Losada Fernando, García-Luna Pedro P, Gómez-Cía Tomás, Garrido Manuela, Pereira Jose L, Marín Fernando, Astorga Ricardo
Department of Endocrinology, Hospital Virgen del Rocío, Avda. Manuel Siurot s/n, 41013-Seville, Spain.
World J Surg. 2002 Jan;26(1):2-8. doi: 10.1007/s00268-001-0170-9. Epub 2001 Oct 25.
Patients suffering severe burns have an accelerated catabolism with a highly negative nitrogen balance that may worsen their prognosis. Somatropin treatment has been shown to improve this balance in different hypercatabolic situations. Moreover, in children with extensive burns it also reduces the healing time of the skin graft donor site and shortens the hospital stay. In the existing literature there are no controlled prospective clinical trials in adult patients that confirm these data. Our aim was to demonstrate the efficacy of recombinant growth hormone (somatropin) in reducing the healing time of the skin graft donor sites and the length of stay in the burn unit in adult patients with severe burns. A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 adult patients with severe burns (more than 40% of the total body surface burned or more than 15% full-thickness burns). Patients received placebo (n = 11) or somatropin (n = 13) at a dosage of 0.15 mg/kg/day divided into two equal doses (every 12 hours) via intramuscular injection. Treatment was initiated the day the first autograft was performed and terminated the day the patient was discharged from the burn unit. The mean number (+/- SD) of skin grafts per patient was similar between the two groups (4.2 +/- 1.8 vs 3.4 +/- 1.8 in the placebo and somatropin groups, respectively). No reduction in the healing time of the skin graft donor site was observed in the somatropin group compared to the placebo group. Likewise, the time admitted to the burn unit was not significantly different, either in the absolute number of days (36.2 +/- 19.7 vs 30.1 +/- 16.8 days in the placebo and somatropin groups, respectively) or in relation to the percentage of the total body surface burned or the body surface with full-thickness burns. Growth hormone and insulin-like growth factor I (IGF-I) levels were three and five times higher, respectively, in the somatropin group than in the placebo group. Ten of the patients treated with somatropin experienced hyperglycemia, and seven of them required insulin treatment. No other adverse side effect was observed. One patient in the placebo group died as a result of sepsis and multiple organ failure. Somatropin, with the treatment regimen and dosage used in these studies, did not reduce the healing time of the skin graft donor sites or the length of hospitalization in the burn unit in adult patients with severe burns.
重度烧伤患者会出现分解代谢加速，伴有高度负氮平衡，这可能会使他们的预后恶化。生长激素治疗已被证明在不同的高分解代谢情况下可改善这种平衡。此外，对于大面积烧伤的儿童，生长激素还可缩短皮肤移植供区的愈合时间并缩短住院时间。在现有文献中，尚无针对成年患者的对照前瞻性临床试验来证实这些数据。我们的目的是证明重组生长激素（生长激素）在缩短重度烧伤成年患者皮肤移植供区愈合时间和烧伤科住院时间方面的疗效。对24例重度烧伤成年患者（烧伤面积超过体表面积的40%或全层烧伤面积超过15%）进行了一项随机、双盲、安慰剂对照临床试验。患者通过肌肉注射接受安慰剂（n = 11）或生长激素（n = 13）治疗，剂量为0.15 mg/kg/天，分为两个相等剂量（每12小时一次）。治疗从首次进行自体移植的当天开始，至患者从烧伤科出院当天结束。两组患者人均皮肤移植次数（+/-标准差）相似（安慰剂组和生长激素组分别为4.2 +/- 1.8次和3.4 +/- 1.8次）。与安慰剂组相比，生长激素组未观察到皮肤移植供区愈合时间缩短。同样，烧伤科住院时间在绝对天数上（安慰剂组和生长激素组分别为36.2 +/- 19.7天和30.1 +/- 16.8天）以及相对于烧伤体表面积百分比或全层烧伤体表面积方面均无显著差异。生长激素组的生长激素和胰岛素样生长因子I（IGF-I）水平分别比安慰剂组高3倍和5倍。接受生长激素治疗的患者中有10例出现高血糖，其中7例需要胰岛素治疗。未观察到其他不良副作用。安慰剂组有1例患者因败血症和多器官功能衰竭死亡。在这些研究中使用的治疗方案和剂量下，生长激素并未缩短重度烧伤成年患者皮肤移植供区的愈合时间或烧伤科住院时间。
