Ko Chun Hay, Yi Sui, Ozaki Risa, Cochrane Heidi, Chung Harriet, Lau Winnie, Koon Chi Man, Hoi Sandy W H, Lo Winnie, Cheng King Fai, Lau Clara B S, Chan Wai Yee, Leung Ping Chung, Chan Juliana C N
Institute of Chinese Medicine, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, New Territories, Hong Kong, China; State Key Laboratory of Phytochemistry and Plant Resources in West China, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, New Territories, Hong Kong, China.
J Diabetes. 2014 Jul;6(4):323-34. doi: 10.1111/1753-0407.12117. Epub 2014 Feb 24.
In the present study, we examined the effect of a two-herb traditional Chinese medicine (NF3), comprised of Astragali Radix and Radix Rehmanniae, on the healing of diabetic foot ulcer and the possible molecular mechanisms involved.
This was a prospective randomized double-blind placebo-controlled study. Sixteen diabetic patients were randomized to receive either placebo or NF3 for 6 months. Ulcer healing and sensory changes were examined. Molecular studies included measurement of serum tumor necrosis factor (TNF)-α and RNA microarray investigation.
The daily rate of reduction in ulcer area was 3.55% in the NF3 group and 1.52% in the placebo group (P = 0.062). In the index limb, the number of negative tests for sensory neuropathy using monofilament was reduced from 27% to 7% in the NF3 group and from 37% to 35% in the placebo group (P < 0.001). In addition, NF3 significantly decreased serum TNF-α levels (P = 0.034). Microarray studies revealed concerted changes following NF3 treatment in the expression of genes implicated in fibroblast regeneration, angiogenesis, and anti-inflammation.
In this proof-of-concept study, 6-month treatment with NF3 was associated with improved wound healing and sensation accompanied by concerted changes in gene expression.
在本研究中，我们考察了由黄芪和生地黄组成的两味中药（NF3）对糖尿病足溃疡愈合的影响及其可能涉及的分子机制。
这是一项前瞻性随机双盲安慰剂对照研究。16例糖尿病患者被随机分为两组，分别接受安慰剂或NF3治疗6个月。检测溃疡愈合情况和感觉变化。分子研究包括测定血清肿瘤坏死因子（TNF）-α以及进行RNA微阵列研究。
NF3组溃疡面积每日缩小率为3.55%，安慰剂组为1.52%（P = 0.062）。在患侧肢体，NF3组使用单丝检查感觉神经病变的阴性测试数量从27%降至7%，安慰剂组从37%降至35%（P < 0.001）。此外，NF3显著降低血清TNF-α水平（P = 0.034）。微阵列研究显示，NF3治疗后，与成纤维细胞再生、血管生成和抗炎相关的基因表达发生了协同变化。
在这项概念验证研究中，NF3治疗6个月与伤口愈合和感觉改善相关，同时基因表达发生了协同变化。
