Hellstrom Wayne J G, Sikka Suresh C
Department of Urology, Tulane University Health Sciences Center, New Orleans, Louisiana 70112, USA.
J Urol. 2006 Oct;176(4 Pt 1):1529-33. doi: 10.1016/j.juro.2006.06.004.
The frequency of ejaculatory dysfunction in men varies among the alpha-blockers used in the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia. We assessed the effect of acute administration of tamsulosin, alfuzosin and placebo on ejaculate volume and sperm concentration in post-ejaculate urine, and addressed the mechanism of action of tamsulosin and alfuzosin on ejaculation.
Using a randomized, 3-way crossover design, the effects of 5 days of treatment with 0.8 mg tamsulosin daily, 10 mg alfuzosin daily and placebo on ejaculation in healthy adult men were compared. The primary end points of the study were ejaculate volume and sperm concentration in post-ejaculate urine on each treatment. To aid in clinical interpretation of primary efficacy end points, each primary end point was transformed into a binary outcome, that is subjects with a greater than 20% decrease in ejaculate volume and subjects with a greater than 20% increase in sperm concentration in post-ejaculate urine.
In healthy volunteers who completed the study (48), tamsulosin resulted in significantly decreased ejaculate volume (-2.4 +/- 0.17 ml) compared to alfuzosin (+0.3 +/- 0.18 ml, p < 0.0001 vs tamsulosin) or placebo (+0.4 +/- 0.18 ml, p < 0.0001 vs tamsulosin, p = nonsignificant vs alfuzosin). Among completers the incidence of more than 20% decreased ejaculate volume was significantly greater with tamsulosin (89.6%) compared to alfuzosin (20.8%, p < 0.0001 vs tamsulosin) or placebo (12.5%, p < 0.0001 vs tamsulosin, p = nonsignificant vs alfuzosin). While on tamsulosin 35.4% of 48 completers had complete lack of ejaculation (anejaculation) and no subjects experienced anejaculation while on alfuzosin or placebo.
On 0.8 mg tamsulosin daily ejaculatory function in subjects was marked by decreased ejaculate volume in almost 90% of subjects and anejaculation in approximately 35% of participants. These ejaculatory disorders with tamsulosin were not attributed to retrograde ejaculation. In contrast, anejaculation was not observed in any subjects in the alfuzosin or placebo groups.
用于治疗与良性前列腺增生相关的下尿路症状的α受体阻滞剂，在男性中引起射精功能障碍的频率有所不同。我们评估了坦索罗辛、阿夫唑嗪和安慰剂急性给药对射精量及射精后尿液中精子浓度的影响，并探讨了坦索罗辛和阿夫唑嗪对射精的作用机制。
采用随机、三向交叉设计，比较了健康成年男性每日服用0.8mg坦索罗辛、每日服用10mg阿夫唑嗪和安慰剂，连续治疗5天对射精的影响。该研究的主要终点是每种治疗方式下的射精量及射精后尿液中的精子浓度。为辅助对主要疗效终点进行临床解读，将每个主要终点转化为二元结果，即射精量减少超过20%的受试者，以及射精后尿液中精子浓度增加超过20%的受试者。
在完成研究的48名健康志愿者中，与阿夫唑嗪（射精量增加0.3±0.18ml，与坦索罗辛相比p<0.0001）或安慰剂（射精量增加0.4±0.18ml，与坦索罗辛相比p<0.0001，与阿夫唑嗪相比p无统计学意义）相比，坦索罗辛导致射精量显著减少（-2.4±0.17ml）。在完成研究的受试者中，射精量减少超过20%的发生率，坦索罗辛组（89.6%）显著高于阿夫唑嗪组（20.8%，与坦索罗辛相比p<0.0001）或安慰剂组（12.5%，与坦索罗辛相比p<0.0001，与阿夫唑嗪相比p无统计学意义）。服用坦索罗辛时，48名完成研究的受试者中有35.4%完全无射精（无射精症），而服用阿夫唑嗪或安慰剂时无受试者出现无射精症。
每日服用0.8mg坦索罗辛时，近90%的受试者射精功能表现为射精量减少，约35%的参与者出现无射精症。坦索罗辛引起的这些射精障碍并非逆行射精所致。相比之下，阿夫唑嗪组或安慰剂组的任何受试者均未观察到无射精症。
