两种α-肾上腺素能受体拮抗剂多沙唑嗪和阿夫唑嗪对良性前列腺增生所致下尿路症状患者的疗效比较

Comparative efficacy of two alpha-adrenoreceptor antagonists, doxazosin and alfuzosin, in patients with lower urinary tract symptoms from benign prostatic enlargement.

作者信息

de Reijke T M, Klarskov P

机构信息

Department of Urology, Academic Medical Centre, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.

出版信息

BJU Int. 2004 Apr;93(6):757-62. doi: 10.1111/j.1464-410X.2003.04720.x.

DOI:10.1111/j.1464-410X.2003.04720.x

PMID:15049986

Abstract

OBJECTIVES

To compare doxazosin and alfuzosin in patients with moderate to severe lower urinary tract symptoms (LUTS) suggestive of bladder outlet obstruction.

PATIENTS AND METHODS

In all, 210 men with LUTS were randomized to receive doxazosin 1-8 mg once daily or alfuzosin 5-10 mg divided in two or three daily doses in a 14-week, multicentre, double-blind, baseline-controlled, dose-titration study. The International Prostate Symptom Score (IPSS) and maximum urinary flow rate were used to assess the efficacy of the treatment.

RESULTS

At study completion, the mean dose of doxazosin was 6.1 mg/day and alfuzosin 8.8 mg/day. The least squares mean (se) change from baseline in total IPSS was -9.23 (0.6) for doxazosin and -7.45 (0.6) (both P < 0.001) for alfuzosin. The respective mean change from baseline in irritative symptoms was -3.5 (0.2) and -2.8 (0.3) (both P < 0.001). The differences between the treatment groups were statistically significant in favour of doxazosin (total IPSS, P = 0.036; irritative symptoms, P = 0.049). The improvement between groups was also significantly different for postvoid residual urine volume, at -29.19 (8.6) and + 9.59 (8.9) mL for doxazosin and alfuzosin, respectively (P = 0.002). Improvements in mean and maximum urinary flow rates were similar for both treatments, at + 1.5 and + 1.2, and + 2.8 and + 2.5 mL/s, respectively. Doxazosin and alfuzosin were both well tolerated, with most all-cause adverse events reported as mild or moderate.

CONCLUSIONS

The mean doses of doxazosin and alfuzosin used in this study were not equipotent. Doxazosin 6.1 mg/day produced significantly greater improvements than alfuzosin 8.8 mg/day in total and irritative urinary symptom scores and postvoid residual urine volume in men with moderate to severe LUTS. Changes in maximum and mean flow rates were comparable. Doxazosin and alfuzosin were both well tolerated.

摘要

目的

比较多沙唑嗪和阿夫唑嗪对提示膀胱出口梗阻的中重度下尿路症状（LUTS）患者的疗效。

患者和方法

在一项为期14周的多中心、双盲、基线对照、剂量滴定研究中，将210例LUTS男性患者随机分为两组，分别接受每日一次1 - 8 mg多沙唑嗪或每日分两次或三次服用5 - 10 mg阿夫唑嗪。采用国际前列腺症状评分（IPSS）和最大尿流率评估治疗效果。

结果

研究结束时，多沙唑嗪的平均剂量为6.1 mg/天，阿夫唑嗪为8.8 mg/天。多沙唑嗪组总IPSS自基线的最小二乘均值（标准误）变化为 - 9.23（0.6），阿夫唑嗪组为 - 7.45（0.6）（P均<0.001）。两组刺激性症状自基线的平均变化分别为 - 3.5（0.2）和 - 2.8（0.3）（P均<0.001）。治疗组间差异具有统计学意义，多沙唑嗪更具优势（总IPSS，P = 0.036；刺激性症状，P = 0.049）。两组间排尿后残余尿量的改善也有显著差异，多沙唑嗪组为 - 29.19（8.6）mL，阿夫唑嗪组为 + 9.59（8.9）mL（P = 0.002）。两种治疗方法的平均尿流率和最大尿流率改善相似，分别为 + 1.5和 + 1.2，以及 + 2.8和 + 2.5 mL/s。多沙唑嗪和阿夫唑嗪耐受性均良好，大多数全因不良事件报告为轻度或中度。