Urology Department, Hospital Universitario de Fuenlabrada, Madrid, Spain.
Department of Urology, Hospital de la Zarzuela, Madrid, Spain.
Ther Adv Urol. 2014 Oct;6(5):192-7. doi: 10.1177/1756287214537331.
Peyronie's disease (PD) is a chronic wound-healing disorder characterized by formation of fibrous inelastic scarring of the tunica albuginea resulting in a variety of penile deformities. In most cases, PD is accompanied by a physical and psychological impact. Xiaflex® is an injectable collagenase clostridium histolyticum (CCh) preparation consisting of a predetermined mixture of two distinct collagenases. Recently the US Food and Drug Administration (FDA) approved Xiaflex® for the nonsurgical treatment of men with PD with curvature of 30° or more and tangible scar tissue plaque in their penis.
This article presents a comprehensive review of the updated information on the use of Xiaflex® for the nonsurgical treatment of PD.
Mean improvements in penile curvature ranging from 29% to 34% and in bother domain scores have been reported. The majority of the reported adverse effects are mild or moderate and 79% resolve without intervention.
The combined results of these trials have led to the FDA approval of CCh for the treatment of PD. However, the long-term effects and results need further investigation, with large follow-up series. Considering these results, future perspectives will probably result in the use of a combined or sequential therapy including CCh.
佩罗尼氏病(PD)是一种慢性创伤愈合障碍,其特征是白膜形成纤维性无弹性瘢痕,导致各种阴茎畸形。在大多数情况下,PD 伴有生理和心理影响。Xiaflex®是一种可注射的胶原酶组织溶菌素(CCh)制剂,由两种不同胶原酶的预定混合物组成。最近,美国食品和药物管理局(FDA)批准 Xiaflex®用于非手术治疗 PD 男性,其阴茎弯曲度为 30°或以上,且有明显的瘢痕组织斑块。
本文对 Xiaflex®在非手术治疗 PD 中的最新信息进行了全面综述。
报告称,阴茎弯曲度的平均改善率为 29%至 34%,苦恼域评分也有所改善。大多数报告的不良反应为轻度或中度,79%无需干预即可自行缓解。
这些试验的综合结果导致 FDA 批准 CCh 用于治疗 PD。然而,长期效果和结果需要进一步调查,需要进行更大的随访研究。考虑到这些结果,未来的研究可能会采用包括 CCh 在内的联合或序贯治疗。