Falanga V, Eaglstein W H, Bucalo B, Katz M H, Harris B, Carson P
Department of Dermatology and Cutaneous Surgery, University of Miami School of Medicine, FL 33101.
J Dermatol Surg Oncol. 1992 Jul;18(7):604-6. doi: 10.1111/j.1524-4725.1992.tb03514.x.
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 micrograms/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 re-epithelialization of venous ulcers. However, a greater reduction in ulcer size and a larger number of healed ulcers with the use of h-EGF are encouraging results.
最近，人们对合成多肽生长因子在促进慢性伤口愈合方面的潜在用途极为关注。在这个于单一中心开展的试点双盲随机研究中，我们使用人重组表皮生长因子（h-EGF）治疗44例下肢静脉溃疡患者。将h-EGF的水溶液（10微克/毫升）每天两次局部应用于溃疡，直至愈合或最长使用10周。每周对患者进行评估，测量溃疡大小以及适合移植的肉芽组织形成情况。9例患者因违反方案被排除在疗效评估之外。因此，35例患者（17例h-EGF组，18例安慰剂组）可进行疗效评估，44例患者（22例h-EGF组，22例安慰剂组）可进行安全性评估。所有患者溃疡基线大小的中位数为18.5平方厘米，h-EGF组和安慰剂组之间无显著差异（分别为12.9平方厘米和19.2平方厘米，P = 0.27）。到研究结束时，h-EGF治疗组的6例（35%）患者和安慰剂组的2例（11%）患者已完全愈合（P = 0.10）。另外6例患者（h-EGF组17例中的2例，安慰剂组18例中的4例；P = 0.50）长出了适合移植的健康肉芽组织。h-EGF组溃疡大小每周中位数减少7%，安慰剂组为3%（P = 0.29），研究结束时分别为73%和33%（P = 0.32）。未发现与应用h-EGF相关的不良副作用。我们得出结论，以本研究中使用的剂量和方式局部应用h-EGF是安全的，但未能显著增强静脉溃疡的再上皮化。然而，使用h-EGF使溃疡大小有更大程度的缩小以及更多患者溃疡愈合，这些结果令人鼓舞。
