Berger J R, Pall L, Hall C D, Simpson D M, Berry P S, Dudley R
Department of Neurology, University of Miami School of Medicine, Florida, USA.
AIDS. 1996 Dec;10(14):1657-62. doi: 10.1097/00002030-199612000-00010.
To evaluate oxandrolone, an oral anabolic steroid with potent anabolic activity and minimal androgenic effects, for the treatment of AIDS-associated myopathy and wasting.
In a multicenter, double-blind study, 63 HIV-seropositive men with > 10% loss of body weight were randomized to receive either placebo, 5 mg/day oxandrolone, or 15 mg/day oxandrolone for 16 weeks. Body weight, neuromuscular evaluation, and measures of well-being were repeatedly assessed.
Patients who received 15 mg/day oxandrolone showed weight gain throughout the 16-week treatment period. Overall, the 5 mg/day oxandrolone group maintained their weight gain over the 16-week period, whereas the placebo group showed continual weight loss. At week 16, significantly more patients in the 15 mg/day dose group reported increases in appetite and activity than those receiving placebo. There were no consistent, dose-related, statistically significant differences from baseline in laboratory values or adverse events.
Oxandrolone, at a dose of either 5 mg/day or 15 mg/day, in contrast to placebo, had a positive impact on the weight and well-being of HIV-seropositive patients suffering from wasting and weakness. Measurable improvement in muscle strength was not noted at the doses employed in this study. Oxandrolone was well tolerated in all the patients who were enrolled in the study. Based on the results reported here, additional studies using higher doses of oxandrolone seem warranted.
评估氧雄龙（一种具有强大合成代谢活性且雄激素作用极小的口服合成代谢类固醇）对艾滋病相关肌病和消瘦的治疗效果。
在一项多中心、双盲研究中，63名体重减轻超过10%的HIV血清阳性男性被随机分为三组，分别接受安慰剂、每日5毫克氧雄龙或每日15毫克氧雄龙治疗，为期16周。对体重、神经肌肉评估和健康状况指标进行反复评估。
接受每日15毫克氧雄龙治疗的患者在整个16周治疗期内体重增加。总体而言，每日5毫克氧雄龙组在16周内维持了体重增加，而安慰剂组体重持续下降。在第16周时，每日15毫克剂量组中报告食欲和活动增加的患者明显多于接受安慰剂的患者。实验室值或不良事件与基线相比，没有一致的、与剂量相关的、具有统计学意义的差异。
与安慰剂相比，每日5毫克或15毫克剂量的氧雄龙对患有消瘦和虚弱的HIV血清阳性患者的体重和健康状况有积极影响。在本研究使用的剂量下，未观察到肌肉力量有可测量的改善。本研究中所有入组患者对氧雄龙耐受性良好。基于此处报告的结果，似乎有必要开展使用更高剂量氧雄龙的进一步研究。
