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单次早期大剂量维生素D补充剂对维生素D缺乏症患者骨折愈合的影响:一项前瞻性随机试验。

The effect of a single early high-dose vitamin D supplement on fracture union in patients with hypovitaminosis D: a prospective randomised trial.

作者信息

Haines N, Kempton L B, Seymour R B, Bosse M J, Churchill C, Hand K, Hsu J R, Keil D, Kellam J, Rozario N, Sims S, Karunakar M A

机构信息

Carolinas Medical Center, 1000 Blythe Boulevard Charlotte, North Carolina, USA.

Indiana University School of Medicine, 1801 N. Senate Ave Indianapolis, Indiana, USA.

出版信息

Bone Joint J. 2017 Nov;99-B(11):1520-1525. doi: 10.1302/0301-620X.99B11.BJJ-2017-0271.R1.

Abstract

AIMS

To evaluate the effect of a single early high-dose vitamin D supplement on fracture union in patients with hypovitaminosis D and a long bone fracture.

PATIENTS AND METHODS

Between July 2011 and August 2013, 113 adults with a long bone fracture were enrolled in a prospective randomised double-blind placebo-controlled trial. Their serum vitamin D levels were measured and a total of 100 patients were found to be vitamin D deficient (< 20 ng/ml) or insufficient (< 30 ng/mL). These were then randomised to receive a single dose of vitamin D orally (100 000 IU) within two weeks of injury (treatment group, n = 50) or a placebo (control group, n = 50). We recorded patient demographics, fracture location and treatment, vitamin D level, time to fracture union and complications, including vitamin D toxicity. Outcomes included union, nonunion or complication requiring an early, unplanned secondary procedure. Patients without an outcome at 15 months and no scheduled follow-up were considered lost to follow-up. The -test and cross tabulations verified the adequacy of randomisation. An intention-to-treat analysis was carried out.

RESULTS

In all, 100 (89%) patients had hypovitaminosis D. Both treatment and control groups had similar demographics and injury characteristics. The initial median vitamin D levels were 16 ng/mL (interquartile range 5 to 28) in both groups (p = 0.885). A total of 14 patients were lost to follow-up (seven from each group), two had fixation failure (one in each group) and one control group patient developed an infection. Overall, the nonunion rate was 4% (two per group). No patient showed signs of clinical toxicity from their supplement.

CONCLUSIONS

Despite finding a high level of hypovitaminosis D, the rate of union was high and independent of supplementation with vitamin D. Cite this article: 2017;99-B:1520-5.

摘要

目的

评估单次早期大剂量补充维生素D对维生素D缺乏且伴有长骨骨折患者骨折愈合的影响。

患者与方法

2011年7月至2013年8月期间,113例长骨骨折成人患者纳入一项前瞻性随机双盲安慰剂对照试验。检测他们的血清维生素D水平,共发现100例患者维生素D缺乏(<20 ng/ml)或不足(<30 ng/mL)。然后将这些患者随机分为两组,受伤后两周内口服单次剂量维生素D(100 000 IU)(治疗组,n = 50)或安慰剂(对照组,n = 50)。我们记录了患者的人口统计学资料、骨折部位和治疗情况、维生素D水平、骨折愈合时间及并发症,包括维生素D毒性。结局包括骨折愈合、骨不连或需要早期计划外二次手术的并发症。15个月时无结局且无预定随访的患者视为失访。t检验和交叉表验证了随机分组的合理性。进行意向性分析。

结果

共有100例(89%)患者存在维生素D缺乏。治疗组和对照组的人口统计学资料及损伤特征相似。两组初始维生素D水平中位数均为16 ng/mL(四分位间距5至28)(p = 0.885)。共有14例患者失访(每组7例),2例出现内固定失败(每组1例),1例对照组患者发生感染。总体而言,骨不连率为4%(每组2例)。无患者出现补充剂临床毒性迹象。

结论

尽管发现维生素D缺乏水平较高,但骨折愈合率较高且与补充维生素D无关。引用本文:2017;99 - B:1520 - 5。

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