Objective: To determine the safety and efficacy of recombinant human growth hormone (rhGH) in the treatment of children who are severely burned.
Summary Background Data: During the last decade, we have used recombinant human growth hormone (rhGH; 0.2 mg/kg/day SQ) 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.
Methods: 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.
Results: 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.
Conclusions: Data indicate that rhGH used in the treatment of children who were severely burned is safe and efficacious.
From the Department of Surgery, University of Texas Medical Branch and Shriners Burns Hospital-Galveston
Presented at the 118th Annual Meeting of the American Surgical Association, April 3, 1998, Palm Beach, Florida.
Address correspondence and reprint requests to David N. Herndon, MD, Shriners Burns Hospital-Galveston, 815 Market, Galveston, TX 77550.
Supported by SHC grants 8660 and 8770, NIH grants 5T32GM08256-07 and 1RO1GM56687-01, and by Genentech grants M0010 and M0353.
Accepted for publication December 1, 1997.