Department of Urology, Pusan National University School of Medicine, Busan, Korea.
World J Mens Health. 2014 Dec;32(3):145-50. doi: 10.5534/wjmh.2014.32.3.145. Epub 2014 Dec 29.
The aim of this study was to investigate the efficacy of mirodenafil in middle-aged male patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS).
Eighty-eight males with CP/CPPS were randomized to receive either levofloxacin (500 mg/d) (group L, 40 patients) or levofloxacin (500 mg/d) and mirodenafil (50 mg/d) (group ML, 48 patients) for six weeks. The International Prostate Symptom Score (IPSS), National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI), and erectile function (EF) domain scores of the International Index of Erectile Function (IIEF) questionnaire were used to grade symptoms at baseline and 6 weeks after treatment.
The mean change in total IPSS from baseline was higher in group ML than that in group L (group L, -1.1 vs. group ML, -4.3; p<0.05). Significant improvements were also seen in the IPSS voiding subscore (group L, -0.7 vs. group ML, -3.0; p<0.05). Changes observed in the NIH-CPSI of group ML at six weeks were greater than those at baseline (group L, -3.2 vs. group ML, -7.2; p<0.05). Significant improvements were seen in the NIH-CPSI voiding (group L, -0.5 vs. group ML, -1.7; p<0.05) and quality of life domains (group L, -1.0 vs. group ML, -1.8; p<0.05). Group ML showed a significantly greater increase in the IIEF-EF score than did group ML (group L, +0.2 vs. group ML, +7.8; p<0.05).
Mirodenafil (50 mg once daily) was well tolerated and resulted in significant symptomatic improvement in middle-aged males with CP/CPPS.
本研究旨在探讨米罗地尔治疗慢性前列腺炎/慢性骨盆疼痛综合征(CP/CPPS)中年男性患者的疗效。
将 88 例 CP/CPPS 男性患者随机分为左氧氟沙星(500mg/d)组(L 组,40 例)和左氧氟沙星(500mg/d)加米罗地尔(50mg/d)组(ML 组,48 例),疗程均为 6 周。采用国际前列腺症状评分(IPSS)、美国国立卫生研究院慢性前列腺炎症状指数(NIH-CPSI)和国际勃起功能指数(IIEF)问卷的勃起功能(EF)域评分评估治疗前和治疗 6 周后的症状。
与 L 组相比,ML 组的总 IPSS 评分从基线的平均变化更大(L 组为-1.1,ML 组为-4.3;p<0.05)。在 IPSS 排尿分项评分方面也观察到显著改善(L 组为-0.7,ML 组为-3.0;p<0.05)。在 ML 组,治疗 6 周时 NIH-CPSI 的变化大于基线时(L 组为-3.2,ML 组为-7.2;p<0.05)。在 NIH-CPSI 的排尿(L 组为-0.5,ML 组为-1.7;p<0.05)和生活质量(L 组为-1.0,ML 组为-1.8;p<0.05)领域也观察到显著改善。与 L 组相比,ML 组的 IIEF-EF 评分显著增加(L 组为+0.2,ML 组为+7.8;p<0.05)。
米罗地尔(每日 1 次 50mg)耐受性良好,可显著改善 CP/CPPS 中年男性的症状。