Department of Anatomy, Faculty of Medicine, University of Colombo, 25, Kynsey Place 8, Colombo, Sri Lanka.
BMC Surg. 2021 Feb 15;21(1):87. doi: 10.1186/s12893-021-01084-8.
Diabetic foot ulcer is a complication with multiple aetiological factors which has a significant impact to patients' lives and costs to the healthcare system. The potential of human amniotic membrane to act as an allograft has been studied in relation to this condition. Aim of this study is to evaluate the current scientific evidence on its effectiveness in healing diabetic foot ulcers.
Pubmed, Cochrane library, and Google scholar were searched using the search terms, "Amnion" OR "Placenta" AND "Diabetic foot". (MeSH terms) in the title or the abstract field from 1st of January 2000 to 30th March 2020. The quality of published reports was assessed using standard methods. We searched for experimental and observational studies in terms of randomized control trials, prospective cohort, retrospective cohort studies and case series.
When searched with Mesh terms, 12 citations in PubMed, 22 citations in Cochrane library and 30 in other data bases were found. After screening the studies and their reference lists, 12 studies met the inclusion criteria and the others were excluded. There were 8 randomized control trials (RCTs), 2 prospective studies and 2 retrospective studies employing different preparation methods of the amniotic membranes. A wide variation in study end points were noted. Majority of the RCTs (n = 7) were concluded with significantly higher wound closure rate compared to the conventional treatment groups. In prospective and retrospective studies, it was shown that large chronic ulcers which were resistant to closure with standard therapy achieved wound closure with amniotic membrane allografts. A meta-analysis could not be performed due to study heterogeneity, and publication bias was not assessed due to the small number of available studies which was not sufficient for accurate comparison.
Even though, the studies had some inherent heterogeneity due to different preparation methods, different study end points and outcome measurements. According to our review the current studies using amniotic membrane allografts give reliable evidence of reduction in healing time over conventional methods.
糖尿病足溃疡是一种多病因的并发症,对患者的生活和医疗系统的成本都有重大影响。人类羊膜作为同种异体移植物的潜力已在这种情况下进行了研究。本研究的目的是评估其在治疗糖尿病足溃疡方面的有效性的现有科学证据。
使用搜索词“羊膜”或“胎盘”和“糖尿病足”在标题或摘要字段中在 Pubmed、Cochrane 图书馆和 Google scholar 中搜索,从 2000 年 1 月 1 日至 2020 年 3 月 30 日。使用标准方法评估已发表报告的质量。我们根据随机对照试验、前瞻性队列研究、回顾性队列研究和病例系列研究,搜索了实验和观察性研究。
使用 Mesh 术语搜索时,在 Pubmed 中发现了 12 条引文,在 Cochrane 图书馆中发现了 22 条引文,在其他数据库中发现了 30 条引文。筛选研究及其参考文献后,有 12 项研究符合纳入标准,其余研究被排除。其中包括 8 项随机对照试验(RCT)、2 项前瞻性研究和 2 项回顾性研究,采用不同的羊膜制备方法。研究终点的差异很大。大多数 RCT(n=7)与常规治疗组相比,伤口闭合率显著提高。前瞻性和回顾性研究表明,对标准治疗方法难以闭合的大慢性溃疡,使用羊膜同种异体移植物可实现伤口闭合。由于研究存在异质性,无法进行荟萃分析,由于可用研究数量不足,无法评估发表偏倚,因此无法进行准确比较。
尽管由于不同的制备方法、不同的研究终点和结果测量,这些研究存在一定的内在异质性,但根据我们的综述,使用羊膜同种异体移植物的现有研究为常规方法的愈合时间缩短提供了可靠的证据。