Department of Urology, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.
Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):e385-92. doi: 10.1016/j.ijrobp.2011.04.026. Epub 2011 Jun 12.
To compare the efficacy of three α(1A)/α(1D)-adrenoceptor (AR) antagonists--naftopidil, tamsulosin, and silodosin--that have differing affinities for the α(1)-AR subtypes in treating urinary morbidities in Japanese men with (125)I prostate implantation (PI) for prostate cancer.
This single-institution prospective randomized controlled trial compared naftopidil, tamsulosin, and silodosin in patients undergoing PI. Patients were randomized and received either naftopidil, tamsulosin, or silodosin. Treatment began 1 day after PI and continued for 1 year. The primary efficacy variables were the changes in total International Prostate Symptom Score (IPSS) and postvoid residual urine (PVR). The secondary efficacy variables were changes in IPSS storage score and IPSS voiding score from baseline to set points during the study (1, 3, 6, and 12 months).
Two hundred twelve patients were evaluated in this study between June 2006 and February 2009: 71, 70, and 71 patients in the naftopidil, tamsulosin, and silodosin groups, respectively. With respect to the primary efficacy variables, the mean changes in the total IPSS at 1 month after PI in the naftopidil, tamsulosin, and silodosin groups were +10.3, +8.9, and +7.5, respectively. There were significantly greater decreases with silodosin than naftopidil at 1 month in the total IPSS. The mean changes in the PVR at 6 months were +14.6, +23.7, and +5.7 mL in the naftopidil, tamsulosin, and silodosin groups, respectively; silodosin showed a significant improvement in the PVR at 6 months vs. tamsulosin. With respect to the secondary efficacy variables, the mean changes in the IPSS voiding score at 1 month in the naftopidil, tamsulosin, and silodosin groups were +6.5, +5.6, and +4.5, respectively; silodosin showed a significant improvement in the IPSS voiding score at 1 month vs. naftopidil.
Silodosin has a greater impact on improving PI-induced lower urinary tract symptoms than the other two agents.
比较 3 种 α(1A)/α(1D)-肾上腺素能受体（AR）拮抗剂——那妥地平、坦索罗辛和西洛多辛——在治疗因前列腺癌行^(125)I 前列腺植入（PI）的日本男性患者的泌尿系统症状方面的疗效，这些药物对 α(1)-AR 亚型的亲和力不同。
这是一项单中心前瞻性随机对照试验，比较了^(125)I 前列腺植入后的患者接受那妥地平、坦索罗辛和西洛多辛治疗的效果。患者被随机分组并接受那妥地平、坦索罗辛或西洛多辛治疗。治疗于 PI 后 1 天开始，持续 1 年。主要疗效变量是国际前列腺症状评分（IPSS）总分和剩余尿量（PVR）的变化。次要疗效变量是研究期间（第 1、3、6 和 12 个月）从基线到设定点时 IPSS 储存评分和 IPSS 排尿评分的变化。
2006 年 6 月至 2009 年 2 月期间，共有 212 例患者入组本研究：那妥地平、坦索罗辛和西洛多辛组分别有 71、70 和 71 例患者。在主要疗效变量方面，PI 后 1 个月时，那妥地平、坦索罗辛和西洛多辛组的总 IPSS 平均变化分别为+10.3、+8.9 和+7.5。与那妥地平相比，西洛多辛在 1 个月时对总 IPSS 的降低作用更显著。6 个月时，那妥地平、坦索罗辛和西洛多辛组的 PVR 平均变化分别为+14.6、+23.7 和+5.7 mL；西洛多辛在 6 个月时的 PVR 改善作用显著优于坦索罗辛。在次要疗效变量方面，那妥地平、坦索罗辛和西洛多辛组在 1 个月时的 IPSS 排尿评分平均变化分别为+6.5、+5.6 和+4.5；与那妥地平相比，西洛多辛在 1 个月时对 IPSS 排尿评分的改善作用更显著。
与其他两种药物相比，西洛多辛对改善 PI 引起的下尿路症状的影响更大。
