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安慰剂对照双盲研究,以测试芳香化酶抑制剂阿那曲唑对无需手术的良性前列腺增生患者的疗效。先灵90.062研究组。

Placebo controlled double-blind study to test the efficacy of the aromatase inhibitor atamestane in patients with benign prostatic hyperplasia not requiring operation. The Schering 90.062 Study Group.

作者信息

Gingell J C, Knönagel H, Kurth K H, Tunn U W

机构信息

Department of Urology, Southmead Hospital, Bristol, Great Britain.

出版信息

J Urol. 1995 Aug;154(2 Pt 1):399-401. doi: 10.1097/00005392-199508000-00020.

DOI:10.1097/00005392-199508000-00020
PMID:7541854
Abstract

PURPOSE

We tested the theoretical concept that a selective decrease in estrogens has a beneficial therapeutic effect on established benign prostatic hyperplasia.

MATERIALS AND METHODS

In a double-blind study 160 patients from 14 centers were randomized between 2 groups to receive either placebo or the aromatase inhibitor atamestane (1-methyl-androsin-1,4 diene-3 17-dione, 400 mg. daily for 48 weeks).

RESULTS

The aromatase inhibitor decreased the mean estradiol level by approximately 40% and estrone by 60%. The testosterone concentration increased by more than 40% and dihydrotestosterone increased to 30%. Analysis of clinical parameters showed no difference between placebo and atamestane.

CONCLUSIONS

The counter regulatory increase in androgens may counterbalance any positive effect of the decrease in estrogens to preserve intraprostatic homeostasis.

摘要

目的

我们测试了一个理论概念,即雌激素的选择性降低对已确诊的良性前列腺增生具有有益的治疗效果。

材料与方法

在一项双盲研究中,来自14个中心的160名患者被随机分为两组,分别接受安慰剂或芳香化酶抑制剂阿那曲唑(1-甲基-雄甾-1,4-二烯-3,17-二酮,每日400毫克,共48周)。

结果

芳香化酶抑制剂使平均雌二醇水平降低约40%,雌酮降低60%。睾酮浓度增加超过40%,双氢睾酮增加到30%。临床参数分析显示安慰剂组和阿那曲唑组之间没有差异。

结论

雄激素的反调节性增加可能会抵消雌激素降低的任何积极作用,以维持前列腺内环境稳定。

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