Kaplan Steven A, Roehrborn Claus G, Hill Lawrence A, Volinn Weining
Weill college of Medicine Cornell University, New York, NY, USA.
Open Access J Urol. 2011 Jun 8;3:89-93. doi: 10.2147/OAJU.S18941. eCollection 2011.
The uroselective α-blocker silodosin significantly improved International Prostate Symptom Score (IPSS) in two 12-week, double-blind (DB), placebo-controlled Phase III studies in men aged ≥ 50 years with symptoms of benign prostatic hyperplasia (BPH) and maintained symptom improvement during a 9-month open-label (OL) extension. This post-hoc analysis evaluated the effects of estimated prostate volume (EPV) on silodosin-mediated symptom improvement.
Patients were stratified by EPV (<30 mL or ≥ 30 mL) calculated from prostate-specific antigen (PSA) concentrations using a published algorithm. Group comparisons were done by analysis of covariance with last observations carried forward.
Of 890 patients with PSA baseline data, 192 had EPV < 30 mL and 698 had EPV ≥ 30 mL. During DB treatment, silodosin was associated with significant symptom improvement (adjusted mean difference versus placebo) in men with EPV < 30 mL (-2.0; P = 0.038) and those with EPV ≥ 30 mL (-3.0; P < 0.0001). Among patients who received silodosin during DB treatment, changes from baseline in IPSS to the end of OL extension (mean ± standard deviation) were similar for EPV < 30 mL (n = 60, -7.0 ± 6.8) and EPV ≥ 30 mL (n = 242, -8.0 ± 7.1; P = 0.416). Also, among patients who received placebo as DB treatment, symptom improvement at the end of OL extension was similar for EPV < 30 mL (n = 62, -6.2 ± 8.1) and EPV ≥ 30 mL (n = 275, -6.7 ± 6.1; P = 0.339).
Silodosin effectively relieved BPH-related symptoms for up to 12 months, irrespective of prostate size, including in patients with enlarged prostates.
在两项针对年龄≥50岁、有良性前列腺增生（BPH）症状男性的12周双盲（DB）、安慰剂对照III期研究中，尿选择性α受体阻滞剂西洛多辛显著改善了国际前列腺症状评分（IPSS），并在9个月的开放标签（OL）延长期内维持了症状改善。这项事后分析评估了估计前列腺体积（EPV）对西洛多辛介导的症状改善的影响。
根据使用已发表算法从前列腺特异性抗原（PSA）浓度计算出的EPV（<30 mL或≥30 mL）对患者进行分层。通过协方差分析并结转最后观察值进行组间比较。
在890例有PSA基线数据的患者中，192例EPV<30 mL，698例EPV≥30 mL。在DB治疗期间，西洛多辛与EPV<30 mL的男性（调整后平均差值与安慰剂相比为-2.0；P = 0.038）和EPV≥30 mL的男性（调整后平均差值与安慰剂相比为-3.0；P<0.0001）的显著症状改善相关。在DB治疗期间接受西洛多辛的患者中，EPV<30 mL（n = 60，-7.0±6.8）和EPV≥30 mL（n = 242，-8.0±7.1；P = 0.416）从基线到OL延长期末IPSS的变化相似。此外，在DB治疗中接受安慰剂的患者中，EPV<30 mL（n = 62，-6.2±8.1）和EPV≥30 mL（n = 275，-6.7±6.1；P = 0.339）在OL延长期末的症状改善相似。
西洛多辛可有效缓解BPH相关症状长达12个月，无论前列腺大小如何，包括前列腺肿大的患者。
