Yeh S-S, Lovitt S, Schuster M W
Northport VAMC, Geriatric Division, Northport, NY 11768, USA.
J Nutr Health Aging. 2009 May;13(5):448-54. doi: 10.1007/s12603-009-0082-1.
The aim of this review is to assess the efficacy and safety of megestrol acetate (MA) in geriatric cachexia. The paper presented here reviews a previously published study of MA use in 69 patients in a randomized double blind placebo-controlled trial. This paper will also address the underlying pathogenesis of cachexia (specifically, the role of cytokines) along with the use of MA, its mechanism of action and its side effects.
To compare the effects of MA oral suspension (O.S.), 800 mg/day, versus placebo on weight in geriatric nursing home patients with weight loss or low body weight.
Twelve weeks, randomized, double-blind, placebo-controlled trial with a 13-week follow-up period.
Northport VAMC Nursing home patients with weight loss of * 5% of usual body weight over the past 3 months, or body weight 20% below their ideal body weight.
Patients were randomly assigned to receive placebo or MA 800 mg/d for 12 weeks and were then followed for 13 weeks off treatment and mortality 4 years post treatment.
Primary outcome- weight and appetite change. Secondary outcome-sense of well being, enjoyment of life, change in depression scale, laboratory nutrition parameters, energy intake counts, body composition, and adverse events.
At 12 weeks there were no significant differences in weight gain between treatment groups, while MA-treated patients reported significantly greater improvement in appetite, enjoyment of life, and well being. At week 25 (3 months after treatment), 61.9% of MA-treated patients had gained * 1.82 kg (4 lbs) compared to 21.7% of placebo patients. There was no difference in survival between MA and placebo groups. Considering possible confounders, higher initial IL-6, initial TNFR-p75 levels, and final neutrophil percentage were associated with elevated mortality, whereas higher initial pre-albumin, initial albumin, final pre-albumin, final albumin and final weight gain were associated with decreased death.
本综述的目的是评估醋酸甲地孕酮（MA）治疗老年恶病质的疗效和安全性。本文回顾了此前发表的一项关于MA的研究，该研究为随机双盲安慰剂对照试验，共纳入69例患者。本文还将探讨恶病质的潜在发病机制（特别是细胞因子的作用）以及MA的使用、作用机制和副作用。
比较每天800毫克MA口服混悬液（O.S.）与安慰剂对老年疗养院体重减轻或体重过低患者体重的影响。
为期12周的随机双盲安慰剂对照试验，随访期为13周。
北港退伍军人事务部医疗中心疗养院的患者，在过去3个月内体重减轻超过平常体重的5%，或体重比理想体重低20%。
患者被随机分配接受安慰剂或每天800毫克MA治疗12周，然后停药随访13周，并在治疗后4年观察死亡率。
主要指标——体重和食欲变化。次要指标——幸福感、生活乐趣、抑郁量表变化、实验室营养参数、能量摄入计数、身体成分和不良事件。
在12周时，各治疗组之间的体重增加无显著差异，而接受MA治疗的患者在食欲、生活乐趣和幸福感方面的改善明显更大。在第25周（治疗后3个月），61.9%接受MA治疗的患者体重增加超过1.82千克（4磅），而接受安慰剂治疗的患者这一比例为21.7%。MA组和安慰剂组的生存率无差异。考虑到可能的混杂因素，较高的初始白细胞介素-6、初始肿瘤坏死因子受体-p75水平和最终中性粒细胞百分比与死亡率升高相关，而较高的初始前白蛋白、初始白蛋白、最终前白蛋白、最终白蛋白和最终体重增加与死亡风险降低相关。
