Robson M C, Phillips T J, Falanga V, Odenheimer D J, Parish L C, Jensen J L, Steed D L
Institute of Tissue Regeneration, Repair, and Rehabilitation, Bay Pines, Florida, USA.
Wound Repair Regen. 2001 Sep-Oct;9(5):347-52. doi: 10.1046/j.1524-475x.2001.00347.x.
About 600,000 people in the United States are estimated to be affected by venous ulcers. The cornerstone of care of chronic venous ulcers involves the application of compression bandages. Other therapies include treatment of associated infection, treatment for edema and inflammation, and debridement when necessary. Repifermin, a recombinant human KGF-2 (fibroblast growth factor-10), exerts a proliferative effect on epithelial cells, in vitro and in vivo, and has been shown to accelerate wound healing in several experimental animal models. A randomized, double-blind, parallel-group, placebo-controlled, multicenter study was conducted to evaluate the safety and efficacy of topical repifermin treatment, for 12 weeks, in the healing of chronic venous ulcers in 94 patients. Repifermin was shown to accelerate wound healing, with significantly more patients achieving 75% wound closure with repifermin than with placebo. The treatment effect appeared more marked for a subgroup of patients with initial wound areas < or = 15 cm2 and wound ages of < or = 18 months. A longer duration of treatment (e.g., 26 weeks) may allow better differentiation of the benefit of repifermin compared with placebo, particularly with respect to complete wound closure. The safety assessment showed that repifermin was well tolerated.
据估计，美国约有60万人受到静脉溃疡的影响。慢性静脉溃疡护理的基石包括应用加压绷带。其他治疗方法包括治疗相关感染、治疗水肿和炎症，以及在必要时进行清创。Repifermin是一种重组人KGF-2（成纤维细胞生长因子-10），在体外和体内对上皮细胞具有增殖作用，并且已在多个实验动物模型中显示出可加速伤口愈合。进行了一项随机、双盲、平行组、安慰剂对照、多中心研究，以评估局部应用Repifermin治疗12周对94例慢性静脉溃疡愈合的安全性和有效性。结果显示，Repifermin可加速伤口愈合，与安慰剂相比，使用Repifermin实现75%伤口闭合的患者明显更多。对于初始伤口面积≤15平方厘米且伤口病程≤18个月的患者亚组，治疗效果似乎更为显著。与安慰剂相比，更长疗程的治疗（例如26周）可能会使Repifermin的益处得到更好的区分，特别是在完全伤口闭合方面。安全性评估表明，Repifermin耐受性良好。
