Queen's University, Kingston, Ontario, Canada.
J Urol. 2011 Jul;186(1):125-31. doi: 10.1016/j.juro.2011.03.028. Epub 2011 May 14.
We evaluated the efficacy and safety of 2 doses of silodosin vs placebo in men with moderate to severe abacterial chronic prostatitis/chronic pelvic pain syndrome who had not been treated previously with α-blockers for chronic prostatitis/chronic pelvic pain syndrome.
In this multicenter, randomized, double-blind, phase II study, men 18 years old or older with chronic prostatitis/chronic pelvic pain syndrome, a total National Institutes of Health Chronic Prostatitis Symptom Index score of 15 or greater and a National Institutes of Health Chronic Prostatitis Symptom Index pain score of 8 or greater received 4 or 8 mg silodosin, or placebo once daily for 12 weeks. The primary efficacy end point was change from baseline to week 12 in National Institutes of Health Chronic Prostatitis Symptom Index total score.
Of 151 patients (mean age 48 years) 52 received 4 mg silodosin, 45 received 8 mg silodosin and 54 received placebo. Silodosin 4 mg was associated with a significant decrease in total National Institutes of Health Chronic Prostatitis Symptom Index score (mean ± SD change -12.1 ± 9.3) vs placebo (-8.5 ± 7.2, p = 0.0224), including a decrease in urinary symptom (-2.2 ± 2.7, placebo -1.3 ± 3.0, p = 0.0102) and quality of life (-4.1 ± 3.1, placebo -2.7 ± 2.5, p = 0.0099) subscores. The 4 mg dose of silodosin also significantly increased Medical Outcomes Study Short Form 12 physical component scores (4.2 ± 8.1, placebo 1.7 ± 9.0, p = 0.0492). During global response assessment 56% of patients receiving 4 mg silodosin vs 29% receiving placebo reported moderate or marked improvement (p = 0.0069). Increasing the dose of silodosin to 8 mg resulted in no incremental treatment effects.
Silodosin 4 mg relieved symptoms and improved quality of life in men with chronic prostatitis/chronic pelvic pain syndrome but its efficacy requires confirmation in additional studies.
我们评估了 2 种剂量的西洛多辛与安慰剂在既往未接受 α 受体阻滞剂治疗的中重度非细菌性慢性前列腺炎/慢性骨盆疼痛综合征男性中的疗效和安全性。
在这项多中心、随机、双盲、二期研究中，年龄在 18 岁及以上、慢性前列腺炎/慢性骨盆疼痛综合征总国立卫生研究院慢性前列腺炎症状指数（NIH-CPSI）评分≥15 分、NIH-CPSI 疼痛评分≥8 分的男性患者，每日接受 4 或 8mg 西洛多辛或安慰剂治疗 12 周。主要疗效终点为基线至 12 周时 NIH-CPSI 总分的变化。
在 151 例患者（平均年龄 48 岁）中，52 例接受 4mg 西洛多辛治疗，45 例接受 8mg 西洛多辛治疗，54 例接受安慰剂治疗。与安慰剂相比，4mg 西洛多辛可显著降低 NIH-CPSI 总分（平均±标准差变化-12.1±9.3）（-8.5±7.2，p=0.0224），包括尿症状（-2.2±2.7，安慰剂-1.3±3.0，p=0.0102）和生活质量（-4.1±3.1，安慰剂-2.7±2.5，p=0.0099）的降低。4mg 西洛多辛剂量还显著增加了医疗结局研究短表 12 项健康调查简表（SF-12）的生理成分评分（4.2±8.1，安慰剂 1.7±9.0，p=0.0492）。在总体反应评估中，56%接受 4mg 西洛多辛治疗的患者与 29%接受安慰剂治疗的患者报告中度或明显改善（p=0.0069）。增加西洛多辛剂量至 8mg 并未带来额外的治疗效果。
4mg 西洛多辛可缓解慢性前列腺炎/慢性骨盆疼痛综合征男性的症状并改善生活质量，但仍需要进一步研究来证实其疗效。
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