Conducting clinical trials on children population is a challenge both for organizers and pediatricians involved in trials. Difficulties in recruiting patients, a significant heterogenecity of the population, specific side reactions, difficulties in identifying the objective final points warrant the specific nature of designing clinical trials in pediatrics. The article illustrates key issues and methodology aspects: planning, design, control groups, patient recruitment. It stresses the need to carefully consider specific characteristics of a child’s system and multi-disciplinary approach involving a pediatrician at the early stages of planning, preliminary consultations with parent organizations, children and regulators.
Key words: clinical trials, methodology, planning, design, patient recruitment, children.

(Pediatric Pharmacology. – 2010; 7(5):6-10)

Since the time antibacterial agents were introduced into a wider medical practice, they have dramatically changed illness patterns and significantly reduced the metrics such as attributive mortality from infectious diseases. At the same time, in recent decades, against the backdrop of a substantial increase in acquired bacterial resistance, an extremely limited number of new antibacterial agents has been put into the actual clinical practice worldwide. This is due to a decrease in the number of trials and developments undertaken by pharmaceutical companies. Authors provide reasons for these trends. It demonstrates key ways of solving these problems through the example of Western European countries and USA. The article illustrates key promising areas in the national pharmaceutical industry from the standpoint of clinical pharmacology.
Key words: antibacterial agents, bacterial resistance, R&D.

(Pediatric Pharmacology. – 2010; 7(5):12-16)

Invasive pneumococcal infection is the most frequent cause of death in patients with immunodeficiences. The antibiotics used previously for prevention purposes are not efficient enough due to the developing antibiotic resistance. Polysaccharide pneumococcal vaccines create short-lived immunity. The overview summarizes the experience of applying conjugated pneumococcal vaccines in patients with primary immunodeficiences, HIV infection, oncological and rheumatic diseases.
Key words: pneumococcal infection, pneumococcal conjugated vaccines, children, immunosuppression.

(Pediatric Pharmacology. – 2010; 7(5):18-23)

Among children with allergies, particularly with bronchial asthma, patients susceptible to frequent acute respiratory infections make up a large group. In recent years, a strong focus has been on persistency of viruses and other pathogenic microorganisms in various areas of the respiratory tract, which leads to change in responsiveness of the organism and warrants the practicability of applying agents with a combined immunomodulating and antiviral effect. The purpose of this study was to assess the clinical and immunological efficacy of inosine pranobex in children with bronchial asthma and frequent respiratory infections. 37 children with atopic persistent moderate asthma at ages 4 to 15 were examined, 26 of which were administered inosine pranobex orally in prevention dosages at 50 mg/kg twice a day over 14 days. The control group was made up of 11 children who were on no immunopharmacological prevention course. Virus antigens in nasopharyngeal smear samples were identified, cytokine status and antibody immune response were studied. In the main group, 23 children (88,5%) were found to have the frequency and length of intercurrent acute respiratory viral infections decreased 1,5 times (p < 0,05) and the number of asthma attacks decreased 1,7 times (p < 0,05). The obtained results demonstrate the efficacy of preventing respiratory infections with inosine pranobex in children with bronchial asthma and other allergic diseases.
Key words: acute respiratory infections, allergy, bronchial asthma, children, prevention, immunomodulators, inosine pranobex.

(Pediatric Pharmacology. – 2010; 7(5):30-37)

Sepsis is one of the leading causes of mortality in children. Timely diagnosis is the most important condition of successful therapy for sepsis. The work provides modern recommendations for diagnosis of the systemic inflammatory response syndrome, sepsis, severe sepsis, septic shock, sets out key guidelines for administering and treating severe sepsis and septic shock in children.
Key words: systemic inflammatory response syndrome, sepsis, septic shock, children.

(Pediatric Pharmacology. – 2010; 7(5):24-29)

Preserving reproductive health of girls is a pressing issue for the modern healthcare industry. The purpose of this study was to determine the metrics of ovarian reserve in healthy adolescent girls aged 15 to 17 in the Republic of Mordovia. 49 healthy adolescent girls aged 15 to 17 were examined in the study. A medical and social audit was conducted at the first state to study their medical history and hereditary factors. Their physical and sexual development (sexual form, characteristic of menstrual cycle, general and gynecological exam) was assessed at the second stage. Hormonal status and ovarian reserve metrics were examined at the third stage. Ultrasonic examination of pelvic organs was conducted and concentrations of LH, FSH, estradiol and anti-Mullerian hormone (AMH) in blood were determined. The study results obtained suggest that a reduced size of ovary in girls aged 16 compared with 15-year-old girls is accompanied with the tendency toward a reduced level of AMH and increased concentration of FSH in blood serum. A significant increase in the average size of both ovaries in 17-year-old adolescents is accompanied with the tendency toward increased AMH, and, by contrast, the tendency toward a reduced level of FSH. The level of estradiol significantly increases over age, i.e. over the period from 15 to 17 years. Hence, at ages 15 and 16 all reproductive system components continue to actively adjust to cyclical functioning. By age 17, a close relationship between ovarian reserve and hormonal status is established.
Key words: reproductive health, ovarian reserve, hormonal status, girls.

(Pediatric Pharmacology. – 2010; 7(5):38-43)

Nimann-Pick Type C Disease is a hereditary progressive disease of the nervous system from the group of lysosomal accumulation diseases resulting from abnormal subcellular lipid distribution, which leads to the accumulation of cholesterol and glycosphingolipid in the brain and other body tissues. Clinical presentation of the disease is varied and manifested as progressive cerebellar, cognitive disorders, vertical ophthalmoparesis, frequently combined with disorders of the liver, spleen and lungs. This article outlines the key mechanisms of Nimann-Pick type C disease pathogenesis, leading clinical presentations depending on the time the disease manifested it self and key therapy approaches. We described two cases of this disease registered in Russia. It provides a comparative clinical analysis with already published data. To date, a pathogenetic treatment course has been developed for this disease, a timely detection of this pathology is, therefore, important to the burdened family. This representative article on modern data on diagnostics and treatment of NPC is intended for neurologists, pediatricians, psychiatrists and geneticists.
Key words: neurodegenerative disease, Nimann-Pick type C disease, convulsions, ataxia, vertical ophthalmoparesis, loss of acquired skills.

(Pediatric Pharmacology. – 2010; 7(5):48-53)

Inflammatory intestinal diseases are among the critical issues in modern pediatrics. The article discusses the specific nature of genetic predisposition and immune mechanisms of this pathology, as well as the impact of intestinal microflora on the development and evolution of inflammatory intestinal diseases in children. It outlines current views on pathogenesis of Crohn’s disease and non-specific ulcerative colitis. It describes in detail the local immune system functioning mechanism of the digestive tract system and functions of its individual components. It explains the phenomenon of food tolerance. It demonstrates the results of modern research and further problem study prospects.
Key words: inflammatory intestinal diseases, non-specific ulcerative colitis, Crohn’s disease, pathogenesis, intestinal microflora, children.

(Pediatric Pharmacology. – 2010; 7(5):54-58)

Pre-school and school-age children are prone to suffer from malnutrition and are an increased risk group. Using nutritional supplements that contain deficient nutrients is an intelligent solution for children who receive insufficient amount of nutritious substances with food. The author takes a detailed look at the role of rational nutrition. The article illustrates the physiological role of vitamins, minerals, polyunsaturated fatty acids and prebiotics. It details key reasons and consequences of their deficiency in nutrition. It demonstrates the need to prevent deficiency of micronutrients by using vitamin complexes.
Key words: children, health, vitamins, minerals, polyunsaturated fatty acids, prebiotics.

(Pediatric Pharmacology. 2010; 7(5):60-70)

One of the key factors driving the development of non-specific ulcerative colitis (NSUC) is the intestinal microflora. The dominant composition of the parietal microflora was studied (Clostridium coccoides, Clostridium leptum, Bacteroides fragilis, Bifidobacterium, Lactobacillus, Prevotella, и Atopobium) in children with non-specific ulcerative colitis (NSUC) using the polymerase chain reaction method in real time. It was shown that it was characteristic of children with NSUC to have increased bacterial density of C. coccoides and Lactobacillus, combined with somewhat reduced Bifidobacterium, B. fragilis and Prevotella. Population levels of individual parietal microflora components (Bacteroides fragilis, Lactobacillus, Clostridium leptum, Clostridium coccoides, Prevotella, Bifidobacterium) vary depending on prevalence, severity and intensity of pathological process in the case of NSUC.
Key words: inflammatory intestinal diseases, non-specific ulcerative colitis, parietal intestinal microflora, polymerase chain reaction, children.

(Pediatric Pharmacology. – 2010; 7(5):71-76)

The article focuses on the issue regarding the survival, preservation of life, health and neuropsychic development of infants with extremely low birth weight. 25 preterm infants aged 0 to 4 weeks were studied. The inclusion criteria were infants aged 28–34 weeks of gestation, with weights ranging from 1,000 to 1,850 g. Enteral feeding consisted of specialized formula with prebiotics (6 hours after birth through a drip feeding tube), increasing to 150 ml/kg a day by the age of 10–12 days. The study results demonstrated that the maximum weight loss was recorded on day 4,0 ± 1,5. The original body weight was restored, on average, on day 13. The average daily weight gain was 14,0 g/kg a day which evidenced good digestion of nutrients and high energy value of the formula. The results of lab tests showed a reduced level of nonesterified fatty acides, a slow waning of _-fetoprotein synthesis. Using a special formula with prebiotics on this category of infants, therefore, provides optimal rate of body weight growth and models protein lipid metabolism in blood serum after the anabolic pattern.
Key words: preterm infants, infants with extremely low birth weight, feeding, special care.

(Pediatric Pharmacology. – 2010; 7(5):78-81)

The article illustrates results of an important trial for the Russian pharmaceutical industry, an assessment of the efficacy and safety of domestic immunosuppressive medication Cyclosporine A. A comparative analysis was made of pharmacokinetics, hepato-, myelo- and renal toxicity of domestic Cyclosporine A and Novartis-manufactured Cyclosporine A in patients with a renal allotransplant. The authors convincingly demonstrated the comparability by practically all studied parameters after a 2-week administration of the domestic analogue.
Key words: Cyclosporine A, efficacy, safety, immunosuppression, kidney transplantation.

(Pediatric Pharmacology. – 2010; 7(5):82-87)

The article provides results of studying the frequency of occurrence of symptoms for functional disorders of the digestive tract in children in their first half a year who are under different types of infant feeding strategies. It was found that 79.6% of children in their first half a year had been diagnosed with the symptoms for disorders of gastrointestinal tract (GIT) function. The most frequent were intestinal colics (56.1%), posseting (53.1%) and delayed defecation (29.6% of cases). A correlation between the intestinal colics, flatulence and posseting was established. It was found that various functional disorders of the digestive tract in infants have common links of pathogenesis. The authors convincingly demonstrated that an infant with functional disorders of GIT needs comprehensive therapy.
Key words: intestinal colics, flatulence, posseting, digestive tract, functional disorders, infants, infancy.

(Pediatric Pharmacology. – 2010; 7(5):88-92)

Bronchial asthma tops the listing of chronic respiratory diseases in children. It was verified that mediators (histamine, serotonin, dopamine, adrenaline, noradrenaline) have influence on the specific nature of bronchial asthma in infants and pre-school children. 121 children (68 patients with bronchial asthma, 23 with relapsing obstructive bronchitis and 30 healthy children) were examined in the course of the study. The results obtained suggest that changes in biogenic amines correlate not only with the disease period and severity but also depend on the nature of the anti-inflammatory therapy.
Key words: biogenic amines, bronchial asthma, relapsing obstructive bronchitis, children.
(Pediatric Pharmacology. – 2010; 7(5):94-96)

The article is devoted to the 29th Congress of the European Academy of Allergy and Clinical Immunology (EAACI-2010) held in the June of 2010 in London. The authors cover in great detail the actual issues related to the prevention, diagnostics and treatment of atopic diseases. The article provides results of research and experiments. It outlines the current views on pre- and postnatal risk factors for developing allergies. It also illustrates the latest data on allergy diagnostics and capabilities of microchips.
Key words: allergology, clinical immunology, congress, children.

(Pediatric Pharmacology. – 2010; 7(5):99-103)

Applying clinical pharmacology guidelines to the mother-fetus system makes it possible to better understand the specifics of pharmacokinetics during pregnancy. The article illustrates the factors that drive these specific features related to both changes in the boy of a future mother and the presence of an extra fetal-placental blood circulation, especially the placenta and developing fetus. These factors influence the results of drug-based treatment during the entire gestational period. Thanks to a rapid development of molecular technologies in the last decade, modern medicine has good prospects of answering questions about individual specifics of pharmacokinetics and metabolism of drugs, increased teratogenic risk driven by specifics of genotypes of the mother and fetus.
Key words: pharmacokinetics, drugs, pregnancy, placenta, mother-fetus system.

(Pediatric Pharmacology. – 2010; 7(5):44-47)