Tadalafil relieves lower urinary tract symptoms secondary to benign prostatic hyperplasia
Tadalafil relieves lower urinary tract symptoms secondary to benign prostatic hyperplasia
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DOI：
10.1016/j.juro.2006.11.037
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发表时间：
2007-04-01
影响因子：
6.6
通讯作者：
Denes, Bela S.
中科院分区：
文献类型：
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作者：
McVary, Kevin T.;Roehrborn, Claus G.;Denes, Bela S.
目的：我们评估了他达拉非每日一次给药治疗良性前列腺增生继发下尿路症状的有效性和安全性。材料和方法：经过为期4周的单盲安慰剂试验，281名男性被随机分配（1：1）至5 mg他达拉非治疗6周，随后剂量递增至20 mg治疗6周或安慰剂治疗12周。他达拉非显著改善了6周时国际前列腺症状评分较基线的平均变化（5 mg他达拉非-2.8 vs安慰剂-1.2）和12周时（5/20 mg他达拉非-3.8 vs安慰剂-1.7）。在第12周纳入安慰剂导入期后观察到较大的变化（5/20 mg他达拉非-7.1 vs安慰剂-4.5）。与安慰剂相比，在国际前列腺症状评分刺激性和阻塞性领域、国际前列腺症状评分生活质量指数、关于泌尿系统症状改善的问题和良性前列腺增生影响指数（在12周时显著）方面也观察到显著改善。国际前列腺症状评分和国际勃起功能指数勃起功能领域评分在56%的性活跃和勃起功能障碍的下尿路症状/良性前列腺增生男性中显著改善。安慰剂组和他达拉非组的尿流率参数变化相似。通常报告的（2%或以上）治疗后出现的不良事件为“勃起增加”、消化不良、背痛、头痛、鼻咽炎和上呼吸道感染（各5.1%或以下）。排尿后残余尿量没有变化被认为与tadalafil treatment.Conclusions：他达拉非每日一次耐受性良好，并表现出临床意义和统计学显着的下尿路症状/良性前列腺增生症状改善。他达拉非还改善了下尿路症状和勃起功能障碍男性的勃起功能。
Purpose: We assessed the efficacy and safety of tadalafil dosed once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia.Materials and Methods: Following a 4-week, single-blind, placebo run-in 281 men were randomly assigned (1:1) to 5 mg tadalafil for 6 weeks, followed by dose escalation to 20 mg for 6 weeks or 12 weeks of placebo.Results: Tadalafil significantly improved the mean change from baseline in International Prostate Symptom Score at 6 weeks (5 mg tadalafil -2.8 vs placebo -1.2) and at 12 weeks (5/20 mg tadalafil -3.8 vs placebo -1.7). Larger changes were observed with inclusion of the placebo run-in at 12 weeks (5/20 mg tadalafil -7.1 vs placebo -4.5). Significant improvements were also seen in the International Prostate Symptom Score irritative and obstructive domains, the International Prostate Symptom Score quality of life index, a question about urinary symptom improvement and the Benign Prostatic Hyperplasia Impact Index (significant at 12 weeks) vs placebo. International Prostate Symptom Score and International Index of Erectile Function erectile function domain scores significantly improved in the 56% of men with lower urinary tract symptoms/benign prostatic hyperplasia who were sexually active and had erectile dysfunction. Changes in uroflowmetry parameters were similar in the placebo and tadalafil groups. Commonly reported (2% or greater) treatment emergent adverse events were "erection increased," dyspepsia, back pain, headache, nasopharyngitis and upper respiratory tract infection (each 5.1% or less). No change in post-void residual volume was seen with tadalafil treatment.Conclusions: Tadalafil once daily was well tolerated and demonstrated clinically meaningful and statistically significant symptomatic improvement for lower urinary tract symptoms/benign prostatic hyperplasia. Tadalafil also improved erectile function in men with lower urinary tract symptoms and erectile dysfunction.