[Treatment of attention deficit hyperactivity disorder in children: results of a multicenter, randomized, double-blind, placebo-controlled clinical trial]. / Terapiya sindroma defitsita vnimaniya s giperaktivnost'yu u detei: rezul'taty mnogotsentrovogo randomizirovannogo dvoinogo slepogo platsebo-kontroliruemogo klinicheskogo issledovaniya.

OBJECTIVE: Evaluation of the efficacy and safety of the new drug Prospekta in the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 7-12 years. MATERIAL AND METHODS: A multicenter (35 clinical centres) double-blind, placebo-controlled, randomized, parallel-group clinical trial enrolled 363 patients. The mean age was 9.3±1.7 years. Children of both sexes aged between 7 and 12 years with a diagnosis of ADHD confirmed by DSM-V diagnostic criteria were included in the study. Patients with a total score of 22 or more on the Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-RS-V) were included in the study. After randomisation, patients in group 1 received Prospekta, 1 tablet twice daily; patients in group 2 received placebo according to the study drug regimen. The primary efficacy criterion was the proportion of patients with a 25% or greater reduction in the overall ADHD-RS-V scale score after 8 weeks of treatment. As additional criteria for efficacy assessment were assessed: change of ADHD-RS-V total score from baseline after 8 weeks of treatment; Clinical Global Impression Efficacy Index (CGI-EI) score after 8 weeks of treatment; side effects. RESULTS: The proportion of patients with a 25% or more reduction in the ADHD-RS-V scale score after 8 weeks of treatment was 55.9% in the Prospekta group, and 43.3% in the placebo group (p=0.0199). There was a reduction of ADHD symptoms in the Prospekta group as a mean ADHD-RS-V score decreased by 10.2±7.7 (in the placebo group by 8.1±7.9); the difference between the mean ADHD-RS-V score reduction during Prospekta and placebo treatment was 2.09±7.81 (p=0.0096). Mean CGI-EI scores calculated on the basis of physician scores were different in the Prospekta group compared to the placebo group at 6.9±3.2 versus 8.0±3.1 (p=0.0012), indicating greater clinical efficacy of the study drug. The frequency of adverse events (AEs) did not differ significantly between the groups. There were a total of 66 AEs in 46 patients, including 31 AEs in 23 (13.2%) Prospekta group participants and 35 AEs in 23 (12.2%) placebo group participants (p=0.87). No cases of serious AEs were reported during the study. Prospekta is compatible with drugs used in pediatric practice. Prospekta did not cause an exciting effect and did not adversely affect the sleep of patients. CONCLUSION: The drug Prospekta is an effective and safe treatment for ADHD in patients 7-12 years old.

[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.

[Therapy of perinatal brain injury outcomes: results of a multicenter double-blind placebo-controlled randomized study of tenoten for children (liquid dosage form)]. / Terapiya posledstvii perinatal'nogo porazheniya tsentral'noi nervnoi sistemy: rezul'taty mnogotsentrovogo dvoinogo slepogo platsebo-kontroliruemogo randomizirovannogo klinicheskogo issledovaniya zhidkoi lekarstvennoi formy preparata Tenoten detskii.

OBJECTIVE: To evaluate the efficacy and safety of tenoten for children (a novel liquid pediatric formulation) in the treatment of perinatal brain injury (PBI) outcomes. MATERIAL AND METHODS: The multicenter double-blind placebo-controlled randomized trial enrolled 184 children (aged 29 days-9 months) with the total score 12-27 according to Djurba-Mastukova scale and the level of physical development 25-75 centiles. Patients were randomized into tenoten (10 drops per day) and placebo groups. Treatment period was 12 weeks ± 5 days. Percentage of patients with ≥4 points improvement according to Djurba-Mastukova scale (responder rate) was used as a primary efficacy endpoint. RESULTS AND CONCLUSION: Patients in the tenoten group had a significant result on primary efficacy endpoint: 77.5% of participants responded to therapy (p=0.02 vs. placebo). In addition, the safety of tenoten for children in the treatment of PBI outcomes is shown. Tenoten for children (a novel liquid pediatric formulation) has been shown to be an effective medication in treatment of PBI outcomes that helps to achieve therapeutic results with minimal side-effects, good tolerability and the high level of adherence to therapy.

[Intraoperative cerebroprotection in total intravenous anesthesia in children of school age]. / Intraoperatsionnaia tserebroprotektsiia pri total'noi vnutrivennoi anestezii u detei shkol'nogo vozrasta.

AIM: To improve the quality of anesthesia in school-age children by using intraoperative metabolic-mediated cerebroprotection to reduce the incidence of cognitive impairment after total intravenous anesthesia based on propofol. MATERIAL AND METHODS: A randomized, prospective, longitudinal clinical study was conducted, involving 60 school-age children operated under total intravenous anesthesia on the basis of propofol. Children were randomized into two equal groups. Patients of the 1st group did not receive intraoperative metabolic-mediated cerebroprotection, patients of the 2nd group were treated with cytoflavin. For Z-assessment of changes in cognitive potential, neuropsychological testing of 30 children of the same age who were not subjected to surgical intervention was performed. RESULTS AND CONCLUSION: On the 1st day of the postoperative period, 13.79% of patients of the 1st group had postoperative cognitive dysfunction (POCD), on the 7th day, POCD was observed in 26.67% of children. In the 2nd group, POCD was detected in 6.67% and 3.33% of patients on the 1st and 7th day, respectively (p=0,009). The results confirm the efficacy of cytoflavin in intraoperative prevention of POCD in school-age children.

[Leber's hereditary optic neuropathy and epilepsy: a case report]. / Nasledstvennaya atrofiya zritel'nykh nervov Lebera i epilepsiya: opisanie klinicheskogo nablyudeniya.

A clinical case of a young man with rapid bilateral visual impairment developed 2 months after the onset of generalized convulsive seizures is presented. The replacement of valproate to levetiracetam led to the remission of seizures, but the prognosis for vision remains poor, particularly given the pessimistic results of optical coherence tomography (OCT).

[Correction of early cognitive disorders in school-age children operated under total intravenous anaesthesia].

UNLABELLED: The aim of the study was to assess the possibility and effectiveness of hopaten acid use for early postoperative cognitive dysfunction correction in children of school age. MATERIALS AND METHODS: In compliance with inclusion and exclusion criteria, totally 40 children of school age (7-16 years old, ASA status I-II) with surgical pathology: (varicocele, cryptorchidism, inguinal hernia) were included A comperative assessment of neuropsychic status during pre - and postoperative are period in children, operated under propofol-fentanyl total intravenous anesthesia (TIVA) was conducted All patients were randomized to the control (without cepebroprotection 1st group, 20 children) and experimental (using cepebroprotection with hopaten acid within 1 month after the operation, 2nd group, 20 children) groups. Dimension of the study: Harvard standard monitoring, respiratory gas composition, neuropsychic tests (Bourdon test, "10 words test", etc.). RESULTS: For full compatibility groups (age, ASA status and anthropometric data, equal operation duration and the equipotential drug dosage adjustment is revealed, that in group of propofol-fentanyl TIVA in the early postoperative period in school age children postoperative cognitive dysfunction (POCD) is developing, which in case of absence of the corresponding correction is maintained after 1 month after operation (at least) in 80% of cases. In the application of hopaten acid cerebroprotection (40 mg/kg per day) severity of POCD reliably is reduced or compensated by the time of discharge from the hospital (3-7-th day when non-traumatic interventions), and 1 month after the operation in 30% of patients experienced improvement of cognitive functions, which proves the effectiveness of hopaten acid for POCD treatment. CONCLUSION: In case of propofol-fentanyl TIVA anesthesia in children of school age is indicated preventive prescription of multimodal cerebroprotectors without age limitations (for example hopaten acid (40 mg/kg per day) for POCD treatment.

Histo- and cytoarchitectonics of the hippocampus in young rats injected with propofol and mexidol.

Light microscopic examination of the hippocampus was carried out in young rats (intact and injected with propofol and mexidol according to different protocols). Propofol had a negative effect on hippocampal neurons causing an almost 2-fold increase in the count of modified cells in comparison with the normal level. Mexidol effectively corrected these shifts.