目的:评估常用于治疗主要是神经性糖尿病足溃疡(DFU)的高级伤口敷料(AWD)的效果。本荟萃分析旨在支持意大利指南的发展。糖尿病足综合症(DFS)的治疗。
方法:截至4月1日,进行了Medline和Embase搜索,2024收集所有RCT,包括糖尿病患者或报告DFU糖尿病患者的亚组分析,比较AWD与安慰剂/标准护理(SoC),持续时间至少为12周。预先确定的终点是:溃疡愈合(主要),时间到愈合,敷料改变的频率,主要和次要截肢,疼痛,和全因死亡率。AWD评估为:藻酸盐;泡沫,水胶体,水凝胶,透明质酸,血红蛋白喷雾剂,银浸渍,蔗糖八硫酸盐浸渍,蜂蜜浸渍,微生物结合,和蛋白酶调节基质敷料。Mantel-Haenzel赔率比和95%置信区间(MH-OR,95%CI)直接从出版物中计算或提取。计算连续变量的加权平均差(WMD)和95%CI。
结果:15项研究符合所有纳入标准。与SoC/安慰剂相比,接受AWD治疗的参与者的溃疡愈合率明显更高,愈合时间更短(MH-OR1.50[0.80,2.79],p=0.20和大规模毁灭性武器:-24.38[-42.90,-5.86]天,p=0.010)。没有观察到对上述报道的预设终点的其他显著影响。对于主端点,证据质量被评为“中等”。
结论:结论:AWD,特别是蔗糖-八硫酸盐,水凝胶,透明质酸,和蜂蜜调料,可以积极促进DFU患者的伤口愈合和缩短愈合时间。
OBJECTIVE: to assess the effects of advanced wound dressings (AWD) commonly used in the treatment of predominantly neuropathic diabetic foot ulcers (DFU) The present meta-analysis was designed to support the development of the Italian Guidelines for the Treatment of Diabetic Foot Syndrome (DFS).
METHODS: A Medline and Embase search were performed up to April 1st, 2024 collecting all RCTs including diabetic patients or reporting subgroup analyses on diabetic patients with DFU comparing AWD with placebo/standard of care (SoC), with a duration of at least 12 weeks. Prespecified endpoints were: ulcer healing (principal), time-to-healing, frequency of dressings change, major and minor amputation, pain, and all-cause mortality. AWD assessed were: alginates; foam, hydrocolloids, hydrogels, hyaluronic acid, hemoglobin spray, silver-impregnated, sucrose octasulfate-impregnated, honey-impregnated, micro-organism-binding, and protease-modulating matrix dressings. Mantel-Haenzel Odds ratios and 95% confidence intervals (MH-OR, 95% CIs) were either calculated or extracted directly from the publications. Weighted mean differences (WMD) and 95% CIs were calculated for continuous variables.
RESULTS: Fifteen studies fulfilled all inclusion criteria. Participants treated with AWD had a significantly higher ulcer healing rate and shorter time-to-healing in comparison with SoC/placebo (MH-OR 1.50 [0.80, 2.79], p = 0.20 and WMD:: - 24.38 [- 42.90, - 5.86] days, p = 0.010). No other significant effect on the above reported prespecified endpoints were observed. For the primary endpoint, the quality of evidence was rated as \"moderate\".
CONCLUSIONS: In conclusion, AWD, particularly sucrose-octasulfate, hydrogels, hyaluronic acid, and honey dressings, can actively promote wound healing and shortening time-to-healing in patients with DFU.