Section of Endocrinology, Diabetes and Nutrition, Boston University School of Medicine and Boston Medical Center, Boston, MA 02118, USA.
Horm Res Paediatr. 2011;76 Suppl 1(Suppl 1):17-23. doi: 10.1159/000329148. Epub 2011 Jul 21.
The number of elderly people is growing worldwide, and a substantial proportion of them report difficulty with mobility and in performing activities of daily living. The demographic trends have created enormous interest in development of function-promoting anabolic therapies. At present, androgens and myostatin inhibitors are the two leading classes of function-promoting anabolic therapies that are the most advanced in the drug development process. However, clinical development has been slowed by vexing trial design issues.
Clinical investigators, regulatory agencies and the National Institutes of Health must continue working toward a consensus about the indications for study, efficacy outcomes and what differences in functional outcomes are needed to determine sample size estimates.
全球老年人口数量不断增加，其中相当一部分人报告说在移动和进行日常生活活动方面存在困难。人口趋势引发了人们对促进功能的合成代谢疗法的巨大兴趣。目前，雄激素和肌肉生长抑制素抑制剂是促进功能的合成代谢疗法中最先进的两类，处于药物开发过程的领先地位。然而，临床试验设计问题令人困扰，这使得临床开发进展缓慢。
临床研究人员、监管机构和美国国立卫生研究院必须继续努力就研究适应症、疗效结果以及需要在功能结果上有何差异来确定样本量估算达成共识。
