Gelbard Martin K, Chagan Larisa, Tursi James P
Urology Associates Medical Group, Burbank, CA, USA.
Auxilium Pharmaceuticals, Chesterbrook, PA, USA.
J Sex Med. 2015 Jun;12(6):1481-9. doi: 10.1111/jsm.12904. Epub 2015 May 5.
The conception of collagenase Clostridium histolyticum (CCH) as treatment for Peyronie's disease (PD) was a vital first step in providing a nonsurgical, minimally invasive FDA-approved treatment for men with PD.
To review the origins, clinical research history, and ultimately FDA approval of collagenase as PD treatment.
A PubMed search using (Peyronie's or Peyronie) AND collagenase, and limited to clinical research studies, returned nine papers that were examined in the current review.
Collagenase as a PD treatment arose in response to a lack of effective nonsurgical treatments and the incomplete understanding of underlying PD etiology. Awareness of dense collagen in PD scarring and parallel initial exploration of collagenase to treat herniated lumbar discs coincided with and inspired laboratory-based investigation of collagenase effects on excised PD plaque tissue. The foundational conceptual work and the critical development of purified injectable collagenase allowed the pursuit of clinical studies. Progression of clinical studies into large-scale robust trials culminated in two important outcomes: development of the first validated, PD-specific measure of psychosexual function, the Peyronie's Disease Questionnaire, and the first FDA-approved treatment for PD.
Collagenase therapy began as an attempt to modify the structure of PD-related tunica albuginea scarring, despite the lack of a fundamental understanding of the scar's origin. If we wish to advance PD treatment beyond this first effective step, the future needs to bring us full circle to the starting point: We need a greater understanding of the control of collagen deposition and wound healing in men with PD.
将溶组织梭状芽孢杆菌胶原酶（CCH）用于治疗佩罗尼氏病（PD）的构想，是为患有PD的男性提供一种经美国食品药品监督管理局（FDA）批准的非手术、微创治疗方法的关键第一步。
回顾胶原酶作为PD治疗方法的起源、临床研究历史以及最终获得FDA批准的过程。
在PubMed上使用（佩罗尼氏病或佩罗尼）和胶原酶进行搜索，并仅限于临床研究，共检索到9篇论文，在本次综述中对其进行了审查。
由于缺乏有效的非手术治疗方法以及对PD潜在病因的不完全了解，胶原酶作为一种PD治疗方法应运而生。对PD瘢痕中致密胶原的认识以及同时对胶原酶治疗腰椎间盘突出症的初步探索，与基于实验室对胶原酶对切除的PD斑块组织作用的研究相契合并激发了该研究。纯化可注射胶原酶的基础概念性工作和关键发展使得能够开展临床研究。临床研究进展到大规模有力试验最终产生了两个重要成果：首个经过验证的、针对PD的性心理功能特异性测量工具——佩罗尼氏病问卷的开发，以及首个获得FDA批准的PD治疗方法。
尽管对瘢痕起源缺乏基本了解，但胶原酶疗法最初是试图改变与PD相关的白膜瘢痕结构。如果我们希望将PD治疗推进到这第一个有效步骤之外，未来需要让我们回到起点：我们需要更深入地了解PD男性中胶原沉积和伤口愈合的控制机制。
