Bella Anthony J, Brant William O, Lue Tom F, Brock Gerald B
Department of Urology, University of California, San Francisco, California 94143-0738, USA.
Can J Urol. 2006 Oct;13(5):3233-8.
To determine whether a causative relationship exists between non-arteritic anterior ischemic optic neuropathy (NAION) and the use of phosphodiesterase-5 (PDE-5) inhibitors for the treatment of erectile dysfunction.
A comprehensive review of the literature was performed to identify the contemporary understanding of NAION pathophysiology, epidemiology, and occurrence in men using the oral PDE-5 inhibitors sildenafil (Viagra, Pfizer), vardenafil (Levitra, Bayer AG), and tadalafil (Cialis, Lilly-ICOS LLC) for the treatment of erectile dysfunction.
NAION is the second most common acquired optic neuropathy in men aged 50 years and older. Risk factors for NAION, cardiovascular disease, and erectile dysfunction are shared and include age, dyslipidemia, diabetes, hypertension, and cigarette smoking. To date, less than 50 cases of NAION associated with PDE-5 use have been reported to the United State's Food and Drug Administration (FDA) and five Canadian cases alerted to Health Canada. Given the large number of men safely using these agents and a limited number of events, it is not possible to determine whether NAION is directly linked to the use of PDE-5 inhibitors, underlying cardiovascular risk factors, ocular anatomical defects, a combination of these variables, or as yet unidentified factors.
PDE-5 inhibitors have gained widespread use for the treatment of erectile dysfunction due to their safety, efficacy, and ease of use. Their role in the pathogenesis of NAION remains controversial. Reasonable and informed consent regarding the possible but low risk of NAION with the use of sildenafil, vardenafil and tadalafil is recommended. Loss or decreased vision, whether painful or painless, demands urgent patient assessment and immediate cessation of PDE-5 inhibitor use.
确定非动脉炎性前部缺血性视神经病变(NAION)与使用磷酸二酯酶-5(PDE-5)抑制剂治疗勃起功能障碍之间是否存在因果关系。
对文献进行全面综述,以了解当代对NAION病理生理学、流行病学以及在使用口服PDE-5抑制剂西地那非(伟哥,辉瑞公司)、伐地那非(艾力达,拜耳公司)和他达拉非(希爱力,礼来-伊科斯公司)治疗勃起功能障碍的男性中其发生情况的认识。
NAION是50岁及以上男性中第二常见的后天性视神经病变。NAION、心血管疾病和勃起功能障碍的危险因素有共同之处,包括年龄、血脂异常、糖尿病、高血压和吸烟。迄今为止,向美国食品药品监督管理局(FDA)报告的与使用PDE-5相关的NAION病例不到50例,向加拿大卫生部通报了5例加拿大病例。鉴于大量男性安全使用这些药物且事件数量有限,无法确定NAION是否与使用PDE-5抑制剂、潜在的心血管危险因素、眼部解剖缺陷、这些变量的组合或尚未明确的因素直接相关。
PDE-5抑制剂因其安全性、有效性和易用性而在勃起功能障碍治疗中得到广泛应用。它们在NAION发病机制中的作用仍存在争议。建议就使用西地那非、伐地那非和他达拉非可能但风险较低的NAION情况获得合理且知情的同意。无论有无疼痛,视力丧失或下降都需要对患者进行紧急评估并立即停止使用PDE-5抑制剂。