RESTORATION OF PLASMA GH LEVELS WITH RHGRF IN OLDER ADULTS

这项研究的具体目的是将正常老年志愿者和充血性心力衰竭患者经常缺乏的血浆生长激素水平恢复到年轻人的水平。剂量、频率和持续时间的研究。随着年龄的增长，循环中的生长激素水平下降，并伴有明显的临床后遗症。老年人中另一种常见的疾病也与功能下降有关，那就是慢性心力衰竭(CHF)。研究表明，恢复血浆生长激素水平可以改善正常老年人的功能(骨密度增加和身体成分改变)，也可以改善CHF患者的心肌功能。用生长激素替代会导致不可接受的不良副作用，而重组人生长激素释放因子可以完全避免这些副作用。然而，最佳给药剂量和给药方式尚未确定。根据IGF-1水平低的评估，生长激素水平下降的老年人将被确定。他们将接受rhGRF的静脉推注，然后随机分为每天或每天两次皮下注射(S.C.)给予重组人生长激素释放因子21天。被诊断为CHF(纽约心脏协会II级和III级)的老年人也将接受与正常老年志愿者相同的方案。老年人的所有反应都将与正常的年轻志愿者进行比较。年轻志愿者将不会接受为期21天的治疗。本研究的终点是评价老年志愿者接受重组人生长激素释放因子治疗21天后的生长激素反应，以及单次静脉注射或皮下注射的生长激素反应。青年志愿者应用重组人粒细胞集落刺激因子。希望这项研究能确定恢复正常老年人和老年充血性心力衰竭患者的生长激素水平所需的最小剂量和频率，而不是年轻人。

The specific aim of this study is to restore plasma growth hormone levels, which are often deficient in normal elderly volunteers and patietns with congestive heart failure, to the levels found in younger adults. A dose, frequency and duration study. There is a decline in circulating GH levels with advancing age, which is accompanied by clinically significant sequelae. Another prevalent condition in the elderly also associated with decline in function is cogestive heart failure (CHF). Restoration of plasma GH levels has been showen to result in improved function both in the normal elderly (increaed bone mineral density and changes in body composition) and in patients with CHF (improved myocardial function). Replacement with GH results in unacceptable untoward side effects which can be entirely avoided with recombinant human growth hormone releasing factor. However, the optimal dose and mode of administration have not been established. Elderly individuals with a decrease in GH levels, as assessed by low IGF-1 levels, will be identified. They will receive an IV bolus infusion of rhGRF and then randomized into a daily or twice daily subcutaneous (s.c.) administration of rhGRF for 21 days. Elderly individuals with a diagnosis of CHF (New York Heart Association class II & III) will also undergo the same protocol as the normal elderly volunteers. All responses in the elderly will be compared to that of normal young volunteers. Young volunteers will not undergo the 21 days of treatment. The end point of this study is the evaluation of GH response follwoing 21 days of rhGRF treatment in the old volunteers and GH response to the single IV or s.c. administration of rhGRF in young volunteers. It is hoped that this study will establish the minimal dose and frequency required to restore GH levels, in the normal elderly and elderly patietns with CHF to those found in young individuals.