Grunwald Juan E, Metelitsina Tatyana, Grunwald Lili
Scheie Eye Institute, Department of Ophthalmology, University of Pennsylvania, Philadelphia, 19104, USA.
Am J Ophthalmol. 2002 Jun;133(6):809-12. doi: 10.1016/s0002-9394(02)01391-0.
The present investigation was conducted to evaluate the effect of sildenafil citrate (Viagra, Pfizer Inc., New York, NY) on retinal blood vessel diameter.
Double-blind randomized, placebo-controlled, cross-over study.
Fifteen healthy male volunteers (mean age 39 years) received 100-mg doses of sildenafil or matching placebo on 2 separate days. Monochromatic fundus photography was obtained in one eye, and brachial artery blood pressure and intraocular pressure were measured at baseline, 1 hour, and 5 hours after dosing. The diameters of two major temporal veins and one artery were measured in a masked fashion from digitized photographic negatives.
In comparison with placebo, no statistically significant change in average venous diameter was observed for the superior (analysis of variance [ANOVA], P =.97), inferior retinal temporal vein (ANOVA, P =.73), or the retinal temporal artery (ANOVA, P =.89) after sildenafil treatment. In comparison to placebo, there was no significant difference in the percentage change from baseline in venous or arterial diameter at 1 or 5 hours after sildenafil. The power to detect a 6.5% change in retinal vascular diameter following sildenafil was approximately 80% (P =.05).
These data suggest that at the maximum therapeutic dose used clinically (100 mg), sildenafil does not have a significant effect on retinal vascular caliber.
进行本研究以评估枸橼酸西地那非(万艾可,辉瑞公司,纽约州纽约市)对视网膜血管直径的影响。
双盲随机、安慰剂对照、交叉研究。
15名健康男性志愿者(平均年龄39岁)在2个不同日期接受100毫克剂量的西地那非或匹配的安慰剂。对一只眼睛进行单色眼底照相,并在给药前、给药后1小时和5小时测量肱动脉血压和眼压。从数字化摄影底片上以盲法测量两条主要颞侧静脉和一条动脉的直径。
与安慰剂相比,西地那非治疗后,上方视网膜颞侧静脉(方差分析[ANOVA],P = 0.97)、下方视网膜颞侧静脉(ANOVA,P = 0.73)或视网膜颞侧动脉(ANOVA,P = 0.89)的平均静脉直径无统计学显著变化。与安慰剂相比,西地那非给药后1小时或5小时,静脉或动脉直径相对于基线的变化百分比无显著差异。检测西地那非后视网膜血管直径6.5%变化的效能约为80%(P = 0.05)。
这些数据表明,在临床使用的最大治疗剂量(100毫克)下,西地那非对视网膜血管口径无显著影响。