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低剂量经皮睾酮治疗可改善慢性稳定型心绞痛男性患者的心绞痛阈值:一项随机、双盲、安慰剂对照研究。

Low-dose transdermal testosterone therapy improves angina threshold in men with chronic stable angina: A randomized, double-blind, placebo-controlled study.

作者信息

English K M, Steeds R P, Jones T H, Diver M J, Channer K S

机构信息

Department of Cardiology, Royal Hallamshire Hospital, Sheffield, UK.

出版信息

Circulation. 2000 Oct 17;102(16):1906-11. doi: 10.1161/01.cir.102.16.1906.

DOI:10.1161/01.cir.102.16.1906
PMID:11034937
Abstract

BACKGROUND

Experimental studies suggest that androgens induce coronary vasodilatation. We performed this pilot project to examine the clinical effects of long-term low-dose androgens in men with angina.

METHODS AND RESULTS

Forty-six men with stable angina completed a 2-week, single-blind placebo run-in, followed by double-blind randomization to 5 mg testosterone daily by transdermal patch or matching placebo for 12 weeks, in addition to their current medication. Time to 1-mm ST-segment depression on treadmill exercise testing and hormone levels were measured and quality of life was assessed by SF-36 at baseline and after 4 and 12 weeks of treatment. Active treatment resulted in a 2-fold increase in androgen levels and an increase in time to 1-mm ST-segment depression from (mean+/-SEM) 309+/-27 seconds at baseline to 343+/-26 seconds after 4 weeks and to 361+/-22 seconds after 12 weeks. This change was statistically significant compared with that seen in the placebo group (from 266+/-25 seconds at baseline to 284+/-23 seconds after 4 weeks and to 292+/-24 seconds after 12 weeks; P:=0.02 between the 2 groups by ANCOVA). The magnitude of the response was greater in those with lower baseline levels of bioavailable testosterone (r=-0. 455, P:<0.05). There were no significant changes in prostate specific antigen, hemoglobin, lipids, or coagulation profiles during the study. There were significant improvements in pain perception (P:=0.026) and role limitation resulting from physical problems (P:=0.024) in the testosterone-treated group.

CONCLUSIONS

Low-dose supplemental testosterone treatment in men with chronic stable angina reduces exercise-induced myocardial ischemia.

摘要

背景

实验研究表明雄激素可诱导冠状动脉扩张。我们开展了这个试点项目,以研究长期低剂量雄激素对心绞痛男性患者的临床影响。

方法与结果

46例稳定型心绞痛男性患者完成了为期2周的单盲安慰剂导入期,随后除当前用药外,通过经皮贴剂每日给予5mg睾酮或匹配的安慰剂进行双盲随机分组,为期12周。在基线以及治疗4周和12周后,测量平板运动试验中出现1mm ST段压低的时间和激素水平,并通过SF-36评估生活质量。积极治疗使雄激素水平增加了两倍,出现1mm ST段压低的时间从基线时的(均值±标准误)309±27秒增加到4周后的343±26秒和12周后的361±22秒。与安慰剂组相比,这一变化具有统计学意义(从基线时的266±25秒增加到4周后的284±23秒和12周后的292±24秒;通过协方差分析,两组之间P=0.02)。生物可利用睾酮基线水平较低者的反应幅度更大(r=-0.455,P<0.05)。研究期间前列腺特异性抗原、血红蛋白、血脂或凝血指标均无显著变化。睾酮治疗组在疼痛感知(P=0.026)和身体问题导致的角色限制(P=0.024)方面有显著改善。

结论

慢性稳定型心绞痛男性患者接受低剂量补充睾酮治疗可减轻运动诱发的心肌缺血。

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