负压创面疗法治疗糖尿病足溃疡的荟萃分析

Efficacy and safety of negative⁃pressure wound therapy for diabetic foot ulcer:a meta⁃analysis

目的探讨前瞻性随机对照试验负压创面疗法(NPWT)治疗糖尿病足溃疡(DFU)的有效性和安全性。方法以“负压、糖尿病足、随机”检索Embase、PubMed、ClinicalTrials.gov、Cochrane Library、CBM、中国知网、万方数据库,检索时限为建库至2020年5月。由2名研究人员独立筛选文献、提取资料并评估纳入研究的偏倚风险,应用RevMan 5.3软件进行荟萃分析。结果最终纳入12个研究。荟萃分析结果显示,NPWT较传统敷料可促进DF创面肉芽组织生长(MD=―19.26,95%CI―20.59~―17.93,P<0.01),缩短创面愈合时间(MD=―30.20,95%CI―33.36~―27.05,P<0.01);单位时间内NPWT能提高创面愈合率(RR=1.42,95%CI 1.22~1.67,P<0.01),降低患者截肢率(RR=0.64,95%CI 0.46~0.89,P<0.01),未增加不良事件发生(RR=1.40,95%CI 0.85~2.28,P=0.18)。结论NPWT可有效促进DFU愈合,提高愈合率,降低截肢率,安全性较好。

Objective To evaluate the efficacy and safety of negative pressure wound therapy(NPWT)for diabetic foot ulcers in prospective randomized controlled trials.Methods Embase,PubMed,ClinicalTrials.gov,Cochrane Library,CBM,CNKI and Wanfang Database were searched using“negative pressure,diabetic foot and randomization”.The retrieval time was until May 2020.Two researchers screened the literature,extracted data,and assessed the risk of bias in the included study independently.Meta⁃analysis was performed using RevMan5.3 software.Results Twelve studies were included.Meta⁃analysis showed that NPWT could promote the growth of granulation tissue in diabetic foot wounds(MD=-19.26,95%CI-20.59^-17.93,P<0.01)and shorten the wound healing time(MD=-30.20,95%CI-33.36^-27.05,P<0.01)compared with traditional dressings.NPWT could improve the wound healing rate(RR=1.42,95%CI 1.22~1.67,P<0.01),and reduce amputation rate(RR=0.64,95%CI 0.46~0.89,P<0.01).The incidence of adverse events were not increased(RR=1.40,95%CI 0.85~2.28,P=0.18).Conclusion NPWT could effectively promote the healing of diabetic foot ulcer,improve the healing rate,and reduce the amputation rate with safety usage.