Neuroendocrine Unit, Bulfinch 457B, Massachusetts General Hospital, Boston, Massachusetts 02114, USA.
J Clin Endocrinol Metab. 2010 Feb;95(2):567-77. doi: 10.1210/jc.2009-1611. Epub 2010 Jan 8.
The effects of GH replacement therapy in patients who develop GH deficiency (GHD) after cure of acromegaly have not been established in a placebo-controlled study.
The objective of the study was to determine whether GH replacement improves body composition, cardiovascular risk markers and quality of life in patients with GHD and prior acromegaly.
This was a 6-month, randomized, placebo-controlled study.
The study was conducted at a clinical translational science center.
Participants included 30 subjects with prior acromegaly and current GHD.
INTERVENTIONs included GH or placebo.
Body composition (dual-energy x-ray absorptiometry and cross-sectional computed tomography at L4), cardiovascular risk markers (high-sensitivity C-reactive protein (hsCRP), total, high-density lipoprotein and low-density lipoprotein cholesterol, fibrinogen, and carotid intimal-medial thickness), and quality of life were measured.
The mean GH dose at 6 months was 0.58 +/- 0.26 mg/d. Total fat mass, visceral adipose tissue (-15.3 +/- 18.6 vs. 1.3 +/- 12.5%, P = 0.01), and total abdominal fat decreased, and fat-free mass increased, in the GH vs. placebo group. Mean hsCRP levels decreased, but there was no GH effect on other cardiovascular risk markers. There was no change in glycosylated hemoglobin or homeostasis model assessment insulin resistance index. Quality of life improved with GH. Side effects were minimal.
This is the first randomized, placebo-controlled study of the effects of GH replacement therapy on body composition and cardiovascular end points in patients who have developed GH deficiency after treatment for acromegaly, a disease complicated by metabolic and body composition alterations and increased cardiovascular risk. GH replacement decreased visceral adipose tissue, increased fat-free mass, decreased hsCRP, and improved quality of life in patients with GHD after cure of acromegaly, with minimal side effects and without an increase in insulin resistance.
在肢端肥大症治愈后发生生长激素缺乏（GHD）的患者中，生长激素替代治疗的效果尚未在安慰剂对照研究中得到证实。
本研究旨在确定生长激素替代治疗是否能改善肢端肥大症治愈后发生 GHD 患者的身体成分、心血管风险标志物和生活质量。
这是一项为期 6 个月的随机、安慰剂对照研究。
研究在一个临床转化科学中心进行。
参与者包括 30 名有肢端肥大症既往史和当前 GHD 的患者。
干预措施包括生长激素或安慰剂。
身体成分（L4 处的双能 X 射线吸收法和横断面计算机断层扫描）、心血管风险标志物（高敏 C 反应蛋白（hsCRP）、总胆固醇、高密度脂蛋白胆固醇、低密度脂蛋白胆固醇、纤维蛋白原和颈动脉内膜中层厚度）和生活质量。
6 个月时的平均 GH 剂量为 0.58 ± 0.26 mg/d。与安慰剂组相比，GH 组的总脂肪量、内脏脂肪组织（-15.3 ± 18.6%对 1.3 ± 12.5%，P = 0.01）和总腹部脂肪减少，而无脂肪量增加。hsCRP 水平下降，但 GH 对其他心血管风险标志物没有影响。糖化血红蛋白或稳态模型评估的胰岛素抵抗指数没有变化。生活质量随着 GH 的应用而改善。副作用很小。
这是第一项肢端肥大症治愈后发生 GHD 的患者接受生长激素替代治疗对身体成分和心血管终点影响的随机、安慰剂对照研究，肢端肥大症是一种代谢和身体成分改变以及心血管风险增加的疾病。GH 替代治疗可减少内脏脂肪组织，增加无脂肪量，降低 hsCRP，并改善肢端肥大症治愈后发生 GHD 患者的生活质量，副作用小，且不会增加胰岛素抵抗。
