Background: A herbal medicinal product (HMP) with centaury, lovage, and rosemary as active ingredients (brand name: Canephron® N) has been widely used for treatment and prevention of urinary tract infections (UTIs) and other urinary system disorders. Non-clinical in vitro and in vivo data indicate its diuretic, spasmolytic, anti-inflammatory, antioxidative and analgesic effects. The purpose of this non-interventional, prospective, multicenter study was to collect data on the use of the HMP in the Russian pediatric outpatient population. Results: In total, 636 outpatients aged 1-17 years were enrolled. Of these, 634 received at least one dose of the HMP and were included in the safety set, which was used for analysis. 61 patients were 12-23 months, 227 were 2-5 years, 234 were 6-11 years and 112 were 12-17 years of age. The oral solution of the HMP was prescribed in 66.4%, and tablets (dragées) in 33.6% of the patients. For 48% of the patients the HMP was prescribed to treat an acute or chronic disease, 25% of the patients received it for prophylaxis, and 27% for both. More than half of the patients (53%) received the HMP as monotherapy. Main treatment indications were UTIs (34.1%) and pyelonephritis (30.0%). The proportion of UTIs was the highest within the youngest age group (51%), while the proportion of different cystitis forms increased in patients older than 2 years. Relevant proportions of different nephritis forms and urolithiasis were only observed in patients aged 12-17 years. Forms of cystitis were more frequent in female than in male patients (15% vs. 1%), while forms of nephritis, urolithiasis, and dysmetabolic nephropathy / crystalluria were more frequent in male patients. At the end of the observational period, 20% of the patients were reported as recovered from their disease, and 65% were reported to show improvements. For 91% of all patients with HMP monotherapy the investigators evaluated the effectiveness of the HMP as 'good' or 'very good'. Nearly all patients (99%) evaluated the tolerability as 'good'or 'very good'. Five adverse drug reactions were observed. Conclusions: The treatment of children aged 1-17 years with the HMP is safe and well tolerated. The study results support the use of the HMP for treatment and prophylaxis of urinary system diseases.
The goal is to discuss the criteria for the early diagnosis of chronic kidney disease (CKD) in children. The article presents data from modern literature on the epidemiology, classification, and criteria for the diagnosis of CKD, own scientific results on clinical and paraclinical characteristics of CKD and regional characteristics of CKD in children of the Orenburg region. Modern approaches to the early diagnosis of CKD in children, the identification of risk factors for the progression of nephropathy and the algorithm for the diagnosis of CKD in childhood, taking into account unfavorable regional factors, are scientifically substantiated. A set of measures for the prevention of nephropathy and a scheme of follow-up observation of children at high risk has been developed. The ways to improve the children's nephrology service are substantiated. Modern pathogenetic approaches to the diagnosis of CKD in children are presented. An algorithm for diagnosing the initial stages of CKD in children at risk for CKD and children with renal pathology without CKD with a preliminary selection of anamnestic and clinical and paraclinical indicators is proposed.
Background and aimsA non-interventional study (NIS) was performed by Bionorica LLC company to collect data on the use of the herbal medicinal product (HMP) Canephron® N in routine paediatric practice in Russia.MethodsChildren of 1–17 years of age with confirmed diagnoses of urinary system disease and who were prescribed treatment with the HMP participated in the study at 26 polyclinics and out-patient departments. Exclusion criteria comprised hypersensitivity to any components of HMP, unsigned informed consent form, gastric ulcer and duodenal ulcer in the acute stage, participation in another clinical trial simultaneously or during 3 months before enrolment. Observational period included study treatment and follow-up period and was limited to a maximum of 6 weeks. Key parameters were prescribed indications, prescribed/actual treatment regimen, duration of treatment, co-medications, global assessments of HMP effectiveness and tolerability by physician and patient/parent, analysis of Adverse Events/Adverse Drug Reactions (AE/ADR). The NIS was approved by the local ethics committees and conducted with site monitoring by a contract research organisation.Results636 children aged 1–17 years were enrolled and 634 (470 girls) of them comprised Safety Set: 61 in the age of 1–2 years, 227 in 2–5 years, 234 in 6–11 years and 112 in 12–17 years. The main indications for HMP prescription were urinary tract infection (34.1%), pyelonephritis (30.0%), dysmetabolic nephropathy (18.9%), cystitis (11.5%), urolithiasis (4.1%) and nephritis (3.6%). HMP was prescribed for treatment in 307 (48.3%) patients, for prophylaxis in 157 (24.7%) and both for treatment and prophylaxis in 172 (27%) of patients. HMP in oral solution was prescribed in 66.4% of patients and tablets in 33.6%. Any concomitant medication was reported in 61.8% of patients. Effectiveness assessments by physician and patient/parent at visit 2 were ‘good’ and ‘very good’ in 88.2% and 87.9% and at visit 3 in 89.1% and 89.1%, correspondingly. Tolerability assessments as ‘good’ and ‘very good’ at visits 2 and 3 varied from 98.1% to 99.2%. In total, 100 AEs were registered and 5 AEs were evaluated as ADRs (including 1 serious ADR (renal colic)).ConclusionsEffectiveness and good tolerability of the HMP in the treatment and prophylaxis of urinary diseases in children of 1–17 years was confirmed. According to registered safety data, the HMP can be considered safe and well tolerated for children of the studied age.
The article presents an analysis of fundamental data on the problem of stress and its role in the development of stressful diseases. Scientific evidence on the role of stress in childhood pathology indicates the extreme pathogenetic significance of stress. It is proved that stress has three interconnected faces: stress as a link in the adaptation mechanism, stress as a link in the pathogenesis of diseases and adaptation to stressful situations as a natural prevention of stressful diseases. The scientific substantiation of the main evolutionarily determined role of stress as an adaptation link indicates the possibility of acquiring some degree of resistance to stressful situations. Prevention of reducing the excess of stress reactions and reducing the possibility of its transformation into a link in the pathogenesis of diseases limits the complex of mechanisms designated as a stress-limiting system. Important information is the development and coordination of the stress response, which is provided by a complex set of mechanisms of neuroendocrine regulation, united by the concept of “stress-implementing system”. The most common forms of stress are fetal hypoxia, metabolic disturbances, and toxic effects leading to uncontrolled oxidative stress at the cellular and tissue levels with the development of pregnancy complications, intrauterine growth retardation syndrome (IUGR), persistent changes and pathological conditions. As the fetus grows, the flow of oxygen and nutrients from the mother through the placenta increases, which is accompanied by an increased risk of the formation of pathologies of the brain, heart, liver and kidneys with the development of a multi-organ pathology in the subsequent life. It has been proven that oxidative stress combined with stress of malnutrition in the prenatal period increases the risk of endocrinopathies, kidney diseases, and a number of other chronic diseases in the adult state. In practical terms, the negative effects of stress are of particular interest. Early detection of psychosocial and sympathomimetic factors causing stress is the basis for the prevention of childhood pathology.
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