Department of Urology, University of Texas Southwestern Medical Center, Dallas, TX 75390-9910, USA.
Prostate Cancer Prostatic Dis. 2011 Jun;14(2):143-8. doi: 10.1038/pcan.2010.46. Epub 2010 Dec 7.
Data from phase 3 studies (NCT00224107, NCT00224120) of silodosin for treatment of BPH symptoms were analyzed to examine the relationship between treatment efficacy and occurrence of abnormal ejaculation. Men aged ≥50 years with International Prostate Symptom Scores (IPSS) ≥13 and peak urinary flow rates (Qmax) of 4-15 ml s(-1) received placebo or silodosin 8 mg once daily for 12 weeks. Silodosin-treated patients were stratified by absence or presence of 'retrograde ejaculation' (RE). Groups were compared using analysis of covariance (for change from baseline) and responder analyses. Of the 466 patients receiving silodosin, 131 (28%) reported RE and 335 (72%) did not; 4 of the 457 patients receiving placebo (0.9%) reported RE. Most RE events in silodosin-treated patients (110/134; 82%) were reported as 'orgasm with absence of seminal emission.' Silodosin-treated patients with (+) and without (-) RE showed significant improvement in IPSS, Qmax and quality of life versus placebo (P<0.02). RE+ patients versus RE- patients experienced numerically greater improvement, but differences were not statistically significant (P>0.05). For RE+ patients, the odds of achieving improvement of ≥3 points in IPSS and ≥3 ml s(-1) in Qmax by study end were 1.75 times those for RE- patients (P=0.0127). Absence of seminal emission may predict superior treatment efficacy of silodosin in individual patients.
对治疗 BPH 症状的西洛多辛的 3 期研究（NCT00224107，NCT00224120）的数据进行了分析，以研究治疗效果与异常射精发生之间的关系。年龄≥50 岁、国际前列腺症状评分（IPSS）≥13 且最大尿流率（Qmax）为 4-15ml/s 的男性接受安慰剂或西洛多辛 8mg 每日 1 次治疗 12 周。根据是否存在“逆行射精”（RE）对接受西洛多辛治疗的患者进行分层。使用协方差分析（用于从基线变化）和应答者分析比较组间差异。在接受西洛多辛治疗的 466 例患者中，131 例（28%）报告有 RE，335 例（72%）无 RE；接受安慰剂的 457 例患者中有 4 例（0.9%）报告有 RE。西洛多辛治疗患者中大多数 RE 事件（110/134；82%）被报告为“无精液射出的性高潮”。与安慰剂相比，有（+）和无（-）RE 的西洛多辛治疗患者的 IPSS、Qmax 和生活质量均显著改善（P<0.02）。RE+患者比 RE-患者的改善程度更大，但差异无统计学意义（P>0.05）。对于 RE+患者，与 RE-患者相比，到研究结束时 IPSS 改善≥3 分和 Qmax 改善≥3ml/s 的可能性高 1.75 倍（P=0.0127）。无精液射出可能预示着西洛多辛在个别患者中的治疗效果更优。
