非那雄胺治疗良性前列腺增生的疗效与安全性：一项为期2年的随机对照试验结果（PROSPECT研究）。保法止安全性与疗效加拿大两年研究。
Efficacy and safety of finasteride therapy for benign prostatic hyperplasia: results of a 2-year randomized controlled trial (the PROSPECT study). PROscar Safety Plus Efficacy Canadian Two year Study.
作者信息
Nickel J C, Fradet Y, Boake R C, Pommerville P J, Perreault J P, Afridi S K, Elhilali M M
机构信息
Queen's University, Kingston, Ont.
出版信息
CMAJ. 1996 Nov 1;155(9):1251-9.
OBJECTIVE
To evaluate the efficacy and safety of 2 years' treatment of moderate benign prostatic hyperplasia (BPH) with finasteride.
DESIGN
Double-blind, parallel-group, placebo-controlled, multicentre, prospective randomized study.
SETTING
Outpatient care in 28 centres across Canada.
PARTICIPANTS
Men aged 45 to 80, in good health, with moderate BPH and no evidence of prostate cancer. A total of 613 men were entered into the study; 472 completed the 2 years of treatment.
INTERVENTION
After 1 month of receiving a placebo (run-in period), patients were given either finasteride (5 mg/d) or a placebo for 2 years.
EFFICACY
changes from baseline in BPH symptom scores, maximum urinary flow rates and prostate volume.
SAFETY
onset, course and resolution of all adverse events during the treatment period.
RESULTS
In the efficacy analyses the mean BPH symptom scores decreased 2.1 points (from 15.8 to 13.7) in the finasteride group, as compared with a decrease of 0.7 points (from 16.6 to 15.9) in the placebo group (P < or = 0.01). The maximum urinary flow rate increased by a mean of 1.4 mL/s (from 11.1 to 12.5 mL/s) in the finasteride group, as compared with an increase of 0.3 mL/s (from 10.9 to 11.2 mL/s) in the placebo group (p < or = 0.01). The mean prostate volume decreased by 21% (from a mean volume of 44.1 cm3 at baseline) in the treatment group; it increased by 8.4% (from a mean volume of 45.8 cm3 at baseline) in the placebo group (p < or = 0.01). In the safety analysis, the proportion of patients who experienced any adverse event was similar in the two groups (81.0% in the treatment group and 81.2% in the placebo group). However, the incidence of adverse events related to sexual dysfunction were significantly higher in the finasteride group than in the placebo group (ejaculation disorder 7.7% v. 1.7% and impotence 15.8% v. 6.3%; p < or = 0.01 for both parameters).
CONCLUSION
Finasteride is a well-tolerated and effective alternative to watchful waiting in the treatment of moderate BPH.
目的
评估非那雄胺治疗中度良性前列腺增生（BPH）2年的疗效和安全性。
设计
双盲、平行组、安慰剂对照、多中心、前瞻性随机研究。
地点
加拿大28个中心的门诊护理。
参与者
年龄在45至80岁之间、身体健康、患有中度BPH且无前列腺癌证据的男性。共有613名男性进入研究；472名完成了2年的治疗。
干预
在接受1个月安慰剂（导入期）后，患者接受非那雄胺（5毫克/天）或安慰剂治疗2年。
疗效
BPH症状评分、最大尿流率和前列腺体积相对于基线的变化。
安全性
治疗期间所有不良事件的发生、过程和缓解情况。
结果
在疗效分析中，非那雄胺组的BPH症状评分平均下降2.1分（从15.8降至13.7），而安慰剂组下降0.7分（从16.6降至15.9）（P≤0.01）。非那雄胺组的最大尿流率平均增加1.4毫升/秒（从11.1增至12.5毫升/秒），而安慰剂组增加0.3毫升/秒（从10.9增至11.2毫升/秒）（P≤0.01）。治疗组的前列腺平均体积下降了21%（从基线时的平均体积44.1立方厘米）；安慰剂组增加了8.4%（从基线时的平均体积45.8立方厘米）（P≤0.01）。在安全性分析中，两组经历任何不良事件的患者比例相似（治疗组为81.0%，安慰剂组为81.2%）。然而，非那雄胺组与性功能障碍相关的不良事件发生率显著高于安慰剂组（射精障碍7.7%对1.7%，阳痿15.8%对6.3%；两个参数P均≤0.01）。
结论
在中度BPH的治疗中，非那雄胺是一种耐受性良好且有效的替代观察等待的药物。
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