妇女健康倡议临床试验：钙和维生素D与激素疗法的相互作用
Women's Health Initiative clinical trials: interaction of calcium and vitamin D with hormone therapy.
作者信息
Robbins John A, Aragaki Aaron, Crandall Carolyn J, Manson JoAnn E, Carbone Laura, Jackson Rebecca, Lewis Cora Elizabeth, Johnson Karen C, Sarto Gloria, Stefanick Marcia L, Wactawski-Wende Jean
机构信息
From the 1Department of Medicine, University of California Davis, Sacramento, CA; 2Fred Hutchinson Cancer Research Center, Seattle, WA; 3Department of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA; 4Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; 5Veterans Affairs Medical Center, Memphis, TN; 6Department of Medicine, University of Tennessee Health Science Center, Memphis, TN; 7Department of Medicine, Ohio State University, Columbus, OH; 8Division of Preventive Medicine, University of Alabama, Birmingham, AL; 9Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN; 10Department of Obstetrics and Gynecology, School of Medicine and Public Health, University of Wisconsin, Madison, WI; 11Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, CA; and 12Department of Social and Preventive Medicine, University at Buffalo, The State University of New York, Buffalo, NY.
出版信息
Menopause. 2014 Feb;21(2):116-23. doi: 10.1097/GME.0b013e3182963901.
OBJECTIVE
This study aims to test the added value of calcium and vitamin D (CaD) in fracture prevention among women taking postmenopausal hormone therapy (HT).
METHODS
This is a prospective, partial-factorial, randomized, controlled, double-blind trial among Women's Health Initiative postmenopausal participants aged 50 to 79 years at 40 centers in the United States with a mean follow-up of 7.2 years. A total of 27,347 women were randomized to HT (0.625 mg of conjugated estrogens alone, or 0.625 mg of conjugated equine estrogens plus 2.5 mg of medroxyprogesterone acetate daily), and 36,282 women were randomized to 1,000 mg of elemental calcium (carbonate) plus 400 IU of vitamin D3 daily, each compared with placebo. A total of 16,089 women participated in both arms. The predefined outcomes were adjudicated hip fractures and measured bone mineral density.
RESULTS
Interaction between HT and CaD on hip fracture (P interaction = 0.01) was shown. The effect of CaD was stronger among women assigned to HT (hazard ratio [HR], 0.59; 95% CI, 0.38-0.93) than among women assigned to placebo (HR, 1.20; 95% CI, 0.85-1.69). The effect of HT on hip fracture was stronger among women assigned to active CaD (HR, 0.43; 95% CI, 0.28-0.66) than among women assigned to placebo (HR, 0.87; 95% CI, 0.60-1.26). CaD supplementation enhanced the antifracture effect of HT at all levels of personal calcium intake. There was no interaction between HT and CaD on change in hip or spine bone mineral density.
CONCLUSIONS
Postmenopausal women at normal risk for hip fracture who are on CaD supplementation experience significantly reduced incident hip fractures beyond HT alone at all levels of personal baseline total calcium intake.
目的
本研究旨在测试钙和维生素D（CaD）在接受绝经后激素治疗（HT）的女性预防骨折方面的附加价值。
方法
这是一项前瞻性、部分析因、随机、对照、双盲试验，在美国40个中心对年龄在50至79岁的女性健康倡议绝经后参与者进行，平均随访7.2年。共有27347名女性被随机分配接受HT（单独使用0.625毫克结合雌激素，或每天使用0.625毫克结合马雌激素加2.5毫克醋酸甲羟孕酮），36282名女性被随机分配每天服用1000毫克元素钙（碳酸盐）加400国际单位维生素D3，每组均与安慰剂进行比较。共有16089名女性同时参与了两个组。预先设定的结局为判定的髋部骨折和测量的骨矿物质密度。
结果
显示HT和CaD在髋部骨折方面存在相互作用（P相互作用 = 0.01）。在分配接受HT的女性中，CaD的效果（风险比[HR]，0.59；95%置信区间，0.38 - 0.93）比分配接受安慰剂的女性更强（HR，1.20；95%置信区间，0.85 - 1.69）。在分配接受活性CaD的女性中，HT对髋部骨折的效果（HR，0.43；95%置信区间，0.28 - 0.66）比分配接受安慰剂的女性更强（HR，0.87；95%置信区间，0.60 - 1.26）。在个人钙摄入量的所有水平上，补充CaD都增强了HT的抗骨折效果。HT和CaD在髋部或脊柱骨矿物质密度变化方面没有相互作用。
结论
在个人基线总钙摄入量的所有水平上，补充CaD的正常髋部骨折风险绝经后女性，其髋部骨折发生率在单独使用HT的基础上显著降低。
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