组织工程皮肤治疗糖尿病足溃疡的Meta分析

目的系统评价组织工程皮肤（tissue—engineered skin，TES）治疗糖尿病足溃疡（diabetic foot ulcer，DFU）的效果。方法计算机检索Cochrane图书馆、PubMed、EMbase、CBM、CNKI、VIP，手工检索有关引用文献，收集以TES为干预措施治疗DFU的随机对照试验（RCT），按Cochrane系统评价方法，评价纳入研究的方法学质量并提取有效数据进行Meta分析。结果共纳入7个RCT，包括880例DFU患者。Meta分析结果显示：在试验的12周中，与保守治疗（conventional treatment，CT）相比，TES明显促进了DFU愈合[OR=1．88，95％CI（1．41，2．51）]；在不良反应方面，TES能降低DFU的感染机会[RR=-0．04，95％CI（-0．06，-0．01）]。有2项试验对DFU复发进行了分析，提示两组无明显差异。结论与保守治疗相比，TES能显著促进DFU愈合，并可降低DFU溃疡面与并发周围组织感染的机会。

A Meta-analysis of Tissue Engineered Skin Improved Wound Closure in Diabetic Foot Ulcers

Objective To systematically analyze the randomized controlled trials that compare tissue-engineered skin （TES） with conventional treatment for chronic diabetic foot ulcer （DFU） in terms of effectiveness and utilization. Methods We searched the electronic databases （PubMed, Embase, Cochrane Central Register of Controlled Trials, CBMWeb, CNKI, and VIP） in order to compare the efficiency and safety between TES and conventional treatment （CT） in the patients with DFU. In addition, we manually searched reference lists from original studies and review articles. Results Seven trials were included, which were all randomized controlled trials and had a duration of DFU over 6 weeks. There were 880 participants that met inclusion criteria in all studies, and all patients underwent pre-treatment procedures and were treated by TES （human skin equivalents, living skin equivalents or bioengineered skin, such as Graftskin, Dermagraft and Graftjacket） for 12 weeks. All trials had two groups： the treatment group and the control group, but the two trials divided the treatment groups into 3 different dosages and 2 different ulcer allocation subgroups, respectively. Meta-analysis results showed significant differences in the rate of complete wound closure （P〈0.000 1, 95%CI 0.08 to 0.20） and in the occurrence of complications and severe adverse events （P=0.008, 95%CI -0.06 to -0.01） between TES treated patients and conventionally treated patients. Conclusion The review shows TES improves completed closure of DFU compared with CT, and it is more effective in reducing side effects.