Acellular Dermal Matrix for Treatment of Diabetic Foot Ulcer: An Overview of Systematic Reviews.

Li Lingyan, Zhao Han, Li Jialu, He Bingyang, Ma Yuanyuan, Qin Peiwei, Ma Peifen, Xu Liwei
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Abstract

Aims: To evaluate the reliability of the methodological quality and outcome measures of systematic reviews (SRs)/metaanalyses (MAs) of the acellular dermal matrix (ADM) for diabetic foot ulcer (DFU). Methods: We searched and retrieved SRs and MAs on the application of ADM for DFU from PubMed, Web of Science, The Cochrane Library, EMBASE, CNKI, CBM, WanFang, and VIP databases. We employed AMSTAR 2 to assess methodological quality, Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system to grade, and the strength of evidence of included SRs/MAs. We excluded the overlapping randomized controlled trials (RCTs) and conducted a re-MA of the primary RCTs. Results: A total of 7 SRs/MAs were included. Results from the AMSTAR 2 evaluation revealed a low overall quality; the GRADE system showed that the evidence was of moderate to very low quality. Our re-MA showed that ADM was superior to standard of care (SOC), with regards to complete wound healing rate at 12 weeks (RR = 1.74, 95% CI:1.34-2.25, P < .0001), complete wound healing rate at 16 weeks (RR = 1.50, 95% CI: 1.26-1.77, P < .00001); healing time (MD = -2.06, 95% CI: -2.57 to -1.54, P < .00001) and adverse events (RR = 0.62, 95% CI: 0.49-0.80, P = .0002). However, a consensus has not yet been reached between ADM and SOC groups with regard to outcome indicators of the reduction of ulcer area and quality of life; and subgroup analyses showed no statistically significant differences between the xenograft ADM and SOC groups (RR = 1.36, 95% CI: 0.95-1.93, P = .09) at 12 weeks. Conclusion: Current evidence suggests that ADM is more effective than the standard of care in the treatment of DFU, particularly for full-thickness, noninfected, and nonischemic foot ulcers, but with low evidence quality. Therefore, the results of this overview should be interpreted dialectically and prudently, and the role of ADM in DFU needs further exploration.

脱细胞真皮基质治疗糖尿病足溃疡:系统综述。
目的:评价脱细胞真皮基质(ADM)治疗糖尿病足溃疡(DFU)的系统评价(SRs)/meta分析(MAs)的方法学质量和结果指标的可靠性。方法:从PubMed、Web of Science、the Cochrane Library、EMBASE、CNKI、CBM、万方、VIP等数据库中检索ADM应用于DFU的SRs和MAs。我们采用AMSTAR 2来评估方法质量、建议分级、评估、发展和评价(GRADE)系统的分级,以及纳入的sr / ma的证据强度。我们排除了重叠随机对照试验(rct),并对主要随机对照试验进行了re-MA分析。结果:共纳入7例SRs/MAs。AMSTAR 2评价结果显示整体质量较低;GRADE系统显示证据质量为中等至极低。我们的re-MA显示,在12周的伤口完全愈合率方面,ADM优于标准护理(SOC) (RR = 1.74, 95% CI:1.34-2.25, P < 0.001);愈合时间(MD = -2.06, 95% CI: -2.57 ~ -1.54, P P = .0002)。然而,ADM组和SOC组在溃疡面积减少和生活质量的结局指标方面尚未达成共识;亚组分析显示,在12周时,异种移植ADM组和SOC组之间无统计学差异(RR = 1.36, 95% CI: 0.95-1.93, P = 0.09)。结论:目前的证据表明,ADM治疗DFU比标准护理更有效,特别是对于全层、非感染和非缺血性足溃疡,但证据质量较低。因此,应该辩证审慎地解读本文综述的结果,ADM在DFU中的作用有待进一步探索。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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