Ziegler T R, Rombeau J L, Young L S, Fong Y, Marano M, Lowry S F, Wilmore D W
Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02215.
J Clin Endocrinol Metab. 1992 Apr;74(4):865-73. doi: 10.1210/jcem.74.4.1548352.
This multicenter, randomized, double-blind study was performed to investigate whether recombinant GH improves the efficacy of total parenteral nutrition (TPN). Fifteen stable patients requiring parenteral feeding due to gastrointestinal/pancreatic disease were studied. Constant maintenance TPN providing approximately 30 kcal/kg day and approximately 1.6 g protein/kg.day was administered during an initial 7-day baseline period. After randomization, daily sc injections of saline (control, n = 9) or GH (10 mg/day, n = 6) were administered a 14-day treatment period as nutrient intake remained constant. Elemental balances for nitrogen (N), potassium (K), phosphorus (P), and sodium (Na) were determined daily and serial blood indices, vital signs, and other clinical parameters were monitored. Nutrient balances approached equilibrium during the baseline week in both groups. With GH administration, a significant increase in N, K, and P balance occurred; in contrast, nutrient balances did not change significantly from baseline values in control patients. The cumulative change (delta) in nutrient balances from the baseline week was also significantly greater in the GH-treated patients (delta N: control+2 +/- 7 g vs. GH+36 +/- 6. g, P less than 0.005; delta K:+57 +/- 45 mmol vs.+199 +/- 19 mmol, P less than 0.03; delta P: -27 +/- 30 mmol vs. +91 +/- 69 mmol, P less than 0.02). Plasma insulin-like growth factor-I concentrations rose 5-fold and serum cholesterol rose slightly with GH; no other significant change in group mean blood values occurred. One patient receiving GH and chronic prednisone therapy developed moderate hyperglycemia and mild peripheral edema; no other deleterious effects attributable to GH were observed. GH was well tolerated and significantly enhanced nutrient retention compared to standard parenteral feeding alone. GH improves the efficacy of parenteral nutrient utilization in patients requiring TPN.
本多中心、随机、双盲研究旨在调查重组生长激素（GH）是否能提高全胃肠外营养（TPN）的疗效。研究对象为15例因胃肠道/胰腺疾病需要肠外营养的稳定患者。在最初7天的基线期，给予持续维持性TPN，提供约30千卡/千克·天的热量和约1.6克蛋白质/千克·天。随机分组后，在为期14天的治疗期内，对照组（n = 9）每日皮下注射生理盐水，GH组（n = 6）每日皮下注射GH（10毫克/天），营养摄入量保持不变。每天测定氮（N）、钾（K）、磷（P）和钠（Na）的元素平衡，并监测系列血液指标、生命体征和其他临床参数。两组在基线周期间营养平衡均接近平衡。给予GH后，N、K和P平衡显著增加；相比之下，对照组患者的营养平衡与基线值相比无显著变化。GH治疗组患者营养平衡从基线周开始的累积变化（差值）也显著更大（差值N：对照组+2±7克 vs. GH组+36±6克，P<0.005；差值K：+57±45毫摩尔 vs. +199±19毫摩尔，P<0.03；差值P：-27±30毫摩尔 vs. +91±69毫摩尔，P<0.02）。GH治疗使血浆胰岛素样生长因子-I浓度升高5倍，血清胆固醇略有升高；两组平均血液值无其他显著变化。1例接受GH和慢性泼尼松治疗的患者出现中度高血糖和轻度外周水肿；未观察到其他归因于GH的有害影响。与单独标准肠外营养相比，GH耐受性良好且显著增强了营养保留。GH可提高需要TPN的患者肠外营养利用的疗效。
