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.%AIM: To assess the effect of a single dose of Sildenafil citrate on the visual function in men with early-stage age-related macular degeneration(AMD).METHODS: Forty men (mean age 71, range from 55-86 years)with early-stage AMD were prospectively randomized to receive either placebo or Sildenafil citrate (Viagra; Pfizer Inc, New York, NY) 100mg as a single oral dose. Subjects underwent visual acuity, Amsler grid and color discrimination in each eye before and at specific intervals within 9 hours after dosing.RESULTS: Compared with placebo, no pattern of errors were evident in any visual function test following Sildenafil administration. No statistically or clinically relevant changes from baseline were observed in visual acuity or color discrimination. No clinically relevant changes were observed in the Amsler grid. Sildenafil treatment was associated with transient mild or moderate headache and flushing. CONCLUSION: A single 100mg dose of Sildenafil was well tolerated and produced no significant acute visual effects in a sample of men with early-stage AMD.
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