Frontiers of Medicine in China

, Volume 3, Issue 2, pp 171–176 | Cite as

Clinical evaluation of recombinant human growth hormone injection in children with growth hormone deficiency

  • Ling Hou
  • Xiaoping Luo
  • Minlian Du
  • Huamei Ma
  • Chunxiu Gong
  • Yuchuan Li
  • Shuixian Shen
  • Zhuhui Zhao
  • Li Liang
  • Guanping Dong
  • Chaoying Yan
  • Hongwei Du
Research Article
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Abstract

Recombinant human growth hormone (rhGH) has been widely used in the clinical treatment of growth hormone deficiency. To simplify the injection process and increase drug compliance, application of the GH injection has become a new treatment plan in recent years. The purpose of the current study was to evaluate the efficacy and safety of rhGH injection for the treatment of growth hormone deficiency (GHD) in children in China. In a nationwide, noncomparative, prospective, randomized, open trial, 31 children with confirmed complete GHD received subcutaneous injection of rhGH at 0.25 mg/kg·wk (0.107 IU/kg·d). The injection was given daily and the total weekly amount was separated into 6–7 injections. The patients were followed up at 3-month intervals and the treatment duration was 12 months. The height (HT), annual growth velocity (GV), mean height standard deviation score (HT SDS), blood serum insulin-like growth factor I (IGF-I), insulin-like growth factor binding protein 3 (IGFBP-3), and bone maturity before and after treatment were compared, and the safety of the treatment was analyzed. The mean HT, GV, and HT SDS were increased from 109.0±14 cm, 2.7±0.9 cm/yr, and −4.62 ±1.46 at baseline to 121.8±13.4 cm, 12.9±3.3 cm/yr, and −2.47±1.86 after 12 months of treatment, respectively (P<0.001). At the same time, blood IGF-I and IGFBP- 3 were increased significantly [41.27±64.43 μg/L vs 159.21±167.92 μg/L and 1540.00±1325.11 mg/L vs 3533.93±1413.82 mg/L, respectively (P<0.001)]. The bone age assessments performed 6 and 12 months after the treatment showed that no advanced bone maturation was noted. No serious adverse events occurred during the treatment, and the drug-related adverse events were mainly decreased thyroid function. We conclude that rhGH injection is a safe and effective drug for treatment of growth hormone deficiency in children.

Keywords

recombinant human growth hormone injection growth hormone deficiency 
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References

  1. 1.
    Wilton P, Widlund L, Guilbaud O. Bioequivalence of genotropin and somatonorm. Acta Paediatr Scand Suppl, 1987 337:118–121PubMedCrossRefGoogle Scholar
  2. 2.
    Brämswig J H, Schlösser H, Kiese K. Final height in children with growth hormone deficiency. Horm Res, 1995 43(4):126–128PubMedCrossRefGoogle Scholar
  3. 3.
    De Luca F, Maghnie M, Arrigo T, Lombardo F, Messina M F, Berasconi S. Final height outcome of growth hormone-deficient patients treated since less than five years of age. Acta Paediatr, 1996 85(10):1167–1171PubMedGoogle Scholar
  4. 4.
    Blethen S L, Baptista J, Kuntze J, Foley T, LaFranchi S, Johanson A. Adult height in growth hormone (GH)-deficient children treated with biosynthetic GH. J Clin Endocrinol Metab, 1997 82(2):418–420PubMedCrossRefGoogle Scholar
  5. 5.
    Birnbacher R, Riedl S, Frisch H. Long-term treatment in children with hypopituitarism: pubertal development and final height. Horm Res, 1998 49(2):80–85PubMedCrossRefGoogle Scholar
  6. 6.
    MacGillivray M H, Blethen S L, Buchlis J G, Clopper R R, Sandberg D E, Conboy T A. Current dosing of growth hormone in children with growth hormone deficiency: how physiologic? Pediatrics, 1998, 102(Suppl 2): 527–530PubMedGoogle Scholar
  7. 7.
    Grumbach M M, Bin-Abbas B S, Kaplan S L. The growth hormone cascade: progress and long-term results of growth hormone treatment in growth hormone deficiency. Horm Res, 1998 49 (Suppl 2):41–57CrossRefGoogle Scholar
  8. 8.
    August G P, Julius J R, Blethen S L. Adult height in children with growth hormone deficiency who are treated with biosynthetic growth hormone: the National Cooperative Growth Study experience. Pediatrics, 1998 102(Suppl 2):512–516PubMedGoogle Scholar
  9. 9.
    Cutfield W, Lindberg A, Albertsson-Wikland K, Chatelain P, Ranke M B, Wilton P. Final height in idiopathic growth hormone deficiency: the KIGS experience. Acta Paediatr Suppl, 1999 88(428):72–75PubMedCrossRefGoogle Scholar
  10. 10.
    Bernasconi S, Arrigo T, Wasniewsk M, Ghizzoni L, Ruggeri C, Di Pasquale G, Vottero A, De Luca F. Long-term results with growth hormone therapy in idiopathic hypopituitarism. Horm Res, 2000 53(Suppl 1):55–59PubMedCrossRefGoogle Scholar
  11. 11.
    Bierich J R. Multicentre clinical trial of authentic recombinant somatropin in growth hormone deficiency. Acta Paediatr Scand Suppl, 1987 337:135–140PubMedCrossRefGoogle Scholar
  12. 12.
    Hu Y M, Jiang Z F. Zhu Futang Practical Pediatrics. 7th ed. Beijing: People’s Health Publishing House, 2002, 27–34 (in Chinese)Google Scholar
  13. 13.
    Guidelines for the use of growth hormone in children with short stature. A report by the Drug and Therapeutics Committee of the Lawson and Wilkins Pediatric Endocrine Society. J Pediatr, 1995, 127(6): 857–867CrossRefGoogle Scholar
  14. 14.
    Rosenfeld R G, Albertsson-Wikland K, Cassorla F, Frasier SD, Hasegawa Y, Hintz RL, Lafranchi S, Lippe B, Loriaux L, Melmed S, Preece MA, Ranke M B, Reiter E O, Rogol A D, Underwood L E, Werther G A. Diagnostic controversy: the diagnosis of childhood growth hormone deficiency revisited. J Clin Endocrinol Metab, 1995 80(5):1532–1540PubMedCrossRefGoogle Scholar
  15. 15.
    Rappaport R, Mugnier E, Limoni C, Crosnier H, Czernichow P, Leger J, Limal J M, Rochiccioli P, Soskin S. A 5-year prospective study of growth hormone (GH)-deficient children treated with GH before the age of 3 years. French Serono Study Group. J Clin Endocrinol Metab, 1997 82(2):452–456CrossRefGoogle Scholar
  16. 16.
    Root A W, Kemp S F, Rundle A C, Dana K, Attie K M. Effect of long-term recombinant growth hormone therapy in children-the National Cooperative Growth Study, USA, 1985-1994. J Pediatr Endocrinol Metab, 1998 11(3):403–412PubMedGoogle Scholar
  17. 17.
    Reiter E O, Price D A, Wilton P, Albertsson-Wikland K, Ranke M B. Effect of growth hormone treatment on the near-final height of 1258 patients with idiopathic GH deficiency: analysis of a large international database. J Clin Endocrinol Metab, 2006 91(6):2047–2054PubMedCrossRefGoogle Scholar
  18. 18.
    Bryant J, Cave C, Mihaylova B, Chase D, McIntyre L, Gerard K, Milne R. Clinical effectiveness and cost-effectiveness of growth hormone in children: a systematic review and economic evaluation. Health Technol Assess, 2002 6(18), 1–175Google Scholar
  19. 19.
    Ranke M B, Price D A, Reiter E O, eds. Growth hormone therapy in pediatrics-20 years of KIGS. Basel, Switzerland: Karger, 2007, XVGoogle Scholar
  20. 20.
    Blethen S L, Allen D B, Graves D, August G, Moshang T, Rosenfeld R. Safety of recombinant deoxyribonucleic acidderived growth hormone: The National Cooperative Growth Study Experience. J Clin Endocr Metab, 1996 81(5):1704–1710PubMedCrossRefGoogle Scholar
  21. 21.
    Müller J, Skakkebaek NE, Jacobsen B B, Keller E, Heinrich U, Hartmann K, Hokken-Koelega A C, Delemarre van de Waal H A. Norditropin SimpleXx: a liquid human growth hormone formulation, a pen system and an auto-insertion device. Horm Res, 1999 51 (Suppl 3):109–112PubMedGoogle Scholar
  22. 22.
    Iyoda K, Moriwake T, Seino Y, Niimi H. The clinical usefulness of liquid human growth hormone (hGH) (Norditropinr SimpleXxTM) in the treatment of GH deficiency. Horm Res, 1999 51(suppl 3):113–115PubMedCrossRefGoogle Scholar
  23. 23.
    Peterkova V, Arslanoglu I, Bolshova-Zubkovskaya E, Romer T, Zdravkovic D, Kratzsch J, Ji H J, Savoy C, Saenger P. A randomized, double-blind study to assess the efficacy and safety of valtropin, a biosimilar growth hormone, in children with growth hormone deficiency. Horm Res, 2007 68(6):288–293PubMedCrossRefGoogle Scholar
  24. 24.
    Romer T, Peter F, Saenger P, Starzyk J, Koehler B, Korman E, Walczak M, Wasik R, Ginalska-Malinowska M, Solyom E, Berghout A. Efficacy and safety of a new ready-to-use recombinant human growth hormone solution. J Endocrinol Invest, 2007 30(7):578–589PubMedGoogle Scholar
  25. 25.
    Ogilvy-Stuart A L. Safety of growth hormone after treatment of a childhood malignancy. Horm Res, 1995 44(Suppl 3):73–79PubMedCrossRefGoogle Scholar
  26. 26.
    Ng S T, Zhou J, Adesanya O O, Wang J, LeRoith D, Bondy CA. Growth hormone treatment induces mammary gland hyperplasia in aging primates. Nat Med, 1997 3(10):1141–1144PubMedCrossRefGoogle Scholar
  27. 27.
    Scirè G, Del Bianco C, Spadoni G L, Cianfarani S. Growth hormone therapy does not alter the insulin-like growth factor-I/insulin-like growth factor binding protein-3 molar ratio in growth hormonedeficient children. J Endocrinol Invest, 2008 31(2):153–158PubMedGoogle Scholar
  28. 28.
    Ranke MB, Traunecker R, Martin D D, Schweizer R, Schwarze CP, Wollmann H A, Binder G. IGF-I and IGF binding protein-3 levels during initial GH dosage step-up are indicators of GH sensitivity in GH-deficient children and short children born small for gestational age. Horm Res, 2005 64(2):68–76PubMedCrossRefGoogle Scholar
  29. 29.
    Oyarzabal M, Aliaga M, Chueca M, Echarte G, Ulied A. Multicentre survey of compliance with growth hormone therapy: what can be improved? Acta Pædiatr, 1998 87(4):387–391PubMedCrossRefGoogle Scholar
  30. 30.
    Portes E S, Oliveira J H, MacCagnan P, Abucham J. Changes in serum thyroid hormones levels and their mechanisms during longterm growth hormone (GH) replacement therapy in GH deficient children. Clin Endocrinol (Oxf), 2000 53(2):183–189CrossRefGoogle Scholar

Copyright information

© Higher Education Press and Springer-Verlag GmbH 2009

Authors and Affiliations

  • Ling Hou
    • 1
  • Xiaoping Luo
    • 1
  • Minlian Du
    • 2
  • Huamei Ma
    • 2
  • Chunxiu Gong
    • 3
  • Yuchuan Li
    • 3
  • Shuixian Shen
    • 4
  • Zhuhui Zhao
    • 4
  • Li Liang
    • 5
  • Guanping Dong
    • 5
  • Chaoying Yan
    • 6
  • Hongwei Du
    • 6
  1. 1.Department of Pediatrics, Tongji Hospital, Tongji Medical CollegeHuazhong University of Science and TechnologyWuhanChina
  2. 2.Department of Pediatricsthe First Affiliated Hospital of Zhongshan UniversityGuangzhouChina
  3. 3.Department of EndocrinologyBeijing Children’s Hospital Affiliated to Capital Medical UniversityBeijingChina
  4. 4.Department of Pediatric Endocrinology and MetabolismChildren’s Hospital of Fudan UniversityShanghaiChina
  5. 5.The Affiliated Children’s Hospital of Zhejiang University School of MedicineHangzhouChina
  6. 6.Department of PediatricsThe First Hospital of Jilin UniversityChangchunChina

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