背景:糖尿病足溃疡(DFU)已成为全球健康问题,这可能导致糖尿病足感染(DFI),小腿截肢,甚至死亡率。尽管护理标准(SOC)实践已被公认为DFU护理的“黄金标准”,仅SOC可能不足以治愈所有DFU并防止其复发。真皮基质的使用已成为增强DFU愈合的辅助治疗。本研究旨在评估真皮基质应用作为SOC辅助治疗的有效性和安全性。
方法:PubMed的数据库,Embase和CENTRAL由两名作者独立搜索,具有以下关键术语:“糖尿病足溃疡”,“脱细胞真皮基质”,“伤口愈合”,等等。随机对照试验(RCT)评估了真皮基质在治疗DFU中的有效性和安全性。分析的主要结果包括最终随访时的完全愈合时间和完全愈合率,而次要结果包括伤口面积,溃疡复发率,截肢风险和并发症风险。使用随机效应或固定效应模型进行荟萃分析,基于异质性检验。
结果:本研究共包括15个随机对照试验,共1524名受试者。其中,689例患者仅接受SOC治疗,835例患者接受SOC加真皮基质治疗。与SOC组相比,真皮基质组达到完全愈合所需的时间明显缩短(MD=2.84,95CI:1.37~4.32,p<0.001***)。与SOC组相比,真皮基质组的完全愈合率(OR=0.40,95CI:0.33〜0.49,p<0.001***)和总体(RR=1.83,95CI:1.15〜2.93,p=0.011*)和主要(RR=2.64,95CI:1.30〜5.36,p=0.007**)明显较低。伤口面积无明显差异,溃疡复发率,两组之间的并发症风险。
结论:与单纯使用SOC相比,真皮基质作为辅助疗法与SOC联合应用可有效改善DFU的愈合过程并降低截肢风险。此外,受试者对真皮基质应用的耐受性良好,无增加的并发症风险.
BACKGROUND: Diabetic foot ulcers (DFUs) have become a global health concern, which can lead to diabetic foot infection (DFI), lower leg amputation, and even mortality. Though the standard of care (SOC) practices have been recognized as the \"gold standard\" for DFU care, SOC alone may not be adequate to heal all DFUs and prevent their recurrence. The use of dermal matrix has emerged as an adjuvant treatment to enhance DFU healing. The current study aimed to evaluate the effectiveness and safety of dermal matrix application as an adjuvant treatment to the SOC.
METHODS: The databases of PubMed, Embase and CENTRAL were independently searched by two authors, with the following key terms: \"diabetic foot ulcer\", \"acellular dermal matrix\", \"wound healing\", and so on. Randomized controlled trials (RCTs) evaluated the efficacy and safety of dermal matrix in the treatment of DFUs were eligible for inclusion. The primary outcomes analyzed included time to complete healing and complete healing rate at the final follow-up, while secondary outcomes included wound area, ulcer recurrence rate, amputation risk and complication risk. Meta-analyses were performed using random-effect or fixed-effect models, based on the heterogeneity test.
RESULTS: This study included a total of 15 RCTs with a total of 1524 subjects. Of these, 689 patients were treated with SOC alone, while 835 patients received SOC plus dermal matrix. Compared to the SOC group, significantly shorter time (MD = 2.84, 95%CI: 1.37 ~ 4.32, p < 0.001***) was required to achieve complete healing in dermal matrix group. Significantly higher complete healing rate (OR = 0.40, 95%CI: 0.33 ~ 0.49, p < 0.001***) and lower overall (RR = 1.83, 95%CI: 1.15 ~ 2.93, p = 0.011*) and major (RR = 2.64, 95%CI: 1.30 ~ 5.36, p = 0.007**) amputation risks were achieved in dermal matrix group compared to SOC group. No significant difference was found in the wound area, ulcer recurrence rate, and complication risk between the two groups.
CONCLUSIONS: The application of dermal matrix as an adjuvant therapy in conjunction with SOC effectively improved the healing process of DFUs and reduced the amputation risk when compared to SOC alone. Furthermore, dermal matrix application was well tolerated by the subjects with no added complication risk.