Robson M C, Mustoe T A, Hunt T K
Institute for Tissue Regeneration, Repair and Rehabilitation, Bay Pines, Florida 33744, USA.
Am J Surg. 1998 Aug;176(2A Suppl):80S-82S. doi: 10.1016/s0002-9610(98)00186-x.
For more than a decade, clinical trials have been conducted of the application of topical exogenous recombinant growth factors in attempts to accelerate the healing of chronic wounds. Although the results of some of these trials have been encouraging, overall the results have been somewhat discouraging. Much of the difficulty lies in the paucity of carefully controlled clinical trials of wound healing. Since wound healing is a complex process that can be influenced, both positively and negatively, by many factors, designing these trials has proved difficult. To date, only a single recombinant growth factor-recombinant human platelet-derived growth factor-BB (rhPDGF-BB)- has been approved by the US Food and Drug Administration; and that only for use in diabetic foot ulcers. It is unlikely, however, that a single growth factor will be able to resolve all issues of repair or strengthen all vulnerabilities of chronic wounds. Our expectation, therefore, is that growth factors, cytokines, and other biologic agents will be used more specifically in the future, for example, by targeting growth factor therapy at those specific components or processes that a given wound uses to heal.
十多年来，人们一直在进行局部外用重组生长因子的临床试验，试图加速慢性伤口的愈合。尽管其中一些试验结果令人鼓舞，但总体结果却有些令人沮丧。很大一部分困难在于缺乏对伤口愈合进行严格对照的临床试验。由于伤口愈合是一个复杂的过程，会受到许多因素的正负两方面影响，因此设计这些试验被证明是困难的。迄今为止，美国食品药品监督管理局仅批准了一种重组生长因子——重组人血小板衍生生长因子-BB（rhPDGF-BB）；而且仅用于糖尿病足溃疡。然而，单一生长因子不太可能解决所有修复问题或强化慢性伤口的所有薄弱环节。因此，我们预计未来生长因子、细胞因子和其他生物制剂将得到更具体的应用，例如，将生长因子疗法针对特定伤口愈合所利用的特定成分或过程。
