Abdel Raheem Amr, Johnson Mark, Ralph David, Garaffa Giulio
Department of Andrology, The Institute of Urology, University College London Hospitals, London, UK -
Department of Andrology, Cairo University Hospital, Cairo, Egypt -
Minerva Urol Nefrol. 2018 Aug;70(4):380-385. doi: 10.23736/S0393-2249.18.03118-1. Epub 2018 May 14.
Peyronie's disease (PD) affects up to 9% of the male population. PD causes scarring of the tunica albuginea of the penis which leads to penile deformity making sexual intercourse difficult or impossible. PD also causes significant psychological, emotional and relationship difficulties for both patient and partner. Up until the licencing of Collagenase clostridium histolyticum (CCH) (Xiapex®, Xiaflex®), surgical correction of the penile deformity was the mainstay of treatment. Many conservative treatment options had been previously tried, however, the safety and efficacy of these options has not been demonstrated in large well-designed clinical trials. Intra-lesional CCH is now the gold standard option for the non-surgical management of PD. It is the first and only treatment approved by the Food and Drug Administration and the European Medicines Agency for PD. In this review article, we will discuss the pharmacology, clinical efficacy, safety and future of CCH intralesional injection.
MEDLINE and PubMed search (from 1946). The search terms ("Collagenase Clostridium Histolyticum" OR "Xiapex" OR "Xiaflex") AND "Peyronie's disease" were used.
The safety and efficacy of intra-lesional CCH in the management of PD has been demonstrated in 2 large-scale multicenter, randomized, double-blind placebo-controlled clinical trials; the investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies I and II (IMPRESS I and IMPRESS II). A new study published by our group suggests a new modified shortened protocol that will reduce the cost and duration of treatment without compromising the safety or efficacy of treatment.
CCH is the gold standard non-surgical option in the management of PD. The safety and efficacy of CCH has been demonstrated in large well-designed clinical trials. The new modified protocol, developed by our group, reduces the cost and inconvenience to patients whilst maintaining the efficacy. This will allow more men to benefit and will reduce the number of men undergoing surgical correction for their PD.
佩罗尼氏病（PD）影响着高达9%的男性人群。PD会导致阴茎白膜瘢痕形成，进而引起阴茎畸形，使性交困难或无法进行。PD还会给患者及其伴侣带来严重的心理、情感和人际关系问题。在溶组织梭菌胶原酶（CCH）（Xiapex®，Xiaflex®）获批之前，阴茎畸形的手术矫正一直是主要的治疗方法。此前曾尝试过许多保守治疗方案，然而，这些方案的安全性和有效性尚未在大型精心设计的临床试验中得到证实。病灶内注射CCH现在是PD非手术治疗的金标准选择。它是美国食品药品监督管理局和欧洲药品管理局批准的首个也是唯一用于PD的治疗方法。在这篇综述文章中，我们将讨论CCH病灶内注射的药理学、临床疗效、安全性及未来发展。
检索MEDLINE和PubMed（始于1946年）。检索词为（“溶组织梭菌胶原酶”或“Xiapex”或“Xiaflex”）以及“佩罗尼氏病”。
病灶内注射CCH治疗PD的安全性和有效性已在两项大型多中心、随机、双盲、安慰剂对照临床试验中得到证实；即最大佩罗尼氏病缩小疗效与安全性研究I和II（IMPRESS I和IMPRESS II）。我们团队发表的一项新研究提出了一种新的改良缩短方案，该方案将降低治疗成本和疗程，同时不影响治疗的安全性或有效性。
CCH是PD治疗的金标准非手术选择。CCH的安全性和有效性已在大型精心设计的临床试验中得到证实。我们团队开发的新改良方案降低了成本和患者的不便，同时保持了疗效。这将使更多男性受益，并减少因PD接受手术矫正的男性数量。
