服用伐地那非6个月精子数量活性不受影响
服用伐地那非6个月精子数量活性不受影响
Urol. 2008 Jan 17 [Epub ahead of print]
Daily Vardenafil for 6 Months Has No Detrimental Effects on Semen Characteristics or Reproductive Hormones in Men With Normal Baseline Levels.
Jarvi K, Dula E, Drehobl M, Pryor J, Shapiro J, Seger M.
Mount Sinai Hospital (KJ), Toronto, Ontario, Canada.
PURPOSE: Phosphodiesterase type 5 inhibitors are the first choice therapy in the treatment of erectile dysfunction. Many men in their reproductive years are now using phosphodiesterase type 5 inhibitors. The purpose of this study was to determine the effects of 6 months of treatment with 20 mg vardenafil, compared with 100 mg sildenafil and placebo, on semen characteristics and reproductive hormones in men with and without erectile dysfunction.
MATERIALS AND METHODS: This was a randomized, double-blind, placebo controlled, parallel group, multicenter study. A total of 200 men with or without erectile dysfunction, able to produce semen samples without erectile dysfunction therapy, 25 to 64 years old, were randomized to daily treatment with vardenafil, sildenafil or placebo for 6 months. The primary variable was the percentage of vardenafil treated individuals with a 50% or greater decrease in mean sperm concentration from baseline to 6-month last observation carried forward, compared with placebo treated individuals.
RESULTS: The between group difference (vardenafil minus placebo) in the percentage of patients with 50% or greater decrease in sperm concentration (baseline to 6 months last observation carried forward) was 0.07% (95% CI, -8.53% to 8.39%). Vardenafil also had no clinically significant effects on any other semen parameters, or on levels of reproductive hormones, when compared with placebo. Similar data were observed with sildenafil.
CONCLUSIONS: This study demonstrated that vardenafil had no adverse effects on sperm concentration, compared with sildenafil and placebo, when administered daily at the maximum recommended dose for 6 months. Specifically, use of vardenafil for 6 months does not impair sperm concentration, total sperm count per ejaculate, or sperm morphology and motility. Levels of reproductive hormones were also unaffected.
Urol. 2008 Jan 17 [Epub ahead of print]
Daily Vardenafil for 6 Months Has No Detrimental Effects on Semen Characteristics or Reproductive Hormones in Men With Normal Baseline Levels.
服用伐地那非6个月对基线水平正常的男性的精液或生殖激素没有危害
Jarvi K, Dula E, Drehobl M, Pryor J, Shapiro J, Seger M.
Mount Sinai Hospital (KJ), Toronto, Ontario, Canada.
PURPOSE: Phosphodiesterase type 5 inhibitors are the first choice therapy in the treatment of erectile dysfunction. Many men in their reproductive years are now using phosphodiesterase type 5 inhibitors. The purpose of this study was to determine the effects of 6 months of treatment with 20 mg vardenafil, compared with 100 mg sildenafil and placebo, on semen characteristics and reproductive hormones in men with and without erectile dysfunction.
目的：磷酸二酯酶5抑制剂是治疗勃起功能障碍的首选用药。目前许多生育期男性在服用磷酸二酯酶5抑制剂。本研究的目的是了解在接受6个月的伐地那非（20mg）、西地那非（100mg）和安慰剂治疗后，有和无勃起功能障碍的男性的精液和生殖激素的变化情况。
MATERIALS AND METHODS: This was a randomized, double-blind, placebo controlled, parallel group, multicenter study. A total of 200 men with or without erectile dysfunction, able to produce semen samples without erectile dysfunction therapy, 25 to 64 years old, were randomized to daily treatment with vardenafil, sildenafil or placebo for 6 months. The primary variable was the percentage of vardenafil treated individuals with a 50% or greater decrease in mean sperm concentration from baseline to 6-month last observation carried forward, compared with placebo treated individuals.
材料和方法：这是一项随机、对照、双盲、平行分组、多中心的研究。共有200名年龄在25到64岁之间的男性纳入研究。这些男性有或无勃起功能障碍，且能在不接受勃起功能障碍治疗的情况下提供精液标本。将受试者随机分组，分别每日给予服用伐地那非、西地那非或安慰剂，持续6个月。研究内容主要是观察伐地那非组中在6个月后平均精子浓度较基线水平下降50%或更多的人数比例，并将其与安慰剂组做对比。
RESULTS: The between group difference (vardenafil minus placebo) in the percentage of patients with 50% or greater decrease in sperm concentration (baseline to 6 months last observation carried forward) was 0.07% (95% CI, -8.53% to 8.39%). Vardenafil also had no clinically significant effects on any other semen parameters, or on levels of reproductive hormones, when compared with placebo. Similar data were observed with sildenafil.
结果：在6个月后平均精子浓度较基线水平下降50%或更多的人数比例方面，伐地那非组与安慰剂组的组间差异为0.07%（95%可信区间为-8.53% 到 8.39%）。与安慰剂组相比，伐地那非对精液的其他参数或生殖激素的水平的影响也没有临床意义。西地那非组也获得类似的结果。
CONCLUSIONS: This study demonstrated that vardenafil had no adverse effects on sperm concentration, compared with sildenafil and placebo, when administered daily at the maximum recommended dose for 6 months. Specifically, use of vardenafil for 6 months does not impair sperm concentration, total sperm count per ejaculate, or sperm morphology and motility. Levels of reproductive hormones were also unaffected.
结论：该研究表明与西地那非和安慰剂相比，按照最大推荐剂量每日服用伐地那非并持续6个月不会对精子浓度造成不良影响。另外明确的一点是服用伐地那非6个月不会对精子浓度、每次射精的总精子数或精子的形态和活力造成损害。生殖激素的水平也不会受到影响。