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钙剂和维生素 D 补充与锯齿状息肉风险增加:一项随机临床试验的结果。

Calcium and vitamin D supplementation and increased risk of serrated polyps: results from a randomised clinical trial.

机构信息

Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.

Department of Epidemiology, Geisel School of Medicine at Dartmouth College, Hanover, New Hampshire, USA.

出版信息

Gut. 2019 Mar;68(3):475-486. doi: 10.1136/gutjnl-2017-315242. Epub 2018 Mar 1.

DOI:10.1136/gutjnl-2017-315242
PMID:29496722
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6286251/
Abstract

OBJECTIVE

Serrated lesions such as sessile serrated adenomas or polyps (SSA/Ps) are important colorectal cancer precursors, but aetiological factors for these lesions are largely unknown. We aimed to determine the effects of calcium and vitamin D supplementation on the incidence of serrated polyps (SPs) in general and hyperplastic polyps and SSA/Ps specifically.

DESIGN

Participants with one or more adenoma at baseline were randomised to receive 1200 mg/day of elemental calcium, 1000 IU/day of vitamin D, both or neither agent. Treatment continued for 3 or 5 years, when risk of polyps was determined from surveillance colonoscopy (treatment phase). Outcomes after treatment ceased were also assessed (observational phase). Adjusted risk ratios (aRRs) of SPs were determined via multivariable generalised linear models.

RESULTS

SPs were diagnosed in 565 of 2058 (27.5%) participants during the treatment phase and 329/1108 (29.7%) during the observational phase. In total, 211 SSA/Ps were identified during follow-up. In the treatment phase, there was no effect of either calcium or vitamin D on incidence of SSA/Ps. However, during the later observational phase, we observed elevated risks of SSA/Ps associated with calcium alone and calcium+vitamin D treatment (aRR (95% CI): 2.65 (1.43 to 4.91) and 3.81 (1.25 to 11.64), respectively).

CONCLUSION

In a large multicentre chemoprevention study, we found evidence that calcium and vitamin D supplementation increased the risk of SSA/Ps. This appeared to be a late effect: 6-10 years after supplementation began. These possible risks must be weighed against the benefits of calcium and vitamin D supplementation. : NUMBER: NCT00153816; Results.

摘要

目的

锯齿状病变,如无蒂锯齿状腺瘤或息肉(SSA/Ps)是重要的结直肠癌前体,但这些病变的病因因素在很大程度上尚不清楚。我们旨在确定钙和维生素 D 补充剂对锯齿状息肉(SPs)总体发生率以及增生性息肉和 SSA/Ps 的具体影响。

设计

基线时存在一个或多个腺瘤的参与者被随机分配接受 1200mg/天的元素钙、1000IU/天的维生素 D、两者或两者均不接受治疗。治疗持续 3 或 5 年,通过监测结肠镜检查确定息肉风险(治疗阶段)。治疗停止后也评估了结果(观察阶段)。通过多变量广义线性模型确定 SPs 的调整风险比(aRR)。

结果

在治疗阶段,2058 名参与者中有 565 名(27.5%)诊断出 SPs,1108 名参与者中有 329 名(29.7%)在观察阶段诊断出 SPs。在随访期间共发现 211 例 SSA/Ps。在治疗阶段,钙或维生素 D 对 SSA/Ps 的发生率均无影响。然而,在随后的观察阶段,我们观察到单独补钙和钙+维生素 D 治疗与 SSA/Ps 相关的风险增加(aRR(95%CI):2.65(1.43 至 4.91)和 3.81(1.25 至 11.64))。

结论

在一项大型多中心化学预防研究中,我们发现证据表明钙和维生素 D 补充剂增加了 SSA/Ps 的风险。这似乎是一种迟发效应:补充开始后 6-10 年。必须权衡这些可能的风险与钙和维生素 D 补充的益处。

注册号

NCT00153816;结果。

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