Reuben David B, Hirsch Susan H, Zhou Kefei, Greendale Gail A
UCLA Multicampus Program in Geriatric Medicine and Gerontology, University of California at Los Angeles, Los Angeles, California 90095, USA.
J Am Geriatr Soc. 2005 Jun;53(6):970-5. doi: 10.1111/j.1532-5415.2005.53307.x.
To provide preliminary evidence on the effectiveness and optimal dosage of megestrol acetate for older persons with impaired appetite after hospitalization.
Randomized clinical trial.
Acute care hospital.
Forty-seven older persons (mean age 83) who were recently discharged from an acute care hospital and had fair or poor appetite.
Participants were randomized to placebo or megestrol acetate suspension 200 mg, 400 mg, or 800 mg daily for 9 weeks.
Appetite, health-related quality of life, and adverse effects were measured at baseline and 20, 42, and 63 days. Serum nutritional markers were measured at baseline and 20 and 63 days.
During the course of the study, there were no significant differences between treatment groups on any of the appetite questions, although participants in the 400-mg and 800-mg groups demonstrated significant improvement from baseline on some questions. At 20 days, prealbumin increased in a dose-response relationship across the four groups (by 0.4, 5.1, 7.5, and 9.0 mg/dL, respectively). Participants in the 400-mg and 800-mg groups demonstrated greater improvement in prealbumin levels at 20 days than those receiving placebo (P=.009 and P=.004, respectively) and those in the 400-mg group also demonstrated improvement at 63 days (P=.02). At 20 days, no participant taking placebo had a morning serum cortisol level less than 8 ng/mL (the lower limit of normal). In contrast, 33%, 70%, and 78% of those taking 200 mg, 400 mg and 800 mg, respectively, had values below this level; by 63 days, these percentages were 11%, 30%, 56%, and 37%, respectively. No patient reported clinical symptoms of adrenal insufficiency. Diarrhea developed in three subjects, and thromboembolism occurred in two receiving active treatment.
Megestrol acetate at doses of 400 mg and 800 mg increases prealbumin in recently hospitalized older persons. Cortisol suppression is common at higher doses and may be persistent. In this small study, the drug did not confer benefit on other nutritional or clinical outcomes.
为醋酸甲地孕酮治疗住院后食欲减退的老年人的有效性和最佳剂量提供初步证据。
随机临床试验。
急症医院。
47名老年人（平均年龄83岁），他们近期从急症医院出院，食欲一般或较差。
参与者被随机分为安慰剂组或每日服用200毫克、400毫克或800毫克醋酸甲地孕酮混悬液组，为期9周。
在基线、第20、42和63天测量食欲、健康相关生活质量及不良反应。在基线、第20和63天测量血清营养标志物。
在研究过程中，各治疗组在任何食欲问题上均无显著差异，尽管400毫克组和800毫克组的参与者在一些问题上较基线有显著改善。在第20天，四组前白蛋白均呈剂量反应关系升高（分别升高0.4、5.1、7.5和9.0毫克/分升）。400毫克组和800毫克组的参与者在第20天时前白蛋白水平的改善程度高于服用安慰剂的参与者（分别为P = 0.009和P = 0.004），400毫克组的参与者在第63天时也有改善（P = 0.02）。在第20天，服用安慰剂的参与者晨血清皮质醇水平均不低于8纳克/毫升（正常下限）。相比之下，服用200毫克、400毫克和800毫克的参与者中，分别有33%、70%和78%的人低于此水平；到第63天时，这些百分比分别为11%、30%、56%和37%。没有患者报告肾上腺皮质功能不全的临床症状。三名受试者出现腹泻，两名接受积极治疗的受试者发生血栓栓塞。
400毫克和800毫克剂量的醋酸甲地孕酮可使近期住院的老年人前白蛋白升高。高剂量时皮质醇抑制常见且可能持续。在这项小型研究中，该药物未对其他营养或临床结局产生益处。
