Kaplan S A, Meade-D'Alisera P, Quiñones S, Soldo K A
Department of Urology, College of Physicians & Surgeons, Columbia University, New York, New York 10032, USA.
Urology. 1995 Oct;46(4):512-7. doi: 10.1016/s0090-4295(99)80264-7.
To compare the effects of doxazosin on blood pressure when used for the treatment of benign prostatic hyperplasia (BPH) in men who are either physiologically or pharmacologically normotensive.
Sixty-three men with BPH were enrolled in two open-label, parallel, randomized studies. Thirty-one were physiologically normotensive and 32 had hypertension controlled by antihypertensive therapy (pharmacologically normotensive). Of these, 17 were taking calcium channel blockers; 6, angiotensin-converting enzyme inhibitors; and 9, beta blockers. After a 3-week titration period, patients from one study received doxazosin (4 mg/day) for 3 months, given as a single dose in either the morning or evening, and in the second study patients were randomized to receive either 4 mg or 8 mg daily, either in the morning or evening. Effects on blood pressure, maximum uroflow, and the Boyarsky symptom score were measured.
Doxazosin produced statistically significant but clinically unimportant reductions in blood pressure in both physiologically and pharmacologically normotensive groups. Statistically and clinically significant improvements in BPH symptoms and maximal perfusion occurred in both groups within 1 month, and further improvements were improved after 3 months. These effects were evident whether doxazosin was administered in the morning or evening. Doxazosin was well tolerated, the only adverse events being dizziness in 5 patients and fatigue in 4. By protocol, all patients reporting adverse events were required to be discontinued from the study. Adverse events did not differ between the groups. There was some indication that patients experiencing adverse events also experienced greater reductions in blood pressure.
Doxazosin may be introduced for the treatment of BPH in hypertensive men whose blood pressure is already controlled by another antihypertensive agent, without a further clinical reduction in blood pressure. It is effective and well tolerated as a once-daily dose given in the morning or evening.
比较多沙唑嗪用于治疗生理血压正常或药物控制血压正常的男性良性前列腺增生（BPH）时对血压的影响。
63例BPH男性患者参加了两项开放标签、平行、随机研究。31例生理血压正常，32例高血压患者通过抗高血压治疗血压得到控制（药物控制血压正常）。其中，17例服用钙通道阻滞剂；6例服用血管紧张素转换酶抑制剂；9例服用β受体阻滞剂。经过3周的滴定期后，一项研究中的患者接受多沙唑嗪（4mg/天）治疗3个月，于早晨或晚上单次给药，另一项研究中的患者随机接受每日4mg或8mg剂量，于早晨或晚上给药。测量对血压、最大尿流率和博亚尔斯基症状评分的影响。
多沙唑嗪在生理血压正常组和药物控制血压正常组均使血压产生了具有统计学意义但临床上无重要意义的降低。两组在1个月内BPH症状和最大尿流率均出现了具有统计学和临床意义的改善，3个月后进一步改善。无论多沙唑嗪是早晨还是晚上给药，这些效果均明显。多沙唑嗪耐受性良好，仅5例患者出现头晕，4例出现疲劳。根据方案，所有报告不良事件的患者均需退出研究。两组不良事件无差异。有迹象表明，出现不良事件的患者血压降低幅度也更大。
对于血压已由另一种抗高血压药物控制的高血压男性患者，可引入多沙唑嗪治疗BPH，而不会使血压进一步出现临床降低。作为早晨或晚上每日一次给药，它有效且耐受性良好。
