Roehrborn Claus G
University of Texas, Southwestern Medical Center, Dallas, TX, USA.
BJU Int. 2006 Apr;97(4):734-41. doi: 10.1111/j.1464-410X.2006.06110.x.
To evaluate the effect of alfuzosin 10 mg once daily administered for 2 years on progression events in men with lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH).
In all, 1522 men at risk of having progression events from LUTS/BPH were randomized to receive alfuzosin 10 mg once daily (759) or placebo (763) for 2 years. Endpoints assessed were the occurrence of a first episode of acute urinary retention (AUR; primary) and the need for BPH-related surgery. Post hoc analyses included a deterioration in the International Prostate Symptom Score (IPSS) of > or = 4 points and overall clinical progression of BPH (occurrence of AUR and/or surgery and/or symptom deterioration).
Over 2 years, symptom deterioration was the most common progression event (14.3%), followed by BPH-related surgery (5.8%) and AUR (2.0%). Alfuzosin did not reduce the risk of AUR (alfuzosin 2.1% vs placebo 1.8%, P = 0.82) but tended to reduce the risk of surgery (5.1% vs 6.5%, P = 0.18); the reduction in risk (RR) and 95% confidence interval with alfuzosin was 22 (-18 to 48)%; and significantly reduced the risk of symptom deterioration (11.7% vs 16.8%; P = 0.0013); the RR was 30 (10-46)%. The overall clinical progression of BPH was significantly lower with alfuzosin than with placebo (16.3% vs 22.1%, P < 0.001); RR 26 (9-40)%. Alfuzosin also significantly improved the IPSS (P = 0.017), quality of life (P < 0.001) and peak flow rate (P = 0.001) compared with placebo. Baseline levels of prostate-specific antigen (PSA) predicted both AUR and BPH-related surgery events, while the baseline postvoid residual urine volume predicted symptom deterioration. The incidence of adverse events with alfuzosin was comparable to that with placebo.
Alfuzosin 10 mg once daily prevents the overall clinical progression of BPH, defined by the occurrence of a deterioration in IPSS of > or = 4 points and/or AUR and/or BPH-related surgery, but does not reduce the primary occurrence of AUR. Alfuzosin significantly improves LUTS and quality of life over 2 years, and is well tolerated.
评估每日一次服用10毫克阿夫唑嗪，持续2年对下尿路症状/良性前列腺增生（LUTS/BPH）男性患者病情进展事件的影响。
共有1522名有LUTS/BPH病情进展风险的男性被随机分为两组，一组每日一次服用10毫克阿夫唑嗪（759人），另一组服用安慰剂（763人），为期2年。评估的终点指标为首次急性尿潴留（AUR；主要指标）的发生情况以及与BPH相关的手术需求。事后分析包括国际前列腺症状评分（IPSS）恶化≥4分以及BPH的整体临床进展（AUR和/或手术和/或症状恶化的发生情况）。
在2年期间，症状恶化是最常见的病情进展事件（14.3%），其次是与BPH相关的手术（5.8%）和AUR（2.0%）。阿夫唑嗪未降低AUR的风险（阿夫唑嗪组为2.1%，安慰剂组为1.8%，P = 0.82），但有降低手术风险的趋势（5.1%对6.5%，P = 0.18）；阿夫唑嗪的风险降低率（RR）及95%置信区间为22（-18至48）%；并显著降低了症状恶化的风险（11.7%对16.8%；P = 0.0013）；RR为30（10 - 46）%。与安慰剂相比，阿夫唑嗪组BPH的整体临床进展显著更低（16.3%对22.1%，P < 0.001）；RR为26（9 - 40）%。与安慰剂相比，阿夫唑嗪还显著改善了IPSS（P = 0.017）、生活质量（P < 0.001）和最大尿流率（P = 0.001）。前列腺特异性抗原（PSA）的基线水平可预测AUR和与BPH相关的手术事件，而基线排尿后残余尿量可预测症状恶化。阿夫唑嗪不良事件的发生率与安慰剂相当。
每日一次服用10毫克阿夫唑嗪可预防BPH的整体临床进展，其定义为IPSS恶化≥4分和/或AUR和/或与BPH相关的手术，但不会降低AUR的首次发生率。阿夫唑嗪在2年期间显著改善了LUTS和生活质量，且耐受性良好。
