancer.Design and Setting The Multiple Outcomes of Raloxifene Evaluation (MORE), a multicenter, randomized, double-blind trial, in which women taking raloxifene or placebo were followed up for a median of 40 months (SD, 3 years), from 1994 through 1998, at 180 clinical centers composed of community settings and medical practices in 25 countries, mainly in the United States and Europe.Participants A total of 7705 postmenopausal women, younger than 81 (mean age, 66.5) years, with osteoporosis, defined by the presence of vertebral fractures or a femoral neck or spine T-score of at least 2.5 SDs below the mean for young healthy women. Almost all participants (96%) were white. Women who had a history of breast cancer or who were taking estrogen were excluded.Intervention Raloxifene, 60 mg, 2 tablets daily; or raloxifene, 60 mg, 1 tablet daily and 1 placebo tablet; or 2 placebo tablets.Main Outcome Measures New cases of breast cancer, confirmed by histopathology. Transvaginal ultrasonography was used to assess the endometrial effects of raloxifene in 1781 women. Deep vein thrombosis or pulmonary embolism were determined by chart review.Results Thirteen cases of breast cancer were confirmed among the 5129 women assigned to raloxifene vs 27 among the 2576 women assigned to placebo (relative risk [RR], 0.24; 95% confidence interval [CI], 0.13-0.44; P