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不同高级伤口敷料与糖尿病足溃疡护理标准相比的有效性:一项关于制定意大利糖尿病足综合征治疗指南的随机对照试验的荟萃分析。

Effectiveness of different advanced wound dressings versus standard of care for the management of diabetic foot ulcers: a meta-analysis of randomized controlled trials for the development of the Italian guidelines for the treatment of diabetic foot syndrome.

作者信息

Monami Matteo, Ragghianti Benedetta, Scatena Alessia, Miranda Cesare, Monge Luca, Uccioli Luigi, Stefanon Laura, Cappella Cristina, Silverii Antonio, Vermigli Cristiana

机构信息

Azienda Ospedaliero Universitaria Careggi and University of Florence, Florence, Italy.

Diabetic Foot Unit, Careggi Teaching Hospital, Florence, Italy.

出版信息

Acta Diabetol. 2024 Dec;61(12):1517-1526. doi: 10.1007/s00592-024-02320-2. Epub 2024 Jun 12.

Abstract

AIM

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.

摘要

目的

评估常用于治疗以神经性为主的糖尿病足溃疡(DFU)的先进伤口敷料(AWD)的效果。本荟萃分析旨在支持意大利糖尿病足综合征(DFS)治疗指南的制定。

方法

截至2024年4月1日,对Medline和Embase进行检索,收集所有纳入糖尿病患者或报告对患有DFU的糖尿病患者进行亚组分析的随机对照试验(RCT),比较AWD与安慰剂/标准治疗(SoC),疗程至少12周。预先设定的终点指标为:溃疡愈合(主要指标)、愈合时间、换药频率、大截肢和小截肢、疼痛以及全因死亡率。评估的AWD包括:藻酸盐;泡沫、水胶体、水凝胶、透明质酸、血红蛋白喷雾、含银、含八硫酸蔗糖酯、含蜂蜜、微生物结合和蛋白酶调节基质敷料。Mantel-Haenzel优势比和95%置信区间(MH-OR,95%CI)直接从出版物中计算得出或提取。对连续变量计算加权平均差(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治疗的参与者溃疡愈合率显著更高,愈合时间更短(MH-OR 1.50 [0.80, 2.79],p = 0.20;WMD:-24.38 [-42.90, -5.86]天;p = 0.010)。未观察到对上述预先设定的终点指标有其他显著影响。对于主要终点,证据质量被评为“中等”。

结论

总之,AWD,特别是八硫酸蔗糖酯、水凝胶、透明质酸和蜂蜜敷料,可积极促进DFU患者的伤口愈合并缩短愈合时间。

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