On December 18, 2024, a meeting of the Expert Council was held to discuss approaches to the treatment of non-specific back pain and pain in rheumatic musculoskeletal disorders. It was noted that non-steroidal anti-inflammatory drugs (NSAIDs) remain the mainstay of therapy for inflammation-related pain and that optimal therapy should provide a balance between high efficacy and good tolerability in each patient. A new NSAID, pelubiprofen (Pelubio®), has been registered in the Russian Federation. According to research data, its efficacy is comparable to that of non-selective and selective NSAIDs and at the same time the drug has a high safety profile. The resolution of the Expert Council states that this medicine can be prescribed within the framework of Russian clinical practice, considering the registered indications for pelubiprofen and the clinical guidelines adopted in Russia for the treatment of acute and chronic non-specific back pain, radiculopathy, osteoarthritis (including gonarthrosis and coxarthrosis) and rheumatoid arthritis.
Aim. To identify significant indicators of cognitive dysfunction based on discriminant analysis and to assess the influence of the course, nature and localization of ischemic stroke on the cognitive status of the patient.Materials and methods. We examined 290 patients diagnosed with ischemic stroke in the carotid artery area. Depending on presence of cognitive dysfunction according to the Montreal Cognitive Assessment Scale (MoSA) patients were divided into 2 groups: 240 patients with cognitive decline (≤25 point by MoCA) and 50 patients without it. In order to verify the markers, anamnestic characteristics were assessed, cognitive-functional indicators (according to the scales of the National Institutes of Health, MoCA, Bartel, Rankin, IQCODE questionnaire, additional scales to assess praxis, semantic aphasia, perception and executive function), data of neuroimaging studies. For statistical analysis machine learning algorithms and Python with its libraries (Pandas and SciPy) were implied.Results. The main neuropsychological indicators for patients with early post-stroke cognitive impairment were decline in the areas of perception, executive function, memory and semantic information processing, affective disturbances and physical fatigue. Relevant indicators identified during estimation of the instrumental and clinical examination results were severity of IS, left frontal and right parietal localisations of ischemia focus, presence of cortical atrophy and leukoaraiosis.Conclusion. Based on multi-factor analysis of clinical and paraclinical parameters using machine learning algorithms, the main markers of cognitive decline of early post-stroke impairments were identified. This will allow us to optimise the choice of neurocognitive rehabilitation strategies and to personalise the approach in the further management of the stroke patient.
OBJECTIVE:To evaluate the concentrations of CC-chemokines and stable metabolites of nitric oxide (NO) and endothelin-1 (ET-1) in patients with atherothrombotic (AT) and cardioembolic (CE) subtypes of ischemic stroke (IS) in the acute period. MATERIAL AND METHODS:Sixty patients diagnosed with IS in the carotid basin were examined. Group 1 included 30 patients with AT, group 2 - 30 patients with CE subtype of IS. The control group consisted of 20 age-matched patients without a history of stroke. All patients were assessed on admission for functional status using the Barthel Index (BI), the Modified Rankin Scale (mRS) and the National Institutes of Health Stroke Scale (NIHSS). Neuroimaging parameters were assessed using CT/MRI data. Laboratory diagnostics included assessment of serum concentrations of interleukin (IL)-1β, IL-6, IL-16, interferon gamma (IFN-γ), CC-chemokines (CCL2, CCL-7, CCL8, CCL13, CCL15, CCL23) and stable metabolites of NO and ET-1. RESULTS:All patients with IS had moderate stroke severity scores according to NIHSS, BI and mRS. Analysis of the indices of the main clinical scales revealed. higher NIHSS scores, the prevalence of body mass index (BMI), the size of IS foci and the presence of multifocal lesions in patients of group 2. Compared with the control group, a significant increase of IFN- γ and IL-16 was noted in patients of both groups; ET-1, CCL2 and CCL15 were elevated in group 1; IL-1β, IL-6, CCL8 and CCL23 - in group 2. A comparative analysis between groups revealed higher concentrations of ET-1, CCL2 and CCL15 in group 1 and the increase of IL-1β, IL-6, IL-16 and CCL13 in group 2. CONCLUSION:The results allow considering cytokines CCL23, IL-6, IL-16, IL-1β and IFN-γ as indicators of IS severity; CCL2, CCL15 and ET-1 as important regulators of atherogenesis and indicators of the AT subtype of IS; IL-1β, IL-6 and CCL13 as markers of complications of atrial fibrillation. The findings indicate the necessity of multicentre studies with a large sample size to determine the potential value of CCR1/CCR2 chemokines and stable metabolites as biomarkers of course of different IS subtypes.
OBJECTIVE:To study the efficacy and safety of the use of high (200 mg) doses of uridine monophosphate in combination with choline (dietary supplement, dietary supplement, Neururidine N) in the treatment of patients with nonspecific back pain. MATERIAL AND METHODS:An open observational study was conducted, which included 101 patients with acute PB; group 1 included 65 patients who received Neurouridine N (1 caps/day) meloxicam (7.5-15 mg/day) and meloxicam (7.5-15 mg/day), 2nd - 36 patients who received only meloxicam (7.5-15 mg/day). The observation period is 30 days. The condition of the patients was assessed on the basis of a visual analog scale (VAS), Roland-Morris questionnaires (ORM) and general clinical impression (CGI). RESULTS:The positive effect of treatment on reducing the severity of pain was noted according to the results of the VAS assessment. In patients of group 1, an earlier improvement in functional status was noted (starting from day 7) according to ORM data (p<0.01), A more pronounced decrease in pain intensity allowed patients of group 1 to stop taking NSAIDs after 14 days (p<0.01). Patients of the 1st group were statistically significantly more satisfied with the results of treatment (CGI questionnaire), the doctors who observed them also regarded the improvement in their condition as more significant compared to the 2nd group. CONCLUSION:The use of dietary supplement Neururidine N is an effective and safe method of coanalgesic therapy in patients with acute LBP.
Introduction. Acute dorsalgia is a common reason to seek outpatient medical care in Russia. The clinical picture usually includes muscular-tonic and pain syndromes. The most common form of dorsalgia by localization is acute lumbar pain (lumbodynia).Aim. To evaluate the effectiveness of Spascuprel®, Traumeel S in the complex treatment of patients with acute lumbar pain in real-world clinical practice.Materials and methods. We conducted a non-interventional, prospective, observational study of 110 outpatients aged 26 to 65 years. Patients received a standard on-demand therapy with nonsteroidal anti-inflammatory drugs (NSAIDs). In addition, Group 1 received Spascuprel® and Traumeel® C, and Group 2 received centrally acting muscle relaxants. The effectiveness of treatment was assessed using the visual analogue scale (VAS) of pain intensity and the limitations of various activities in daily living were measured using the Roland – Morris questionnaire. Consideration was given to the exacerbation duration, the need for additional intake of NSAIDs, and the number of cases of pain exacerbation within 60 days from the start of participation in the observational study.Results. Under treatment, pain intensity showed statistically significant decreases in VAS scores (from 61.0 to 35.5 scores out of 100 according to VAS by Day 7 and to 19.5 scores by Day 14 of treatment in Group 1, from 61.2 to 41.1 and to 25.8 scores in Group 2, respectively (p < 0.05)). A more rapid decrease was observed in VAS pain intensity score from baseline in Group 1. Over 2-month observation period, group 1 had less exacerbations (p < 0.05) and fewer cases of need for additional intake of NSAIDs (p < 0.05). The frequency and severity of adverse events did not differ between two groups.Conclusion. A more rapid decrease in VAS pain intensity scores and reduction in the need for NSAIDs were noted in the group of patients with acute dorsalgia who used Traumeel® C and Spascuprel® in addition to standard NSAID therapy.
The use of slow-acting disease-modifying symptomatic drugs, such as bioactive concentrate from small marine fish (BCSMF, Alflutop), is considered a potential element of complex therapy for chronic non-specific back pain (CNBP). Objective : to evaluate the efficacy of the BCSMF in patients with CNBP in real-life clinical practice. Material and methods . An open observational study included 10,047 patients with CNBP (age – 58.3±14.9 years, 58.4% women) with moderate or severe pain – 60 [50; 70] mm on the visual analogue scale (VAS). All patients received a course of BCSMF medication: 1 ml intramuscular (IM) daily No. 20 or 2 ml IM every other day No. 10. 68.8 % of patients also took non-steroidal anti-inflammatory drugs. Treatment outcomes were assessed 10 days after completion of BCSMF therapy (30 days after initiation of treatment). Results and discussion . As a treatment result, the pain intensity according to the VAS decreased from 60 [50; 70] to 20 [10; 30] mm (p<0.0001), the patients’ overall health assessment according to the VAS increased from 50 [30; 60] to 80 [60; 90] mm (p><0.0001) and the quality of life assessment (EQ-5D) – from 0.52 [0.06; 0.66] to 0.8 [0.71; 1] points (p>< 0.0001). A good response to treatment (pain reduction >50%) was observed in 73% of patients. On average, an improvement was observed on the 8th [5; 10] day of BCSMF therapy. There were no serious adverse effects associated with the use of the drug. Older age, overweight, initially more severe pain, and the presence of comorbid conditions were slightly more frequently associated with a less pronounced response to therapy. Conclusion . The use of BCSMF rapidly and effectively reduces the severity of pain and other symptoms associated with CNBP.
OBJECTIVE:To assess phenotype and identify biomarkers of cognitive impairment (CI) of varying severity in patients in the acute period of ischemic stroke (IS) based on the analysis of clinical and paraclinical indicators. MATERIAL AND METHODS:Two hundred and forty patients with diagnosed IS and presence of CI were examined. Depending on the scores on the Montreal Cognitive Assessment Scale, patients were divided into two groups: group 1 (n=182) with mild CI, group 2 (n=58) with dementia. On admission, stroke severity according to the National Institutes of Health Stroke Scale (NIHSS), activities of daily living assessed by the Barthel Scale and patient independence assessed by the modified Rankin Scale (mRS) were determined. Neuropsychological examination was performed on day 14 and included investigation of episodic memory, executive functions, speech, gnosis, praxis, and the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) parameters. Immunological diagnostics included a study of the concentration of cytokines of various groups (interleukin (IL)-1b, IL-6, IL-16, granulocyte-macrophage colony-stimulating factor (GM-CSF), chemokines CXCL10, CXCL11, CXCL9, tumor necrosis factor α (TNFα)). Neuroimaging parameters were assessed using brain MRI data with verification of the STRIVE criteria and the medial temporal lobe atrophy scale (MTA). The standard application software package SPSS Statistics, Pandas and SciPy libraries were used for statistical analysis. RESULTS:Patients of group 2 had lower scores in all cognitive domains with the greatest reduction in perception, constructive praxis, semantic information processing and mnestic function. These analyses revealed a higher degree of IQCODE, prevalence of features corresponding to STRIVE/MTA criteria in patients of group 2, while patients of group 1 had higher NIHSS and mRS scores. When serum concentrations of cytokines were assessed, patients of group 1 showed higher concentrations of IL-1b, IL-6, GM-CSF and TNFα, while group 2 patients had higher concentrations of cytokine CXCL10. CONCLUSION:The presence of pre-stroke CI, baseline indicators of the patient's functional status, neuroimaging parameters of MTA/STRIVE and age are reflected in the structure and severity of cognitive deficit in the acute period of IS. Investigation of the role of interleukins, GM-CSF, TNFα and CXCL10 in the pathogenesis of IS and their association with the progression of post-stroke CI requires further studies with a larger sample size and longer follow-up period.
In recent decades, there has been an increase in the prevalence and medical and social burden of osteoarthritis (OA) and nonspecific back pain in all countries of the world. The First Multidisciplinary Bilateral Russia-Uzbekistan Expert Council presented innovations in the prognosing, personalized prevention and adjuvant therapy of degenerative-dystrophic diseases of the joints and spine, the evidence base for the effectiveness and safety of the use of drugs that modify the course of OA (Disease-modifying osteoarthritis drugs, DMOADs): chondroitin sulfate, glucosamine sulfate, undenatured type II collagen for adjuvant pharmaconutraceutical support – prevention and adjuvant therapy (treatment) of OA and nonspecific lumbosacral pain. The expert counsil resolution presents an optimized algorithm for the management, prevention and adjuvant therapy of OA and non-specific back pain, maintaining the function of healthy joints after intense physical activity with the inclusion of the drug Chondroguard solution for intra-articular and intramuscular administration (INN – chondroitin sulfate) and a new pharmaconutraceutical from the DMOADs group – TRIO trademark Chondroguard® (Chondroguard®TRIO).
Bioregulatory drug Newrexan in the treatment of anxiety and dissomnia. Resolution of the Council of Experts.
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 significant difference between treatment groups in the number of patients with AEs (p=0.5196). In both groups, there were no patients with AEs with severity ≥3, serious AEs (SAEs), SAEs with fatal outcome, or SAEs that led to discontinuation of study therapy. No clinically significant abnormalities were noted during assessment of vital signs, laboratory parameters, or ECG parameters Conclusion. The superiority of Vespireit® prolonged-release tablets (PR) 15 mg therapy over placebo in reducing FD in patients with autonomic dysfunction syndrome was confirmed. The drug demonstrated a favorable safety profile comparable to placebo.
Результаты консенсуса специалистов. Роль фиксированной комбинации напроксена и дифенгидрамина — препарата НОВЕМА НАЙТ в терапии пациентов с болевым синдромом, сопровождающимся нарушениями сна.
Peripheral nervous system involvement in patients with type 2 diabetes mellitus is a severe complication associated with a decrease in the quality of life, the development of disability and lethal outcomes. The most negative in terms of prognosis is autonomic diabetic polyneuropathy (DPN).Objective: to study the effectiveness of the drug ipidacrine (Ipigrix) in patients with DPN.Patients and methods. 49 patients with DPN were observed, they were divided into three groups. Patients of the 1st group (n=16) received ipidacrine 20 mg orally 3 times a day for 60 days, patients of the 2nd group (n=17) received ipidacrine 15 mg 1 time per day intramuscularly for 15 days, then – 20 mg 3 times a day orally up to 2 months; patients of the 3rd group (n=16) received only basic therapy. The clinical condition, severity of pain syndrome according to the Neurological Symptoms Score (NSS), vegetative tests, and treatment tolerance were assessed.Results and discussion. The therapy was effective in terms of reducing the severity of neuropathic pain syndrome, as well as normalizing the results of vegetative tests. In patients of the 1st group, the total scores on the NSS scale decreased by 37% (p<0.05) by the 60th day of treatment. In patients of the 2nd group, the total scores on the NSS scale decreased by 22% by the 30th day (p<0.05) and by 35% (p<0.05) by the 60th day of treatment. A pronounced positive effect in terms of vegetative tests was noted on the 60th day of treatment in the 1st and 2nd groups of patients. No adverse events were observed during the treatment period in any of patients of the 1st and the 2nd groups. In the comparison group, there were no significant changes in scores on the NSS scale and indicators of vegetative samples.Conclusion. The effectiveness of the drug ipidacrine (Ipigrix) in patients with pain and vegetative manifestations of DPN was noted.
OBJECTIVE To analyze the effect of Alflutop on neuroinflammation in patients with chronic lower back pain (CBP). MATERIAL AND METHODS Forty-one patients with a verified CBP diagnosis were enrolled in the study. Alflutop was used for treating CBP, 1 ml once/day, for 20 days. Treatment efficacy was monitored using the Visual Analogue Scale (VAS), DN4 test; the Roland-Morris questionnaire; the index of pain activity in the lumbar spine; and the level of tumor necrosis factor-α (TNF-α) in blood plasma. There were three visits in total: screening (visit 0), treatment start (visit 1, 0-3 days after screening) and visit 2 (3 months later (±7 days) from the start of treatment). RESULTS Before the start of therapy, in some patients (group 1, n=14 (34.1%) the TNF-α concentration in the blood plasma was below the detectable level (less than 4.0 pg/ml), while in group 2 (n=27 (659%)), the expression of TNF-α in peripheral blood was observed at the level of 6.3 [4.9; 7.4] pg/ml. Patients in group 2 significantly (p<0.05) differed from patients in group 1 by the greater number of CBP exacerbations over the last year as well as by the results of testing on DN4 (higher values) and SBI (greater discomfort). In group 2, a significant relationship was found between the TNF-α level in blood plasma and the number of exacerbations as well as between the TNF-α level and the number of DN4 points. At visit 2, patients in group 2 had a significant (p<0.05) decrease in pain intensity according to VAS, an improvement in the quality of life according to the Roland-Morris questionnaire, a decrease in the severity of the neuropathic component of pain according to DN4 test as well as subjective condition improvement associated with the activity of pain in the lumbar spine. A significant relationship was found between the level of TNF-α and the number of DN4 points after treatment and the period of active observation. CONCLUSIONS In the majority of CBP patients, the high relapse rate and neuropathic nature of pain may be associated with persistent neuroinflammation due to TNF-α synthesis. Alflutop inhibits the TNF-α expression substantially, which significantly correlates with a decrease in the neuropathic pain syndrome component according to the DN4 questionnaire. The use of Alflutop can be considered as an effective method of treating patients with CBP, which has an impact on the process of neuroinflammation as one of the leading causes of changes in the pain nature and its chronicity.
OBJECTIVEThe purpose of the study. Comparison of efficacy and safety of treatment with Texared/Neurobion and Amelotex/Milgama in patients with acute dorsalgia.MATERIAL AND METHODSAn open, observational, retrospective - prospective study involved 70 patients with acute lumbar dorsalgia. Two groups of 35 patients were formed, who were prescribed step therapy with Texared and Neurobion (group 1) and Amelotex and Milgamma (group 2). The groups of patients are comparable by gender (in group 1 - 25 (71%) women, in group 2 - 24 (69%), the average age is 50.1±10.5 and 52.8±12.0 years, respectively. The groups are comparable in the nature and severity of clinical symptoms, but not homogeneous in the nature of concomitant diseases.RESULTS AND CONCLUSIONIn two groups, there was a comparable improvement in the condition after treatment according to the Oswestry and Roland-Morris questionnaires, an increase in the quality of sleep by the 10th day of observation. In the 1st group, the decrease in pain syndrome by VAS is more pronounced: by the 3rd visit, the decrease is 7.5 points more than in the 2nd group (p<0.05). In group 1, by the 2nd visit, the median pain intensity for VAS decreased by 10 points (p<0.05), by the 3rd - by 30 points (p<0.05). In group 1, the improvement in general well-being according to the assessment of the patient and the doctor was more pronounced (p<0.05). Evaluation of the effectiveness of both types of therapy demonstrated comparable results, both in the opinion of the doctor and in the opinion of the patient. The results of treatment in both groups are comparable in terms of satisfaction with treatment and ease of use according to the patient's assessment. In group 1, there was less pain of intramuscular administration of the drug. 32 (91%) patients of group 1 positively assessed the convenience of using the proposed treatment regimen. No significant adverse events were detected in the two groups.
In our country, alpha-lipoic acid is widely used as a pathogenetic therapy for diabetic polyneuropathy (DPN).Objective: to compare the efficiency and safety of using oral and injectable α-lipoic acid for DPN.Patients and methods. The investigation enrolled 47 patients with a verified diagnosis of DPN, who were divided into two groups. Group 1 included 23 patients (10 men and 13 women; mean age, 62.9±7.5 years), Group 2 consisted of 24 patients (9 men and 15 women, mean age, 65.5±7.9 years). All the patients used Berlithione: Group 1 received its intravenous doses of 600 mg for 14 days, then oral ones of 600 mg for other 16 days; Group 2 took oral doses of 600 mg for 30 days. The therapy results were assessed using the digital rating scale (DRS), the Douleur Neuropathique 4 (DN4) neuropathic pain rating scale, and the neurological soft signs (NSS), and electroneuromyography (ENMG) data.Results and discussion. Berlithione was found to have a good tolerability. No adverse reactions were detected in any case; and there was no need to discontinue this drug. On day 21 of therapy, there were statistically significant differences in the indicators of pain intensity on DRS in Group 1 patients (p<0.05), some of them (n=8) had positive clinical changes as a reduction in the severity of hypesthesia. Both groups showed a tendency to improve ENMG parameters as a certain increase in excitation propagation velocity and M-response amplitude; however, these changes did not reach a statistical significance level. At the same time, in 6 out of the 8 patients in Group 1 with positive clinical changes, the described ENMG changes correlated with a reduction in the severity of hypesthesia. There were no significant changes on the NSS scale after 3 weeks of therapy. On day 30 of treatment, both groups were recorded to have statistically significant changes in pain intensity measures versus the baseline values, but no significant inter-group differences.Conclusion. Thus, Berlithione demonstrated its efficacy in both patient groups, but its positive effect occurred 1 week earlier in the step therapy group. It is noted that it is expedient to use this drug long (>1 month) for DPN.
We studied the effect of chloral hydrate on the reaction of microglia and neurons of the hippocampal CA1 field in old Wistar rats. According to the results of morphological and immunohistochemical analysis, chloral hydrate at a dose of 400 mg/kg does not lead to a decrease in the population of neurons in the stratum pyramidale in the hippocampal CA1 field in rats aged 24 months after 48 h. The reaction of microglia is registered as an increase in immunoreactivity to Iba1 and morphological transformations of microgliocytes without a considerable change in their number in the stratum oriens, stratum pyramidale, and stratum radiatum of the hippocampal CA1 as compared to non-anesthetized animals. Microglia activation following anesthesia with chloral hydrate may underlie the earlier shown cognitive impairment in aged rats.
The article is devoted to the principles and features of the multidisciplinary team’s activity which are providing the adequate maintaining in stroke patients. The principles of carrying out, advantages and risks of early rehabilitation and early verticalization are considered. The main principles of physical rehabilitation are analyzed also.