ABSTRACT
OBJECTIVES: To evaluate the efficacy and safety of two dosing regimens of Mexidol film-coated tablets, 125 mg («RPC «PHARMASOFT¼ LLC Russia), compared with placebo in children with attention deficit hyperactivity disorder (ADHD) aged 6 to 12 years. MATERIAL AND METHODS: A multicenter randomized, double-blind, placebo-controlled study in 3 parallel groups was conducted in 14 clinical centres of the Russian Federation to assess efficacy and safety of Mexidol film-coated tablets, 125 mg («RPC «PHARMASOFT¼ LLC Russia) in the treatment of attention deficit hyperactivity disorder (ADHD) in children 6-12 years old with different dosing regimens. The study involved 333 boys and girls aged 6 to 12 years with a confirmed diagnosis of ADHD established in accordance with ICD-10 and DSM-5 criteria. After screening (up to 14 days) the patients were randomised into 3 treatment groups in a 1:1:1: Mexidol 125 mg 2 times daily, Mexidol 125 mg daily+placebo and the placebo group. The duration of treatment in all groups was 42 days. 332 children completed the study. ADHD and comorbid disorders assessment scales were used. RESULTS: There were statistically significant changes in the sum of the total scores on the SNAP-IV inattention and hyperactivity/impulsivity subscales after 6 weeks of therapy in all three study groups (p<0.05). There were statistically significant differences between the Mexidol 125 mg and placebo groups and between the Mexidol 125 mg 2 times daily and placebo groups (for the PP population: p=0.000308 and p=0.000024, respectively; for the FAS population: p=0.000198 and p=0.000024, respectively), indicating that Mexidol therapy is superior to placebo. Statistically significant differences (p<0.05) were also obtained for most of the secondary efficacy criteria (average change in SNAP-IV inattention subscale score, average change in SNAP-IV hyperactivity/impulsivity subscale score, average change in SNAP-IV subscale score - Conners index, average change in ADHD-RS-IV score, change in CGI-ADHD-S scores, change in CGI-I score - the Clinical Global Impressions Scale - Improvement) when comparing Mexidol therapy with placebo. The results of statistical analysis of the incidence of adverse events, laboratory values, physical examination show no significant differences between the compared groups in the main safety parameters. CONCLUSIONS: The regimen of Mexidol, 125 mg film-coated tablets twice daily has been shown to be superior to the regimen of Mexidol, 125 mg film-coated tablets once daily and placebo. The safety profiles of the studied dosing regimens of Mexidol and placebo were comparable.
Subject(s)
Attention Deficit Disorder with Hyperactivity , Central Nervous System Stimulants , Attention Deficit Disorder with Hyperactivity/diagnosis , Attention Deficit Disorder with Hyperactivity/drug therapy , Child , Female , Humans , Male , Picolines/adverse effects , Tablets/therapeutic useABSTRACT
OBJECTIVE: To demonstrate the experience of a personalized approach to the treatment of pediatric patients with multiple sclerosis using the example of the Moscow patient population. MATERIALS AND METHODS: The authors describe the clinical follow-up of 79 pediatric patients with demyelinating diseases of the nervous system during 2019, including 39 patients with multiple sclerosis, including one patient with a primary progressive course of the disease (clinical case). RESULTS: The experience of the Moscow office for the treatment of multiple sclerosis in children and adolescents demonstrates the effectiveness of the personalized approach to the treatment of pediatric cases confirmed by the case report of biological therapy by recombinant humanized monoclonal antibody directed against CD20-expressing B-cells for early treatment of the adolescent patient with primary progressive multiple sclerosis. CONCLUSION: The identification of patient's groups with different levels of disease activity and different risks of disability progression is highly relevant in the pediatric population of patients with multiple sclerosis, especially in the context of expanding therapeutic opportunities.
Subject(s)
Multiple Sclerosis, Chronic Progressive , Multiple Sclerosis , Adolescent , Antibodies, Monoclonal, Humanized , Child , Disease Progression , Humans , Moscow , Multiple Sclerosis/drug therapy , Multiple Sclerosis, Chronic Progressive/drug therapyABSTRACT
Cognitive dysfunction in multiple sclerosis (MS) is a disabling factor and extends to the processes of memory, attention, verbal and logical thinking, visual-spatial, and motor skills. 40-70% of patients have a decrease in the rate of information processing, dysfunction of executive functions, and decrease in the quality of training. Cognitive dysfunction is also often reduced quality of life with MS. The most common methods of non-drug cognitive function correction are cognitive rehabilitation and exercise. This article reviews current research on the positive effects of regular physical activity on the cognitive functions of adults and children with MS.
Subject(s)
Multiple Sclerosis , Adult , Child , Cognition , Executive Function , Exercise , Humans , Quality of LifeABSTRACT
AIM: To assess the safety and clinical and neurophysiological efficacy of xeomin in children with spastic equinus and equinovarus foot deformity in cerebral palsy. MATERIAL AND METHODS: Sixty-four patients with spastic forms of cerebral palsy (levels I-IV on the GMFCS) were enrolled into this multi-center open-label comparative randomized trial. The patients were administered xeomin or botox once, each drug being administered to 32 patients. Efficacy was evaluated based on clinical characteristics (the modified Ashworth scale, goniometry) and electromyography data. The subjects were observed for 3 months (90±7 days) after injections. The incidence, severity and intensity of adverse events (AE) was also determined. RESULTS: Treatment with xeomin according to the suggested protocol has proven its high clinical efficacy. The efficacy was demonstrated by significant, stable and long-term decrease in the gastrocnemius muscle tone: in the xeomin group, the score on the modified Ashworth scale decreased from 2.6±0.49 points at baseline to 1.8±0.54 points (Ñ<0.000001, paired t-test; Ñ<0.000004, Wilcoxon test). In the botox group, this score decreased from 2.4±0.56 points to 1.6±0.45 points (Ñ<0.000001, paired t-test; Ñ<0.000002, Wilcoxon test). The increased range of ankle joint movements at passive and voluntary feet extension. In the xeomin group, the significant proportion of patients (45.1%) moved to the group of lower spasticity defined as less than two score points on the modified Ashworth scale. The clinical data fully matched the changes in electromyography parameters, which were characterized by the lower amplitude and area of the target muscle (lateral and medial gastrocnemius heads) M-responses. AE developed in three patients (9.4%) administered xeomin and in two patients (6.3%) administered botox. The AE recorded in the study are described in the recommendations on the use of xeomin and botox. In three cases (50.0%), AE intensity was determined as mild, in the remaining three cases (50.0%) as moderate. CONCLUSION: The results have shown the safety and efficacy of xeomin in the treatment of gastrocnemius spasticity in pediatric patients with cerebral palsy. These data are confirmed by the lack of significant differences in any clinical or electromyography parameters with the results in the reference group administered botox.
Subject(s)
Botulinum Toxins, Type A/therapeutic use , Cerebral Palsy/drug therapy , Neuromuscular Agents/therapeutic use , Cerebral Palsy/physiopathology , Child , Clubfoot , Electromyography , Female , Humans , Injections, Intramuscular , Male , Muscle Spasticity/drug therapy , Muscle Tonus , Muscle, Skeletal/physiopathology , Treatment OutcomeABSTRACT
AIM: To study a group of patients with secondary generalized tonic-clonic seizures (SGTCS) in view of nosology, medical history, clinical, electroencephalographic and neuroimaging features. MATERIAL AND METHODS: The study included 471 patients, 244 (51.8%) men and 227 (48.2%) women. RESULTS: SGTCS were observed in many epileptic syndromes. The most frequent were symptomatic focal epilepsy (33.8%), cryptogenic focal epilepsy (23.8%), rolandic epilepsy (12.6%), FEBL-BEDC syndrome (12.3%). Other forms of epilepsy were less frequent. The onset of epilepsy ranged over a wide age range from the first month of life to 18 years. The average age of onset was 5.7±4.96 years. SGTCS as the only type of paroxysms were observed in 28.3% of cases. Two or more types of seizures were observed in 71.7% of patients, three or more types in 39.3%. Epileptiform activity on EEG during long VEM was detected in 91.3% of patients with SGTCS. In 37.2% of patients, benign epileptiform discharges of childhood were recorded. Treatment with antiepileptic drugs (AEP) led to complete remission in 57.1% of cases of epilepsy associated with SGTCS. A reduction of the frequency of seizures by 50% or more was found in 33.6% of patients treated with AEP. No effect was observed in 9.3% of patients. CONCLUSION: Significant differences in the prognosis and therapeutic approaches to specific epileptic syndromes associated with SGTCS necessitate the use of the entire spectrum of diagnostic measures, which should include careful history taking, clinical examination, video-EEG monitoring with the inclusion of sleep dynamics, MRI / CT brain, genetic testing.
Subject(s)
Epilepsies, Partial , Epilepsy, Tonic-Clonic , Epileptic Syndromes , Seizures , Anticonvulsants , Child , Child, Preschool , Electroencephalography , Epilepsies, Partial/complications , Epilepsies, Partial/diagnostic imaging , Epilepsies, Partial/physiopathology , Epilepsy, Tonic-Clonic/complications , Epilepsy, Tonic-Clonic/diagnostic imaging , Epilepsy, Tonic-Clonic/physiopathology , Epileptic Syndromes/complications , Epileptic Syndromes/diagnostic imaging , Epileptic Syndromes/physiopathology , Female , Humans , Infant , Male , Seizures/etiologyABSTRACT
AIM: To evaluate efficacy and safety of biosimilars of interferon beta-1b (Infibeta) in patients aged 14 to 17 years. MATERIAL AND METHODS: Interferon beta 1b (Infibeta) was appointed 9 children and adolescents (4 boys and 5 girls) between the ages of 14 to 17 years (mean age of onset of therapy 16.22±1.09). RESULTS: In the course of therapy there was a significant decrease in the annualrelapse rate (ARR) to 0.33±0.5 (from 0 to 1, r≤0,0001) and the of regression of neurological deficit on the EDSS scale up to ±1.94±0.68 (1.5 to 3, p≤0.05). No cases of cancellation was not recorded due to poor tolerability or inefficiency. CONCLUSION: Although numerically small so far, but quite successful results on the use of Russian interferon beta-1b biosimilar (Infibeta) in children, we can recommend this treatment as sufficiently safe and effective.
Subject(s)
Biosimilar Pharmaceuticals/therapeutic use , Interferon beta-1b/therapeutic use , Multiple Sclerosis/drug therapy , Adolescent , Biosimilar Pharmaceuticals/administration & dosage , Biosimilar Pharmaceuticals/adverse effects , Child , Female , Humans , Interferon beta-1b/administration & dosage , Interferon beta-1b/adverse effects , Male , Russia , Treatment OutcomeABSTRACT
The vast majority of therapies are being evaluated and introduced for the treatment of adult multiple sclerosis (MS). A role of these drugs in the management of pediatric MS has yet to be defined both in Russia and in the whole world. Despite the fact that today the study of new drugs in the pediatric population have included in routine practices of the big pharmaceutical agencies, such as FDA and EMA, recommendations for the treatment of pediatric patients with MS are based not so much on a long period of systematic clinical research, but on professional consensus of international expert associations, in particular, the International pediatric multiple sclerosis study group (IPMSSG). The clinical trials include the small number of patients which is not comparable to those conducted in adults. Therefore, there is a need for study designs for assessment of efficacy and safety of the drugs for MS treatment in children and adolescents. The authors present the IPMSSG concept on the treatment of pediatric MS taking into account peculiarities of the Russian legislation and experience of national experts.
Subject(s)
Immunologic Factors , Multiple Sclerosis/drug therapy , Adolescent , Child , Consensus , Humans , RussiaABSTRACT
Currently music therapy plays an important role in the drug-free treatment and rehabilitation of children and adults with acute and chronic neurological and somatic diseases including demyelinating diseases. Existing studies show the effectiveness of music therapy in the improvement of social skills, cognitive function and sleep as well as in the reduction in the severity of depression, anxiety and pain in patients with multiple sclerosis.
Subject(s)
Multiple Sclerosis/therapy , Music Therapy , Anxiety , Cognition Disorders/etiology , Cognition Disorders/therapy , Depression/etiology , Depression/therapy , Humans , Multiple Sclerosis/complications , Multiple Sclerosis/psychology , Pain , Pain Management , Sleep Wake Disorders/etiology , Sleep Wake Disorders/therapyABSTRACT
The diagnosis of multiple sclerosis in children and adolescence should be differentiated from a group of rare white matter diseases, with fuzzy diagnostic criteria. Some of these conditions require modern diagnostic techniques and wide knowledge of the doctor. The Moscow Division for treatment of children and adolescents with multiple sclerosis is a specialized advisory structure, which has specialists with experience in the differential diagnosis of multiple sclerosis with pediatric onset. The emphasis on the clinical aspects in differential diagnosis of early onset multiple sclerosis can reduce the time for the diagnosis and help to avoid diagnostic mistakes.
Subject(s)
Diagnostic Imaging/methods , Multiple Sclerosis/diagnosis , Societies, Medical , Adolescent , Age of Onset , Child , Diagnosis, Differential , Disease Progression , Humans , Moscow/epidemiology , Multiple Sclerosis/epidemiology , PrognosisABSTRACT
A randomized study on the efficacy and safety of the hopantenic acid preparation (pantocalcin) and its effect on cognitive functions in children with cerebral palsy (CCP) has been carried out. The positive effect of pantocalcin on the visual memory and attention concentration, activity and fatigability has been shown. At the same time, there was a decrease of anxiety in children and adolescents with CCP. No evidence for the effect of the drug on visual-motor skills has been found. The results of the study have demonstrated the high safety profile of pantocalcin when used in pediatric practice.
Subject(s)
Cerebral Palsy/drug therapy , Nootropic Agents/therapeutic use , Pantothenic Acid/analogs & derivatives , gamma-Aminobutyric Acid/analogs & derivatives , Adolescent , Anxiety/etiology , Attention/drug effects , Child , Cognition/drug effects , Female , Humans , Male , Memory/drug effects , Motor Skills/drug effects , Nootropic Agents/adverse effects , Pantothenic Acid/adverse effects , Pantothenic Acid/therapeutic use , gamma-Aminobutyric Acid/adverse effects , gamma-Aminobutyric Acid/therapeutic useABSTRACT
The aim of the study was to describe the atrophy of the thalamus in young patients with active relapsing multiple sclerosis (MS) treated with cerebrolysin. Eighteen MS patients (mean age 20.10±0.45 years) with disease onset in childhood or adolescence were studied. Neurological examination using the EDSS, neuropsychological testing and MRI were used. At baseline, MRI revealed the hypotrophy of the thalamus that was not correlated with the performance on neuropsychological tests. After treatment with cerebrolysin, there was the decrease in the level of atrophy that suggested the neuroprotective effect of this drug. This effect was more prominent in younger patients with the high frequency of previous relapses.
Subject(s)
Amino Acids/therapeutic use , Magnetic Resonance Imaging/methods , Multiple Sclerosis, Relapsing-Remitting/diagnosis , Nerve Degeneration , Neuroprotective Agents/therapeutic use , Thalamus/pathology , Adolescent , Disease Progression , Female , Humans , Male , Multiple Sclerosis, Relapsing-Remitting/drug therapy , Organ Size , Reproducibility of Results , Young AdultABSTRACT
The experience of the treatment of patients with remitting multiple sclerosis (MS) with intramuscular introduction of beta-interferon-1a (avonex) is presented. Seventeen children and adolescents, aged from 11 to 18 years, and 55 adults, aged over 55 years, were treated for at least one-year period. Results revealed a significant reduction of exacerbations in both groups (from 1.35 to 0.06 in average in adolescents and from 0.86 to 0.17 in adults). The changes were accompanied by the stabilization of MS severity index: EDSS scores have decreased in 23.6% of adults and in 17.6% of adolescents. In both groups, good tolerability of the treatment was noted. There was a low probability of side-effects with the exception of increased frequency of a flu-like syndrome (47% cases) in patients younger than 18 years that demands special attention from children neurologists. The high efficacy and good tolerability and safety profile of beta-interferon-1a give grounds for administering this drug to children and adolescents with MS.
Subject(s)
Adjuvants, Immunologic/administration & dosage , Interferon-beta/administration & dosage , Multiple Sclerosis, Relapsing-Remitting/drug therapy , Adjuvants, Immunologic/adverse effects , Adolescent , Child , Drug Administration Schedule , Female , Humans , Injections, Intramuscular , Interferon beta-1a , Interferon-beta/adverse effects , Male , Middle Aged , Treatment OutcomeABSTRACT
Spasticity in children cerebral palsy has its own peculiarities due to the presence of pathological tonic reflexes, pathological sinkinetic activity during arbitrary movements, disturbance of coordinative interactions of muscle synergists and antagonists, increase of total reflex excitability. Physiotherapeutic methods, massage, therapeutic exercises, kinesitherapy, biological feedback training (BFT), methods of orthopedic correction, neurosurgery are widely used in the treatment of spasticity. The use of botulinum toxin type A is a new effective approach to the treatment of spasticity that improves motor functions and quality of life of children with children cerebral palsy. It is being used in the treatment of children and adolescence in a polyclinic unit of the Moscow psychoneurological hospital since 2001. The experience of treatment with botulinum and wide implementation of this method indicated that botulinum toxin injections in the complex treatment of spasticity allow to optimize approaches to treatment of children and adolescence with children cerebral palsy and to increase significantly the quality of medical-social rehabilitation of patients.
Subject(s)
Cerebral Palsy/physiopathology , Cerebral Palsy/therapy , Anti-Dyskinesia Agents/therapeutic use , Baclofen/therapeutic use , Botulinum Toxins/therapeutic use , Child , Child, Preschool , Humans , Infant , Muscle Relaxants, Central/therapeutic use , Muscle Spasticity/diagnosis , Muscle Spasticity/drug therapy , Muscle Spasticity/therapy , Physical Therapy Modalities , Tolperisone/therapeutic useABSTRACT
Neurological diseases, mental disorders and inherited developmental abnormalities held a prominent place in the structure of primary children disability. Children cerebral palsy is the main cause of children disability, its prevalence reaching 2-3.5 cases per 1000 children. This disease has the noticeable negative consequences (both clinical and economic). Adherence to treatment means patient's compliance with doctor's orders including taking medicines as prescribed, sticking to diet and changing life style habits. While the adult patient plays an active role in doctor-patient alliance, the child patient interacts with the doctor together with his/her family. The authors consider the effect of different factors on the adherence basing on the analysis of 270 questionnaires completed by persons involved in the treatment of minor patients.
Subject(s)
Caregivers/psychology , Cerebral Palsy/rehabilitation , Family/psychology , Patient Compliance , Cerebral Palsy/diagnosis , Cerebral Palsy/epidemiology , Child , Child, Preschool , Female , Humans , Male , Moscow/epidemiology , Prevalence , Surveys and QuestionnairesABSTRACT
Epilepsy is one of the most frequent and difficult for treatment co-morbid disease of cerebral palsy. In therapeutic aspect, the difficulty of the problem is defined by the necessity to combine the active restoration of motor disorders with a regime of antiepileptic treatment. It leads frequently to stopping the restoration process and aggravation of patient's motor disability. The diagnosis of epilepsy in the child with cerebral palsy should in no way discontinue the rehabilitation measures, albeit in case of the concomitant pathology a plan of rehabilitation scheme should be adjusted. The pharmacological control of epileptic seizures should be the first step of the new rehabilitation scheme. Epileptologists usually conduct the selection of multi-component antiepileptic treatment in patients with drug resistant epilepsy, however a neurologist of an outpatient clinics who follows up the patient in different stages of development and rehabilitation should play a key role. The authors suggest the general treatment tactics for children with cerebral palsy and epilepsy by the neurologist of the polyclinics.
Subject(s)
Anticonvulsants/administration & dosage , Cerebral Palsy/complications , Epilepsy/complications , Epilepsy/drug therapy , Child , Epilepsy/rehabilitation , Humans , Prognosis , Treatment OutcomeABSTRACT
We have analyzed morphologic and chronologic characteristics of epileptiform activity, with account for repeated EEG-study during the follow-up, in patients with periventricular leukomalacia and children cerebral palsy without epilepsy. The high frequency of "benign epileptiform patterns of childhood" (BEPC) was noted. The epileptiform activity recorded by chronologic criteria corresponded to BEPC in 67% of children. The high probability of epileptiform activity of symptomatic character was identified in 33% of children. The results obtained in this study of the parameters of epileptiform activity could be of great importance for predicting the risk for the development of epilepsy and tactics of rehabilitation of motor disorders.
Subject(s)
Brain/physiopathology , Cerebral Palsy/physiopathology , Epilepsy/physiopathology , Leukomalacia, Periventricular/physiopathology , Cerebral Palsy/complications , Child , Child, Preschool , Electroencephalography , Female , Humans , Infant , Infant, Newborn , Leukomalacia, Periventricular/complications , MaleABSTRACT
Ninety children, aged from 7 days to 12 months, with perinatal damage of the central nervous system (CNS) were virologically tested. The persistence of cytomegalovirus (CMV) DNA in the blood, urine and oropharyngeal swabs was identified in 18.9% of children. In 14.4% of children, CMV DNA was found only in oropharyngeal swabs and urine samples. In some cases, the severity of neurologic symptoms and absence of positive changes in the restoration treatment could be caused by the activity of CMV infection, blood CMV DNA and the increase in blood-brain barrier permeability. The authors recommend performance of a comprehensive immunological and molecular-biological survey in patients with suspected CMV infection. In case of positive reactions, a specific antiviral treatment should be started. Tree clinical cases are reported.
Subject(s)
Central Nervous System Viral Diseases/diagnosis , Central Nervous System/virology , Cytomegalovirus Infections/diagnosis , Cytomegalovirus/isolation & purification , Antiviral Agents/therapeutic use , Blood-Brain Barrier/virology , Carrier State/diagnosis , Carrier State/virology , Central Nervous System Viral Diseases/drug therapy , Cytomegalovirus Infections/drug therapy , DNA, Viral/analysis , DNA, Viral/blood , Humans , Infant , Infant, Newborn , MaleABSTRACT
Autoimmune thyroiditis and subclinical hypothyreosis occurred in 20-25% of patients with multiple sclerosis (MS) before the beginning of immunomodulating therapy. No correlation was found between thyroid disease and demographical characteristics (age, sex), type of MS course, rate of disease progression and disability scores on the EDSS. Thyroid disease in patients with MS may be provoked or enhanced by disease-modifying drugs (DMD). Female sex and a history of autoimmune thyroid disease were predict the thyroid gland dysfunction during the therapy with beta-interferons. Clinical thyreotoxicosis is the most dangerous and the therapy should be discontinued. We present the own data on thyroid function in 191 patients managed in the Central administrative okrug of Moscow and in the Moscow Center for Multiple Sclerosis. Thyroid disease was found in 34.6% of patients (the formation of nodes and subclinical hypothyreosis). Changes in the thyroid function were seen in patients treated with beta-interferon and the development of node goiter was found in patients treated with glatimer acetate (copaxon). The dynamics of thyroid gland structure during the treatment with DMD was followed during one year. Beta-interferons provoked the development of hypothyreosis. The study of thyroid gland in MS patients, in particular, those treated with DMD is needed.
Subject(s)
Immunologic Factors/adverse effects , Immunotherapy/adverse effects , Interferon-beta/adverse effects , Multiple Sclerosis/drug therapy , Peptides/adverse effects , Thyroid Diseases/immunology , Adult , Female , Glatiramer Acetate , Humans , Immunologic Factors/therapeutic use , Interferon-beta/therapeutic use , Male , Middle Aged , Peptides/therapeutic use , Thyroid Diseases/pathologyABSTRACT
Motor and coordination disorders are the most prominent clinical presentations of multiple sclerosis. Currently, good results were achieved in the pathogenetic treatment of the disease. However methods of treatment of motor and coordination disorders are not widely used. The positive experience in the treatment of motor disorders using the apparatus Moto-med is presented. The use of this treatment led to positive changes in the state of motor functions, i.e. the decrease of neurologic deficit and improvement of quality of life, of patients.
