The effectiveness and safety of use of a soluble recombinant growth hormone formulation in the treatment of shortness in children with retarded intrauterine development

The study was undertaken to investigate the effectiveness and safety of 12-week use of the recombinant growth hormone (rGH) Nor-dithropin-Simplex (NovoNordisk, Denmark) in children with retarded intrauterine development (RIUD) and significant postnatal shortness. A group of examinees comprised 15 prepubescent children with RIUD without hormone growth hormone deficiency. The evaluation criteria were growth (absolute and SDS), the rate of growth (absolute and SDS), and the time course of changes in bone maturation, hormonal and biochemical parameters. Treatment included subcutaneous daily injections of Nordithropin-Simplex, 0.067 mg/kg, at night. Control examinations were made every 3 months. Intragroup birth height SDS averaged 3.61±1.15; body mass SDS was 3.65±0.71. Before treatment, the mean chronological age was 5.46+1.65years; the bone age averaged 1.42±0.70years less than the chronological one; growth SDS was 3.24+0.81; and growth rate SDS was -1.24±1.10. After 12-month rGH treatment, growth rate SDS increased up to 4.98±2.65 (p <0.0005), growth ∆ SDS for chronological age averaged 1.02±0.39 with variations from -3.24±0.81 to -2.22+0.78 (p < 0.0005). During 12-month therapy, bone age increase by, on the average, 0.91±0.42years. Two-fold dose rGH therapy, as compared with replacement therapy, was well tolerated and produced no serious side effects. It is concluded that 12-month therapy with Nordithropin-Simplex in a dose of 0.067 mg/kg/day in children with RIUD and significant postnatal growth retardation can induce acceleration of growth rates without causing a significant adverse reactions. Long-term multicenter centers are required to analyze the impact of rGH therapy on final growth, metabolic effects and to evaluate the safety of its long-term use.

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