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美国FDA于2013年12月6日批准Auxilium Pharmaceuticals,Inc.公司的Xiaflex(collagenase clostridium histolyticum,溶组织梭菌胶原酶)用于治疗佩罗尼氏病(Peyronie’s disease,又称阴茎硬结症)。这是FDA批准的首种用于治疗此病的药品。Xiaflex是一种生物药品,最早于2010年获FDA批准用于治疗掌腱膜挛缩症(Dupuytren’s contracture),此次被获准用于治疗佩罗尼氏病只是增加其适应证范围。佩罗尼氏病又称阴茎硬结症,患者阴茎内部长有硬结肿块(疤痕组织),导致阴茎勃起时形成至少30°的弯曲畸形,通常造成性交障碍。之前佩罗尼氏病的治疗方法只有通过外科手术切除阴茎内的硬结肿块,但效果常不够
The U.S. FDA approved Xiaflex (Collagenase Clostridium histolyticum) from Auxilium Pharmaceuticals, Inc. on December 6, 2013 for the treatment of Peyronie’s disease (Peyronie’s disease). This is the first FDA-approved drug to treat the disease. Xiaflex, a biopharmaceutical product, was first approved by the FDA in 2010 for the treatment of Dupuytren’s contracture. The approval for Peyronie’s disease this time merely adds to the range of indications. Peyronie’s disease, also known as penile sclerosis, has long tuberculous masses (scar tissue) in the penis, resulting in a flexion deformity of at least 30 ° at penile erection, often resulting in sexual intercourse. Peyronie’s disease before the treatment is only by surgical removal of the penile tuberculoma, but the effect is often not enough