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维生素D补充剂对糖尿病足溃疡患者伤口愈合及代谢状况的影响:一项随机、双盲、安慰剂对照试验。

The effects of vitamin D supplementation on wound healing and metabolic status in patients with diabetic foot ulcer: A randomized, double-blind, placebo-controlled trial.

作者信息

Razzaghi Reza, Pourbagheri Hamideh, Momen-Heravi Mansooreh, Bahmani Fereshteh, Shadi Jafar, Soleimani Zahra, Asemi Zatollah

机构信息

Department of Infectious Disease, School of Medicine, Kashan University of Medical Sciences, Kashan, I.R. Iran.

Department of Infectious Disease, School of Medicine, Kashan University of Medical Sciences, Kashan, I.R. Iran; Social Determinants of Health Research Center, Kashan University of Medical Sciences, Kashan, I.R. Iran.

出版信息

J Diabetes Complications. 2017 Apr;31(4):766-772. doi: 10.1016/j.jdiacomp.2016.06.017. Epub 2016 Jun 23.

Abstract

OBJECTIVE

This study was conducted to evaluate the effects of vitamin D supplementation on wound healing and metabolic status in patients with diabetic foot ulcer (DFU).

METHODS

This randomized, double-blind, placebo-controlled trial was performed among 60 patients with grade 3 DFU according to "Wagner-Meggitt's" criteria. Participants were randomly divided into two groups (each 30 participants) and received either 50,000IU vitamin D supplements every 2weeks for 12weeks (group A) or placebo (group B). Fasting blood samples were taken at study baseline and after 12-week intervention to determine related markers.

RESULTS

After 12weeks of intervention, compared with the placebo, vitamin D supplementation resulted in a significant reduction in ulcer length (-2.1±1.1 vs. -1.1±1.1cm, P=0.001), width (-2.0±1.2 vs. -1.1±1.0cm, P=0.02) and depth (-1.0±0.5 vs. -0.5±0.5cm, P<0.001), and erythema rate (100% vs. 80%, P=0.01). In addition, in supplemented patients changes in serum insulin concentration (-3.4±9.2 vs. +2.8±9.3 μIU/mL, P=0.01), homeostasis model of assessment-estimated insulin resistance (-1.5±4.1 vs. +1.7±5.1, P=0.01), the quantitative insulin sensitivity check index (+0.006±0.02 vs. -0.006±0.02, P=0.03) and HbA1c (-0.6±0.6 vs. -0.1±0.5%, P=0.004) were significantly different from those of patients in the placebo group. Additionally, following supplementation with vitamin D, significant reductions in serum total- (-15.8±18.9 vs. +5.3±31.8mg/dL, P=0.003), LDL- (-17.2±19.8 vs. +2.2±28.6mg/dL, P=0.003), total-/HDL-cholesterol ratio (-1.1±0.8 vs. -0.2±1.1, P=0.001), high sensitivity C-reactive protein (hs-CRP) (-0.4±2.5 vs. +1.9±4.2μg/mL, P=0.01), erythrocyte sedimentation rate (ESR) (-34.7±32.4 vs. -18.0±26.6mm/h, P=0.03) and plasma malondialdehyde (MDA) concentrations (-0.7±0.9 vs. -0.2±0.5μmol/L, P=0.008) were seen compared with the placebo.

CONCLUSIONS

Overall, vitamin D supplementation for 12weeks among patients with DFU had beneficial effects on glucose homeostasis, total-, LDL-, total-/HDL-cholesterol, ESR, hs-CRP and MDA levels. In addition, vitamin D may have played an indirect role in wound healing due to its effect on improved glycemic control.

摘要

目的

本研究旨在评估补充维生素D对糖尿病足溃疡(DFU)患者伤口愈合及代谢状况的影响。

方法

根据“瓦格纳 - 梅吉特(Wagner - Meggitt)”标准,对60例3级DFU患者进行了这项随机、双盲、安慰剂对照试验。参与者被随机分为两组(每组30人),分别接受每2周一次、共12周的50,000IU维生素D补充剂(A组)或安慰剂(B组)。在研究基线和12周干预后采集空腹血样以测定相关指标。

结果

干预12周后,与安慰剂组相比,补充维生素D使溃疡长度(-2.1±1.1 vs. -1.1±1.1cm,P = 0.001)、宽度(-2.0±1.2 vs. -1.1±1.0cm,P = 0.02)和深度(-1.0±0.5 vs. -0.5±0.5cm,P < 0.001)以及红斑发生率(100% vs. 80%,P = 0.01)显著降低。此外,补充维生素D的患者血清胰岛素浓度变化(-3.4±9.2 vs. +2.8±9.3 μIU/mL,P = 0.01)、稳态模型评估的胰岛素抵抗(-1.5±4.1 vs. +1.7±5.1,P = 0.01)、定量胰岛素敏感性检查指数(+0.006±0.02 vs. -0.006±0.02,P = 0.03)和糖化血红蛋白(HbA1c)(-0.6±0.6 vs. -0.1±0.5%,P = 0.004)与安慰剂组患者有显著差异。另外,补充维生素D后,与安慰剂组相比,血清总胆固醇(-15.8±18.9 vs. +5.3±31.8mg/dL,P = 0.003)、低密度脂蛋白胆固醇(-17.2±19.8 vs. +2.2±28.

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