Department of Dermatology, Sheba Medical Center, Ramat Gan, Israel.
University of Minnesota: Twin Cities, Minneapolis, Minnesota, US.
J Wound Care. 2020 May 2;29(5):295-302. doi: 10.12968/jowc.2020.29.5.295.
The aim of this study was to evaluate the therapeutic effects of natural matrix biopolymer membrane (NMBM) in the treatment of venous leg ulcers (VLUs).
Patients exhibiting one or more VLU were assigned to a test group receiving NMBM or to a control group receiving conventional treatment. Patients exhibiting venous insufficiency-related ulcers within 0.1-170cm were included. Efficacy was assessed based on ulcer size and visual analogue scale (VAS) pain scores at baseline and at weeks one, two and four. Ulcer size and pain were compared between groups using a two-way ANOVA.
In this study, 25 patients with 32 VLUs (NMBM group: 14 patients with 17 ulcers; control group: 11 patients with 15 ulcers) were included in the final analysis. At four weeks after baseline measurements, the mean percentage change in VLU area of patients in the NMBM group was 61.6% (95% CI: 40.3-82.9) compared with 84.1% (95% CI: 56.5-111.7) for control group patients. Additionally, the mean percentage change in VLU volume of NMBM group patients was 51.2% (95% CI: 31.8-70.6) compared with 84.0% (95% CI: 57.0-121.0) for control group patients. The NMBM group patients exhibited a mean decrease of 0.38 (95% CI: -0.85-1.61) in VAS pain score over four weeks, compared with a mean decrease of 0.13 (95% CI: -1.32-1.58) for control group patients. No significant differences in VLU area (p=0.210), volume (p=0.122) or VAS pain score (p=0.460) were shown between groups.
NMBM was found to be as effective and safe as the control group treatments. This pilot study suggests NMBM can be used safely to promote ulcer healing.
本研究旨在评估天然基质生物聚合物膜（NMBM）在治疗静脉性腿部溃疡（VLU）中的治疗效果。
将表现出一个或多个 VLU 的患者分配到接受 NMBM 的实验组或接受常规治疗的对照组。纳入静脉功能不全相关溃疡在 0.1-170cm 范围内的患者。根据基线和第 1、2 和 4 周的溃疡大小和视觉模拟量表（VAS）疼痛评分评估疗效。使用双向方差分析比较两组之间的溃疡大小和疼痛。
在这项研究中，最终分析纳入了 25 名患有 32 个 VLU 的患者（NMBM 组：14 名患者，17 个溃疡；对照组：11 名患者，15 个溃疡）。与对照组患者相比，NMBM 组患者的 VLU 面积在基线测量后四周的平均百分比变化为 61.6%（95%CI：40.3-82.9）。此外，NMBM 组患者的 VLU 体积平均百分比变化为 51.2%（95%CI：31.8-70.6），而对照组患者为 84.0%（95%CI：57.0-121.0）。NMBM 组患者在四周内 VAS 疼痛评分平均下降 0.38（95%CI：-0.85-1.61），而对照组患者平均下降 0.13（95%CI：-1.32-1.58）。两组之间在 VLU 面积（p=0.210）、体积（p=0.122）或 VAS 疼痛评分（p=0.460）方面均无显著差异。
NMBM 的疗效和安全性与对照组治疗相当。这项初步研究表明，NMBM 可以安全地用于促进溃疡愈合。
