Center for Genetic Engineering and Biotechnology (CIGB), Havana, Cuba.
MEDICC Rev. 2013 Jan;15(1):11-5. doi: 10.37757/MR2013V15.N1.4.
Diabetic foot ulcer is a principal diabetic complication. It has been shown that diabetic patients have decreased growth factor concentrations in their tissues, particularly epidermal growth factor. Growth factor shortage impairs wound healing, which leads to chronic nonhealing wounds and sometimes eventual amputation. Ischemic diabetic foot ulcer is the most difficult to treat and confers the highest amputation risk. Injecting epidermal growth factor deep into the wound bottom and contours encourages a more effective pharmacodynamic response in terms of granulation tissue growth and wound closure. Epidermal growth factor injected into the ulcer matrix may also result in association with extracellular matrix proteins, thus enhancing cell proliferation and migration. Heberprot-P is an innovative Cuban product containing recombinant human epidermal growth factor for peri- and intra-lesional infiltration; evidence reveals it accelerates healing of deep and complex ulcers, both ischemic and neuropathic, and reduces diabetes-related amputations. Clinical trials of Heberprot-P in patients with diabetic foot ulcers have shown that repeated local infiltration of this product can enhance healing of chronic wounds safely and efficaciously. As a result, Heberprot-P was registered in Cuba in 2006, and in 2007 was included in the National Basic Medications List and approved for marketing. It has been registered in 15 other countries, enabling treatment of more than 100,000 patients. Heberprot-P is a unique therapy for the most complicated and recalcitrant chronic wounds usually associated with high amputation risk. Local injection in complex diabetic wounds has demonstrated a favorable risk-benefit ratio by speeding healing, reducing recurrences and attenuating amputation risk. Further testing and deployment worldwide of Heberprot-P would provide an opportunity to assess the product's potential to address an important unmet medical need.
糖尿病足溃疡是一种主要的糖尿病并发症。已经表明，糖尿病患者的组织中生长因子浓度降低，特别是表皮生长因子。生长因子的缺乏会损害伤口愈合，导致慢性不愈合的伤口，有时最终导致截肢。缺血性糖尿病足溃疡是最难治疗的，截肢风险最高。将表皮生长因子深层注射到伤口底部和轮廓处，可以促进肉芽组织生长和伤口闭合方面更有效的药效反应。表皮生长因子注入溃疡基质中也可能与细胞外基质蛋白结合，从而增强细胞增殖和迁移。Heberprot-P 是古巴的一种创新产品，含有重组人表皮生长因子，用于周边和腔内浸润；有证据表明，它可以加速缺血性和神经性深而复杂溃疡的愈合，并减少与糖尿病相关的截肢。Heberprot-P 在糖尿病足溃疡患者中的临床试验表明，重复局部浸润该产品可以安全有效地促进慢性伤口的愈合。因此，Heberprot-P 于 2006 年在古巴注册，并于 2007 年被列入国家基本药物清单并获准上市。它已在其他 15 个国家注册，使超过 10 万名患者得到治疗。Heberprot-P 是一种独特的疗法，适用于最复杂和难治性的慢性溃疡，通常与高截肢风险相关。在复杂的糖尿病伤口中进行局部注射，通过加速愈合、减少复发和降低截肢风险，显示出良好的风险效益比。在全球范围内进一步测试和部署 Heberprot-P 将有机会评估该产品解决重要未满足医疗需求的潜力。
