Evaluation of the effectiveness of combined therapy of pre-pubertal children with Growth hormone deficiency with recombinant growth hormone and vitamin D drugs

Abstract

The treatment of somatotropic insufficiency (SI) remains one of the most important problems in paediatric endocrinology. Since 1985, recombinant growth hormone (rGH) has been widely used to correct the growth of children with SI. Sufficient clinical experience has been gained in the use of rGH preparations, and the efficacy and safety of rGH therapy in children and adolescents with various forms of short stature has been proven. However, there are a number of factors that can have a significant impact on the achievement of final height in adulthood, including a wide range of sensitivity to exogenous growth hormone (GH), the degree of endogenous GH deficiency, patient compliance, and other uncertain factors. Patients with GH deficiency require long-term treatment, the effectiveness of which decreases significantly over time, prompting the search for optimal treatment options. Purpose - to evaluate the effectiveness of combined therapy of pre-pubertal children with SI with rGH and vitamin D drugs. Materials and methods. 23 pre-pubertal children with isolated SI were examined, who took monotherapy with rGH for 3 years. When the effectiveness of monotherapy decreases, vitamin D are added to the treatment complex. The level of 25(OH)D in blood serum is determined by the immunochemiluminescence method on microparticles (Abbott, USA). The levels of GH and insulin-like growth factor-1 were studied by solid-phase enzyme immunoassay using Immulite 2000 XPI kits. Results. At the end of the first year of rGH monotherapy, all patients showed a significant (p<0.05) increase in height. However, already after the second and third years of treatment, height velocity (HV) decreased in all patients. The increase in HV in the third year of treatment with rGH was significantly lower (p<0.05) than in the first year. Thanks to the addition of vitamin D, the further decrease in HV was stopped after the third year of monotherapy with rGH. The increase in HV during the first year of combined therapy was significantly (p<0.05) greater than during the third year of treatment with rGH monotherapy. The same trend was observed after the second year of combined therapy. Conclusions. In the presence of a decrease in the effectiveness of therapy with rGH after the first years of treatment, it is considered appropriate to use combined therapy of children with SI with rGH and vitamin D. The research was carried out in accordance with the principles of the Helsinki Declaration. The study protocol was approved by the Local Ethics Committee of the participating institution. The informed consent of the patient was obtained for conducting the studies. No conflict of interests was declared by the authors.