Papadakis M A, Grady D, Black D, Tierney M J, Gooding G A, Schambelan M, Grunfeld C
University of California, San Francisco, California, USA.
Ann Intern Med. 1996 Apr 15;124(8):708-16. doi: 10.7326/0003-4819-124-8-199604150-00002.
To determine whether growth hormone replacement in older men improves functional ability.
Randomized, controlled, double-blind trial.
General community.
52 healthy men older than 69 years of age with well-preserved functional ability but low baseline insulin-like growth factor 1 levels.
Growth hormone (0.03 mg/kg of body weight) or placebo given three times a week for 6 months.
Body composition, knee and hand grip muscle strength, systemic endurance, and cognitive function.
The participants' mean age was 75.0 years (range, 70 to 85 years). At 6 months, lean mass had increased on average by 4.3% in the growth hormone group and had decreased by 0.1% in the placebo group, a difference of 4.4 percentage points (95% CI, 2.1 to 6.8 percentage points). Fat mass decreased by an average of 13.1% in the growth hormone group and by 0.3% in the placebo group, a difference of 12.8 percentage points (CI, 8.6 to 17.0 percentage points). No statistically or clinically significant differences were seen between the groups in knee or hand grip strength or in systemic endurance. The mean Trails B score in the growth hormone group improved by 8.5 seconds, whereas scores in the placebo group deteriorated by 5.0 seconds, a difference of 13.5 seconds (CI, 3.1 seconds to 23.9 seconds; P = 0.01). However, the growth hormone group's score on the Mini-Mental Status Examination deteriorated by 0.4, whereas the placebo group's score improved by 0.2, a difference of 0.6 (P = 0.11). The two treatment groups had almost identical scores on the Digit Symbol Substitution Test (P > 0.2). Twenty-six men in the growth hormone group had 48 incidents of side effects, and 26 placebo recipients had 14 incidents of side effects (P = 0.002). Dose reduction was required in 26% of the growth hormone recipients and in none of the placebo recipients (P < 0.001).
Physiologic doses of growth hormone given for 6 months to healthy older men with well-preserved functional abilities increased lean tissue mass and decreased fat mass. Although body composition improved with growth hormone use, functional ability did not improve. Side effects occurred frequently.
确定老年男性补充生长激素是否能改善功能能力。
随机、对照、双盲试验。
普通社区。
52名69岁以上的健康男性，其功能能力保存良好，但基线胰岛素样生长因子1水平较低。
生长激素（0.03毫克/千克体重）或安慰剂，每周给药3次，共6个月。
身体成分、膝关节和手握力、全身耐力及认知功能。
参与者的平均年龄为75.0岁（范围70至85岁）。6个月时，生长激素组的瘦体重平均增加了4.3%，安慰剂组减少了0.1%，差异为4.4个百分点（95%可信区间，2.1至6.8个百分点）。生长激素组的脂肪量平均减少了13.1%，安慰剂组减少了0.3%，差异为12.8个百分点（可信区间，8.6至17.0个百分点）。两组在膝关节或手握力以及全身耐力方面未观察到统计学或临床显著差异。生长激素组的平均连线测验B得分提高了8.5秒，而安慰剂组的得分恶化了5.0秒，差异为13.5秒（可信区间，3.1秒至23.9秒；P = 0.01）。然而，生长激素组简易精神状态检查表的得分恶化了0.4，而安慰剂组的得分提高了0.2，差异为0.6（P = 0.11）。两组在数字符号替换测验中的得分几乎相同（P > 0.2）。生长激素组的26名男性出现了48次副作用事件，26名接受安慰剂的男性出现了14次副作用事件（P = 0.002）。26%接受生长激素治疗的患者需要减少剂量，而接受安慰剂治疗的患者无一需要减少剂量（P < 0.001）。
给功能能力保存良好的健康老年男性给予6个月的生理剂量生长激素，可增加瘦组织量并减少脂肪量。虽然使用生长激素改善了身体成分，但功能能力并未改善。副作用频繁发生。
