Grunfeld Carl, Kotler Donald P, Dobs Adrian, Glesby Marshall, Bhasin Shalender
University of California-San Francisco, and Department of Veterans Affairs Medical Center, 4150 Clement Street, San Francisco, CA 94121, USA.
J Acquir Immune Defic Syndr. 2006 Mar;41(3):304-14. doi: 10.1097/01.qai.0000197546.56131.40.
To evaluate the efficacy and safety of oxandrolone in promoting body weight and body cell mass (BCM) gain in HIV-associated weight loss.
Randomized, double-blind, placebo-controlled trial. Two hundred sixty-two HIV-infected men with documented 10% to 20% weight loss or body mass index < or =20 kg/m were randomized to placebo or to 20, 40, or 80 mg of oxandrolone daily. After 12 weeks, subjects were allowed to receive open-label oxandrolone at a dose of 20 mg for another 12 weeks.
Body weight increased in all groups, including the group receiving placebo, during the double-blind phase (1.1 +/- 2.7, 1.8 +/- 3.9, 2.8 +/- 3.3, and 2.3 +/- 2.9 kg in placebo and 20-, 40-, and 80-mg oxandrolone groups, respectively; all P < 0.014 vs. baseline). BCM increased from baseline in all groups (0.45 +/- 1.7, 0.91 +/- 2.2, 1.5 +/- 2.5, and 1.8 +/- 1.8 kg in placebo and 20-, 40-, and 80-mg oxandrolone groups, respectively). At 12 weeks, only the gain in weight at the 40-mg dose of oxandrolone and the gain in BCM at the 40- and 80-mg doses of oxandrolone were greater than those in the placebo group, however. Oxandrolone treatment was associated with significant suppression of sex hormone-binding globulin, luteinizing hormone, follicle-stimulating hormone, and total and free testosterone levels. Treatment was generally well tolerated but accompanied by significant increases in transaminases and low-density lipoprotein as well as decreases in high-density lipoprotein.
Oxandrolone administration is effective in promoting dose-dependent gains in body weight and BCM in HIV-infected men with weight loss.
评估氧雄龙促进HIV相关体重减轻患者体重和身体细胞质量（BCM）增加的疗效和安全性。
随机、双盲、安慰剂对照试验。262名记录有10%至20%体重减轻或体重指数≤20kg/m²的HIV感染男性被随机分为安慰剂组或每日服用20、40或80mg氧雄龙组。12周后，受试者被允许再接受12周的20mg开放标签氧雄龙治疗。
在双盲阶段，所有组的体重均增加，包括接受安慰剂的组（安慰剂组、20mg、40mg和80mg氧雄龙组的体重分别增加1.1±2.7、1.8±3.9、2.8±3.3和2.3±2.9kg；与基线相比，所有P<0.014）。所有组的BCM均较基线增加（安慰剂组、20mg、40mg和80mg氧雄龙组的BCM分别增加0.45±1.7、0.91±2.2、1.5±2.5和1.8±1.8kg）。然而，在12周时，仅40mg剂量氧雄龙组的体重增加以及40mg和80mg剂量氧雄龙组的BCM增加大于安慰剂组。氧雄龙治疗与性激素结合球蛋白、促黄体生成素、促卵泡生成素以及总睾酮和游离睾酮水平的显著降低相关。治疗总体耐受性良好，但伴有转氨酶和低密度脂蛋白显著升高以及高密度脂蛋白降低。
对于体重减轻的HIV感染男性，服用氧雄龙可有效促进体重和BCM的剂量依赖性增加。
