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一项随机双盲安慰剂对照试验,旨在研究补充钙和维生素D对成年囊性纤维化患者骨矿物质密度和骨代谢的影响。

Randomised double blind placebo controlled trial investigating the effect of calcium and vitamin D supplementation on bone mineral density and bone metabolism in adult patients with cystic fibrosis.

作者信息

Haworth Charles S, Jones Andrew M, Adams Judith E, Selby Peter L, Webb A Kevin

机构信息

Manchester Adult Cystic Fibrosis Unit, South Manchester University Hospitals NHS Trust, Wythenshawe Hospital, Southmoor Road, Manchester, M23 9LT, UK.

出版信息

J Cyst Fibros. 2004 Dec;3(4):233-6. doi: 10.1016/j.jcf.2004.08.002.

Abstract

BACKGROUND

Low bone mineral density (BMD) is prevalent in adults with cystic fibrosis and might be related to calcium and vitamin D malabsorption from the gastrointestinal tract. The aim of this study was to investigate the effect of calcium and vitamin D supplementation on BMD and bone metabolism in these subjects.

METHODS

Patients were invited to participate if they had a BMD Z score of -1 or less in the lumbar spine, proximal femur or distal forearm. Patients were randomised to receive calcium 1 g+vitamin D 800 IU or placebo daily, in addition to their regular vitamin D supplements (900 IU/day). BMD and bone biochemical markers were measured before and after 1 year of treatment.

RESULTS

After 12 months, the treatment group (n=15) showed a reduced rate of bone loss compared with the control group (n=15) in the lumbar spine (mean difference 1.9% [CI -0.9% to 4.6%]), total hip (mean difference 0.7% [CI -2.2% to 3.5%]) and distal forearm (mean difference 1.7% [CI -2.2% to 5.5%]), but these changes did not reach statistical significance. There was also a trend towards a reduction in bone turnover in the treatment group.

CONCLUSIONS

Calcium and vitamin D supplementation reduced the rate of bone turnover and bone loss in adult patients with cystic fibrosis, but these changes did not reach statistical significance. These data suggest that a longer term trial of this simple intervention would be justified.

摘要

背景

低骨矿物质密度(BMD)在成年囊性纤维化患者中普遍存在,可能与胃肠道对钙和维生素D的吸收不良有关。本研究的目的是调查补充钙和维生素D对这些受试者骨密度和骨代谢的影响。

方法

如果患者腰椎、股骨近端或前臂远端的骨密度Z评分小于或等于-1,则邀请其参与研究。患者被随机分为两组,除常规补充维生素D(900 IU/天)外,一组每天接受1 g钙 + 800 IU维生素D,另一组接受安慰剂。在治疗1年前和1年后测量骨密度和骨生化指标。

结果

12个月后,治疗组(n = 15)与对照组(n = 15)相比,腰椎(平均差异1.9% [可信区间 -0.9%至4.6%])、全髋(平均差异0.7% [可信区间 -2.2%至3.5%])和前臂远端(平均差异1.7% [可信区间 -2.2%至5.5%])的骨丢失率降低,但这些变化未达到统计学显著性。治疗组骨转换率也有下降趋势。

结论

补充钙和维生素D可降低成年囊性纤维化患者的骨转换率和骨丢失率,但这些变化未达到统计学显著性。这些数据表明,对这种简单干预措施进行长期试验是合理的。

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