在患有与人类免疫缺陷病毒相关体重减轻的男性中，甲地孕酮疗法补充睾酮并不能增加瘦组织积累：一项随机、双盲、安慰剂对照、多中心试验。
Testosterone supplementation of megestrol therapy does not enhance lean tissue accrual in men with human immunodeficiency virus-associated weight loss: a randomized, double-blind, placebo-controlled, multicenter trial.
作者信息
Mulligan Kathleen, Zackin Robert, Von Roenn Jamie H, Chesney Margaret A, Egorin Merrill J, Sattler Fred R, Benson Constance A, Liu Tun, Umbleja Triin, Shriver Sharon, Auchus Richard J, Schambelan Morris
机构信息
Department of Medicine, University of California, San Francisco, California 94110, USA.
出版信息
J Clin Endocrinol Metab. 2007 Feb;92(2):563-70. doi: 10.1210/jc.2006-0954. Epub 2006 Nov 7.
CONTEXT
Reduced energy intake is a primary factor in HIV-associated wasting. Megestrol acetate (MA) stimulates appetite and weight gain. However, much of the weight gained is fat, possibly as a result of MA-induced hypogonadism.
OBJECTIVE
The objective of the study was to determine whether coadministration of testosterone with MA could enhance lean body mass (LBM) accrual and evaluate the effects of MA, alone or combined with testosterone, on sexual functioning and the hypothalamic-pituitary-adrenal axis.
DESIGN
This was a randomized, double-blind, placebo-controlled, multicenter trial.
SETTING
Fourteen AIDS Clinical Trials Units in the United States participated in the study.
SUBJECTS
Seventy-nine HIV-positive men with 5% or more weight loss or body mass index less than 20 kg/m2 took part in the study.
INTERVENTION
Subjects were randomized to receive MA (800 mg daily) plus testosterone enanthate (200 mg; MA/TE; n = 41) or placebo (MA/PL; n = 38) biweekly for 12 wk.
MAIN OUTCOME MEASURES
Weight, body composition (bioelectric impedance analysis), adrenal and gonadal hormones, and sexual functioning (questionnaire) were measured.
RESULTS
Both groups experienced robust increases in weight (median 5.3 and 7.3 kg in MA/TE and MA/PL, respectively), LBM (3.3 and 3.3 kg), and fat (3.0 and 3.8 kg). There were no significant differences between groups in the magnitude or composition of weight gain (P = 0.44, 0.90, and 0.11 for weight, LBM, and fat, respectively). Trough testosterone concentrations decreased to a greater extent in MA/PL (-12.3 vs. -6.1 nmol/liter in MA/TE; P = 0.04). Cortisol levels became nearly undetectable in subjects with plasma MA levels greater than 150 ng/ml. Sexual functioning was preserved with MA/TE but worsened in MA/PL.
CONCLUSIONS
MA produced robust weight gain. Coadministration of testosterone preserved sexual functioning but did not enhance LBM accrual.
背景
能量摄入减少是与HIV相关的消瘦的主要因素。醋酸甲地孕酮（MA）可刺激食欲并增加体重。然而，增加的体重大部分是脂肪，这可能是MA引起性腺功能减退的结果。
目的
本研究的目的是确定睾酮与MA联合使用是否能增加瘦体重（LBM），并评估MA单独使用或与睾酮联合使用对性功能和下丘脑-垂体-肾上腺轴的影响。
设计
这是一项随机、双盲、安慰剂对照的多中心试验。
地点
美国14个艾滋病临床试验单位参与了该研究。
受试者
79名体重减轻5%或更多或体重指数低于20kg/m²的HIV阳性男性参与了研究。
干预
受试者被随机分为两组，每两周接受一次MA（每日800mg）加庚酸睾酮（200mg；MA/TE；n = 41）或安慰剂（MA/PL；n = 38），共12周。
主要观察指标
测量体重、身体成分（生物电阻抗分析）、肾上腺和性腺激素以及性功能（问卷调查）。
结果
两组体重（MA/TE组和MA/PL组中位数分别为5.3kg和7.3kg）、LBM（3.3kg和3.3kg）和脂肪（3.0kg和3.8kg）均显著增加。两组体重增加的幅度或组成无显著差异（体重、LBM和脂肪的P值分别为0.44、0.90和0.11）。MA/PL组的谷值睾酮浓度下降幅度更大（-12.3 vs. MA/TE组的-6.1nmol/L；P = 0.04）。血浆MA水平大于150ng/ml的受试者皮质醇水平几乎检测不到。MA/TE组性功能得以保留，而MA/PL组性功能恶化。
结论
MA可显著增加体重。睾酮联合使用可保留性功能，但未增加LBM。
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