Von Roenn J H, Armstrong D, Kotler D P, Cohn D L, Klimas N G, Tchekmedyian N S, Cone L, Brennan P J, Weitzman S A
Northwestern University, Chicago, IL 60611.
Ann Intern Med. 1994 Sep 15;121(6):393-9. doi: 10.7326/0003-4819-121-6-199409150-00001.
To compare the effects of oral suspensions of megestrol acetate, 800 mg/d, and placebo on body weight in patients with acquired immunodeficiency syndrome (AIDS)-related weight loss.
Randomized, double-blind, placebo-controlled trial.
Outpatient community and university patient care setting.
Consecutive patients with AIDS who had substantial weight loss and anorexia were enrolled. Of 271 patients, 270 and 195 were evaluable for safety and efficacy, respectively.
Patients were randomly assigned to receive placebo or megestrol acetate (100 mg, 400 mg, or 800 mg) daily for 12 weeks.
The primary efficacy criterion was weight gain. Patients were evaluated at 4-week intervals for changes in weight and body composition, caloric intake, sense of well-being, toxic effects, and appetite.
For evaluable patients receiving 800 mg of megestrol acetate per day, 64.2% gained 2.27 kg (5 pounds) or more compared with 21.4% of patients receiving placebo (P < 0.001). An intent-to-treat analysis showed significant differences (P = 0.002) between those receiving placebo and those receiving 800 mg of megestrol acetate for the number of patients who gained 2.27 kg (5 pounds) or more (8 of 32 [25%] compared with 38 of 61 [62.3%], respectively). Compared with patients receiving placebo at the time of maximum weight change, evaluable patients receiving megestrol acetate, 800 mg/d, reported improvement in overall well-being and had an increase in mean weight gain (-0.725 compared with 3.54 kg [-1.6 compared with +7.8 pounds]; P < 0.001), lean body mass (-0.772 compared with +1.14 kg [-1.7 compared with +2.5 pounds]; P < 0.001), appetite grade (P < 0.001), and caloric intake (-107 compared with +645.6 calories/d; P = 0.001).
In patients with AIDS-related weight loss, megestrol acetate can stimulate appetite, food intake, and statistically significant weight gain that is associated with a patient-reported improvement in an overall sense of well-being.
比较醋酸甲地孕酮口服混悬液（800mg/d）与安慰剂对获得性免疫缺陷综合征（AIDS）相关体重减轻患者体重的影响。
随机、双盲、安慰剂对照试验。
门诊社区及大学患者护理机构。
纳入体重显著减轻且伴有厌食的连续性AIDS患者。271例患者中，分别有270例和195例可进行安全性和疗效评估。
患者被随机分配，每天接受安慰剂或醋酸甲地孕酮（100mg、400mg或800mg）治疗，为期12周。
主要疗效标准为体重增加。每隔4周对患者的体重和身体组成变化、热量摄入、幸福感、毒性作用及食欲进行评估。
对于每天接受800mg醋酸甲地孕酮治疗的可评估患者，64.2%的人体重增加2.27kg（5磅）或更多，而接受安慰剂治疗的患者这一比例为21.4%（P<0.001）。意向性分析显示，体重增加2.27kg（5磅）或更多的患者中，接受安慰剂治疗的患者与接受800mg醋酸甲地孕酮治疗的患者之间存在显著差异（P = 0.002）（分别为32例中的8例[25%]和61例中的38例[62.3%]）。与体重变化最大时接受安慰剂治疗的患者相比，每天接受800mg醋酸甲地孕酮治疗的可评估患者报告整体幸福感有所改善，平均体重增加（-0.725kg与3.54kg相比[-1.6磅与+7.8磅相比]；P<0.001）、瘦体重（-0.772kg与+1.14kg相比[-1.7磅与+2.5磅相比]；P<0.001）、食欲等级（P<0.001）和热量摄入（-107卡路里/d与+645.6卡路里/d相比；P = 0.001）均有所增加。
在AIDS相关体重减轻患者中，醋酸甲地孕酮可刺激食欲、食物摄入，并使体重显著增加，且患者报告整体幸福感有所改善。
