Pub Date : 2023-10-23DOI: 10.14412/2074-2711-2023-5-20-34
M. V. Zamergrad, V. A. Parfenov, A. S. Agafina, N. V. Lyamina, M. M. Gavrik, L. R. Kuchumova, E. R. Barantsevich, V. S. Krasnov, A. A. Ivanova, A. L. Vladykin, K. А. Ishchenko
Functional dizziness (FD) is one of the most common causes of chronic dizziness for which there is no effective drug therapy, highlighting the importance of searching for new treatment technologies. Objective: to evaluate the efficacy and safety of Vespireit® (INN buspirone) prolonged-release tablets 15 mg2 (JSC “Valenta Pharm”, Russia) compared with placebo in the treatment of patients with autonomic dysfunction syndrome accompanied by FD. Material and methods . The clinical trial (CT) included a total of 268 patients with autonomic dysfunction syndrome accompanied by FD and a DHI (The Dizziness Handicap Inventory) dizziness scale score of 36 to 52 inclusive, who were randomly divided into 2 groups and treated in a double-blind fashion. 135 patients (Group 1) received Vespireit® prolonged-release tablets 15 mg at a dose of 15 mg (1 tablet) once daily for 28 days. 133 patients (Group 2) received placebo at the same dosage regimen. Treatment was given against a background of vestibular gymnastic exercises. The primary outcome of the clinical trial was assessment of patient response rate (proportion of responders), i.e., a ≥50% reduction in total DHI for dizziness score at Visit 5 (day 28±1) compared with baseline (Visit 1, day 1). Secondary efficacy measures included assessment of: 1) treatment response rates (≥50% reduction in DHI total score compared to Visit 1) at Visits 2, 3, and 4; 2) DHI total score at Visits 2, 3, 4, and 5; 3) changes in DHI total score at Visits 2, 3, 4, and 5 compared to Visit 1; 4) proportion of patients with a 30% or greater reduction in DHI scale dizziness compared with baseline at Visit 2, 3, 4, and 5; 5) time elapsed until total DHI score decreased by ≥50% compared to baseline; 6) time elapsed until total DHI score decreased by ≥30% compared to baseline; 7) changes in Digital Rating Scale (DRS) score from Visit 1 to Visit 2, 3, 4, 5; 8) scores on the DRS at Visits 2, 3, 4, 5; 9) proportion of patients with different response to treatment on the Likert scale at Visits 2, 3, 4, and 5. Additional secondary criteria of efficacy were also assessed: total Hamilton Depression Rating Scale (HDRS) score at Visits 4 and 5; change in total Hamilton scale score at Visits 4 and 5 compared to Visit 1. The safety criterion assessed in the clinical trial was monitoring of adverse events (AEs), clinically significant deviations in vital signs, laboratory parameters, and ECG parameters. Results. The proportion of responders with a ≥50% reduction in DHI total score at Visit 5 (Day 28±1) compared to baseline (Visit 1, Day 1) was 68.7% (n=92) in Group 1, which was 52.9% more than in Group 2 – 15.8% (n=21) (p<0.0001). Evaluation of all secondary (including additional) efficacy criteria also showed a statistically significant benefit of therapy in Group 1 compared to Group 2 (p<0.0001). A total of 61 AEs were recorded in 46 (17.2%) patients: 30 AEs in 21 (15.6%) patients in Group 1 and 31 AEs in 25 (18.8%) patients in Group 2. There was no
{"title":"Efficacy and safety of Vespireit® (buspirone) prolonged-release tablets (PR) 15 mg in the therapy of patients with functional dizziness: results of the double-blind, placebo-controlled, multicenter, randomized, phase 3 clinical trial","authors":"M. V. Zamergrad, V. A. Parfenov, A. S. Agafina, N. V. Lyamina, M. M. Gavrik, L. R. Kuchumova, E. R. Barantsevich, V. S. Krasnov, A. A. Ivanova, A. L. Vladykin, K. А. Ishchenko","doi":"10.14412/2074-2711-2023-5-20-34","DOIUrl":"https://doi.org/10.14412/2074-2711-2023-5-20-34","url":null,"abstract":"Functional dizziness (FD) is one of the most common causes of chronic dizziness for which there is no effective drug therapy, highlighting the importance of searching for new treatment technologies. Objective: to evaluate the efficacy and safety of Vespireit® (INN buspirone) prolonged-release tablets 15 mg2 (JSC “Valenta Pharm”, Russia) compared with placebo in the treatment of patients with autonomic dysfunction syndrome accompanied by FD. Material and methods . The clinical trial (CT) included a total of 268 patients with autonomic dysfunction syndrome accompanied by FD and a DHI (The Dizziness Handicap Inventory) dizziness scale score of 36 to 52 inclusive, who were randomly divided into 2 groups and treated in a double-blind fashion. 135 patients (Group 1) received Vespireit® prolonged-release tablets 15 mg at a dose of 15 mg (1 tablet) once daily for 28 days. 133 patients (Group 2) received placebo at the same dosage regimen. Treatment was given against a background of vestibular gymnastic exercises. The primary outcome of the clinical trial was assessment of patient response rate (proportion of responders), i.e., a ≥50% reduction in total DHI for dizziness score at Visit 5 (day 28±1) compared with baseline (Visit 1, day 1). Secondary efficacy measures included assessment of: 1) treatment response rates (≥50% reduction in DHI total score compared to Visit 1) at Visits 2, 3, and 4; 2) DHI total score at Visits 2, 3, 4, and 5; 3) changes in DHI total score at Visits 2, 3, 4, and 5 compared to Visit 1; 4) proportion of patients with a 30% or greater reduction in DHI scale dizziness compared with baseline at Visit 2, 3, 4, and 5; 5) time elapsed until total DHI score decreased by ≥50% compared to baseline; 6) time elapsed until total DHI score decreased by ≥30% compared to baseline; 7) changes in Digital Rating Scale (DRS) score from Visit 1 to Visit 2, 3, 4, 5; 8) scores on the DRS at Visits 2, 3, 4, 5; 9) proportion of patients with different response to treatment on the Likert scale at Visits 2, 3, 4, and 5. Additional secondary criteria of efficacy were also assessed: total Hamilton Depression Rating Scale (HDRS) score at Visits 4 and 5; change in total Hamilton scale score at Visits 4 and 5 compared to Visit 1. The safety criterion assessed in the clinical trial was monitoring of adverse events (AEs), clinically significant deviations in vital signs, laboratory parameters, and ECG parameters. Results. The proportion of responders with a ≥50% reduction in DHI total score at Visit 5 (Day 28±1) compared to baseline (Visit 1, Day 1) was 68.7% (n=92) in Group 1, which was 52.9% more than in Group 2 – 15.8% (n=21) (p<0.0001). Evaluation of all secondary (including additional) efficacy criteria also showed a statistically significant benefit of therapy in Group 1 compared to Group 2 (p<0.0001). A total of 61 AEs were recorded in 46 (17.2%) patients: 30 AEs in 21 (15.6%) patients in Group 1 and 31 AEs in 25 (18.8%) patients in Group 2. There was no","PeriodicalId":37732,"journal":{"name":"Nevrologiya, Neiropsikhiatriya, Psikhosomatika","volume":"43 2","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135414144","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-10-23DOI: 10.14412/2074-2711-2023-5-65-71
A. S. Kamaeva, E. A. Kiryanova, G. R. Tabeeva
Visual snow syndrome (VSS) is a visual perception disorder characterized by persistent positive visual symptoms described by patients as “tiny dots, pixel vision, interference as on TV”. To date, the prevalence of VSS may be as high as 2.2–3.7% of the population, which significantly increases the interest not only of physicians but also of medical researchers. In addition, patients may have other visual symptoms as well as tinnitus, migraine, dizziness, tremor, fibromyalgia, paresthesias, depersonalization, derealization, anxiety, and depression. VSS may affect quality of life, educational, professional and social activities. The article discusses the criteria for diagnosis, pathogenesis, differential diagnosis, clinical cases, and approaches to the treatment of VSS.
{"title":"The phenomenon of “visual snow”: clinical and pathophysiological correlations, differential diagnosis and treatment (literature review)","authors":"A. S. Kamaeva, E. A. Kiryanova, G. R. Tabeeva","doi":"10.14412/2074-2711-2023-5-65-71","DOIUrl":"https://doi.org/10.14412/2074-2711-2023-5-65-71","url":null,"abstract":"Visual snow syndrome (VSS) is a visual perception disorder characterized by persistent positive visual symptoms described by patients as “tiny dots, pixel vision, interference as on TV”. To date, the prevalence of VSS may be as high as 2.2–3.7% of the population, which significantly increases the interest not only of physicians but also of medical researchers. In addition, patients may have other visual symptoms as well as tinnitus, migraine, dizziness, tremor, fibromyalgia, paresthesias, depersonalization, derealization, anxiety, and depression. VSS may affect quality of life, educational, professional and social activities. The article discusses the criteria for diagnosis, pathogenesis, differential diagnosis, clinical cases, and approaches to the treatment of VSS.","PeriodicalId":37732,"journal":{"name":"Nevrologiya, Neiropsikhiatriya, Psikhosomatika","volume":"48 11","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135413980","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-10-23DOI: 10.14412/2074-2711-2023-5-13-19
A. A. Kulesh, D. A. Demin, O. I. Vinogradov
Stroke in the arteries of the vertebrobasilar system is characterized by a variety of nonspecific symptoms, many mimickers, and often atypical clinical presentation, which, together with the low sensitivity of CT and MRI of the brain, leads to incorrect and untimely diagnosis. This article addresses in detail the issues of differential diagnosis of this disease with Guillain–Barre syndrome, myasthenic crisis, central pontine myelinolysis, multiple sclerosis, Wernicke encephalopathy, vestibular neuronitis, Meniere's disease, and vestibular migraine.
{"title":"Differential diagnosis of ischemic stroke in the arteries of the vertebrobasilar system","authors":"A. A. Kulesh, D. A. Demin, O. I. Vinogradov","doi":"10.14412/2074-2711-2023-5-13-19","DOIUrl":"https://doi.org/10.14412/2074-2711-2023-5-13-19","url":null,"abstract":"Stroke in the arteries of the vertebrobasilar system is characterized by a variety of nonspecific symptoms, many mimickers, and often atypical clinical presentation, which, together with the low sensitivity of CT and MRI of the brain, leads to incorrect and untimely diagnosis. This article addresses in detail the issues of differential diagnosis of this disease with Guillain–Barre syndrome, myasthenic crisis, central pontine myelinolysis, multiple sclerosis, Wernicke encephalopathy, vestibular neuronitis, Meniere's disease, and vestibular migraine.","PeriodicalId":37732,"journal":{"name":"Nevrologiya, Neiropsikhiatriya, Psikhosomatika","volume":"43 3","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135414142","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-10-23DOI: 10.14412/2074-2711-2023-5-79-86
G. M. Usov
Since the appearance of the first antidepressants, ideas about the goals of long-term treatment of depression have changed considerably. The prevailing priority in the 1960s to 1980s of relieving current depressive symptoms and ending the current episode – shifted to achieving remission in the early 1990s and functional recovery in the mid-2010s. The general recognition of a new approach to the treatment of depression is reflected in the inclusion of functional disorder in the ICD-11 diagnostic criteria for a depressive episode. The paradigm shift in therapy has been driven by advances in the field of psychopharmacology that have led to the development of antidepressants with a fundamentally new mechanism of action that provides a broader therapeutic effect combined with a more favorable tolerability profile. Agomelatine provides a harmonious and complete reduction of depression symptoms, including those resistant to other antidepressants, and a stable clinical and functional remission of high quality, i.e., it allows the achievement of all three therapeutic goals.
{"title":"Diagnosis and treatment of depression according to the functional recovery paradigm","authors":"G. M. Usov","doi":"10.14412/2074-2711-2023-5-79-86","DOIUrl":"https://doi.org/10.14412/2074-2711-2023-5-79-86","url":null,"abstract":"Since the appearance of the first antidepressants, ideas about the goals of long-term treatment of depression have changed considerably. The prevailing priority in the 1960s to 1980s of relieving current depressive symptoms and ending the current episode – shifted to achieving remission in the early 1990s and functional recovery in the mid-2010s. The general recognition of a new approach to the treatment of depression is reflected in the inclusion of functional disorder in the ICD-11 diagnostic criteria for a depressive episode. The paradigm shift in therapy has been driven by advances in the field of psychopharmacology that have led to the development of antidepressants with a fundamentally new mechanism of action that provides a broader therapeutic effect combined with a more favorable tolerability profile. Agomelatine provides a harmonious and complete reduction of depression symptoms, including those resistant to other antidepressants, and a stable clinical and functional remission of high quality, i.e., it allows the achievement of all three therapeutic goals.","PeriodicalId":37732,"journal":{"name":"Nevrologiya, Neiropsikhiatriya, Psikhosomatika","volume":"51 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135414267","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-10-23DOI: 10.14412/2074-2711-2023-5-39-45
E. V. Isakova, E. A. Stepanova, S. V. Kotov, Yu. A. Belova
The article presents a review of the literature and a description of a clinical case of osmotic demyelination syndrome manifested by pontine and extrapontine myelinolysis in a 36-year-old woman after her third surgical preterm delivery. The reasons for the development of a demyelinating lesion of the central nervous system are discussed, and clinical cases described in world literature sources are presented. An analysis of the pathogenesis of the development of this disease in women during pregnancy, childbirth, and lactation is provided. The importance of this period in a woman's life as an independent significant risk factor for the development of osmotic demyelination syndrome is discussed.
{"title":"Osmotic demyelination syndrome: central pontine and extrapontine myelinolysis in a patient in the early postpartum period. Clinical observation","authors":"E. V. Isakova, E. A. Stepanova, S. V. Kotov, Yu. A. Belova","doi":"10.14412/2074-2711-2023-5-39-45","DOIUrl":"https://doi.org/10.14412/2074-2711-2023-5-39-45","url":null,"abstract":"The article presents a review of the literature and a description of a clinical case of osmotic demyelination syndrome manifested by pontine and extrapontine myelinolysis in a 36-year-old woman after her third surgical preterm delivery. The reasons for the development of a demyelinating lesion of the central nervous system are discussed, and clinical cases described in world literature sources are presented. An analysis of the pathogenesis of the development of this disease in women during pregnancy, childbirth, and lactation is provided. The importance of this period in a woman's life as an independent significant risk factor for the development of osmotic demyelination syndrome is discussed.","PeriodicalId":37732,"journal":{"name":"Nevrologiya, Neiropsikhiatriya, Psikhosomatika","volume":"49 11","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135414270","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-10-23DOI: 10.14412/2074-27112023-5-4-12
V. A. Parfenov, N. N. Yakhno, M. L. Kukushkin, O. S. Davydov, M. V. Churyukanov, V. A. Golovacheva, G. Yu. Evzikov, A. I. Isaikin, M. A. Bakhtadze, L. A. Medvedeva, P. P. Kalinsky, V. A. Shirokov
Neck pain (NP) is one of the most common complaints of patients in outpatient practice and is predominantly non-specific (musculoskeletal) in nature. When examining a patient with NP, it is necessary to rule out a specific cause of the condition. The diagnosis of nonspecific NP (NNP) is based on a clinical examination that excludes signs of specific NP (“red flags”). If there are no signs of specific NP (“red flags”), early (in the first 4 weeks) magnetic resonance imaging is not indicated. It is recommended to inform the patient with NNP about the favorable prognosis of the disease, its risk factors, avoidance of prolonged excessive static and physical activity, incorrect (non-physiological) positions and postures, the effectiveness of therapeutic exercises (kinesiotherapy) and the advisability of maintaining physical activity. Non-steroidal anti-inflammatory drugs and muscle relaxants can be used to relieve NNP. For subacute and chronic NNP, kinesiotherapy, manual therapy in combination with psychological therapy methods (for depressive and anxiety disorders, pain catastrophizing, pain behavior), and antidepressants are recommended. Radiofrequency denervation may be effective for chronic NNP associated with cervical facet joint pathology. There are no convincing data on the efficacy of electrotherapy, ultrasound, traction, and wearing a cervical collar in the absence of orthopedic indications. For preventive treatment of NNP, kinesiotherapy and an educational program to avoid excessive static and physical activity, incorrect positions and postures are recommended. The issues of duration and frequency of therapeutic exercises for the treatment and prevention of NNP need further investigation.
{"title":"Non-specific neck pain (cervicalgia). Guidelines of the Russian Society for the Study of Pain (RSSP)","authors":"V. A. Parfenov, N. N. Yakhno, M. L. Kukushkin, O. S. Davydov, M. V. Churyukanov, V. A. Golovacheva, G. Yu. Evzikov, A. I. Isaikin, M. A. Bakhtadze, L. A. Medvedeva, P. P. Kalinsky, V. A. Shirokov","doi":"10.14412/2074-27112023-5-4-12","DOIUrl":"https://doi.org/10.14412/2074-27112023-5-4-12","url":null,"abstract":"Neck pain (NP) is one of the most common complaints of patients in outpatient practice and is predominantly non-specific (musculoskeletal) in nature. When examining a patient with NP, it is necessary to rule out a specific cause of the condition. The diagnosis of nonspecific NP (NNP) is based on a clinical examination that excludes signs of specific NP (“red flags”). If there are no signs of specific NP (“red flags”), early (in the first 4 weeks) magnetic resonance imaging is not indicated. It is recommended to inform the patient with NNP about the favorable prognosis of the disease, its risk factors, avoidance of prolonged excessive static and physical activity, incorrect (non-physiological) positions and postures, the effectiveness of therapeutic exercises (kinesiotherapy) and the advisability of maintaining physical activity. Non-steroidal anti-inflammatory drugs and muscle relaxants can be used to relieve NNP. For subacute and chronic NNP, kinesiotherapy, manual therapy in combination with psychological therapy methods (for depressive and anxiety disorders, pain catastrophizing, pain behavior), and antidepressants are recommended. Radiofrequency denervation may be effective for chronic NNP associated with cervical facet joint pathology. There are no convincing data on the efficacy of electrotherapy, ultrasound, traction, and wearing a cervical collar in the absence of orthopedic indications. For preventive treatment of NNP, kinesiotherapy and an educational program to avoid excessive static and physical activity, incorrect positions and postures are recommended. The issues of duration and frequency of therapeutic exercises for the treatment and prevention of NNP need further investigation.","PeriodicalId":37732,"journal":{"name":"Nevrologiya, Neiropsikhiatriya, Psikhosomatika","volume":"44 6","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135414383","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-08-18DOI: 10.14412/2074-2711-2023-2s-1-10
V. A. Parfenov, L. M. Antonenko, E. V. Silina
Data on benign paroxysmal positional vertigo (BPPV) are presented: prevalence, etiology and pathogenesis, clinical manifestations, diagnosis and treatment. Clinical observations demonstrating successful recognition and treatment of BPPV are presented.
{"title":"Benign paroxysmal positional vertigo","authors":"V. A. Parfenov, L. M. Antonenko, E. V. Silina","doi":"10.14412/2074-2711-2023-2s-1-10","DOIUrl":"https://doi.org/10.14412/2074-2711-2023-2s-1-10","url":null,"abstract":"Data on benign paroxysmal positional vertigo (BPPV) are presented: prevalence, etiology and pathogenesis, clinical manifestations, diagnosis and treatment. Clinical observations demonstrating successful recognition and treatment of BPPV are presented.","PeriodicalId":37732,"journal":{"name":"Nevrologiya, Neiropsikhiatriya, Psikhosomatika","volume":"6 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136020033","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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