TOPICAL USE OF HUMAN RECOMBINANT EPIDERMAL GROWTH-FACTOR (H-EGF) IN VENOUS ULCERS
TOPICAL USE OF HUMAN RECOMBINANT EPIDERMAL GROWTH-FACTOR (H-EGF) IN VENOUS ULCERS
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DOI：
10.1111/j.1524-4725.1992.tb03514.x
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发表时间：
1992-07-01
期刊：
影响因子：
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通讯作者：
CARSON, P
中科院分区：
文献类型：
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作者：
FALANGA, V;EAGLSTEIN, WH;CARSON, P
最近，大量的兴趣集中在合成多肽生长因子刺激慢性伤口愈合的潜在用途上。在这个试点双盲随机研究在一个单一的中心进行，我们使用人重组表皮生长因子（h-EGF）治疗44例下肢静脉溃疡。将h-EGF的水溶液（10 μ g/mL）局部应用于溃疡，每天两次，直到愈合发生或最多10周。每周评估患者的溃疡大小和适合移植的肉芽组织的形成。9例患者因方案违背而从疗效评价中排除。因此，35例患者（17例h-EGF，18例安慰剂）可评价疗效，44例患者（22例h-EGF，22例安慰剂）可评价安全性。所有患者的中位基线溃疡大小为18.5 cm 2，h-EGF和安慰剂组之间无显著差异（分别为12.9 cm 2和19.2 cm 2，P = 0.27）。研究结束时，h-EGF治疗组有6名（35%）患者和安慰剂组有2名（11%）患者完全愈合（P = 0.10）。另外6名患者（2/17 h-EGF，4/18安慰剂，P = 0.50）出现了适合移植的健康肉芽组织。每周h-EGF组溃疡面积减少的中位数为7%，安慰剂组为3%（P = 0.29），研究结束时为73%，安慰剂组为33%（P = 0.32）。未发现与h-EGF应用相关的不良反应。我们的结论是，局部应用的h-EGF，在本研究中使用的剂量和方式，是安全的，但未能显着提高静脉溃疡的上皮再生。然而，更大的减少溃疡大小和愈合溃疡的大量使用h-EGF是令人鼓舞的结果。
A great deal of interest has been focused recently on the potential use of synthetic polypeptide growth factors to stimulate healing of chronic wounds. In this pilot double-blind randomized study conducted at a single center, we used human recombinant epidermal growth factor (h-EGF) to treat 44 patients with venous ulceration of the lower extremities. An aqueous solution (10-mu-g/mL) of h-EGF was applied topically to the ulcers twice a day until healing occurred or for a maximum of 10 weeks. Patients were evaluated weekly for measurements of ulcer size and for the formation of granulation tissue suitable for grafting. Nine patients were excluded from efficacy evaluation because of protocol violations. Therefore, 35 patients (17 h-EGF, 18 placebo) were evaluable for efficacy, and 44 patients (22 h-EGF, 22 placebo) were available for safety. The median baseline ulcer size for all patients was 18.5 cm2, and was not significantly different between h-EGF and placebo group (12.9 cm2 versus 19.2 cm2, respectively, P = .27). By study end, six (35%) of h-EGF treated patients and two (11%) in the placebo group had healed completely (P = .10). Another 6 patients (2 of 17 h-EGF, 4 of 18 placebo, P = .50) developed healthy granulation tissue that was suitable for grafting. The median ulcer size reduction was 7% for h-EGF versus 3% for placebo per week (P = .29), and 73% versus 33% at study end (P = .32). No untoward side effects were related to the application of h-EGF. We conclude that topical application of h-EGF, in the dose and manner used in this study, was safe but failed to significantly enhance reepithelialization of venous ulcers. However, a greater reduction duction in ulcer size and a larger number of healed ulcers with the use of h-EGF are encouraging results.