Department of Urology, Roswell Park Cancer Institute, Buffalo, NY 14263, USA.
J Sex Med. 2011 Oct;8(10):2894-903. doi: 10.1111/j.1743-6109.2011.02382.x. Epub 2011 Jul 19.
Phosphodiesterase type 5 (PDE5) inhibitors are the first line drugs for treatment of erectile dysfunction. Sildenafil (Viagra(R)), tadalafil (Cialis(R)), and vardenafil (Levitra(R)) are from the same class of drugs that inhibit PDE5. Transient visual symptoms such as change in color perception and increased light sensitivity are well-known adverse effects of these drugs and occur in 3-11% of sildenafil users. Vision-threatening (serious) ocular complications, such as nonarteritic ischemic optic neuropathy and cilio-retinal artery occlusion have rarely been reported in PDE5 inhibitor users.
To highlight and analyze the most recently published case literature on serious ocular complications of PDE5 inhibitors.
Search of the peer-reviewed English literature was conducted using Medline. The following databases also were searched: Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, Global Health, and MD Consult. The causality assessment of the reported adverse drug reactions was analyzed by applying both the World Health Organization (WHO) Probability Scale and the criteria utilized by the National Registry of Drug-Induced Ocular Side Effects.
To scientifically and objectively find out if PDE5 inhibitors are associated with vision-threatening ocular complications.
Eight case reports of serious PDE5 inhibitor-associated ocular complications were identified since January 2006 until February 2011. Case reports included cases of anterior and posterior nonarteritic ischemic optic neuropathy, central retinal vein occlusion, cilio-retinal artery occlusion, acute angle closure glaucoma and optic atrophy after sildenafil use.
There is lack of conclusive evidence to indicate a direct cause-effect relationship between PDE5 inhibitor use and vision-threatening ocular events. Men who use PDE5 inhibitors appear to suffer vision-threatening complications at the same frequency as the general population. However, minor visual adverse effects occur in 3-11% of users and they are transient and reversible.
磷酸二酯酶 5（PDE5）抑制剂是治疗勃起功能障碍的一线药物。西地那非（伟哥（R））、他达拉非（希爱力（R））和伐地那非（艾力达（R））均属于抑制 PDE5 的同一类药物。这些药物的已知不良反应包括短暂的视觉症状，如色觉改变和光敏感度增加，发生率为 3-11%的西地那非使用者。PDE5 抑制剂使用者中罕见报告出现威胁视力（严重）的眼部并发症，如非动脉炎性前部缺血性视神经病变和睫状视网膜动脉阻塞。
强调和分析最近发表的关于 PDE5 抑制剂严重眼部并发症的病例文献。
使用 Medline 对同行评议的英文文献进行了检索。还检索了以下数据库：护理和联合健康文献累积索引、Cochrane 图书馆、全球健康和 MD Consult。通过应用世界卫生组织（WHO）概率量表和国家药物诱导性眼部副作用登记处使用的标准，分析报告的药物不良反应的因果关系评估。
客观科学地确定 PDE5 抑制剂是否与威胁视力的眼部并发症相关。
自 2006 年 1 月至 2011 年 2 月，共发现 8 例严重 PDE5 抑制剂相关眼部并发症的病例报告。病例报告包括使用西地那非后发生的前部和后部非动脉炎性前部缺血性视神经病变、视网膜中央静脉阻塞、睫状视网膜动脉阻塞、急性闭角型青光眼和视神经萎缩。
目前尚无确凿证据表明 PDE5 抑制剂的使用与威胁视力的眼部事件之间存在直接的因果关系。使用 PDE5 抑制剂的男性发生威胁视力的并发症的频率与一般人群相同。然而，3-11%的使用者出现轻微的视觉不良反应，这些不良反应是短暂的和可逆的。
