Department of Surgery, University of Texas Medical Branch and Shriners Hospitals for Children, Galveston, TX 77550, USA.
Ann Surg. 2009 Oct;250(4):514-23. doi: 10.1097/SLA.0b013e3181b8f9ca.
Recovery from a massive burn is characterized by catabolic and hypermetabolic responses that persist up to 2 years and impair rehabilitation and reintegration. The objective of this study was to determine the effects of long-term treatment with recombinant human growth hormone (rhGH) on growth, hypermetabolism, body composition, bone metabolism, cardiac work, and scarring in a large prospective randomized single-center controlled clinical trial in pediatric patients with massive burns.
A total of 205 pediatric patients with massive burns over 40% total body surface area were prospectively enrolled between 1998 and 2007 (clinicaltrials.gov ID NCT00675714). Patients were randomized to receive either placebo (n = 94) or long-term rhGH at 0.05, 0.1, or 0.2 mg/kg/d (n = 101). Changes in weight, body composition, bone metabolism, cardiac output, resting energy expenditure, hormones, and scar development were measured at patient discharge and at 6, 9, 12, 18, and 24 months postburn. Statistical analysis used Tukey t test or ANOVA followed by Bonferroni correction. Significance was accepted at P < 0.05.
RhGH administration markedly improved growth and lean body mass, whereas hypermetabolism was significantly attenuated. Serum growth hormone, insulin-like growth factor-I, and IGFBP-3 was significantly increased, whereas percent body fat content significantly decreased when compared with placebo, P < 0.05. A subset analysis revealed most lean body mass gain in the 0.2 mg/kg group, P < 0.05. Bone mineral content showed an unexpected decrease in the 0.2 mg/kg group, along with a decrease in PTH and increase in osteocalcin levels, P < 0.05. Resting energy expenditure improved with rhGH administration, most markedly in the 0.1 mg/kg/d rhGH group, P < 0.05. Cardiac output was decreased at 12 and 18 months postburn in the rhGH group. Long-term administration of 0.1 and 0.2 mg/kg/d rhGH significantly improved scarring at 12 months postburn, P < 0.05.
This large prospective clinical trial showed that long-term treatment with rhGH effectively enhances recovery of severely burned pediatric patients.
大面积烧伤后的恢复过程表现为分解代谢和高代谢反应，持续时间可达 2 年，这会影响康复和重新融入社会。本研究的目的是确定长期使用重组人生长激素（rhGH）对大面积烧伤的儿科患者进行大型前瞻性随机单中心对照临床试验中生长、高代谢、身体成分、骨代谢、心脏工作和瘢痕形成的影响。
1998 年至 2007 年期间，前瞻性纳入了 205 名大面积烧伤超过 40%总体表面积的儿科患者（clinicaltrials.gov ID NCT00675714）。患者随机分为接受安慰剂（n=94）或长期 rhGH 治疗组（0.05、0.1 或 0.2mg/kg/d）（n=101）。在患者出院时以及烧伤后 6、9、12、18 和 24 个月时，测量体重、身体成分、骨代谢、心输出量、静息能量消耗、激素和瘢痕形成的变化。统计分析采用 Tukey t 检验或方差分析，然后进行 Bonferroni 校正。P<0.05 为差异有统计学意义。
rhGH 治疗显著改善了生长和瘦体重，而高代谢显著减轻。与安慰剂相比，血清生长激素、胰岛素样生长因子-I 和 IGFBP-3 显著增加，体脂百分比显著降低，P<0.05。亚组分析显示，0.2mg/kg 组的瘦体重增加最多，P<0.05。0.2mg/kg 组的骨矿物质含量意外下降，同时甲状旁腺激素下降，骨钙素水平升高，P<0.05。rhGH 治疗可改善静息能量消耗，以 0.1mg/kg/d rhGH 组最为明显，P<0.05。rhGH 组在烧伤后 12 个月和 18 个月时心输出量下降。0.1 和 0.2mg/kg/d rhGH 长期治疗可显著改善烧伤后 12 个月的瘢痕形成，P<0.05。
这项大型前瞻性临床试验表明，长期使用 rhGH 可有效促进严重烧伤的儿科患者康复。
