Fourcade R O
Service d'Urologie, Centre Hospitalier d'Auxerre, France.
Prog Urol. 2000 Apr;10(2):246-53.
To compare, in general practice, the efficacy and safety of terazosin (5 mg per day in single dose) versus alfuzosin (7.5 mg per day in 3 doses) in patients with symptomatic benign prostatic hyperplasia (BPH) treated for 16 weeks.
Thirteen investigators included patients over the age of 50 years presenting with BPH with an International Prostate Symptom Score (IPSS) greater than 12 and a post-voiding residual volume less than 300 ml. After a one-week observation period, these patients were randomized to receive either terazosin or alfuzosin for 16 weeks (112 days) under double-blind conditions. The primary endpoint was the percentage reduction of the IPSS score at 3 weeks and 16 weeks; the secondary endpoint was the IPSS quality of life score. Safety was evaluated by recording adverse events and monitoring blood pressure.
Seventy four patients were included: 39 in the terazosin group, 35 in the alfuzosin group. The 2 groups were not significantly different before treatment. Improvement of the IPSS score was similar in the 2 treatment groups (p = 0.97 at 3 weeks, and p = 0.29 at 16 weeks), as was the improvement of the quality of life score (p = 0.47 at 3 weeks and p = 0.71 at 16 weeks). Treatment was considered to be "effective or very effective" in 31 patients (86%) in the terazosin group, and in 28 patients (82%) in the alfuzosin group. The IPSS score was greater than or equal to 12 before treatment for all patients included in the study. Twenty-five patients had a score < 12 at 3 weeks versus 56 at 16 weeks (p = 0.0001). Seven patients had a quality of life score less than 2 before treatment, versus 38 at 3 weeks, and 56 at 16 weeks (p = 0.0001). No significant difference was observed between the 2 groups in terms of the number of adverse events reported, or the course of blood pressure and prostate specific antigen. No patient dropped out of the study because of treatment-related adverse events. Two deaths were observed in the terazosin group (2 patients aged 86 and 93 years), but any relation to treatment was excluded.
During this study, terazosin appeared to be as effective and as well tolerated as alfuzosin.
在全科医疗中，比较多沙唑嗪（每日5毫克单剂量）与阿夫唑嗪（每日7.5毫克分3次服用）对有症状的良性前列腺增生（BPH）患者进行16周治疗的疗效和安全性。
13名研究者纳入了年龄超过50岁、国际前列腺症状评分（IPSS）大于12且排尿后残余尿量小于300毫升的BPH患者。经过1周的观察期后，这些患者在双盲条件下被随机分配接受多沙唑嗪或阿夫唑嗪治疗16周（112天）。主要终点是3周和16周时IPSS评分的降低百分比；次要终点是IPSS生活质量评分。通过记录不良事件和监测血压来评估安全性。
共纳入74例患者：多沙唑嗪组39例，阿夫唑嗪组35例。两组治疗前无显著差异。两个治疗组IPSS评分的改善情况相似（3周时p = 0.97，16周时p = 0.29），生活质量评分的改善情况也相似（3周时p = 0.47，16周时p = 0.71）。多沙唑嗪组31例患者（86%）、阿夫唑嗪组28例患者（82%）的治疗被认为“有效或非常有效”。纳入研究的所有患者治疗前IPSS评分均大于或等于12。25例患者3周时评分< 12，16周时为56例（p = 0.0001）。7例患者治疗前生活质量评分小于2，3周时为38例，16周时为56例（p = 0.0001）。两组报告的不良事件数量、血压和前列腺特异性抗原的变化过程均无显著差异。没有患者因治疗相关不良事件退出研究。多沙唑嗪组观察到2例死亡（2例患者年龄分别为86岁和93岁），但排除了与治疗的任何关联。
在本研究中，多沙唑嗪似乎与阿夫唑嗪疗效相当且耐受性良好。
