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为什么只有很少的FDA批准的治疗方法用于伤口愈合?

Mei Chen¹, Cheng Chang¹, Brandon Levian¹

¹Department of Dermatology, USC-Norris Comprehensive Cancer Center, University of Southern California Keck Medical Center, Los Angeles, CA 90033, USA.

International journal of molecular sciences

|October 28, 2023

概括

25年来,没有新的伤口愈合疗法得到批准,与癌症药物不同. 需要一个新的范式,因为单分子治疗不能重建复杂的伤口损伤.

科学领域:

再生医学是一种再生医学.
生物技术是生物技术.
药物开发药物开发

背景情况:

25多年来,FDA没有批准用于伤口愈合的新疗法,不同于对各种人类瘤批准的250多种药物.
贝卡普莱明凝 (Regranex,0.01%的人类重组PDGF-BB) 仍然是FDA批准的唯一用于伤口愈合的治疗药物,突出了治疗选择中的重大差距.
伤口愈合与瘤学之间的治疗进步差异,尽管病理学描述的相似之处,如"不愈合的伤口",是一个关键问题.

研究的目的:

批判性地评估伤口愈合的历史治疗发展策略.
确定基于单分子的方法在解决复杂的伤口病理方面的理论局限性.
为未来开发有效的伤口愈合疗法提出必要的范式转变.

主要方法:

在伤口愈合和瘤之间对药物批准趋势的比较分析.
理论评估分子修复能力与复杂组织再生要求的理论评估.
文献审查和对现有的伤口愈合治疗策略的批判性评估.

主要成果:

在治疗创新方面存在鲜明的对比,伤口愈合远远落后于瘤学药物开发.
单分子疗法在理论上不足以解决与伤口愈合固有的多层次,多细胞和多途径损伤.
针对单个分子进行伤口修复的现有策略从根本上是有缺陷的.

结论:

目前的基于单个分子的策略,用于开发伤口愈合疗法是不充分的,需要从根本上重新评估.
伤口愈合的未来进步需要向更全面,多方面的治疗方法转变范式.
解决伤口愈合疗法缺陷需要创新策略,超越当前分子标的局限性.

关键词:

建筑商对阵破坏者治疗药物治疗药物伤口愈合伤口愈合

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