Ramirez R J, Wolf S E, Barrow R E, Herndon D N
Department of Surgery, University of Texas Medical Branch and Shriners Burns Hospital-Galveston, 77550, USA.
Ann Surg. 1998 Oct;228(4):439-48. doi: 10.1097/00000658-199810000-00001.
To determine the safety and efficacy of recombinant human growth hormone (rhGH) in the treatment of children who are severely burned.
During the last decade, we have used recombinant human growth hormone (rhGH; 0.2 mg/kg/day s.q.) to successfully treat 130 children with more than 40% total body surface area (TBSA) burns to enhance wound healing and decrease protein loss. A significant increase in the mortality of adult patients in the intensive care unit who were given rhGH has recently been reported in two large European trials which questions the therapeutic safety of rhGH.
The records of 263 children who were burned were reviewed. Patients receiving either rhGH at 0.2 mg/kg/day subcutaneously as part of a randomized clinical trial (n = 48) or therapeutically (n = 82) were compared with randomized placebo-administered controls (n = 54), contiguous matched controls (n = 48), and matched patients admitted after August 1997, after which no patients were treated with rhGH (n = 31). Morbidity and mortality, which might be altered by rhGH therapy, were considered with specific attention to organ function or failure, infection, hemodynamics, and calcium, phosphorous, and albumin balance.
A 2% mortality was observed in both rhGH and saline placebo groups in the controlled studies, with no differences in septic complications, organ dysfunction, or heart rate pressure product identified. In addition, no difference in mortality could be shown for those given rhGH therapeutically versus their controls. No patient deaths were attributed to rhGH in autopsies reviewed by observers blinded to treatment. Hyperglycemic episodes and exogenous insulin requirements were higher among rhGH recipients, whereas exogenous albumin requirements and the development of hypocalcemia was reduced.
Data indicate that rhGH used in the treatment of children who were severely burned is safe and efficacious.
确定重组人生长激素（rhGH）治疗重度烧伤儿童的安全性和有效性。
在过去十年中，我们使用重组人生长激素（rhGH；0.2毫克/千克/天，皮下注射）成功治疗了130名烧伤面积超过40%体表面积（TBSA）的儿童，以促进伤口愈合并减少蛋白质流失。最近在两项大型欧洲试验中报告，接受rhGH治疗的重症监护病房成年患者死亡率显著增加，这对rhGH的治疗安全性提出了质疑。
回顾了263名烧伤儿童的记录。将作为随机临床试验一部分接受0.2毫克/千克/天皮下注射rhGH的患者（n = 48）或接受治疗性rhGH的患者（n = 82）与随机接受安慰剂的对照组（n = 54）、连续匹配对照组（n = 48）以及1997年8月后入院的匹配患者（n = 31）进行比较，1997年8月后没有患者接受rhGH治疗。考虑了可能因rhGH治疗而改变的发病率和死亡率，特别关注器官功能或衰竭、感染、血流动力学以及钙、磷和白蛋白平衡。
在对照研究中，rhGH组和生理盐水安慰剂组的死亡率均为2%，在脓毒症并发症、器官功能障碍或心率血压乘积方面未发现差异。此外，接受治疗性rhGH的患者与对照组相比，死亡率也没有差异。在由对治疗不知情的观察者进行的尸检中，没有患者死亡归因于rhGH。rhGH接受者的高血糖发作和外源性胰岛素需求较高，而外源性白蛋白需求和低钙血症的发生率则降低。
数据表明，rhGH用于治疗重度烧伤儿童是安全有效的。
