Traore Elizabeth J, Wang William, Yafi Faysal A, Hellstrom Wayne J G
Department of Urology, Tulane University School of Medicine, New Orleans, LA, USA.
Department of Urology, Tulane University Health Sciences Center, 1430 Tulane Avenue SL-42, New Orleans, LA 70112, USA.
Ther Adv Urol. 2016 Jun;8(3):192-202. doi: 10.1177/1756287216637569. Epub 2016 Mar 22.
Peyronie's disease (PD) is a connective tissue disorder resulting in the abnormal accumulation of scar or plaques in the tunica albuginea of the penis. The condition is characterized by two phases: an active, inflammatory phase, and a stable, chronic phase. Collagenase Clostridium histolyticum (CCH) was isolated in the mid-1900s and postulated as a potential pharmacologic strategy for breaking down the abnormal connective tissue plaques of PD. Prior to the introduction of CCH, a wide variety of treatment modalities for PD were used in clinical practice, including oral and topical medications, intralesional injections, electromotive drug administration, extracorporeal shockwave therapy, traction, and invasive surgery, all with variable results. This review aims to examine the known data surrounding the use of intralesional CCH injections in the treatment of PD.
CCH is a recently US Food and Drug Administration approved pharmacologic treatment for PD. Clinical trials using intralesional CCH injection therapy for the treatment of PD were reviewed for clinical safety and efficacy of treatment.
Studies demonstrated that CCH treatment administered in multiple cycles led to significant benefit in both the psychological and physical aspects of PD. The strongest evidence for CCH's effectiveness was revealed in large, multicenter randomized controlled trials (Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies I and II) in which intralesional CCH was combined with manual modeling of the penis. Although adverse events from treatment are relatively common, the majority are mild to moderate in degree, including penile pain, swelling, and bruising, which all resolve spontaneously.
Overall, evidence indicates that CCH is a valuable, effective, and safe minimally invasive treatment option for men with PD.
佩罗尼氏病(PD)是一种结缔组织疾病,会导致阴茎白膜中瘢痕或斑块异常积聚。该病有两个阶段:活跃的炎症阶段和稳定的慢性阶段。溶组织梭状芽孢杆菌胶原酶(CCH)于20世纪中叶分离出来,并被认为是分解佩罗尼氏病异常结缔组织斑块的一种潜在药物策略。在CCH引入之前,临床实践中使用了多种治疗佩罗尼氏病的方法,包括口服和外用药物、病灶内注射、电动药物给药、体外冲击波疗法、牵引和侵入性手术,所有这些方法的效果各不相同。本综述旨在研究有关病灶内注射CCH治疗佩罗尼氏病的已知数据。
CCH是美国食品药品监督管理局最近批准的一种治疗佩罗尼氏病的药物。对使用病灶内注射CCH治疗佩罗尼氏病的临床试验进行了回顾,以评估治疗的临床安全性和有效性。
研究表明,多周期给予CCH治疗在佩罗尼氏病的心理和身体方面均带来显著益处。在大型多中心随机对照试验(最大程度减少佩罗尼氏病疗效和安全性研究I和II)中,病灶内注射CCH与阴茎手法塑形相结合,揭示了CCH有效性的最有力证据。虽然治疗引起的不良事件相对常见,但大多数为轻度至中度,包括阴茎疼痛、肿胀和瘀伤,这些都会自行消退。
总体而言,证据表明CCH对于患有佩罗尼氏病的男性是一种有价值、有效且安全的微创治疗选择。