Chihara Kazuo, Fujieda Kenji, Shimatsu Akira, Miki Takami, Tachibana Katsuhiko
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-Cho, Tyuo-ku, Kobe, Hyogo 650-0017, Japan.
Growth Horm IGF Res. 2010 Jun;20(3):205-11. doi: 10.1016/j.ghir.2010.01.003. Epub 2010 Feb 21.
A clinical study was carried out to investigate the efficacy and safety of two doses of GH treatment on adult growth hormone deficiency (AGHD) patients in Japan. Dose-responsiveness between GH doses and changes of body composition was examined.
A 24-week, randomized, placebo-controlled, double-blind clinical study in 96 Japanese AGHD patients followed by a 48-week, open-label, long-term study.
During the double-blind study, serum insulin-like growth factor (IGF)-I SDS and lean body mass increased and total fat mass and serum total cholesterol decreased similarly in both GH treated groups. Mean changes in IGF-I SDS were 3.63+/-1.67, 1.97+/-1.27, and -0.13+/-0.55 in high-dose (HD) group (0.012 mg/kg/day), low-dose (LD) group (0.006 mg/kg/day), and placebo group, respectively. Trunk fat mass decreased significantly (p<0.001) in HD group and LD group but not in placebo group (mean changes in percent trunk fat mass were -4.6+/-2.6%, -3.0+/-2.5% and 0.2+/-2.1% in HD group, LD group and placebo group, respectively). Serum LDL-cholesterol decreased in both GH treated groups but significantly only in HD group. Statistically significant dose-responsiveness was shown among three groups (p<0.001) with regards to IGF-I SDS, trunk fat mass, total fat mass, and lean body mass. The changes in serum IGF-I SDS, body composition, total cholesterol, and LDL-cholesterol at the end of double-blind study persisted throughout the open-label study. In addition, there was no clinically relevant adverse event during the both studies.
GH treatment significantly improved serum levels of IGF-I and body composition in a dose-responsive manner in Japanese AGHD patients. Total cholesterol and LDL-cholesterol levels also decreased. GH treatment was safe and generally well tolerated.
开展一项临床研究，以调查两剂生长激素（GH）治疗日本成年生长激素缺乏症（AGHD）患者的疗效和安全性。研究了GH剂量与身体成分变化之间的剂量反应性。
一项针对96名日本AGHD患者的为期24周的随机、安慰剂对照、双盲临床研究，随后是一项为期48周的开放标签长期研究。
在双盲研究期间，两个GH治疗组的血清胰岛素样生长因子（IGF）-I标准差积分（SDS）和去脂体重均增加，总脂肪量和血清总胆固醇均有类似程度的下降。高剂量（HD）组（0.012毫克/千克/天）、低剂量（LD）组（0.006毫克/千克/天）和安慰剂组的IGF-I SDS平均变化分别为3.63±1.67、1.97±1.27和-0.13±0.55。HD组和LD组的躯干脂肪量显著下降（p<0.001），而安慰剂组未下降（HD组、LD组和安慰剂组的躯干脂肪量百分比平均变化分别为-4.6±2.6%、-3.0±2.5%和0.2±2.1%）。两个GH治疗组的血清低密度脂蛋白胆固醇均下降，但仅HD组有显著下降。三组在IGF-I SDS、躯干脂肪量、总脂肪量和去脂体重方面显示出具有统计学意义的剂量反应性（p<0.001）。双盲研究结束时血清IGF-I SDS、身体成分、总胆固醇和低密度脂蛋白胆固醇的变化在整个开放标签研究期间持续存在。此外，两项研究期间均未出现临床相关不良事件。
在日本AGHD患者中，GH治疗以剂量反应性方式显著改善了血清IGF-I水平和身体成分。总胆固醇和低密度脂蛋白胆固醇水平也有所下降。GH治疗安全且总体耐受性良好。
