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髋部骨折手术后初始负荷剂量维生素D与安慰剂对比:一项随机对照试验(REVITAHIP)的基线特征

An initial loading-dose vitamin D versus placebo after hip fracture surgery: baseline characteristics of a randomized controlled trial (REVITAHIP).

作者信息

Mak Jenson C D, Klein Linda A, Finnegan Terry, Mason Rebecca S, Cameron Ian D

机构信息

Department of Geriatric Medicine, Gosford Hospital, Gosford, NSW, Australia.

出版信息

BMC Geriatr. 2014 Sep 9;14:101. doi: 10.1186/1471-2318-14-101.

DOI:10.1186/1471-2318-14-101
PMID:25200552
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4164764/
Abstract

BACKGROUND

Hypovitaminosis D is particularly common among older people with a proximal femoral (hip) fracture. There are currently no agreed strategies for vitamin D replenishment after hip fracture surgery. The REVITAHIP Study is a multisite, double-blinded randomized-controlled trial investigating the effects of an oral vitamin D loading dose on gait velocity after hip fracture surgery. We describe the baseline characteristics of participants, aiming to document hypovitaminosis D and its associations after hip fracture.

METHODS

Participants, over 65, recruited within 7 days following hip fracture surgery from 3 Australia hospitals, were randomly allocated to receive a loading dose of vitamin D3 (250,000IU) or placebo, followed by oral maintenance vitamin D3/calcium (800 IU/500 mg) and the usual hip fracture rehabilitation pathway. Demographic and clinical data were collected, including surgical procedure, pre-fracture functional status, Mini Mental State Examination (MMSE) score, serum 25-hydroxyvitamin D (25-OHD), Verbal Rating Scale (VRS) for pain, grip strength and gait velocity. The associations of baseline 25-OHD levels with demographic and clinical data were assessed using Pearson's correlation, ANOVA and regression analyses.

RESULTS

Two-hundred-and-eighteen people with hip fracture participated in the study. Mean age was 83.9+/-7.2 years, 77% were women and 82% lived in private homes. Fifty-six percent had a subcapital fracture. Mean comorbidity count was 3.13+/-2.0. Mean MMSE was 26.1+/-3.9. Forty-seven percent of participants had hypovitaminosis D (<50 nmol/L). Multivariate regression models demonstrated higher baseline vitamin D levels were significantly associated with higher premorbid Barthel index scores, lower post-operative VRS pain levels and use of vitamin D.

CONCLUSION

This study cohort shared similar demographic characteristics and comorbidities with other cohorts of people with hip fracture, with the probable exception of less cognitive impairment. Hypovitaminosis D was not as prevalent as previously documented. Patients taking vitamin D supplements and with higher premorbid Barthel index, reflecting greater independence and activity, tended to have higher 25-OHD levels at baseline. Further, lower VRS pain ratings following surgery were associated with higher vitamin D levels. Such associations will need further investigation to determine causation. (ANZCTR number, ACTRN12610000392066).

TRIAL REGISTRATION

The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry ANZCTRN ACTRN12610000392066.

摘要

背景

维生素D缺乏症在股骨近端(髋部)骨折的老年人中尤为常见。目前对于髋部骨折手术后维生素D补充尚无一致的策略。REVITAHIP研究是一项多中心、双盲随机对照试验,旨在研究口服维生素D负荷剂量对髋部骨折手术后步态速度的影响。我们描述了参与者的基线特征,旨在记录髋部骨折后维生素D缺乏症及其关联因素。

方法

从澳大利亚3家医院在髋部骨折手术后7天内招募的65岁以上参与者被随机分配接受维生素D3负荷剂量(250,000国际单位)或安慰剂,随后口服维持剂量的维生素D3/钙(800国际单位/500毫克)以及常规的髋部骨折康复方案。收集了人口统计学和临床数据,包括手术方式、骨折前功能状态、简易精神状态检查表(MMSE)评分、血清25-羟维生素D(25-OHD)、疼痛视觉模拟评分(VRS)、握力和步态速度。使用Pearson相关性分析、方差分析和回归分析评估基线25-OHD水平与人口统计学和临床数据之间的关联。

结果

218例髋部骨折患者参与了研究。平均年龄为83.9±7.2岁,77%为女性,82%居住在私人住宅。56%为股骨头下骨折。平均合并症数为3.13±2.0。平均MMSE为26.1±3.9。47%的参与者患有维生素D缺乏症(<50 nmol/L)。多变量回归模型显示,较高的基线维生素D水平与较高的病前Barthel指数评分、较低的术后VRS疼痛水平以及维生素D的使用显著相关。

结论

该研究队列与其他髋部骨折人群队列具有相似的人口统计学特征和合并症,认知障碍可能较少除外。维生素D缺乏症并不像之前记录的那样普遍。服用维生素D补充剂且病前Barthel指数较高,反映出更大的独立性和活动能力的患者,基线时25-OHD水平往往较高。此外,术后较低的VRS疼痛评分与较高的维生素D水平相关。这种关联需要进一步研究以确定因果关系。(澳大利亚新西兰临床试验注册中心编号,ACTRN12610000392066)。

试验注册

本研究方案已在澳大利亚新西兰临床试验注册中心注册,编号为ANZCTRN ACTRN12610000392066。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7d33/4164764/3222d4de67a4/1471-2318-14-101-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7d33/4164764/0e8c21f2451e/1471-2318-14-101-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7d33/4164764/3222d4de67a4/1471-2318-14-101-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7d33/4164764/0e8c21f2451e/1471-2318-14-101-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7d33/4164764/3222d4de67a4/1471-2318-14-101-2.jpg

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