维生素 D 预防骨折的剂量需求的汇总分析。

A pooled analysis of vitamin D dose requirements for fracture prevention.

机构信息

Center on Aging and Mobility, University of Zurich and Waid City Hospital, Zurich, Switzerland.

出版信息

N Engl J Med. 2012 Jul 5;367(1):40-9. doi: 10.1056/NEJMoa1109617.

DOI:10.1056/NEJMoa1109617

PMID:22762317

Abstract

BACKGROUND

The results of meta-analyses examining the relationship between vitamin D supplementation and fracture reduction have been inconsistent.

METHODS

We pooled participant-level data from 11 double-blind, randomized, controlled trials of oral vitamin D supplementation (daily, weekly, or every 4 months), with or without calcium, as compared with placebo or calcium alone in persons 65 years of age or older. Primary end points were the incidence of hip and any nonvertebral fractures according to Cox regression analyses, with adjustment for age group, sex, type of dwelling, and study. Our primary aim was to compare data from quartiles of actual intake of vitamin D (including each individual participant's adherence to the treatment and supplement use outside the study protocol) in the treatment groups of all trials with data from the control groups.

RESULTS

We included 31,022 persons (mean age, 76 years; 91% women) with 1111 incident hip fractures and 3770 nonvertebral fractures. Participants who were randomly assigned to receive vitamin D, as compared with those assigned to control groups, had a nonsignificant 10% reduction in the risk of hip fracture (hazard ratio, 0.90; 95% confidence interval [CI], 0.80 to 1.01) and a 7% reduction in the risk of nonvertebral fracture (hazard ratio, 0.93; 95% CI, 0.87 to 0.99). By quartiles of actual intake, reduction in the risk of fracture was shown only at the highest intake level (median, 800 IU daily; range, 792 to 2000), with a 30% reduction in the risk of hip fracture (hazard ratio, 0.70; 95% CI, 0.58 to 0.86) and a 14% reduction in the risk of any nonvertebral fracture (hazard ratio, 0.86; 95% CI, 0.76 to 0.96). Benefits at the highest level of vitamin D intake were fairly consistent across subgroups defined by age group, type of dwelling, baseline 25-hydroxyvitamin D level, and additional calcium intake.

CONCLUSIONS

High-dose vitamin D supplementation (≥800 IU daily) was somewhat favorable in the prevention of hip fracture and any nonvertebral fracture in persons 65 years of age or older. (Funded by the Swiss National Foundations and others.).

摘要

背景

评估维生素 D 补充与骨折减少之间关系的荟萃分析结果并不一致。

方法

我们对 11 项口服维生素 D 补充（每日、每周或每 4 个月）的双盲、随机对照试验的参与者水平数据进行了汇总，这些试验联合或不联合钙治疗，与安慰剂或单独补钙进行了比较。纳入 65 岁及以上人群。主要终点是 Cox 回归分析的髋部和任何非椎体骨折发生率，调整了年龄组、性别、居住类型和研究因素。我们的主要目的是比较所有试验治疗组中维生素 D 实际摄入量（包括每个参与者对治疗的依从性和研究方案之外的补充剂使用）的四分位数数据与对照组的数据。

结果

共纳入 31022 名参与者（平均年龄 76 岁，91%为女性），有 1111 例髋部骨折和 3770 例非椎体骨折。与对照组相比，随机分配接受维生素 D 治疗的参与者髋部骨折风险降低 10%（风险比，0.90；95%置信区间[CI]，0.80 至 1.01），非椎体骨折风险降低 7%（风险比，0.93；95%CI，0.87 至 0.99）。按实际摄入量的四分位数，仅在最高摄入水平（中位数 800IU/日；范围 792 至 2000）显示骨折风险降低，髋部骨折风险降低 30%（风险比，0.70；95%CI，0.58 至 0.86），任何非椎体骨折风险降低 14%（风险比，0.86；95%CI，0.76 至 0.96）。在维生素 D 最高摄入量水平，获益在按年龄组、居住类型、基线 25-羟维生素 D 水平和额外钙摄入定义的亚组中基本一致。