University of North Carolina, Division of Urology, Chapel Hill, NC 27599-7235, USA.
Expert Rev Med Devices. 2010 May;7(3):311-7. doi: 10.1586/erd.10.6.
Inflatable penile prostheses are the definitive therapy for erectile dysfunction refractory to medical therapy. For years mechanical malfunction was the most common cause of device failure, but recent advances in design have largely eliminated this, and now infection is the most significant problem with these implants. Antibiotic-coated medical devices, such as central venous and bladder catheters, have proven effective in reducing bacterial colonization and biofilm formation, leading to decreased rates of infection. In 2001, American Medical Systems (AMS) released its AMS 700 series penile prosthesis impregnated with a proprietary combination of the antibiotics rifampin and minocycline, called InhibiZone. Multiple studies have found that this device significantly reduces infection rates in men receiving penile prostheses. In July 2009, the US FDA approved the AMS 700 with InhibiZone as the only inflatable penile prosthesis with clinical evidence showing significant reduction in the rate of revision surgery due to infection.
可膨胀阴茎假体是治疗对药物治疗无反应的勃起功能障碍的确定性疗法。多年来,机械故障是器械故障的最常见原因,但最近在设计方面的进步在很大程度上消除了这一问题,现在感染是这些植入物最严重的问题。抗生素涂层医疗器械,如中心静脉和膀胱导管,已被证明可有效减少细菌定植和生物膜形成,从而降低感染率。2001 年,美国医疗系统(AMS)发布了其 AMS 700 系列阴茎假体,该假体用专有组合抗生素利福平(rifampin)和米诺环素(minocycline)浸渍,称为 InhibiZone。多项研究发现,该器械可显著降低接受阴茎假体植入的男性的感染率。2009 年 7 月,美国食品和药物管理局(FDA)批准了 AMS 700 与 InhibiZone,这是唯一一种具有临床证据表明可显著降低因感染而进行翻修手术的充气阴茎假体。