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富血小板纤维蛋白胶联合口服维生素 E 和 C 治疗难愈性糖尿病足溃疡的效果:一项随机、双盲、平行分组临床试验。

The effect of platelet-rich plasma-fibrin glue dressing in combination with oral vitamin E and C for treatment of non-healing diabetic foot ulcers: a randomized, double-blind, parallel-group, clinical trial.

机构信息

Department of Clinical Biochemistry, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.

Vascular and Endovascular Surgery Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.

出版信息

Expert Opin Biol Ther. 2021 May;21(5):687-696. doi: 10.1080/14712598.2021.1897100. Epub 2021 Apr 13.

DOI:10.1080/14712598.2021.1897100
PMID:33646060
Abstract

OBJECTIVE

The current study assesses the effects of platelet-rich plasma-fibrin glue (PRP-FG) dressing along with oral vitamin E and C on wound healing and biochemical markers in patients with non-healing diabetic foot ulcers (non-healing DFU).

METHODS

This randomized controlled trial was performed on 25 patients with non-healing DFU. Patients were treated with PRP-FG dressing plus oral vitamin E and C (intervention group) or PRP-FG dressing plus placebo (control group) for 8 weeks.

RESULTS

Eight weeks after treatment, six wounds in the intervention group and two wounds in the control group were completely closed, and also wound size significantly reduced in both intervention and control groups ( < 0.05). This reduction in wound size was significantly greater in the intervention group compared to the control group ( = 0.019). Also, a significant decrease in prooxidant-antioxidant balance (PAB) , ESR, and hs-CRP was observed in the intervention group compared to the control group ( < 0.05).

CONCLUSION

Our results showed that PRP-FG dressing along with oral vitamin E and C could be used to increase wound healing in patients with non-healing DFU by enhancing the wound healing process and reducing oxidative stress.

TRIAL REGISTRATION

This trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT04315909).

摘要

目的

本研究评估了富含血小板的纤维蛋白胶(PRP-FG)敷料联合口服维生素 E 和 C 对非愈合性糖尿病足溃疡(非愈合性 DFU)患者伤口愈合和生化标志物的影响。

方法

这是一项随机对照试验,纳入了 25 名非愈合性 DFU 患者。患者接受 PRP-FG 敷料联合口服维生素 E 和 C(干预组)或 PRP-FG 敷料联合安慰剂(对照组)治疗 8 周。

结果

治疗 8 周后,干预组 6 个伤口和对照组 2 个伤口完全闭合,两组的伤口面积均显著减小(<0.05)。与对照组相比,干预组的伤口面积减小更为显著(=0.019)。此外,与对照组相比,干预组的促氧化剂-抗氧化剂平衡(PAB)、红细胞沉降率(ESR)和高敏 C 反应蛋白(hs-CRP)显著降低(<0.05)。

结论

我们的结果表明,PRP-FG 敷料联合口服维生素 E 和 C 通过促进伤口愈合过程和降低氧化应激,可以增加非愈合性 DFU 患者的伤口愈合。

试验注册

本试验在 ClinicalTrials.gov(CT.gov 标识符:NCT04315909)注册。

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