[The possibilities of Mexidol usage in neuropediatrics]. / Vozmozhnosti primeneniya Meksidola v neiropediatrii.

Mexidol (ethylmethylhydroxypyridine succinate) is a modern neurometabolic medication increasingly being used in neuropediatrics. The results of recent studies confirming the positive effects of Mexidol pharmacotherapy in children with attention deficit hyperactivity disorder (ADHD), perinatal damages of the central nervous system (hypoxic-ischemic encephalopathy) and their consequences, neurological disorders and neurodevelopmental delay after surgery for congenital heart defects, neuroinfections (meningitis, encephalitis), posttraumatic epilepsy. Taking into account the unique multimodal action of Mexidol, it seems promising to expand the range of indications for its application in neuropediatrics, based on the results of new clinical trials organized in accordance with modern principles of evidence-based medicine.

[Neurodevelopmental disorders in children and the possibilities of their pharmacotherapy]. / Rasstroistva nervno-psikhicheskogo razvitiya u detei i vozmozhnosti ikh farmakoterapevticheskoi korrektsii.

Neurodevelopmental disorders (NDD) are characterized by disturbances of the formation of cognitive functions, communication skills, behavior characteristics and/or motor skills, which are caused by abnormalities in the course of the processes of neuroontogenesis. In the clinical practice of a pediatric neurologist and pediatrician, a significant part consists of patients with NDD without a general decrease in intelligence, primarily with speech development disorders, attention deficit hyperactivity disorder (ADHD), specific learning disorders (dyslexia, dysgraphia, dyscalculia). NDD represent a heterogeneous group of diseases, having multifactorial origin and a neurobiological nature, which are caused by genetic mechanisms and early (perinatal) brain damage. Among children with NDD, there is a higher occurrence of anxiety disorders compared to their peers. With NDD, early intervention is indicated, and its positive effect is possible during the period when the brain is most plastic and capable of changes. The published results of multicenter, double-blind, placebo-controlled, randomized clinical trials of pharmacotherapy with the medication "Tenoten for children" for ADHD, specific learning disorders, anxiety disorders and the consequences of perinatal damage to the central nervous system are reviewed.

[Developmental dysphasia in children: a comparison of the effectiveness of two modes of peptidergic nootropic therapy]. / Disfaziya razvitiya u detei: sravnenie effektivnosti dvukh rezhimov peptidergicheskoi nootropnoi terapii.

OBJECTIVE: To study the therapeutic efficacy of two treatment modes of peptidergic nootropic medication cortexin in children with developmental dysphasia aged 3-4 years. MATERIAL AND METHODS: Ninety-four children with developmental dysphasia were divided into three groups. In group 1 (27 patients), cortexin was administered once a day intramuscularly for 10 days. After this course, the children were not prescribed drug therapy, a second examination was carried out 2 months after the start of treatment. In group 2 (40 patients), two courses of cortexin were administered at 1-month intervals, and the children were also followed up for two months. Control group 3 (27 patients) did not receive medication, but was also followed up for two months. All the parents were provided with recommendations for the stimulation of speech development in children. Before the study and two months later, speech development was assessed with special scales and questionnaires for parents. RESULTS: The increase ratio of the active vocabulary volume by 2 times or more was observed in group 2 (two courses of cortexin treatment) in 80.0% of patients (significant differences with groups 1 and 3, p<0.001), in 44.4% of group 1 (one course of cortexin), in 22.2% of the control group. Over a two-month period, the increase ratio in the active vocabulary and the number of uttered phrases in group 2 was 2.8 and 4.2 times, in group 1 2.3 and 3.6 times, respectively, in the control group it was only 1.4 and 1.5 times. Furthermore, the volume of active vocabulary in group 2 (42.4±3.6) became significantly larger (p=0.01) than in group 1 (31.7±5.6), although its initial values in group 1 (13.7±1.8) and group 2 (14.9±1.7) were similar. CONCLUSION: The results of the study confirm the higher effectiveness of two courses of the peptidergic nootropic medication cortexin in the pharmacotherapy of developmental dysphasia in children, aged 3-4 years, conducted over two months, compared with the indication of one treatment course.

[Developmental disorders of academic skills in children: the efficacy and safety of Tenoten for children in the multicenter double-blind placebo-controlled randomized study]. / Narusheniya razvitiya uchebnykh navykov u detei: effektivnost' i bezopasnost' Tenotena detskogo po dannym mnogotsentrovogo dvoinogo slepogo platsebo-kontroliruemogo randomizirovannogo issledovaniya.

OBJECTIVE: To evaluate the efficacy and safety of tenoten for children in the treatment of specific developmental disorders of academic skills in children of 1-3 grades. MATERIAL AND METHODS: Two hundred and forty children, aged 7-9 years, (Total set, Safety population) with verified specific reading disorder (F81.0), specific spelling disorder (F81.1), specific disorder of arithmetical skills (F81.2), mixed disorder of scholastic skills (F81.3; F81.2+F81.0, or F81.2+F81.1, or F81.2+F81.0+F81.1), diagnosed with the use of logopedic or psychological testing (15-35 scores in Fotekova T.A. and Akhutina T.V. reading and writing tests; 5-15 scores in arithmetical subscale of the Wechsler Intelligence Scale for Children) were enrolled in the study. CT was conducted in 10 clinical centers in Russian Federation in 2015- 2019. Patients were randomized into two groups. The first one (n=122) received tenoten for children in a dose of 1 tablet 3 times a day, the second one (n=118) was administered placebo in the same dosage regimen. The clinical data on 237 children (121 of the tenoten group and 116 of the placebo group) were used for Intention-to-treat efficacy analysis. Data on 220 children (115 of the tenoten group and 105 of the placebo group) were included in Per-protocol analysis. The duration of study was 12 weeks. The mean total academic skills (reading, spelling, and counting) score in groups after 12 weeks of treatment was set as the primary efficacy endpoint. RESULTS: The mean total academic skills score increased by 18.55±15.87 points. The significant total difference between the median changes in the total score in the tenoten and placebo groups was 5 points. There was a trend towards positive changes in reading and spelling mean scores in tests that didn't reach statistical significance due to lack of normal distribution of points in samples. There were 73 adverse events (AEs) in 42 patients of the tenoten group and 95 AEs in 31 children of the placebo group. No serious or severe AEs were registered in the tenoten group. No AEs definitely related to the study treatment were registered. No negative drug interactions were observed in the tenoten group. CONCLUSIONS: Tenoten for children is an effective and safe treatment for specific developmental disorders of academic skills in primary school children. Tenoten for children is well tolerated. The treatment is characterized by a high level of adherence of children and their parents to therapy.

[Attention deficit hyperactivity disorder in children and adolescents]. / Sindrom defitsita vnimaniya i giperaktivnosti u detei i podrostkov.

OBJECTIVE: To evaluate the level of adaptive functioning in patients with attention deficit hyperactivity disorder (ADHD). MATERIALS AND METHODS: One hundred children and adolescents with ADHD (79 male and 21 female) were examined using M. Weiss functional impairment rating scale (WFIRS). The total score on the ADHD-DSM-IV was at least 24 and ADHD severity was rated as «Moderately ill¼ or «Markedly ill¼ on CGI-S-ADHD scale. RESULTS: Typical for ADHD difficulties with adaptive functioning in «Family¼, «Learning and school¼, «Life skills¼, «Social activities¼ domains are more pronounced in «Markedly ill¼ patients compared to «Moderately ill¼ and increase during the transition from childhood to adolescence. Comorbid disorders (oppositional defiant disorder and anxiety disorders) lead to a significant increase in adaptive functioning impairments in most domains of daily life, including «Family¼, «Learning and school¼, «Child's self concept¼, «Social activities¼ and «Risky activities¼. CONCLUSION: It is necessary not only to assess core symptoms in the follow-up of patients with ADHD, but also evaluate comorbid disorders and the level of functional impairment across the main domains of daily life.

[Potential of peptidergic nootropic therapy in developmental dysphasia in children]. / Vozmozhnosti peptidergicheskoi nootropnoi terapii pri disfazii razvitiia u detei.

AIM: To study the therapeutic efficacy of peptidergic nootropic medication Cortexin during two-month follow-up in children with developmental dysphasia aged 3-4 years. MATERIAL AND METHODS: Fifty-four children with developmental dysphasia were randomized into two equal groups. The cortexin group received the drug once daily intramuscularly during 10 days. After this course, children did not receive any pharmacotherapy and were examined two months after the beginning of treatment. The control group did not receive pharmacotherapy and was examined twice in two months interval. All the parents were provided with recommendations for the stimulation of speech development in dysphasic children. Before treatment and two months later, speech development was assessed by special scales and questionnaires for parents. RESULTS AND CONCLUSION: After treatment with Cortexin, a significant improvement was achieved not only on the 'expressive language' scale but also on the 'attention to speech' and 'impressive language' scales. The volume of active vocabulary was increased by 2.3 times, the number of articulated phrases by 3.6 times. The evaluation of parents' questionnaires demonstrated the decrease of cerebrasthenic, psychosomatic problems, motor clumsiness, hyperactivity, attention deficit and problems with emotional control in children. The therapy contributed to the reduction of difficulties in communication and social adaptation. The positive effect of Cortexin was observed after the completion of treatment (the protracted effect).

[Pharmacotherapy of attention deficit hyperactivity disorder in children: the results of a multicenter double-blind placebo-controlled study of hopantenic acid]. / Farmakoterapiia sindroma defitsita vnimaniia s giperaktivnost'iu u detei: rezul'taty mnogotsentrovogo dvoinogo slepogo platsebo-kontroliruemogo issledovaniia gopantenovoi kisloty.

AIM: To assess the efficacy and safety of hopantenic acid (pantogam) compared to placebo in the treatment of attention deficit hyperactivity disorder (ADHD) in children, aged from 6 to 12 years, during 4 month in the prospective multicenter comparative double-blind placebo-controlled study in parallel groups. MATERIAL AND METHODS: One hundred patients enrolled in the safety assessment population were stratified into two equal pantogam and placebo groups. Eighty-nine patients who completed the study in according to the protocol were included in the efficacy assessment group: 45 in the pantogam group and 44 in the placebo group. Pantogam was administered in tablets (250 mg) in the therapeutic dose 30 mg/kg of body mass, divided into 2 doses, during 4 month. Patient's state was assessed by the total score on ADHD-DSM-IV, CGI-S WFIRS-P and results of the Toulouse-Piéron test for sustained attention. RESULTS AND CONCLUSION: There was a trend towards an increase in the percentage of patients with positive changes (a decrease in the total ADHD-DSM-IV by ≥25%) in the end of the 3rd and 4th month in the pantogam group (treatment response was 66.7 and 68.9%, respectively) compared to the placebo group (treatment response was 52.3 and 61.4%, respectively). A significant decrease in disease severity assessed by the CGI-S was noted in the pantogam group compared to the placebo group. After 4 month of treatment with pantogam, the severity of functional disturbances was reduced by 4 out of 6 WFIRS-P domains: Family, School and learning, Child's self-concept and Risky activities. Pantogam improved the measures of sustained attention (accuracy and speed) in the Toulouse-Piéron test. The drug used in mean daily dose 30 mg/kg during 4 month had a favorable safety profile which did not differ from that of placebo.

[Treatment of speech disorders in preschool children]. / Terapiia rasstroistva razvitiia rechi u detei doshkol'nogo vozrasta.

AIM: To study the efficacy of neyroferon in developmental speech disorders (SDD). MATERIAL AND METHODS: Thirty preschool children were stratified into 3 groups: 4-5 years (n=8), 5-6 years (n=10) and 6-7 years (n=12). The children were treated with neyroferon in dose 1 tablet three times a day during 2 month. A multifaceted study of speech disorders using several methods was conducted. General mental state, emotional and behavioral characteristics of the children were assessed as well. RESULTS AND CONCLUSION: A therapeutic effect of neyroferon (the improvement of auditory-speech memory, expressive speech, phonemic perception, articulatory movements, vocabulary activity, connected speech etc) as well as the decrease in anxiety, hyperactivity and attention deficit was found in children with SDD. The safety of the drug was confirmed. The results should be treated as preliminary ones.

[Current possibilities in pharmacotherapy of anxiety disorders in children and adolescents].

OBJECTIVE: To assess the efficacy and safety of children tenoten in the treatment of children and adolescents with anxiety disorders. MATERIAL AND METHODS: It was conducted a multicenter, double-blind, placebo-controlled trial of the drug tenoten children at a dose of 1 tablet 3 times a day for 12 weeks. The study included 98 patients (boys and girls from 5 to 15 years with a confirmed diagnosis of anxiety disorder), randomized into two groups: the first included 48 patients treated tenotenom children, in the second - 50 patients receiving placebo. RESULTS AND CONCLUSION: Tenoten children has a strong anti-anxiety effect both on the results of self-assessment of patients, and on the reports of parents. This anxiolytic activity of the drug manifested most significantly in children aged 5 to 7 years. In addition, in patients 8-15 years of treatment spent tenotenom children to regress the symptoms of anxiety disorders by anxiety subscales SCAS «Separation anxiety¼, «panic attacks and agoraphobia¼ and «social phobia¼. Throughout the course of treatment tenoten children have been no adverse events.