AN EDITORIAL ARTICLE
Experts at FSUE R&D Centre Microgen of the RF’s Healthcare Ministry have developed a national drug designed to prevent rubella — Cultural live vaccine against rubella on the basis of vaccinal strain RA 27/3. A pre-clinical study was conducted to examine neurovirulent properties of the seed virus (S. V. 30 passage) and production strain RA 27/3 of rubella virus (P. S. — 30 passage) on rubella virusantibody negative cynomolgus monkeys. The study was conducted at the laboratory of the Branch of Federal State Institution «48 Central Research Institute of Russia’s Defense Ministry — Virologic Centre» pursuant to requirements of 43 of the report issued by WHO Expert Committee on biological standardization. During the experiment, the following indicators were examined: neurovirulency of the production strain; neurovirulency of the seed virus; immunogenic properties of the seed virus and production strain; contagiousness of the seed virus and production strain. Results obtained in the study indicate that the seed virus and production strain have no neurovirulent properties and contagiousness, and that the developed vaccine has high immunogenic properties.
Key words: vaccine against rubella, seed virus, production strain, neurovirulency, contagiousness, immunogenicity.
(Pediatric Pharmacology. – 2010; 7(4):125-128)
CLINICAL TRIALS IN PEDIATRICS
Prescription of a drug for children is often accompanied with failure to follow the indications, methods of administration, dosages recommended (as a rule, for adults) by product directions. The article illustrates factors that prevent the conduct of clinical trials involving children on a larger scale. As a result, for most drugs there are no data on their efficacy, safety, required doses, optimal ways of administration, etc. Currently to improve this situation, new regulations, rules, requirements are being drafted that on the one hand, encourage, and, on the other hand, require pharmaceutical companies to conduct pediatric trials.
Key words: drugs, clinical trials, children.
(Pediatric Pharmacology. – 2010; 7(4):7-11)
VACCINATION
The article describes a step-by-step strategy for establishing a regional vaccination programme. The authors draw attention to the need for expansion of the National Schedule given the current domestic epidemiological situation — a significant increase in the frequency of severe pneumonias, meningitis, otitis and their complications. It provides examples of immunization programmes in the Sverdlovsk region, Tyumen, Republic of Sakha (Yakutia), shows the importance of the regional component in the National Immunizations Schedule as an effective tool to control infectious disease incidence in the area.
Key words: regional programme of vaccination, vaccinoprophylaxis, infection control, children, pneumococcal infection.
(Pediatric Pharmacology. – 2010; 7(4):19-23)
Currently varicella is incorporated into the immunizations schedules in many European countries. However, in the Russian Federation vaccinal prevention for varicella is not routine and is not part of the National Schedule for preventive immunizations. Varicella effectively remains an unmanageable infection which results in high disease incidence rates. The article illustrates results of vaccinal prevention for varicella in Yekaterinburg. It demonstrates its high efficacy: vaccination allows reductions in disease incidence while post-exposure prevention makes it possible to contain pockets of infection in organized groups and in-patient units.
Key words: varicella, prevention, vaccination, children.
(Pediatric Pharmacology. – 2010; 7(4):34-36)
Oncological diseases are the second leading cause of deaths. Immune system disorders and enzymatic imbalances undoubtedly play a role in the development of tumors. Despite the multifactorial nature of oncological pathology development, endogenous lysozyme deficiency is an important condition of a disease nosogenesis. The article provides a theoretical and experimental validation for the use of lysozyme and antioxidant agents as an alternative therapy for oncological diseases.
Key words: oncological diseases, lycozyme, isoantigens, muramine, free radicals.
(Pediatric Pharmacology. – 2010; 7(4):37-39)
CASE REPORT
EMERGENCY CONDITIONS IN CHILDREN
The major causes of death in children and adolescents in Russia are the external reasons, such as traumas, poisonings, drowning and transport incidents. Many injuries are preventable. Popularization of up to date methods of basic life support is one of methods of declining of a mortality of victims of out-of-hospital arrest. This article highlights the American Heart Association Guidelines for Pediatric Basic Life Support.
Key words: basic life support, children, adolescents.
(Pediatric Pharmacology. – 2010; 7(4):24-29)
Study of human resuscitation development history is the first step in understanding modern approaches to cardiopulmonary resuscitation. A significant increase in survival parameters is driven by accumulation of knowledge, expertise, improvement in resuscitation technologies. Development of cardiopulmonary resuscitation structure, development of recommendations approved for study and practical use, addressing these issues at the state level are accompanied with a significant reduction in mortality both at the hospital and pre-hospital levels.
Key words: children, cardiopulmonary resuscitation, development stages, training of pediatricians.
(Pediatric Pharmacology. – 2010; 7(3):25-27)
LECTURE
Most bronchiolitis cases and viral pneumonias in young children are caused by respiratory syncytial viral (RSV) infection. Children with chronic diseases of lungs, congenital heart defects, pre-mature infants are at high risk of severe type of this infection. Hospitalization and mortality rates in these children are almost several times higher than originally health children. The article illustrates issues relating to the immunization prevention for severe forms of RSV infections in risk group children. The article discusses efficacy and safety of palivizumab, a RSV monoclonal antibodies medication.
Key words: respiratory syncytial virus, respiratory infections, children, bronchiolitis, immunoprophylaxis, palivizumat, preterm infants, bronchopulmonary dysplasia, congenital heart defects.
(Pediatric Pharmacology. – 2010; 7(4):40-47)
The lecture is devoted to oncogenic viruses, particularly human papilloma virus. Papilloma viral infection is found in all parts of the globe and highly contagious. In addition to exhaustive current data on classification, specifics of papilloma viruses composition and epidemiology, the author describes in great detail the malignization mechanisms of papilloma viruses pockets. Also, issues of diagnostics and specific prevention and treatment of diseases caused by this virus are illustrated.
Key words: oncogenic viruses, papilloma viruses, prevention, vaccination.
(Pediatric Pharmacology. – 2010; 7(4):48-55)
ORIGINAL ARTICLES
Objectives: to determine the extent of unlicensed and off-label drugs prescriptions in one of the hospitals in Smolensk. Patients and methods: The prospective pharmacoepidemiological survey for the period from January 1 to June 30, 2006 covered children admitted to the neonatal pathology unit (NPU) (newborns aged 1–30 days), medical department No. 1 for infants (aged 1 month — 3 years), medical department No. 2 for early and middle-age children (aged 4–13 years) and medical department No. 3 for teenagers (aged 14–17 years) who were prescribed at least one drug. The unlicensed drug category included: any prescriptions of drugs not registered in Russia; adult pharmaceutical forms of registered drugs that are not permitted for use in children; incorrect use of permitted pharmaceutical forms; use of chemical substances as drugs; drugs prepared by the hospital pharmacy. Prescriptions were considered off-label in the following cases: 1. off-label use; 2. failure to follow label directions; 3. counter-indications, including age restrictions. Product directions provided by drug manufacturers and 2005 National Drug Register were used as sources of information about drugs. Results: Four hundred sixty nine patients aged 1 day to 17 years (median age of 8.9 years) were included in the survey. A total of 34% prescriptions were unlicensed and 54% off-label. Prescriptions for unlicensed drugs were written at frequency rates of 39, 31, 24 and 39%, while those for off-label drugs were at 70, 58, 43 and 43% at NPU, medical department No. 1, medical department No. 2 and medical department No. 3 respectively. The most common category of unlicensed use was the administration of drugs manufactured by the local pharmacy (73%), followed by the use of adult pharmaceutical forms not permitted for use in children (14%). The most common reason for off-label prescriptions was off-label use (54%); failure to follow label directions and age restrictions in 33% and 12% of cases, respectively. Conclusion: The practice of off-label and unlicensed drug use was quite common in hospitalized children in Smolensk especially in neonatal wards. These findings highlight the shortage of clinical data on the use of drugs in pediatrics as well as the need to set up clinical trials in children, education programs for pediatricians and more active implementation of treatment standards and protocols.
Key words: madications, unlicensed drug, off-label drug, children.
(Pediatric Pharmacology. – 2010; 7(4):56-60)
The authors have conducted a study with the aim of evaluating the internal reliability of the developed questionnaire to determine the impact of atopic dermatitis on the life of a sick child’s family, examining the interrelationship of its parameters with pharmacotherapy and intensity of disease presentation before and during treatment. It was found that internal reliability is medium. The questionnaire’s values proved dependent on the intensity of manifestations (objective SCORAD), outcomes (objective SCORAD after treatment) and after-effects (adverse events) of therapy, as well as on the age and duration of disease.
Key words: atopic dermatitis, a questionnaire to determine the impact of atopic dermatitis on the life of a sick child’s family.
(Pediatric Pharmacology. – 2010; 7(4):62-67)
For Pediatricians' Practice
We are currently seeing a stabilization of child disability indicators, while the number of children suffering effects of craniocerebral injuries is not decreasing. Modern medical and social assessment of such children and assigning them disability category «disabled child» play a special role in the process of medical and social rehabilitation. A medical and social analysis is made to identify causes of disability in children suffering effects of severe craniocerebral injuries. Recommendations on how to improve the process of assessment and rehabilitation of disabled children are made.
Key words: disabled child, disabled children suffering effects of severe craniocerebral injuries, medical and social assessment.
(Pediatric Pharmacology. – 2010; 7(4):68-70)
Examined was the efficacy of integrated therapy for cephalgia syndrome in 201 children aged 7 to 17 years with various forms of arterial hypertension through daily monitoring of arterial pressure and transcranial dopplerography of brain vessels. Treatment was performed in courses over 3 years. Results were assessed at 1,5 and 3 years from the launch of treatment. Tactics were determined for treating cephalgia syndrome in children and adolescents depending of the form of arterial hypertension and specifics and cerebral hemodynamics.
Key words: cephalgia, arterial hypertension, daily monitoring of arterial pressure, transcranial dopplegraphy, disorders of the vegetative nervous system, children.
(Pediatric Pharmacology. – 2010; 7(4):72-80)
Vitamin and mineral deficiency is a condition widely spread all over the world and dangerous for the health of child population. In addition to improved nutrition, children’s living conditions to eliminate this deficiency, use of vitamin and mineral complexes plays a major role. The authors provided detailed information about these agents, particularly the matters involving their registration as a medication or a biologically active supplement, the composition of different complexes, the manufacturing technology, and the tactics of application in pediatrics.
Key words: hypovitaminosis, deficiency of minerals, vitamin and mineral complexes, registration of vitamin and mineral complexes, composition, manufacturing technology, indications for prescription, children.
(Pediatric Pharmacology. – 2010; 7(4):81-85)
The article provides analysis of the pediatric unit of the emergency call station in Kazan. Case-studied are 4,316 emergency calls over one month (April 2009). Structural and organisational specifics and level of emergency aid provided are assessed through a review of a number of indicators, particularly addresses of aided children assigning emergency call sites to areas covered by a specific sub-division, time spent, comparison against the standards, profile of the in-patient unit where a child was taken for hospitalization, etc. The results obtained allowed the authors to suggest measures to improve medical services for children’s population in the region.
Key words: emergency call service, children.
(Pediatric Pharmacology. – 2010; 7(4):86-89)
Varicocele is the most common and rological pathology. Varicocele is no. 1 cause of sterility in men. The article illustrates the stages of spermatogenesis that control its hormones and biologically active substances studied in adolescents who have undergone operations for a left-side varicocele. The results obtained indicate the need for and safety of a timely surgery (if there are indications for it) in order to correct varicocele for improved spermatogenic function.
Key words: varicocele, antisperm antibodies, inhibin B.
(Pediatric Pharmacology. – 2010; 7(4):92-94)
Cough is one of the most frequent reasons parents take their child to a doctor. Most frequently it develops against the backdrop of respiratory infections of viral, mixed viral-bacterial and bacterial aetiology. Currently the issue of applying efficient and at the same time safe medications for acute respiratory infections in young children is quite pressing. The article provides data from studies in which a complex plant drug is administered in children with respiratory infections. The results obtained indicate the efficacy of including herbal syrup in the therapy for children with acute respirator infections. The medication lowers the intensity of the cough providing a soft expectorant and spasmolytic effect, and reduces medicinal burden on the child’s system.
Key words: cough, respiratory infections, children.
(Pediatric Pharmacology. – 2010; 7(4):95-100)
FROM THE UNION OF PEDIATRICIANS OF RUSSIA
EDITORIAL COMMENT
TRAINING FOR TRAINERS — EDUCATIONAL PROGRAM FOR PARENTS
One of the clinical manifestations of discernible gastroesophageal reflux (GER) in young children is regurgitation which is caused by gastric contents passing into fauces. Regurgitation may be both physiological and pathological. According to S. R. Orenstein’s data (2001), it may occur at least once a day in half of infants during the first three months, in two thirds of infants under 4 months and only in 5% of infants aged 10–12 months. A percentage of infants may have pathological GER characterised by a constant and prolonged reflux of acid stomach contents into oesophagus and accompanied by developing inflammation with express clinical manifestations. Pathological GER may cause an unexpected death in infants during sleep. The unequivocal conclusion, therefore, is that gastroesophageal reflux should be treated! This article covers the key causes of them as well as tactics for correction and treatment.
Key words: regurgitation, vomiting, projectile vomiting, gastroesophageal reflux, oesophagus, stomach, regurgitation, exicosis, oesophagitis.
(Pediatric Pharmacology. – 2010; 7(4):106-112)
Materials (WHO, EPA/UNESPA, IPA)
ISSN 2500-3089 (Online)