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随机分配钙和维生素 D 补充剂对老年女性健康的长期影响:一项随机临床试验的干预后随访。

Long-Term Effect of Randomization to Calcium and Vitamin D Supplementation on Health in Older Women : Postintervention Follow-up of a Randomized Clinical Trial.

机构信息

Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, Arizona (C.A.T.).

Fred Hutchinson Cancer Center, Seattle, Washington (A.K.A., R.L.P.).

出版信息

Ann Intern Med. 2024 Apr;177(4):428-438. doi: 10.7326/M23-2598. Epub 2024 Mar 12.

DOI:10.7326/M23-2598
PMID:38467003
Abstract

BACKGROUND

Although calcium and vitamin D (CaD) supplementation may affect chronic disease in older women, evidence of long-term effects on health outcomes is limited.

OBJECTIVE

To evaluate long-term health outcomes among postmenopausal women in the Women's Health Initiative CaD trial.

DESIGN

Post hoc analysis of long-term postintervention follow-up of the 7-year randomized intervention trial of CaD. (ClinicalTrials.gov: NCT00000611).

SETTING

A multicenter ( = 40) trial across the United States.

PARTICIPANTS

36 282 postmenopausal women with no history of breast or colorectal cancer.

INTERVENTION

Random 1:1 assignment to 1000 mg of calcium carbonate (400 mg of elemental calcium) with 400 IU of vitamin D daily or placebo.

MEASUREMENTS

Incidence of colorectal, invasive breast, and total cancer; disease-specific and all-cause mortality; total cardiovascular disease (CVD); and hip fracture by randomization assignment (through December 2020). Analyses were stratified on personal supplement use.

RESULTS

For women randomly assigned to CaD versus placebo, a 7% reduction in cancer mortality was observed after a median cumulative follow-up of 22.3 years (1817 vs. 1943 deaths; hazard ratio [HR], 0.93 [95% CI, 0.87 to 0.99]), along with a 6% increase in CVD mortality (2621 vs. 2420 deaths; HR, 1.06 [CI, 1.01 to 1.12]). There was no overall effect on other measures, including all-cause mortality (7834 vs. 7748 deaths; HR, 1.00 [CI, 0.97 to 1.03]). Estimates for cancer incidence varied widely when stratified by whether participants reported supplement use before randomization, whereas estimates on mortality did not vary, except for CVD mortality.

LIMITATION

Hip fracture and CVD outcomes were available on only a subset of participants, and effects of calcium versus vitamin D versus joint supplementation could not be disentangled.

CONCLUSION

Calcium and vitamin D supplements seemed to reduce cancer mortality and increase CVD mortality after more than 20 years of follow-up among postmenopausal women, with no effect on all-cause mortality.

PRIMARY FUNDING SOURCE

National Heart, Lung, and Blood Institute of the National Institutes of Health.

摘要

背景

尽管钙和维生素 D(CaD)补充剂可能会影响老年女性的慢性疾病,但长期对健康结果的影响证据有限。

目的

评估妇女健康倡议 CaD 试验中绝经后妇女的长期健康结果。

设计

对 CaD 为期 7 年的随机干预试验的长期干预后随访进行事后分析。(ClinicalTrials.gov:NCT00000611)。

地点

美国多中心(=40)试验。

参与者

36282 名无乳腺癌或结直肠癌病史的绝经后妇女。

干预

随机 1:1 分配至每天 1000 毫克碳酸钙(400 毫克元素钙)加 400 IU 维生素 D 或安慰剂。

测量

结直肠癌、浸润性乳腺癌和总癌症的发病率;特定疾病和全因死亡率;总心血管疾病(CVD);和髋部骨折按随机分组(截至 2020 年 12 月)。分析按个人补充剂使用情况分层。

结果

与接受 CaD 治疗的女性相比,接受安慰剂治疗的女性在中位累积随访 22.3 年后观察到癌症死亡率降低 7%(1817 例与 1943 例死亡;风险比 [HR],0.93 [95%CI,0.87 至 0.99]),同时 CVD 死亡率增加 6%(2621 例与 2420 例死亡;HR,1.06 [CI,1.01 至 1.12])。全因死亡率(7834 例与 7748 例死亡;HR,1.00 [CI,0.97 至 1.03])等其他指标无总体影响。当按参与者在随机分组前是否报告补充剂使用情况进行分层时,癌症发病率的估计值差异很大,而死亡率的估计值则没有差异,除了 CVD 死亡率。

局限性

髋部骨折和 CVD 结局仅在一部分参与者中可用,并且无法区分钙与维生素 D 与联合补充剂的作用。

结论

在超过 20 年的随访后,钙和维生素 D 补充剂似乎降低了绝经后妇女的癌症死亡率并增加了 CVD 死亡率,而对全因死亡率没有影响。

主要资金来源

美国国立卫生研究院国家心肺血液研究所。

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