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维生素 D 是否能改善膝关节骨关节炎:一项随机对照的初步试验。

Does vitamin D improve osteoarthritis of the knee: a randomized controlled pilot trial.

机构信息

Department of Orthopaedic Surgery, King George's Medical University, Nabiullah Road, near Daliganj Chauraha, Lucknow, India.

出版信息

Clin Orthop Relat Res. 2013 Nov;471(11):3556-62. doi: 10.1007/s11999-013-3201-6. Epub 2013 Aug 1.

Abstract

BACKGROUND

Animal, epidemiologic, and human clinical studies suggest a putative role for vitamin D in osteoarthritis (OA). Inadequate sunlight exposure and lower serum levels of 25(OH)D appear in some reports to be associated with an increased risk for progression of knee OA.

QUESTIONS/PURPOSES: We asked whether treatment with vitamin D would (1) reduce knee pain (WOMAC and VAS), (2) improve function (WOMAC), and (3) change levels of relevant biochemical markers in patients with knee OA with vitamin D insufficiency.

METHODS

This randomized controlled pilot trial prospectively enrolled 107 patients with knee OA with vitamin D insufficiency (25(OH)D ≤ 50 nmol/L) to receive oral vitamin D or placebo. The primary outcome measures were pain and function, and the secondary were biochemical markers. At baseline, the two groups were comparable. The patients were followed for 1 year.

RESULTS

At 12 months, knee pain had decreased in the vitamin D group by mean -0.26 (95% CI, -2.82 to -1.43) on VAS and -0.55 (95% CI, -0.07 to 1.02) on the WOMAC, whereas in the placebo group, it increased by mean 0.13 (95% CI, -0.03 to 0.29) on the VAS and 1.16 (95% CI, 0.82 to 1.49) on the WOMAC (effect size = 0.37 and 0.78). Likewise knee function improved in the vitamin D group by mean -1.36 (95% CI, -1.87 to -0.85) over the placebo group which had a mean 0.69 (95% CI, -0.03 to 1.41; effect size = 0.06). There were significant biochemical changes in serum total calcium, 25(OH)D and alkaline phosphatase.

CONCLUSIONS

The results above suggest there is a small but statistically significant clinical benefit to vitamin D treatment in patients with knee OA, although we recommend a long-term study to determine whether these changes are clinically important and whether they will be sustained with time. Further studies with long-term radiologic evaluations are needed.

摘要

背景

动物、流行病学和人类临床研究表明,维生素 D 在骨关节炎(OA)中具有潜在作用。在一些报告中,阳光照射不足和血清 25(OH)D 水平较低似乎与膝关节 OA 进展的风险增加有关。

问题/目的:我们想知道维生素 D 的治疗是否会:(1)减轻膝关节疼痛(WOMAC 和 VAS),(2)改善功能(WOMAC),以及(3)改变维生素 D 不足的膝关节 OA 患者的相关生化标志物水平。

方法

这项随机对照试验前瞻性纳入了 107 例维生素 D 不足(25(OH)D ≤ 50 nmol/L)的膝关节 OA 患者,接受口服维生素 D 或安慰剂治疗。主要结局指标为疼痛和功能,次要结局指标为生化标志物。基线时,两组患者具有可比性。患者随访 1 年。

结果

在 12 个月时,维生素 D 组的膝关节疼痛在 VAS 上平均下降 -0.26(95%CI,-2.82 至-1.43),在 WOMAC 上平均下降-0.55(95%CI,-0.07 至 1.02),而安慰剂组在 VAS 上平均增加 0.13(95%CI,-0.03 至 0.29),在 WOMAC 上平均增加 1.16(95%CI,0.82 至 1.49)(效应大小分别为 0.37 和 0.78)。同样,维生素 D 组的膝关节功能在 12 个月时平均改善 -1.36(95%CI,-1.87 至-0.85),而安慰剂组平均改善 0.69(95%CI,-0.03 至 1.41;效应大小=0.06)。血清总钙、25(OH)D 和碱性磷酸酶均有显著的生化变化。

结论

上述结果表明,维生素 D 治疗膝关节 OA 患者具有较小但有统计学意义的临床获益,尽管我们建议进行长期研究以确定这些变化是否具有临床意义,以及它们是否会随着时间的推移而持续。需要进一步进行长期放射学评估的研究。

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