Vol 67, No 12 (2012)

A review describes general trends and directions of personalized medicine. These include, but not limited to, prediction of disease based on genomic data, diagnostics and therapy monitoring using genomic and postgenomic technologies as well as therapeutic drug monitoring and regenerative cell technologies. The personalized medicine is considered in terms of results of the Human Genome Project and succeeding Human Proteome Project. An importance of personalized approach for modern medicine is emphasized.

Study of immunomodulatory effect of atypical antipsychotic amisulpride has revealed a positive clinical effect after 6-week therapy of schizophrenic patients regarding both positive and negative symptoms. A decrease in activity of humoral immunity factors (В lymphocytes, immunoglobulins, HLA-DR⁺-cells) identified among schizophrenic patients in the process of amisulpride therapy can be attributed to a positive effect optimizing the ratio Th₁/Th₂. Amisulpride when used under experimental conditions produced a suppression of IgM-immune response in mice of the C57BL/6J strain. This effect was more expressed in animals with aggressive behavior pattern.

The formation of microbial biomembranes complicates clinical course of infectious diseases. The review deals with the problem of interaction between immune system and specific components of microbial biofilms. The immune mechanisms which may destroy biomembranes and damage biomembrane-associated microorganisms are analyzed. The vulnerable spots of immune defense against microbal biomembranes are described. This review also issues future prospects of immune-based control of microbal biomembrane processes.

The data on prophylaxis efficacy of the Palivizumab (synagis) against respiratory syncytial viral infection in premature children with bronchopulmonary dysplasia are shown in the article. No side-effects, good tolerance and decrease of the frequency of bronchopulmonary dysplasia relapses and other viral diseases in whole in such children were registered.

This article reviews modern trends in development of new instruments, standards and approaches to drugs safety, efficacy and quality assessment in USA and EU that can be called by unique term — «regulatory science» which is a new concept for Russian Federation. New education programs (curricula) developed by USA and EU universities within last 3 years are reviewed. These programs were designed in order to build workforce capable to utilize science approach for drug regulation. The principal mechanisms for financing research in regulatory science used by Food and Drug Administration are analyzed. There are no such science and relevant researches in Russian Federation despite the high demand as well as needs for the system for higher education and life-long learning education of specialists for regulatory affairs (or compliance).

The problem of workers reproductive health protection from harmful occupational and environmental exposures is amongst the national priorities due to demographic situation in Russia and decrease of the manpower. Some issues of women's reproductive health disorders are considered from occupational health standpoint. The demographic and epidemiological data on pregnancy course and outcome, birth defects, children’s morbidity etc. are presented and discussed. Some proposal as to risk management and medical surveillance of reproductive health, including legal instruments are put forward.

Niemann-Pick disease, type C is a rare hereditary disorder of the group of lisosomal storage diseases, caused by mutations in the genes NPC1 or NPC2. Depending on the onset age, several clinical forms of this disease, which differs by manifestation age, main clinical signs and clinical course, are distinguished. Niemann-Pick disease type C can imitate other hereditary and acquired diseases, which complicates its early diagnostics. Clinical and genetic diversity of this disorder, considered on the clinical cases diagnosed at the FSI «RCMG» of RAMS, are discussed in this review.