Tchero Huidi, Herlin Christian, Bekara Farid, Kangambega Pauline, Sergiu Fluieraru, Teot Luc
Department of Trauma and Orthopedic Surgery, CH Saint Martin, Guadeloupe, France.
Department of Reconstructive and Plastic Surgery, Montpellier, France.
Wound Repair Regen. 2017 Aug;25(4):691-696. doi: 10.1111/wrr.12554. Epub 2017 Jun 21.
Diabetic foot ulcer (DFU) is a frequent complication in diabetic patients, occurring in up to 25% of those affected. Among the treatments available to clinicians, the use of bioengineered skin substitutes is an attractive alternative. Artificial dermis functions as a matrix, covering the wound and supporting healing and reconstruction of the lost tissue. This study was aimed at reviewing the use of five regeneration matrices (namely, Integra, Nevelia, Matriderm, Pelnac, and Renoskin) as reported by clinical trials. We searched Medline, Embase, ISI Web of Science, Scopus, and Cochrane Central Register of Controlled Trials databases for relevant studies. Risk of failure rates was analysed by relative risk ratio method and complete ulcer healing was studied using network meta-analysis. Thirteen studies (12 randomized clinical trials and one cohort study) were eligible for analysis. The network meta-analysis based on a single study for Matriderm and 12 studies for other products showed that Matriderm was statistically inferior in achieving complete ulcer healing, as compared to all other products combined. In the second phase analysis, which was limited to three studies using artificial dermis products, there was a 57% reduction in the risk of reepithelialization failure for DFU patients who used Matriderm or Pelnac, compared to those who used Pelnac with basic fibroblast growth factor spray or skin grafting. The data showed an overall low failure rate suggesting that these bioengineered skin products provide a suitable support and microenvironment for healing of DFUs with low ulcer recurrence rates. This systematic review with meta-analysis highlights the pressing need for more studies investigating the safety, efficacy and failure rates of regeneration matrices in the treatment of DFUs.
糖尿病足溃疡(DFU)是糖尿病患者常见的并发症,在高达25%的患者中发生。在临床医生可用的治疗方法中,使用生物工程皮肤替代物是一种有吸引力的选择。人工真皮起基质作用,覆盖伤口并支持受损组织的愈合和重建。本研究旨在回顾临床试验报道的五种再生基质(即Integra、Nevelia、Matriderm、Pelnac和Renoskin)的使用情况。我们在Medline、Embase、ISI科学网、Scopus和Cochrane对照试验中央注册库数据库中检索相关研究。采用相对风险比方法分析失败率风险,并使用网状Meta分析研究溃疡完全愈合情况。13项研究(12项随机临床试验和1项队列研究)符合分析条件。基于一项关于Matriderm的研究和12项关于其他产品的研究的网状Meta分析表明,与所有其他产品组合相比,Matriderm在实现溃疡完全愈合方面在统计学上较差。在第二阶段分析中,该分析仅限于三项使用人工真皮产品的研究,与使用含碱性成纤维细胞生长因子喷雾的Pelnac或皮肤移植的患者相比,使用Matriderm或Pelnac的DFU患者再上皮化失败风险降低了57%。数据显示总体失败率较低,表明这些生物工程皮肤产品为DFU愈合提供了合适的支持和微环境,溃疡复发率较低。这项带有Meta分析的系统评价强调了迫切需要更多研究来调查再生基质在DFU治疗中的安全性、有效性和失败率。