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目的:评估单剂量枸橼酸西地那非片对早期年龄相关性黄斑变性(AMD)男性患者视功能的急性效应。方法:早期年龄相关性黄斑变性男40例,年龄58～86(平均71)岁,前瞻性随机接受安慰剂或者枸橼酸西地那非片(Viagra;Pfizer Inc,New York,NY)100mg,单次口服。受试者双眼在接受药物之前及之后9h内特定的时间间期进行视力、Amsler方格表及辨色力检查。结果:与安慰剂相比,服用枸橼酸西地那非片后视功能检查均未有明显改变。视力和辨色力检查在基线水平上未见有统计意义或临床相关的改变,Amsler方格表检查未见临床相关的改变。服用枸橼酸西地那非片与短暂的轻度至中度头痛和面红有关。结论:单次口服100mg枸橼酸西地那非片,在早期年龄相关性黄斑变性男性样本人群中,耐受性良好,未对视觉产生显著急性效应。
PURPOSE: To evaluate the acute effect of single-dose sildenafil citrate on visual function in men with early age-related macular degeneration (AMD). METHODS: Forty patients with age-related age-related macular degeneration, aged 58 to 86 years (mean, 71 years), were prospectively randomized to placebo or 100 mg of Viagra; Pfizer Inc, New York, Single oral. Subjects underwent visual acuity, Amsler checklist, and colorimetric examination at specific time intervals within 9 hours before and after receiving medication. RESULTS: There was no significant change in the posterior visual function of sildenafil citrate compared with placebo. There was no statistically significant or clinically relevant change in visual acuity and colorimetric examination at the baseline level, and no clinically relevant changes were observed in the Amsler grid. Taking sildenafil citrate tablets is associated with transient mild to moderate headaches and blushing. CONCLUSIONS: A single oral dose of 100 mg sildenafil citrate tablets was well tolerated in the early age-related macular degeneration male sample population with no significant acute effect on vision.