异体脱细胞真皮基质治疗糖尿病足溃疡临床效果荟萃分析

Meta-analysis on the clinical effects of allogenic acellular dermal matrix treatment for diabetic foot ulcer

目的应用荟萃分析方法系统评价异体ADM治疗糖尿病足溃疡（DFU）的临床效果。方法以“diabetic foot、diabetic ulcer、diabetic wound、acellular dermal matrix、acellular dermal regenerative tissue matrix、acellular regenerative tissue matrix、AlloDerm、SureDerm、KaroDerm、Graftjacket、Hyalomatrix PA、Hyalograft 3D”为检索词检索《PubMed》《Cochrance Library》《Embase》《OVID EBM Reviews》数据库，以“糖尿病足、糖尿病足溃疡、异体脱细胞真皮基质、真皮基质”为检索词检索《中国生物文献数据库》《中国期刊全文数据库》《维普数据库》《万方数据库》，对1990年1月-2015年7月公开发表的有关异体ADM治疗糖尿病足的研究文献进行荟萃分析。结局指标为：创面缩小率、创面愈合率、创面完全上皮化时间、并发症发生率。应用RevMan5．2统计软件进行荟萃分析。结果共纳入5篇文献426例DFU患者，包括接受异体ADM治疗的ADM组224例和接受传统湿性治疗的传统治疗组202例。ADM组与传统治疗组患者创面缩小率比较，差异无统计学意义，均数差为20．34（95％置信区间为-25．27—65．94，P=0．38）。ADM组患者创面愈合率高于传统治疗组，相对危险度（RR）为1．90（95％置信区间为1．29～2．80，P〈0．01）。ADM组与传统治疗组患者创面完全上皮化时间比较，差异无统计学意义，均数差为1．20（95％置信区间为-2．93～0．52，P=0．17）。ADM组患者并发症发生率低于传统治疗组，RR=0．54（95％置信区间为0．38～0．76，P〈0．001）。创面缩小率、创面完全上皮化时间、创面愈合率和并发症发生率均可能存在发表偏倚。结论与传统湿性治疗相比，异体ADM能显著促进DFU患者创面愈合，减少并发症的发生。

Objective To analyze the clinical effects of allogenic acellular dermal matrix （ADM） treatment for diabetic foot ulcer （DFU） with meta-analysis. Methods Databases including PubMed , Cochrance Library , Embase , and OVID EBM Reviews were searched using key words ＂ diabetic foot, dia- betic ulcer, diabetic wound, acellular dermal matrix, acellular dermal regenerative tissue matrix, acellular regenerative tissue matrix, AlloDerm, SureDerm, KaroDerm, Graftjacket, Hyalomatrix PA, and Hyalograft 3D＂, and Chinese Biological Abstracts, Chinese Journals Full-text Database, VIP Database, and Wanfang Database were searched using key words in Chinese version ＂糖尿病足,糖尿病足溃疡,异体脱细胞真皮基质,真皮基质＂ to obtain the published trials of allogenic ADM treatment for DFU from January 1990 to July 2015, and then meta-analysis was used to analyze the trials. The measurement indexes were wound contraction rate, wound healing rate, complete epithelization time of wound, and complication rate. Meta-analysis was conducted by RevMan 5.2 statistical software. Results A total of 5 trials involving 426 DFU patients were included, with 224 patients in group ADM who received allogenic ADM treatment and 202 patients in conventional treatment group （CT） who received conventional moist treatment. There was no statistically significant difference between group ADM and group CT in wound contraction rate, with mean difference 20.34 （ with 95% confidence interval - 25.27 - 65.94, P = 0.38）. The wound healing rate of patients in group ADM was higher than that in group CT, with relative risk （RR） 1.90 （with 95% confidence interval 1.29 - 2.80, P 〈 0.01 ）. There was no statistically significant difference between group ADM and group CT in complete epithelization time of wound, with mean difference 1.20 （with 95% confidence interval -2.93 -0. 52, P = 0.17）. The complication rate of patients in group ADM was lower than that in group CT, RR = 0.54 （ with 95% confidence interval 0.38 - 0.76, P 〈 0. 001 ）. Publication bias might exist in wound contraction rate, wound healing rate, complete epithelization time of wound, and complication rate. Conclusions Compared with conventional moist treatment, allogenic ADM treatment can accelerate wound healing and reduce complication rate in patients with DFU.