Lepor H, Kaplan S A, Klimberg I, Mobley D F, Fawzy A, Gaffney M, Ice K, Dias N
Department of Urology, New York University.
J Urol. 1997 Feb;157(2):525-30. doi: 10.1016/s0022-5347(01)65193-0.
We evaluated the sustained efficacy and safety of doxazosin for long-term treatment (up to 48 months) of normotensive and hypertensive patients with benign prostatic hyperplasia (BPH).
A total of 272 normotensive and 178 mildly to moderately hypertensive men entered a long-term extension study of doxazosin therapy (1 to 8 and 1 to 12 mg. 1 time daily, respectively) for BPH following participation in double-blind, placebo controlled studies. The starting dose of doxazosin was 1 mg. with upward titrations at 2-week intervals to a stable, efficacious and well tolerated dose. At the time of data analysis patients had received between 1 and 48 months of stable dose doxazosin therapy (mean 668 days for normotensive and 807 for hypertensive patients). Mean daily doses were 4 and 6.4 mg. for normotensive and hypertensive men, respectively.
At the end point analysis doxazosin treatment resulted in significant increases above baseline in maximum and average urinary flow rates (1.9 and 1.0 ml. per second, respectively). As assessed by the patient, total, obstructive and irritative BPH symptoms also improved significantly with doxazosin treatment. In the 28 patients who completed 45 to 48 months of treatment improvement in symptom bothersomeness (13.2%) was similar to that of the overall group at the end point (14.8%). Sustained blood pressure decreases (approximately 8/11 mm. Hg systolic/diastolic blood pressure) with doxazosin were statistically and clinically significant in hypertensive patients. Blood pressure decreases in normotensive patients were not clinically significant (approximately 4/2 mm. Hg) and few withdrew from study for reasons related directly to decreased blood pressure or hypotension. Changes in heart rate were not significant. Doxazosin was well tolerated with almost 90% of adverse experiences considered mild or moderate in severity. The most common adverse events were dizziness, headache and fatigue in normotensive and hypertensive patients.
In this study long-term doxazosin treatment was significantly effective and well tolerated for treating BPH in normotensive and hypertensive patients.
我们评估了多沙唑嗪对患有良性前列腺增生（BPH）的血压正常和高血压患者进行长期治疗（长达48个月）的持续疗效和安全性。
共有272名血压正常和178名轻度至中度高血压男性在参与双盲、安慰剂对照研究后，进入了一项多沙唑嗪治疗BPH的长期扩展研究（分别为每日1次，剂量为1至8毫克和1至12毫克）。多沙唑嗪的起始剂量为1毫克，每2周递增剂量至稳定、有效且耐受性良好的剂量。在数据分析时，患者已接受了1至48个月的稳定剂量多沙唑嗪治疗（血压正常患者平均668天，高血压患者平均807天）。血压正常和高血压男性的平均每日剂量分别为4毫克和6.4毫克。
在终点分析时，多沙唑嗪治疗使最大尿流率和平均尿流率较基线显著增加（分别为每秒1.9毫升和1.0毫升）。根据患者评估，多沙唑嗪治疗也使BPH的总体、梗阻性和刺激性症状显著改善。在完成45至48个月治疗的28名患者中，症状困扰程度的改善（13.2%）与终点时总体组的改善情况（14.8%）相似。多沙唑嗪使高血压患者的血压持续下降（收缩压/舒张压约下降8/11毫米汞柱），在统计学和临床上均具有显著意义。血压正常患者的血压下降在临床上无显著意义（约4/2毫米汞柱），很少有患者因与血压下降或低血压直接相关的原因退出研究。心率变化不显著。多沙唑嗪耐受性良好，几乎90%的不良事件被认为严重程度为轻度或中度。血压正常和高血压患者中最常见的不良事件是头晕、头痛和疲劳。
在本研究中，长期使用多沙唑嗪治疗血压正常和高血压患者的BPH具有显著疗效且耐受性良好。
