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多沙唑嗪治疗轻度至中度原发性高血压合并良性前列腺增生症患者:一项双盲、安慰剂对照、剂量反应多中心研究。

Doxazosin for the treatment of benign prostatic hyperplasia in patients with mild to moderate essential hypertension: a double-blind, placebo-controlled, dose-response multicenter study.

作者信息

Gillenwater J Y, Conn R L, Chrysant S G, Roy J, Gaffney M, Ice K, Dias N

机构信息

Department of Urology, University of Virginia Medical School, Charlottesville, USA.

出版信息

J Urol. 1995 Jul;154(1):110-15.

PMID:7539854
Abstract

A total of 248 hypertensive patients 45 years old or older with benign prostatic hyperplasia (BPH) was included in this 16-week, multicenter, double-blind, placebo-controlled, parallel-group dose-response study. Doxazosin, a selective alpha 1-adrenoceptor antagonist, produced a significant increase in maximum urinary flow rate (2.3 to 3.6 ml. per second) at doses of 4 mg., 8 mg. and 12 mg., and in average flow rate (8 mg. and 12 mg.) compared with placebo. The increase in maximum flow rate was significant with doxazosin versus placebo within 1 week of initiating double-blind therapy. Doxazosin compared to placebo significantly decreased patient-assessed total, obstructive and irritative BPH symptoms. Blood pressure was significantly lower with all doxazosin doses compared with placebo. Adverse events, primarily mild to moderate in severity, were reported in 48% of patients on doxazosin and 35% on placebo. Our results strongly support the use of doxazosin as a nonoperative therapeutic alternative in the management of uncomplicated BPH. Doxazosin would also be particularly useful in the management of patients who have BPH and hypertension.

摘要

本项为期16周的多中心、双盲、安慰剂对照、平行组剂量反应研究纳入了248例年龄在45岁及以上的患有良性前列腺增生(BPH)的高血压患者。多沙唑嗪是一种选择性α1肾上腺素能受体拮抗剂,在4毫克、8毫克和12毫克剂量时,与安慰剂相比,最大尿流率(从每秒2.3毫升增至3.6毫升)以及平均尿流率(8毫克和12毫克剂量时)均显著增加。在开始双盲治疗的1周内,多沙唑嗪与安慰剂相比,最大尿流率的增加具有显著性。与安慰剂相比,多沙唑嗪显著减轻了患者评估的BPH总体症状、梗阻性症状和刺激性症状。与安慰剂相比,所有多沙唑嗪剂量组的血压均显著降低。多沙唑嗪组48%的患者和安慰剂组35%的患者报告了不良事件,主要为轻至中度。我们的结果有力地支持了多沙唑嗪作为非手术治疗方法用于单纯性BPH的治疗。多沙唑嗪在患有BPH和高血压的患者管理中也将特别有用。

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