Santema T B Katrien, Poyck Paul P C, Ubbink Dirk T
Department of Surgery, Academic Medical Center, Amsterdam, The Netherlands.
Department of Vascular and Transplant Surgery, Radboudumc, Nijmegen, The Netherlands.
Wound Repair Regen. 2016 Jul;24(4):737-44. doi: 10.1111/wrr.12434. Epub 2016 Jun 3.
Skin substitutes are increasingly used in the treatment of various types of acute and chronic wounds. The aim of this study was to perform a systematic review and meta-analysis to evaluate the effectiveness of skin substitutes on ulcer healing and limb salvage in the treatment of diabetic foot ulcers. Randomized clinical trials were searched and assessed following the methodology of The Cochrane Collaboration. We included 17 trials, totaling 1655 randomized participants. Risk of bias was variable among included trials. Thirteen trials compared the skin substitutes with standard care. The pooled results showed that that skin substitutes can, in addition to standard care, increase the likelihood of achieving complete ulcer closure compared with standard care alone after 6-16 weeks (risk ratio 1.55, 95% confidence interval [CI] 1.30-1.85). Four of the included trials compared two types of skin substitutes but no particular product showed a superior effect over another. Two trials reported on total incidence of lower limb amputations. Pooling the results of these two trials yielded a statistically significantly lower amputation rate among patients treated with skin substitutes (risk ratio 0.43, 95% CI 0.23-0.81), although the absolute risk difference was small (-0.06, 95% CI -0.10 to -0.01). This systematic review provides evidence that skin substitutes can, in addition to standard care, increase the likelihood of achieving complete ulcer closure compared with standard care alone in the treatment of diabetic foot ulcers. However, effectiveness on the long term, including lower limb salvage and recurrence, is currently lacking and cost-effectiveness is unclear.
皮肤替代物在各类急慢性伤口治疗中的应用日益广泛。本研究旨在进行系统评价和荟萃分析，以评估皮肤替代物在治疗糖尿病足溃疡中促进溃疡愈合和挽救肢体的有效性。按照Cochrane协作网的方法检索并评估随机临床试验。我们纳入了17项试验，共有1655名随机分组的参与者。纳入试验的偏倚风险各不相同。13项试验将皮肤替代物与标准治疗进行了比较。汇总结果显示，与单纯标准治疗相比，皮肤替代物除标准治疗外，在6至16周后能增加实现溃疡完全愈合的可能性（风险比1.55，95%置信区间[CI]1.30 - 1.85）。纳入试验中的4项试验比较了两种类型的皮肤替代物，但没有一种特定产品显示出比另一种更优的效果。两项试验报告了下肢截肢的总发生率。汇总这两项试验的结果显示，使用皮肤替代物治疗的患者截肢率在统计学上显著更低（风险比0.43，95%CI 0.23 - 0.81），尽管绝对风险差异较小（-0.06，95%CI -0.10至-0.01）。本系统评价提供的证据表明，在治疗糖尿病足溃疡时，与单纯标准治疗相比，皮肤替代物除标准治疗外能增加实现溃疡完全愈合的可能性。然而，目前缺乏关于长期有效性（包括挽救下肢和复发情况）的证据，且成本效益尚不清楚。
