女性慢性心力衰竭患者的睾酮治疗：一项双盲、随机、安慰剂对照的初步研究。

Testosterone therapy in women with chronic heart failure: a pilot double-blind, randomized, placebo-controlled study.

机构信息

Department of Medical Sciences, Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele Roma, Roma, Italy.

出版信息

J Am Coll Cardiol. 2010 Oct 12;56(16):1310-6. doi: 10.1016/j.jacc.2010.03.090.

DOI:10.1016/j.jacc.2010.03.090

PMID:20888520

Abstract

OBJECTIVES

The primary objective of this study was to assess the effect of a 6-month testosterone supplementation therapy on functional capacity and insulin resistance in female patients with chronic heart failure (CHF).

BACKGROUND

Patients with CHF show decreased exercise capacity and insulin sensitivity. Testosterone supplementation improves these variables in men with CHF. No study has evaluated the effects of testosterone supplementation on female patients with CHF.

METHODS

Thirty-six elderly female patients with stable CHF, (ejection fraction 32.9 ± 6) were randomly assigned (2:1 ratio) to receive testosterone transdermal patch (T group, n = 24) or placebo (P group, n = 12), both on top of optimal medical therapy. At baseline and after 6 months, patients underwent 6-min walking test (6MWT), cardiopulmonary exercise test, echocardiogram, quadriceps maximal isometric voluntary contraction, dynamic quadriceps isokinetic strength (peak torque), and insulin resistance assessment by homeostasis model.

RESULTS

Distance walked at 6MWT as well as peak oxygen consumption significantly improved in the T group, whereas they were unchanged in the P group (p < 0.05 for all comparisons). The homeostasis model was significantly reduced in the T group in comparison with the P group (-16.5% vs. +5%, respectively; p < 0.05). Maximal voluntary contraction and peak torque increased significantly in the T group but did not change in the P group. Increase in distance walked at 6MWT was related to the increase in free testosterone levels (r = 0.593, p = 0.01). No significant changes in echocardiographic parameters were observed in either group. No side effects requiring discontinuation of T were detected.

CONCLUSIONS

Testosterone supplementation improves functional capacity, insulin resistance, and muscle strength in women with advanced CHF. Testosterone seems to be an effective and safe therapy for elderly women with CHF.

摘要

目的

本研究的主要目的是评估 6 个月的睾酮补充治疗对慢性心力衰竭（CHF）女性患者的功能能力和胰岛素抵抗的影响。

背景

CHF 患者的运动能力和胰岛素敏感性降低。睾酮补充治疗可改善 CHF 男性患者的这些变量。尚无研究评估睾酮补充治疗对 CHF 女性患者的影响。

方法

36 名患有稳定 CHF 的老年女性患者（射血分数 32.9 ± 6）被随机分配（2:1 比例）接受睾酮透皮贴剂（T 组，n = 24）或安慰剂（P 组，n = 12），同时接受最佳药物治疗。在基线和 6 个月后，患者进行了 6 分钟步行测试（6MWT）、心肺运动测试、超声心动图、股四头肌最大等长随意收缩、动态股四头肌等速力量（峰值扭矩）和通过稳态模型评估胰岛素抵抗。

结果

T 组 6MWT 步行距离以及峰值耗氧量显著改善，而 P 组则无变化（所有比较均为 p < 0.05）。与 P 组相比，T 组的稳态模型显著降低（分别为-16.5%和+5%；p < 0.05）。T 组的最大自愿收缩和峰值扭矩显著增加，但 P 组没有变化。6MWT 步行距离的增加与游离睾酮水平的增加相关（r = 0.593，p = 0.01）。两组超声心动图参数均无明显变化。未发现需要停止 T 治疗的不良反应。