Health risks and benefits from calcium and vitamin D supplementation: Women's Health Initiative clinical trial and cohort study.

Health risks and benefits from calcium and vitamin D supplementation: Women's Health Initiative clinical trial and cohort study.
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DOI:
10.1007/s00198-012-2224-2
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发表时间:
2013-02
影响因子:
4
通讯作者:
Rossouw, J. E.
Rossouw, J. E.
中科院分区:
医学2区
文献类型:
--
作者:
Prentice, R. L.;Pettinger, M. B.;Jackson, R. D.;Wactawski-Wende, J.;LaCroix, A. Z.;Anderson, G. L.;Chlebowski, R. T.;Manson, J. E.;Van Horn, L.;Vitolins, M. Z.;Datta, M.;LeBlanc, E. S.;Cauley, J. A.;Rossouw, J. E.

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妇女健康倡议(WHI)双盲,安慰剂对照临床试验随机分配36,282名美国绝经后妇女每天服用1,000 mg元素碳酸钙加400 IU维生素D3或安慰剂,平均干预期为7.0年。该试验旨在测试钙加维生素D补充剂在广泛使用这些补充剂的人群中是否会减少髋部骨折,其次是全骨折和结直肠癌。这项研究使用WHI数据进一步研究了钙和维生素D补充剂的健康益处和风险,重点是骨折,心血管疾病,癌症和总死亡率。对干预期结束时的WHI钙和维生素D随机临床试验(CT)数据进行了进一步分析,重点是与补充持续时间相关的治疗效果,并将这些数据与WHI前瞻性观察性研究(OS)的相应数据进行了对比和合并。在基线时未服用个人钙或维生素D补充剂的女性中,与安慰剂相比,服用钙和维生素D补充剂5年或更长时间后CT中髋部骨折发生的风险比[HR]为0.62(95%置信区间(CI),0.38-1.00)。在CT和OS数据的联合分析中,相应的HR为0.65(95%CI,0.44-0.98)。补充效果对心肌梗死,冠心病,总心脏病,中风,总心血管疾病,结直肠癌或总死亡率的风险并不明显,而钙加维生素D使用者乳腺癌风险和总浸润性癌症风险降低的证据只是提示性的。虽然主要是基于一个子集的分析,长期使用钙和维生素D似乎赋予一个减少,可能是在绝经后妇女髋部骨折的风险显着。在考虑的剂量下,补充剂的其他健康益处和风险,包括尿路结石形成的升高,似乎是适度的,大致平衡。本文的在线版本(doi:10.1007/s 00198 -012-2224-2)包含补充材料,可供授权用户使用。
The Women's Health Initiative (WHI) double-blind, placebo-controlled clinical trial randomly assigned 36,282 postmenopausal women in the U.S. to 1,000 mg elemental calcium carbonate plus 400 IU of vitamin D3 daily or placebo, with average intervention period of 7.0 years. The trial was designed to test whether calcium plus vitamin D supplementation in a population in which the use of these supplements was widespread would reduce hip fracture, and secondarily, total fracture and colorectal cancer. This study further examines the health benefits and risks of calcium and vitamin D supplementation using WHI data, with emphasis on fractures, cardiovascular disease, cancer, and total mortality. WHI calcium and vitamin D randomized clinical trial (CT) data through the end of the intervention period were further analyzed with emphasis on treatment effects in relation to duration of supplementation, and these data were contrasted and combined with corresponding data from the WHI prospective observational study (OS). Among women not taking personal calcium or vitamin D supplements at baseline, the hazard ratio [HR] for hip fracture occurrence in the CT following 5 or more years of calcium and vitamin D supplementation versus placebo was 0.62 (95 % confidence interval (CI), 0.38–1.00). In combined analyses of CT and OS data, the corresponding HR was 0.65 (95 % CI, 0.44–0.98). Supplementation effects were not apparent on the risks of myocardial infarction, coronary heart disease, total heart disease, stroke, overall cardiovascular disease, colorectal cancer, or total mortality, while evidence for a reduction in breast cancer risk and total invasive cancer risk among calcium plus vitamin D users was only suggestive. Though based primarily on a subset analysis, long-term use of calcium and vitamin D appears to confer a reduction that may be substantial in the risk of hip fracture among postmenopausal women. Other health benefits and risks of supplementation at doses considered, including an elevation in urinary tract stone formation, appear to be modest and approximately balanced. The online version of this article (doi:10.1007/s00198-012-2224-2) contains supplementary material, which is available to authorized users.
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