Study of the effectiveness and safety of Rastan in children with growth hormone deficiency and Turner's syndrome

The effectiveness and safety of the new Russian drug Rastan^® (recombinant human growth hormone) were evaluated in children with growth hormone deficiency (GHD) and Turner's syndrome (TS). An open-labeled clinical study of the drug was performed in 35 children with GHD or TS. The main efficacy criteria were growth changes and yearly calculated height velocity; the secondary criteria were changes in height SDS and IGF-1 and IGFBP-3 levels. Rastan^® was subcutaneously injected daily for 6 months; the dose of the drug being 0.033 mg/kg in GHD and 0.05 mg/day in TS. All enrolled 35 patients completed the study. During the study, the patients' growth significantly increased in all the patients (P < 0 0001), in those with GHD (P < 0.0001) and TS (P < 0.0001). Height SDS statistically significantly increased in all the patients (P < 0.0001) and in the GHD (P < 0.0001) and TS (P < 0.0001) groups. Over 6 months of therapy, the average estimated height velocity was 12.4±3.76 cm/year. There were 2-3-fold increases in lower baseline IGF-1 and IGFBR levels. The advene reactions were mild and required no drug discontinuation. Rastan^® was effective and well tolerated in patients with GHD or TS.

1. Дедов И. И., Тюльпаков А. Н., Петеркова В. А. Соматотропная недостаточность. - М , 1998.

2. Дедов И. И., Петеркова В. А., Безлепкина О. Б., Нагаева Е. В. Атлас. Соматотропная недостаточность у взрослых. -М., 2004.

3. Диагностика и лечение соматотропной недостаточности у детей. Национальный консенсус. - М., 2005. - С. 1-5.

4. Bannik Е. M., Raat Н. et al. // J. Pediatr. - 2006. - Vol. 148, N 1.-Р. 95-101.

5. Bowlby D. А., Rapaport R. // Pediatr. Endocrinol. Rev. - 2004. - Suppl. 1. - P. 68-77.

6. Bramswig J. H. // Endocrine. - 2001. - Vol. 15, N1. - P. 5-13.

7. Cuneo R. С. et al. // J. Clin. Endocrinol. Metab. - 1998. - Vol. 83.-P. 107-116.

8. Cufield W. S., Lindberg A. et al. // Horm. Res. - 2006. - Vol. 65. - Suppt. 3. - P. 153-159.

9. D'Amico S., Shi J. et al. // Am. J. Clin. Nutr. - 2006. - Vol. 84, N 1. -P. 204-211.

10. Fuqua J. S. // Semin. Pediatr. Surg. - 2006. - Vol. 15, N 3. -P. 162-169.

11. GH Research Society. Consensus guidelines for the diagnosis and treatment of growth hormone (GH) deficiency in childhood and adolescence: summary statement of the GH Research Society // J. Clin. Endocrinol. Metab. - 2000. - Vol. 85. - P. 3990-3993.

12. Koltowska-Haggstrom M. et al. // Eur. J. Endocrinol. - 2006. -Vol. 155, N l.-P. 109-119.

13. Lindholm J. // Pituitary. - 2006. - Vol. 9, N 1. - P. 5-10.

14. Macario M. E. et al. // Br. Med. J. - 1991. - Vol. 302. - P. 1149.

15. Magiakou M. A. // Pediatr. Endocrinol. Rev. - 2004. - Suppl. 3. - P. 484-489.

16. Mahan J. D. et al. // Pediatr. Nephorol. - 2006. - Vol. 21, N 7. - P. 917-930.

17. Myers S. E. et al. // J. Pediatr. - 2000. - Vol. 137. - P. 42- 49.

18. Park E., Bailey J. D., Cowell С. А. // Pediatr. Res. - 1983.- Vol. 17. - P. 1-7.

19. Schambelan M. et al. // Ann. Intern. Med. - 1996. - Vol. 125. - P. 873-882.

20. Sizonenko P. C., Clayton P. E., Cohen P. et al. // Growth Horm. IGF Res. - 2001. - Vol. 11, N 3. - P. 137-165.

21. Van den Broeck J., Van Teunenbroek A., Hokken-Koelega A. et al. // J. Pediatr. Endocrinol. Metab. - 1999. - Vol. 12. - P. 673-676.

22. Waters D. et al. // Ann. Intern. Med. - 1996. - Vol. 125. - P. 865-872.