A Randomized Controlled Trial of Growth Hormone in Active Pediatric Crohn Disease
| Autor: | Edgar T. Ballard, Erin Bonkowski, Ramona Bezold, Cade M. Nylund, David J Klein, Rebecca Carey, Lee A. Denson, Margaret H. Collins, Mi-Ok Kim, Tara Willson, M. Susan Moyer, Bankole Osuntokun, Dandan Li |
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| Rok vydání: | 2010 |
| Předmět: |
Male
medicine.medical_specialty Adolescent Colon Colonoscopy Disease Growth hormone Gastroenterology Inflammatory bowel disease Article law.invention Pharmacotherapy Crohn Disease Intestinal mucosa Randomized controlled trial Adrenal Cortex Hormones law Internal medicine medicine Humans Single-Blind Method Intestinal Mucosa Child medicine.diagnostic_test Human Growth Hormone business.industry Remission Induction medicine.disease Ulcerative colitis Pediatrics Perinatology and Child Health Drug Therapy Combination Female business |
| Zdroj: | Journal of Pediatric Gastroenterology & Nutrition. 51:130-139 |
| ISSN: | 0277-2116 |
| Popis: | Growth hormone (GH) may reduce symptoms and improve growth in Crohn disease (CD). The effect on mucosal inflammation is not known. We hypothesized that GH would improve both clinical and mucosal disease activity and stimulate linear growth in pediatric CD.Twenty patients ages 7 to 18 receiving corticosteroids (CTX) for active CD were randomized to begin GH, 0.075 mg x kg(-1) x day(-1) (group A), or continue CTX alone (group B). Clinical and endoscopic disease activities were assessed after 12 weeks. Group B began GH at 12 weeks, and clinical disease activity was assessed at 24 weeks. Subjects who experienced a clinical response after 12 weeks of GH therapy continued treatment for an additional 52 weeks, and linear growth was assessed.Sixty-five percent of patients receiving GH achieved clinical remission, compared with 20% treated with CTX alone (P = 0.03). Although endoscopic disease activity trended toward an improvement at week 12 in group A, this did not differ between the groups. Sixty-one percent of week 12 GH responders maintained their clinical response through week 64. Mean (95th confidence interval) height z score on GH increased from -1.1 (-1.6, -0.6) to -0.4 (-1, 0.2), P = 0.004 during this 52-week extension phase. GH was well tolerated with no unexpected safety signals.The addition of GH to CTX therapy did not induce a reduction in mucosal inflammation, relative to CTX alone. However, GH was safe and effective as an adjunct to CTX for treatment of clinical disease activity and growth failure in pediatric CD. |
| Databáze: | OpenAIRE |
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