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十一酸睾酮口服治疗少精子症:一项双盲安慰剂对照试验的结果

Oral treatment of oligozoospermia with testosterone-undecanoate: results of a double-blind-placebo-controlled trial.

作者信息

Pusch H H

机构信息

University Hospital for Gynecology and Obstetrics, Graz/Austria.

出版信息

Andrologia. 1989 Jan-Feb;21(1):76-82.

PMID:2653110
Abstract

30 patients with normogonadotrophic oligozoospermia from 1-20 mill/ml (group A) and 30 men with a sperm density from 210-40,0 mill/ml (group B) from the andrologic laboratory of the University Clinic for Gynecology and Obstetrics, Graz, Austria were treated with a 120 mg testosteron-undecanoate per os for 100 days. One randomized half of the patients received a placebo in a double blind manner. Conventional spermiograms were supplemented by extended morphologic analysis and motility determinations by laser-Doppler-spectroscopy. Statistical evaluation of data revealed no differences between verum and placebo group before treatment. After therapy significantly higher levels of testosterone could be observed in the verum group. Statistical calculations of differences between spermiogram parameters before treatment, after treatment and six weeks thereafter revealed significant improvements of sperm morphology in group A and B as well as significantly lower numbers of spermatozoa with head-deformations. A reduction of tail deformities could be observed at the control spermiogram six weeks after end of treatment. Besides improvements of sperm morphology, enhancements of sperm density could be observed in the verum group; sperm motility remained generally unchanged. During the duration of the trial four pregnancies (1 abortion) occurred in the placebo group, six females became pregnant in the verum group: five belonged to group A (1 x gemini), one pregnancy occurred in group B.

摘要

来自奥地利格拉茨大学妇产科男科实验室的30名患有促性腺激素正常性少精子症(精子浓度为1 - 20百万/毫升)的患者(A组)和30名精子密度为210 - 400百万/毫升的男性(B组)口服120毫克十一酸睾酮,持续100天。其中一半患者以双盲方式随机接受安慰剂治疗。传统的精液分析辅以扩展形态学分析以及通过激光多普勒光谱法进行的活力测定。数据的统计评估显示治疗前真药组和安慰剂组之间没有差异。治疗后,真药组中观察到睾酮水平显著升高。对治疗前、治疗后及之后六周精液参数差异的统计计算显示,A组和B组的精子形态有显著改善,头部畸形的精子数量显著减少。在治疗结束六周后的对照精液分析中可观察到尾部畸形减少。除了精子形态改善外,真药组还观察到精子密度增加;精子活力总体保持不变。在试验期间,安慰剂组有4例妊娠(1例流产),真药组有6名女性怀孕:5例属于A组(1例双胞胎),1例妊娠发生在B组。

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Guidelines for drug treatment of male infertility.男性不育症药物治疗指南。
Drugs. 1991 Jan;41(1):60-8. doi: 10.2165/00003495-199141010-00006.