КОМПЛЕКСНАЯ ОЦЕНКА ФАРМАКОКИНЕТИКИ ОДНОКРАТНОЙ БОЛЮСНОЙ ДОЗЫ КОЛЕКАЛЬЦИФЕРОЛА С ТОЧКИ ЗРЕНИЯ ЭФФЕКТИВНОСТИ И БЕЗОПАСНОСТИ

Abstract

Background : The lack of a unified approach to the treatment of deficiency and vitamin D deficiency stimulated a detailed study of the dynamics of indicators of phosphorus-calcium metabolism, parathyroid hormone, 25(OH)D (calcidiol). Aim : To evaluate the pharmacokinetic properties of colecalciferol at a dosage of 150 000 IU, from the standpoint of its efficacy and safety in clinical practice. Materials and methods : Observational, single-center, prospective, selective, uncontrolled study of a comprehensive assessment of the pharmacokinetic properties of a single saturating dose of 150 000 IU of colecalciferol. To assess the pharmacokinetic properties of colecalciferol at a dosage of 150 000 IU, we set efficacy and safety criteria. The criterion for the effectiveness of treatment was to achieve an adequate level of vitamin D (more than 30 ng / ml at the initial insufficient level and more than 20 ng / ml for patients with vitamin D deficiency). The safety criteria for the correction of vitamin D deficiency or deficiency were the absence of patient complaints, adverse events and / or serious adverse events, as well as the preservation of the main laboratory parameters of phosphorus-calcium metabolism within the reference values. Results : When studying the efficacy of a dose of 150 000 IU in patients with vitamin D deficiency and insufficiency, it was found that the level of calcidiol was significantly higher in the group after treatment with colecalciferol compared with the group before treatment (p <0.05). The peak of the maximum value for patients with deficiency was established on the 14 day from the moment of administration of colecalciferol and was 37.1 ± 6.28 ng / ml, and for patients with initial vitamin D deficiency 40.1 ± 3.71 ng / ml. In the study of the safety of colecalciferol in a bolus dose of 150 000 IU, there were no statistically significant differences in the laboratory parameters of calcium-phosphorus metabolism, both in the group before treatment and after correction of deficiency and vitamin D insufficiency in both groups. Conclusion : Colecalciferol in the form of a single bolus dose of 150 000 IU demonstrated its efficacy and safety in real clinical practice.