[Comparative, placebo-controlled clinical study of efficacy and safety of glatiramer acetate 20 mg in patients with relapsing-remitting multiple sclerosis: results of the first year of the study]. / Sravnitel'noe platsebo-kontroliruemoe klinicheskoe issledovanie effektivnosti i bezopasnosti preparatov glatiramera atsetata 20 mg u patsientov s remittiruyushchim rasseyannym sklerozom: rezul'taty pervogo goda nablyudeniya.

The article presents the results of international multicenter randomized double-blind, active and placebo-controlled, comparative phase 3 trial. The goal of the study was to demonstrate non-inferiority of BCD-063 (glatiramer acetate, manufactured by JSC «BIOCAD¼, Russia) to copaxone-Teva (Teva Pharmaceutical Enterprise Co., Ltd., Israel) in patients with relapsing-remitting multiple sclerosis. METHODS: 158 patients with relapsing-remitting multiple sclerosis were randomly assigned into 3 groups: BCD-063, copaxone-Teva and placebo, at a ratio of 2:2:1, respectively. RESULTS AND CONCLUSION: Efficacy analysis after 48 weeks of therapy demonstrated no differences between BCD-063 group and copaxone-Teva group in both MRI parameters and frequency of relapses. The mean (SD) of number of MRI-confirmed relapses per patient per year (the primary endpoint) in BCD-063 group was 0.098361 (0.351422), in copaxone-Teva group - 0.098361 (0, 351 422) and in placebo group - 0.178571 (0.390021). There were also no differences between the groups for all other efficacy parameters (EDSS and MSFC). Both investigational BCD-063 and copaxone-Teva demonstrated a favorable safety profile. The data obtained from the present study confirm the therapeutic equivalence of BCD-063 (CJSC BIOCAD, Russia) and copaxone-Teva, that is important for further implementation of glatiramer acetate generic in the clinical practice of multiple sclerosis therapy.

[Prognostication of immunological reactivity and the choice of the variant of reflexotherapy for a newborn infant].

AIM: The objective of the present study was to determine the classification differences in immunological reactivity and to identify its predictors in the newborn infants. MATERIAL AND METHODS: The study involved 115 full-term newborn infants presenting with grade 3 prenatal hypoxic ischemic encephalopathy in the late neonatal period. The features of immunological reactivity under the influence of acupuncture were examined. Statistical processing was carried out by means of discriminant analysis. RESULTS: The assessment and prediction of the effectiveness of acupuncture in the neonates suffering from cerebral ischemia are based on the index of immunological reactivity and the leukocyte index of intoxication, as well as on the ratio of monocytes to band neutrophils content. For generation of the group classifier of immunological predictors in a newborn infant and development of indications for reflex therapy, nine parameters of interest were measured. The group specificity of the child was determined by three variables, viz. leukocyte index of intoxication, monocyte and band neutrophil counts with values of the Fisher's exact test (F) and reliability (Wilks Lambda 0.90894; approximation F (3.144) = 4.809; p < 0.0032). The partial Wilks Lambda values showed that the greatest contribution was provided by the leukocyte index of intoxication and monocytes. Prediction accuracy of the classification matrix in the standard treatment group reached 30.8% and 91.7% respectively when reflex therapy was included in the combined rehabilitation treatment. Overall, classification accuracy amounted to 70.3%. The presence of distinctive changes in the subgroups preconditioned a personalized approach to the prescription of reflex therapy to the newborn infants and the choice of the treatment modality on an individual basis (parent, child, or both) in the "mother-newborn" system. The variant of treatment was determined by comparing the values of the results of the formulas. The newborns were referred to the subgroup with the highest value of the classification function. The predictors made it possible to reliably distinguished the second (p = 0.032) and the third (p = 0.022) subgroups from the first one, with some degree of overlapping between the edge zones of centroids of the second and third subgroups (p = 0.073). Therefore, the sensitivity of classification in the individual subgroups was lower than in the group model and was estimated at 34.4, 71.9, and 65.6% for the first, second and third groups, respectively. CONCLUSION: The mathematical models can discriminatebetween the immunological characteristics and predict them in individual newborn infants; also, they can be helpful for preventing the disruption of their adaptation process.

[Change in iron metabolism as affected by ionizing radiation]. / Izmenenie metabolizma zheleza pod deistviem ioniziruiushchei radiatsii.

Iron metabolism parameters (increased level of serum ferritin, appearance of an iron pool specifically unrelated to transferrin, reduced ceruloplasmin level, etc.) were found changed in subjects who participated in liquidation of Chernobyl power plant accident aftereffects. These shifts in iron metabolism are explained by reduced antioxidant activity of plasma and indicative of mononuclear phagocyte dysfunction, thus necessitating a dynamic monitoring of this population.

[Indicators of iron metabolism in pregnant women and infants]. / Pokazateli metabolizma zheleza u beremennykh zhenshchin i detei rannego vozrasta.

Iron metabolism parameters were studied in pregnant women in time course of trimesters depending on the pregnancy character and in newborns and infants in relation to the antenatal period. The dynamic study of serum and erythrocytic ferritins has confirmed the expediency of iron therapy during pregnancy for prevention of iron deficiency in infants. Differences detected in the rate of using iron reserves by infants of the first year of life depending on the antenatal period character have necessitated an individual approach to preventive iron therapy.

[Erythrocytic ferritin in pregnant women and infants in the first year of life]. / Eritrotsitarnyi ferritin u beremennykh zhenshchin i detei rannego vozrasta.

Erythrocytic ferritin levels were followed up in pregnant women with reference to its course, in newborns, and in infants during the first year of life. It is shown that the level of erythrocytic ferritin remains high enough in women with complicated pregnancy attended by a sharp reduction of iron reserves. No clear dependence of erythrocytic ferritin concentration on the character of the antenatal period course was observed in infants. The highest values of erythrocytic ferritin parameters were recorded by the first month and they decreased constantly by the first year of life.