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比较标准外科敷料与脱水羊膜和血小板衍生生长因子敷料在糖尿病足溃疡愈合率方面的效果:一项随机临床试验。

Comparing the standard surgical dressing with dehydrated amnion and platelet-derived growth factor dressings in the healing rate of diabetic foot ulcer: A randomized clinical trial.

机构信息

Department of General Surgery, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Department of General Surgery, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

出版信息

Diabetes Res Clin Pract. 2022 Mar;185:109775. doi: 10.1016/j.diabres.2022.109775. Epub 2022 Feb 9.

Abstract

AIMS

The management of diabetic foot ulcers is a challenging issue due to the pathophysiological background, delay in healing, and prevalence of diabetes. The purpose of this study was to compare the therapeutic effects of the three methods of diabetic wound care: surgical debridement and dressing, dressing with dehydrated amnion powder, and dressing with platelet-derived growth factor gel.

METHODS

In this multi-arm parallel-group randomized trial, 243 patients with a minimum 4-week medical history of diabetic foot ulcers with Wagner's grades 1 and 2, no infection, and adequate tissue blood flow were randomly assigned to one of three 81-person groups: surgical debridement (the standard method), dehydrated amnion dressing, or platelet-derived growth factor dressing. The follow-up period lasted 12 weeks. The percentage area reduction (PAR) was measured as the final target. SPSS version 25 was used to perform statistical analysis on the data.

RESULTS

All three study groups were comparable in terms of the type of ulcer, the area of ulcer, Wagner's grade, the period, and the ulcer's size. The PAR in the surgical debridement, platelet-derived growth factor, and dehydrated amnion groups were 7.4%, 14.8%, and 49.3% in week 4; 20.1%, 35.8%, and 79% in week 6; 43.7%, 56.8%, 86.4% in week 8; and 50%, 61.7%, and 87.6% in weeks 10 and 12, respectively. The observed differences were statistically significant (p < 0.05) over the entire period.

CONCLUSION

The study concluded that dehydrated amnion dressing, when compared to platelet-derived growth factor dressing and surgical debridement, resulted in better-improved healing in diabetic foot ulcer patients.

摘要

目的

由于糖尿病的病理生理背景、愈合延迟和患病率,糖尿病足溃疡的治疗是一个具有挑战性的问题。本研究的目的是比较三种糖尿病伤口护理方法的治疗效果:外科清创和敷料、脱水羊膜粉敷料和血小板衍生生长因子凝胶敷料。

方法

在这项多臂平行组随机试验中,将 243 名患有糖尿病足溃疡病史至少 4 周、Wagner 分级 1 和 2 级、无感染且组织血液供应充足的患者随机分为三组,每组 81 人:外科清创(标准方法)、脱水羊膜敷料或血小板衍生生长因子敷料。随访期为 12 周。最终目标是测量面积减少百分比(PAR)。使用 SPSS 版本 25 对数据进行统计分析。

结果

所有三组在溃疡类型、溃疡面积、Wagner 分级、病程和溃疡大小方面均具有可比性。在第 4 周,外科清创、血小板衍生生长因子和脱水羊膜组的 PAR 分别为 7.4%、14.8%和 49.3%;第 6 周分别为 20.1%、35.8%和 79%;第 8 周分别为 43.7%、56.8%和 86.4%;第 10 周和第 12 周分别为 50%、61.7%和 87.6%。整个观察期的差异均具有统计学意义(p<0.05)。

结论

与血小板衍生生长因子敷料和外科清创相比,脱水羊膜敷料可使糖尿病足溃疡患者的愈合改善更明显。

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