ESPE Abstracts (2015) 84 P-3-982

Experience of the Use of Genetically Engineered GH 'Rastan' by Children in Clinical Practice

Elena Kulaginaa, Elena Savelyevaa & Galina Chistousovab

aOrenburg Children’s Clinical Hospital, Orenburg, Russia; bPerm Regional Children’s Clinical Hospital, Perm, Russia

Objective: To evaluate the efficacy of the drug ‘Rastan’, (manufacturer JSC ‘Pharmstandard-Ufa Vita’), in children with GH deficiency at the beginning of treatment at different ages.

Materials and methods: We examined two groups of patients with GH deficiency who receive the drug for 3 years. In group 1, nine boys and two girls with age at debut of therapy 5.88±1.35 (from 3.3 to 7.1 years); in the 2nd group of ten boys and two girls at the beginning of treatment in 10.57±1.76 (from 8.3 to 13.7 years). The diagnosis is established on the basis of the standard stimulus samples, the maximum release of GH in the sample with clonidine in group 1 3.46±2.81 ng/ml were evaluated by growth rate, bone age S.D.s of growth.

Results: At the start of treatment age in group 1 5.88±1.35, bone age 2.39±0.56, S.D.s growth 4.11±0.83; respectively in group 2, the patients’ age 10.57±1.76, bone age 6.87±2.0 S.D.s growth – 3.201±0.34. For 1 year of treatment, the growth rate in group 1 amounted 8.04±3.30 cm, in group 2 9.05 of 2.72 cm, which has no significant differences (P=0.75). S.D.s of growth did not change significantly and amounted to −3.48±0.97 cm (P=0.28) in group 1, −2.82±38 cm (P=0.077) in group 2. For 3 years in the growth one and group 2 added 23.46±6.87 cm and 22.30±6.44 cm (P=0.28) respectively. SDs growth decreased from −4.11±0.83 cm to −2.43±1.139 cm (P=0.007) in group 1 and in group 2 with-3.20±1.34 cm to −2.02±1.21 cm (P=0.045). Bone age increased in group 1 comparison with 2.39±0.56 to 5.76±1.57 (P=0.007) and in group 2 with 6.87±2.0 to 11.01±1.91 (P=0.013).

Conclusions: These clinical observations demonstrate a significant effect of the drug ‘Rastan’ in the treatment of GH deficiency by children for 3 years regardless of the age of the patients at the beginning of therapy. Experience of the use of genetically engineered GH ‘Rastan’ by children in clinical practice.

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