Effects of Oxandrolone on Cardiometabolic Health in Boys With Klinefelter Syndrome: A Randomized Controlled Trial

Effects of Oxandrolone on Cardiometabolic Health in Boys With Klinefelter Syndrome: A Randomized Controlled Trial
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DOI:
10.1210/jc.2016-2904
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发表时间:
2017-01-01
影响因子:
5.8
通讯作者:
Ross, Judith L.
Ross, Judith L.
中科院分区:
医学2区
文献类型:
--
作者:
Davis, Shanlee M.;Cox-Martin, Matthew G.;Ross, Judith L.

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背景:Klinefelter综合征(KS)是男性常见的疾病,导致雄激素缺乏和心脏代谢性疾病。目的:为了确定补充小剂量雄激素是否有益于青春期前KS男孩的身体成分。设计、环境和参与者:我们对93名4-12岁KS男孩进行了一项随机、双盲、安慰剂对照临床试验的二次分析。干预措施:口服奥雄酮(Ox)0.06 mg/kg/d或服用安慰剂2年。结果:主要结果是2年后的体脂标准偏差百分比(%BF SDS)。结果:在调整了年龄和基线%BF-SD(平均值为20.86-20.19SD的95%可信区间,P=0.009)后,治疗2年时的%BF-SD(0.29+/-0.76SD)显著低于安慰剂组(0.81+/-0.72SD)。OX使甘油三酯降低(P=0.043),高密度脂蛋白胆固醇降低(P=0.001),骨龄增加更快(P=0.011)。结论:OX对青春期前KS男孩的心脏代谢健康指标有积极作用,但它确实降低高密度脂蛋白胆固醇,提高骨龄。
Context: Klinefelter syndrome (KS) is a common condition in males, resulting in androgen deficiency and cardiometabolic diseases. These interrelated conditions may be present in prepubertal boys with KS.Objective: To determine whether supplemental low-dose androgen has a beneficial effect on body composition in prepubertal boys with KS.Design, Setting, and Participants: We conducted a secondary analysis of a randomized, double-blind, placebo-controlled clinical trial in 93 boys with KS aged 4 to 12 years.Interventions: Oral oxandrolone (Ox) 0.06 mg/kg/d or placebo for 2 years.Outcome Measures: The primary outcome was percent body fat standard deviation score (% BF SDS) at 2 years. Secondary outcomes included additional measures of cardiometabolic health and safety.Results: The % BF SDS at 2 years was significantly lower in the treatment (0.29 +/- 0.76 SDS) compared with placebo group (0.81 +/- 0.72 SDS) after adjusting for age and baseline % BF SDS (95% confidence interval for the difference between means 20.86 to 20.19 SDS, P = 0.009). Ox resulted in lower triglycerides (P = 0.043), but also lower high-density lipoprotein (HDL) cholesterol (P, 0.001) and a more rapid advancement in bone age (P = 0.011).Conclusions: Ox has positive effects on measures of cardiometabolic health in prepubertal boys with KS; however, it does lower HDL cholesterol and advance bone age.