Why Are There So Few FDA-Approved Therapeutics for Wound Healing?
Why Are There So Few FDA-Approved Therapeutics for Wound Healing?
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DOI：
10.3390/ijms242015109
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发表时间：
2023-10-12
影响因子：
5.6
通讯作者：
Li W
中科院分区：
文献类型：
--
作者：
Chen M;Chang C;Levian B;Woodley DT;Li W
自从25年前FDA批准贝卡普明凝胶(RegranexTM，0.01%人重组PDGF-BB)作为(糖尿病)伤口愈合疗法以来，没有任何一种新的疗法(不包括物理疗法、设备、敷料、抗菌剂或其他预防性治疗)进入临床应用。在同一时期，FDA批准了另外250种治疗各种人类肿瘤的新药，这些肿瘤被著名地描述为“无法愈合的伤口”。两种相似的病理情况在治疗方法上经历了如此巨大的差异。更令人惊讶的是，伤口愈合界中似乎很少有人对这种神秘的缺陷感到震惊。正如人们常说的，“破坏比重建容易得多”。与抗癌药物破坏信号网络的单个分子的主要职责不同，伤口修复药物必须能够重建伤口中的多个层次的损害。没有已知的单一分子能够同时修复多细胞类型和多途径的损伤。我们认为，以前发展伤口愈合疗法的单分子策略在理论上存在严重缺陷。未来有效的伤口愈合疗法的成功需要从根本上改变这一范式。
Since the only and the milestone FDA approval of becaplermin gel (RegranexTM, 0.01% human recombinant PDGF-BB) as a (diabetic) wound healing therapeutic more than 25 years ago, no new therapeutic (excluding physical therapies, devices, dressings, anti-microbial agents, or other preventive treatments) for any type of wound healing has advanced to clinical applications. During the same period of time, the FDA has approved additional 250 new drugs for various human tumors, which were famously described as “wounds that do not heal”. Two similar pathological conditions have experienced such a dramatic difference in therapeutics. More surprisingly, few in the wound healing community seem to be alarmed by this mysterious deficit. As it is often said, “damaging is far easier than re-building”. In contrast to the primary duty of a cancer drug to damage a single molecule of the signaling network, a wound healing drug must be able to re-build the multi-level damages in the wound. No known single molecule alone is capable of repairing multi-cell-type and multi-pathway damages all at once. We argue that the previous single molecule-based strategy for developing wound healing therapeutics is profoundly flawed in theory. The future success of effective wound healing therapeutics requires a fundamental change in the paradigm.
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影响因子：
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