Long-term safety of recombinant human growth hormone in children.
نویسندگان
چکیده
BACKGROUND Between 1985 and 2006, the National Cooperative Growth Study (NCGS) monitored the safety and efficacy of recombinant human growth hormone (rhGH) in 54,996 children. METHODS Enrolled patients were followed until rhGH discontinuation. Investigators submitted adverse event reports for targeted events or those potentially rhGH-related. RESULTS Early concerns about de novo leukemia in patients without risk factors have not been substantiated--three observed vs. 5.6 expected in age-matched general population based on years at risk [standard incidence ratio (SIR), 0.54; 95% confidence interval (CI), 0.11-1.58]. De novo malignancies (intracranial and extracranial) were not significantly increased in patients without risk factors (29 confirmed vs. 26 expected; SIR, 1.12; 95% CI, 0.75-1.61). Second neoplasms occurred in 49 patients, of whom 37 had irradiation for their initial tumors (including five of 16 retinoblastoma patients, three of whom had bilateral retinoblastoma) consistent with an increased risk with rhGH. Thirty-three patients developed type 1 diabetes mellitus (DM) (37 expected; SIR, 0.90; 95% CI, 0.62-1.26). Type 2 DM and nonspecified DM were reported in 20 and eight patients, respectively. Two deaths were reported in patients with Prader-Willi syndrome and five deaths from aortic dissection in patients with Turner syndrome. In patients with organic GH deficiency and idiopathic panhypopituitarism, 11 events of acute adrenal insufficiency occurred, including four deaths, consistent with a reported increased risk for adrenal insufficiency in hypopituitary patients with or without rhGH treatment. CONCLUSION After more than 20 yr, leukemia, a major safety issue initially believed associated with GH, has not been confirmed, but other signals, including risk of second malignancies in patients previously treated with irradiation, have been detected or confirmed through the NCGS. These data further clarify the events associated with rhGH and, although confirming a favorable overall safety profile, they also highlight specific populations at potential risk.
منابع مشابه
Papillary Carcinoma of Thyroid Gland in a Patient Treated with Recombinant Growth Hormone
The first successful treatment of growth hormone (GH) deficient children with GH extracted from human pituitary was introduced during late 1950's. The subsequent availability and use of recombinant GH (rhGH) for different clinical conditions raised the question of whether this new therapeutic modality increases the risk of certain conditions such as leukemia or malignancy. Herein, we report o...
متن کاملEvaluation of Heat Induction Strategy for Recombinant Human Growth Hormone Expression in Fed-Batch Fermentation
متن کامل
Effects of Low-Dose Recombinant Human Growth Hormone on Bone Densities of Radius, Tibia and 4th Lumbar Vertebrae in Rabbits
Objective- To determine the effects of growth hormone (GH) therapy on bone density in controlled conditions in healthy adult rabbits. Design- Experimental in vivo study. Animal- 20 healthy, adult New Zealand White rabbits. Procedures- The rabbits were divided into 2 groups; receiving Human GH (0.006 mg/kg/d) and controls; receiving placebo for 3 months. The density of radius and tibia was m...
متن کاملSafety of growth hormone replacement therapy in adults.
Growth hormone (GH) is a powerful metabolic hormone that regulates fuel homeostasis through its protein anabolic and lipolytic actions. The introduction of recombinant human GH has expanded the narrow indication of treating children with severe GH deficiency (GHD) to include a broader target population of children with growth retardation and short stature and adults with hypopituitarism and sev...
متن کاملCONSTRUCTION OF RECOMBINANT PLASMIDS FOR PERIPLASMIC EXPRESSION OF HUMAN GROWTH HORMONE IN ESCHERICHIA COLI UNDER T7 AND LAC PROMOTERS
In order to study the periplasmic expression of human growth hormone (hGH) in Escherichia coli, the related cDNA was inserted in two expression plasmids carrying pelB signal peptide, one with lac bacterial promoter and the other with a bacteriophage T7-based promoter. The recombinant plasmids were moved to TG1 and BL21 strains of E. coli, respectively. To induce the expression systems, IPTG and...
متن کاملA Comparison of Outcomes from IVF Cycles Stimulated with either Recombinant Luteinizing Hormone or Human Menopausal Gonadotropins in Subjects Treated with Long Gonadotropin Releasing Hormone Agonist Protocols, a Retrospective Analysis.
Objective The objective of this study is to compare rates of pregnancy and IVF parameters in subjects who were stimulated with follicle stimulating hormone (FSH) plus either recombinant human luteinizing hormone (r-LH) or human menopausal gonadotropins (hMG), in long gonadotropin releasing hormone (GnRH) agonist IVF protocols. MaterialsAndMethods This is a cohort study of patients undergoing IV...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
عنوان ژورنال:
- The Journal of clinical endocrinology and metabolism
دوره 95 1 شماره
صفحات -
تاریخ انتشار 2010