Department of Urology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Urology. 2010 Dec;76(6):1446-50. doi: 10.1016/j.urology.2010.03.015. Epub 2010 May 15.
To provide clinical evidence that ejaculation disorder caused by selective alpha(1A)-blockers may be associated with larger symptomatic improvements in patients with benign prostatic hyperplasia.
Post hoc analyses of data from a randomized, double-blind, placebo-controlled clinical trial of silodosin in Japan were performed. Subjects were randomized into 3 treatments: silodosin (4 mg twice daily), tamsulosin (0.2 mg once daily), or placebo. For statistical analysis, subjects receiving silodosin were stratified by the presence or absence of ejaculation disorder. Efficacy was assessed using total International Prostate Symptom Score (IPSS), IPSS subscores, 25% reduction in total IPSS, and quality of life score. Safety was assessed by frequency of adverse drug reactions (ADRs) and silodosin discontinuation.
The silodosin subgroup with ejaculation disorder (SIL+EjD) showed larger change in total IPSS than the silodosin subgroup without ejaculation disorder (SIL-EjD) (difference: -4.36 [95% CI: -6.44 to -2.27]) and the placebo group (difference: -6.29 [95% CI: -8.44--4.14]). Remarkable improvement was observed at all time points. The success rate in SIL+EjD was higher than in SIL-EjD and placebo when measured using a 25% reduction in the total IPSS category. There were no significant differences in ADR rates other than ejaculation disorder. Discontinuation rates between SIL+EjD and SIL-EjD were similar.
Our results suggest that ejaculation disorder caused by selective alpha(1A)-blockers is associated with very large improvements in lower urinary tract symptoms. Patients with ejaculation disorder may have larger symptomatic improvements without incremental risk for adverse events.
提供选择性α1A-阻滞剂引起的射精障碍与良性前列腺增生患者更大的症状改善相关的临床证据。
对在日本进行的选择性α1A-阻滞剂 silodosin 的随机、双盲、安慰剂对照临床试验数据进行了事后分析。受试者随机分为 3 种治疗组：silodosin（4mg 每日 2 次）、tamsulosin（0.2mg 每日 1 次）或安慰剂。对于统计分析，根据是否存在射精障碍将接受 silodosin 的受试者分层。采用总国际前列腺症状评分（IPSS）、IPSS 亚评分、总 IPSS 减少 25%和生活质量评分评估疗效。通过不良反应（ADR）的发生频率和 silodosin 的停药评估安全性。
存在射精障碍的 silodosin 亚组（SIL+EjD）的总 IPSS 变化大于无射精障碍的 silodosin 亚组（SIL-EjD）（差异：-4.36[95%CI:-6.44 至-2.27]）和安慰剂组（差异：-6.29[95%CI:-8.44 至-4.14]）。所有时间点均观察到显著改善。使用总 IPSS 减少 25%的类别评估，SIL+EjD 的成功率高于 SIL-EjD 和安慰剂。除射精障碍外，ADR 发生率无显著差异。SIL+EjD 和 SIL-EjD 的停药率相似。
我们的结果表明，选择性α1A-阻滞剂引起的射精障碍与下尿路症状的极大改善相关。存在射精障碍的患者可能会有更大的症状改善，而不会增加不良事件的风险。
