Kawabe K, Tsuchida S, Shimazaki J, Morita T, Yasuda K, Kageyama S
Department of Urology, Hamamatsu University School of Medicine, Japan.
Urol Int. 1993;50(1):27-32. doi: 10.1159/000282443.
In a prospective multicentric double-blind trial, urapidil, an alpha 1-adrenergic antagonist, was investigated for its efficacy in benign prostatic hypertrophy (BPH). After 1 week of baseline on placebo, 214 patients with BPH were randomly assigned to 4 groups; group P was given placebo, group L, 15 mg of urapidil b.i.d. for 3 weeks, group M, 15 mg b.i.d. for 1 week followed by 30 mg b.i.d. for 2 weeks, and group H, 15 mg b.i.d. for 1 week followed by 45 mg b.i.d. for 2 weeks. In all groups, day and night urinary frequency improved significantly (p < 0.01 or p < 0.05) compared to baseline, but the differences were not significant between groups. The residual urine rate was significantly (p < 0.05 vs. group P) decreased in group H. Average and maximum flow rate improved significantly (p < 0.01 or p < 0.05) in group M and group H, but intergroup differences were not noted. Overall impression evaluated by investigators improved significantly (p < 0.01 vs. group P) in group M and group H. More patients in group H (7/55) and group M (4/51) had side effects than in group P (2/54). None of them were severe. In summary, a daily dosage of 60 mg urapidil proved to be the most beneficial in the treatment of patients with BPH.
在一项前瞻性多中心双盲试验中，对α1肾上腺素能拮抗剂乌拉地尔治疗良性前列腺增生（BPH）的疗效进行了研究。在服用安慰剂的基线期1周后，214例BPH患者被随机分为4组；P组给予安慰剂，L组给予15mg乌拉地尔，每日2次，共3周，M组给予15mg，每日2次，共1周，随后给予30mg，每日2次，共2周，H组给予15mg，每日2次，共1周，随后给予45mg，每日2次，共2周。与基线相比，所有组的昼夜尿频均有显著改善（p<0.01或p<0.05），但组间差异不显著。H组残余尿率显著降低（与P组相比，p<0.05）。M组和H组的平均流速和最大流速显著改善（p<0.01或p<0.05），但未观察到组间差异。研究者评估的总体印象在M组和H组显著改善（与P组相比，p<0.01）。H组（7/55）和M组（4/51）出现副作用的患者比P组（2/54）多。均无严重副作用。总之，每日60mg乌拉地尔剂量被证明对BPH患者的治疗最有益。
