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1.
Vestn Otorinolaringol ; 84(3): 82-88, 2019.
Article in Russian | MEDLINE | ID: mdl-31486434

ABSTRACT

Medical scientific sources about randomized clinical trials of Cycloferon were studied as a single plot of 531 articles. AIM was to get the generalized cycloferon efficacy's assessment in comparison with basic therapies curing the otorhinolaryngologic diseases. Groups heterogeneity and responding parameters' variability were estimated also. Comparison groups were symmetric enough to annihilate end-point variabilities, so the results' interpretations were clear enough and vector of clinical effects was detectable. Comparison groups were integrated to increase statistical power of metaanalysis. In result, cycloferon additional administration in treatment of otorhinolaryngologic diseases added 25% to absolute and relative usefulness of medical intervention. Also cycloferon increased 3,5 times the chances of recovery and absence of recurrent exacerbation.


Subject(s)
Acridines/therapeutic use , Interferon Inducers/therapeutic use , Respiratory Tract Infections/drug therapy , Humans , Nose Diseases
2.
Ter Arkh ; 89(11): 84-92, 2017.
Article in Russian | MEDLINE | ID: mdl-29260751

ABSTRACT

The authors carried out a systematic review and subsequent meta-analysis of randomized clinical trials evaluating the efficacy of the immunomodulator agent cycloferon as tablets in adults and children with viral respiratory diseases. A total estimate of its clinical efficacy was obtained in terms of compared heterogeneous groups and response variables. The data published in 16 articles were used to calculate the formal parameters of the clinical efficacy of cycloferon (increased absolute and relative benefits, odds ratio (OR); the number of patients needed to be additionally treated with cycloferon to achieve a favorable outcome or to prevent a poor outcome in one patient, etc.). High heterogeneity hampered the unequivocal interpretation of results; however, combining the compared homogeneous groups in the meta-analysis (with adjustments for fixed and random effects) increased the statistical power of the investigation. In children aged 6 to 18 years, the OR for the positive effect of the drug (no new cases after its preventive administration) was 5.3 (95% confidence interval (CI), 4.8-5.9), heterogeneity test, χ2 = 249.5; p=0.000...; I2 = 94.8% (95% CI, 92.7-96.3%). This suggested the heterogeneity of clinical trial data and extrapolated this estimate to medical practice. The use of cycloferon in adults to treat acute respiratory viral infection enhanced their chances of enduring the disease in a mild form and avoiding serious complications: the OR for positive outcomes was 9.7 (95% CI, 7.0-13.0), while the effect was more homogeneous than in children (heterogeneity test, χ2 = 7.4; p=0.061...; I2 = 59.4% (95% CI, 0-86.5). Thus, the use of cycloferon to treat and prevent acute viral respiratory infections showed a more than 5-fold increase in the probability of avoiding the disease or enduring the latter in a mild form.


Subject(s)
Acridines/pharmacology , Immunomodulation , Interferon Inducers/pharmacology , Respiratory Tract Infections/drug therapy , Virus Diseases/drug therapy , Acridines/administration & dosage , Humans , Interferon Inducers/administration & dosage
3.
Article in Russian | MEDLINE | ID: mdl-28399094

ABSTRACT

AIM: To carry out an integral quantitative assessment of the clinical efficacy of parenteral use of cytoflavin in treatment of patients with CNS disorders based on the systemic selection of published controlled clinical trials and their meta-analysis. MATERIAL AND METHODS: Twenty-one high evidence-based studies on the efficacy of parenteral use of cytoflavin in different CNS disorders (4314 patients) have been analyzed. Comparisons with basic treatment groups were undertaken to clarify the drug clinical effects adjusted for heterogeneity and variability of response parameters. RESULTS AND CONCLUSION: An analysis of formalized efficacy indicators (increase in the absolute and relative value, odds ratio (OR) etc.) has demonstrated the advantages of cytoflavin. Group combination has increased the statistical power of the meta-analysis. Two models with fixed (Mantel-Haenszel amendment) and random effects were used. All the estimation protocols in different clinical groups of patients with neurologic diseases provided similar results and confirmed the stability of calculated values irrespective of heterogeneity of data arrays. OR of positive outcomes in neuropathologies treated with cytoflavin was 3,02 with χ2 heterogeneity 427,3 and p = 0,000…, I2= 85,7% (82%; 88%).


Subject(s)
Central Nervous System Diseases/drug therapy , Flavin Mononucleotide/therapeutic use , Inosine Diphosphate/therapeutic use , Niacinamide/therapeutic use , Succinates/therapeutic use , Drug Combinations , Flavin Mononucleotide/administration & dosage , Humans , Infusions, Parenteral , Inosine Diphosphate/administration & dosage , Niacinamide/administration & dosage , Succinates/administration & dosage , Treatment Outcome
4.
Article in Russian | MEDLINE | ID: mdl-27635610

ABSTRACT

AIM: Meta-analysis was undertaken to evaluate rufinamide safety and effectiveness in numerous heterogeneous groups of patients with severe and drug resistant epileptic disorders. MATERIAL AND METHODS: There were 164 relevant articles available via medico-clinical periodic databases, but only 15 have been chosen suitable for meta-analysis. All together 1847 participants were included into common massive, with Lennox-Gastaut syndrome (LGS) and similar encephalopathy syndromes, and with drug-resistant partial epileptic forms. 1169 were administered rufinamide additionally to typical anti-epileptic medications (experimental group). 686 received treatment with common practice drugs without rufinamide (control group). RESULTS AND CONCLUSION: Patient with more than 50% seizures reduction were more numerous in rufinamide group (χ2=89.7 with р=0.000...; ОR=2.9 with 95% CI 2.3-3.7). Most frequent and statistically reliable complications of rufinamide use were headache/dizziness and nausea/vomiting. Rufinamide is safe and effective for treatment of different epilepsies including LGS and drug-resistant partial seizures. Rufinamide may be used as second-line adjuvant for routine neurologic practice.


Subject(s)
Anticonvulsants/therapeutic use , Drug Resistant Epilepsy/drug therapy , Epilepsies, Partial/drug therapy , Triazoles/therapeutic use , Anticonvulsants/adverse effects , Humans , Lennox Gastaut Syndrome/drug therapy , Treatment Outcome , Triazoles/adverse effects
5.
Anesteziol Reanimatol ; 61(4): 314-319, 2016 Jul.
Article in Russian | MEDLINE | ID: mdl-29470907

ABSTRACT

THE AIM: a synthesis of evaluations ofReamberin's clinical efficacy as energy protectorfor the results of a meta-analysis of published data obtained during controlled clinical studies with the same design and a high level of evidence. MATERIALS AND METHODS: To estimate succinic acid based remedy for infusions (reamberin), the meta-analysis was undertaken with data of reamberin use in intensive care, resuscitation departments, in critical post surgery period, in oncology (multiple chemotherapy of tumors), in emergent toxicology and pediatrics. 32 controlled randomized trials and all together 6221 patients were included. RESULTS: Unified indicators of clinical efficiency were systemically and thoroughly processed with advanced statistic tools, resulting data were sufficient for association and assessment of their heterogeneity in different articles. The adjuvant effects of reamberin were proven, as good outcome frequency enlarged more than by 25%, absolute and relative treatment benefits increased more than by 50%, positive outcome chance grew twice and more. CONCLUSIONS: According to sensitivity analysis and this meta-analysis results reamberin may be positioned as adjuvant energetic protector valid to improve effectiveness of pharmacologic correction during the treatment of emergencies joint with hypoxia, energy deficiencies and vegetative disregulations.


Subject(s)
Critical Care/methods , Energy Metabolism/drug effects , Meglumine/analogs & derivatives , Resuscitation/methods , Succinates/therapeutic use , Chemotherapy, Adjuvant , Humans , Meglumine/administration & dosage , Meglumine/therapeutic use , Succinates/administration & dosage , Treatment Outcome
6.
Article in Russian | MEDLINE | ID: mdl-26356615

ABSTRACT

AIM: To compare clinical and morphological results of treatment of ischemic stroke in three groups of patients which differed by the forms and duration of an antioxidant therapy. MATERIAL AND METHODS: A randomized clinical trial was performed in 8 vascular centers of the Russian Federation in 2010-2014. It included 373 patients with ischemic stroke in the carotid territory. Patients were randomized into 3 groups to receive different regimens of antioxidant therapy as an adjunct to standard therapy: control group (ascorbic acid; 132 patients); cytoflavin (20 ml per day for 10 days; 133 patients); cytoflavin (the dose was decreased to 10 ml per day from 11th to 20th day) (108 patients). Patient's condition was assessed in 1, 10 and 21 day by a complex of clinical, laboratory and instrumental methods. RESULTS AND CONCLUSION: The analysis of CT in 1th and 21th day revealed a significant 1,5-1,7- fold decrease in the cerebral ischemic lesion in both groups treated with cytoflavin with no significant morphologic changes in the ascorbic acid group. The percentage of patients with ischemic lesion, increased during days 1-21, was 2-fold higher in the ascorbic acid group compared to cytoflavin groups. Morphologic changes were correlated with clinical variables and outcome. In patients with ≥14 points on NIH scale on admission, prolonged 20 day cytoflavin therapy was associated with a more prominent improvement of neurologic, functional and cognitive status compared to 10-day cytoflavin infusion. No differences in clinical variables were observed in patients with mild symptoms (<14 points on NIH scale on admission) receiving cytoflavin for 10 and 20 days.


Subject(s)
Antioxidants/therapeutic use , Ascorbic Acid/therapeutic use , Brain Infarction/drug therapy , Brain Infarction/pathology , Flavin Mononucleotide/therapeutic use , Inosine Diphosphate/therapeutic use , Niacinamide/therapeutic use , Succinates/therapeutic use , Adult , Aged , Aged, 80 and over , Antioxidants/administration & dosage , Ascorbic Acid/administration & dosage , Brain Infarction/diagnostic imaging , Drug Combinations , Energy Metabolism , Female , Flavin Mononucleotide/administration & dosage , Humans , Infusions, Intravenous , Inosine Diphosphate/administration & dosage , Male , Middle Aged , Niacinamide/administration & dosage , Russia , Succinates/administration & dosage , Tomography, X-Ray Computed , Treatment Outcome
7.
Antibiot Khimioter ; 60(11-12): 43-9, 2015.
Article in Russian | MEDLINE | ID: mdl-27141647

ABSTRACT

Metaanalysis was applied to the published data on the randomized clinical trials of Remaxol in the treatment of various diseases associated with the liver injury: chronic hepatitis B and C, severe ethanol intoxication, drug-induced pathologies due to tuberculosis chemotherapy, leptospirosis, psoriasis, tumor polychemotherapy. The database included information on 2250 patients. The total number of the patients of the control group (n = 1099) were treated according to the routine schemes (active placebo) and that of the main group (n = 1151) were additionally treated with Remaxol. Combination of the frequency characteristics of the positive outcomes (% of elimination of the main clinical symptoms and complications) in the patients of the reference groups allowed to estimate the general clinical efficacy of Remaxol, that was equal to 1.75 by the outcome frequency characteristics. The odds ratio of the positive outcomes equaled 5.3 [1.8; 17.0] and the number of the patients needed to treat (NPNT) equaled 8 [6; 14]. Therefore, the infusion Remaxol hepatoprotector based on succinic acid was shown to have statistically and clinically significant therapeutic efficacy in pharmacologic correction of the liver pathologies of diverse genesis.


Subject(s)
Liver Diseases/drug therapy , Liver Diseases/etiology , Protective Agents/therapeutic use , Succinates/therapeutic use , Energy Metabolism/drug effects , Humans , Liver Diseases/metabolism , Liver Function Tests , Protective Agents/administration & dosage , Protective Agents/adverse effects , Randomized Controlled Trials as Topic , Succinates/administration & dosage , Succinates/adverse effects , Treatment Outcome
8.
Ter Arkh ; 85(1): 56-61, 2013.
Article in Russian | MEDLINE | ID: mdl-23536947

ABSTRACT

AIM: To pool the published results of trials of the new infusion hepatoprotector remaxol for the integral quantification of the magnitude of its clinical efficacy. SUBJECTS AND METHODS: The authors made a systematized review of the published results of randomized clinical trials of the succinate-containing infusion hepatoprotector remaxol in diseases associated with hepatic lesions (chronic hepatitis B and C, severe ethanol intoxication in the presence of alcohol dependence, drug-induced liver lesion during treatment of tuberculosis, and metabolic syndrome). The pooled database included information on 935 patients. The combined control group (n = 447) received traditional pharmacotherapy drugs (active placebo), the treatment group (n = 628) additionally took remaxol. RESULTS: Meta-analysis of the frequency characteristics of positive outcomes (the rate of disappearance of major clinical symptoms and complications) and the activity range for the enzymes characterizing hepatocyte cytolysis (alanine aminotransferase and aspartate aminotransferase) and cholestasis (alkaline phosphatase and gamma-glutamate transpeptidase) in the compared groups could provide an integral evaluation of the clinical efficacy of remaxol, which was 1.57 for enzymatic activity and 1.78 for the frequency characteristics of outcomes. The odds ratio of positive outcomes was 2.9 (range 1.9 to 3.9) and the number of patients who needed to be treated with remaxol during the follow-up to prevent a poor outcome in one patient was 6 (range 4 to 8). CONCLUSION: The succinic acid-based infusion hepatoprotector remaxol provides a statistically and clinically significant therapeutic effect in the drug correction of hepatic lesions of varying genesis.


Subject(s)
Liver Diseases/drug therapy , Liver/drug effects , Succinates/administration & dosage , Humans
9.
Eksp Klin Farmakol ; 73(6): 5-9, 2010 Jun.
Article in Russian | MEDLINE | ID: mdl-20726343

ABSTRACT

Mechanisms of the vibroprotective action of nifedipine, a calcium channel blocker, have been studied in myocardiocytes of rabbits. Changes in the functional activity of mitochondria were observed in rabbits after prolonged (56 days) general vibration. Nifedipine (7.5 mg/kg per os) activated the NAD-dependent site of respiratory chain and prevented hyperactivation of the succinate-dependent breath. The positive energotropic action of nifedipine was accompanied by stability of the histomorphological cytoarchitecture of rabbit myocardium. It is suggested that nifedipine protects myocardium from negative effects of prolonged vibration.


Subject(s)
Cardiotonic Agents/pharmacology , Mitochondria, Heart/metabolism , Myocardium/metabolism , Myocytes, Cardiac/metabolism , Nifedipine/pharmacology , Vibration/adverse effects , Animals , Calcium Channel Blockers/pharmacology , Electron Transport/drug effects , Male , Mitochondria, Heart/pathology , Myocardium/pathology , Myocytes, Cardiac/pathology , Rabbits , Time Factors
11.
Bull Exp Biol Med ; 142(4): 441-6, 2006 Oct.
Article in English, Russian | MEDLINE | ID: mdl-17415432

ABSTRACT

Mitochondrial substrate-based preparations corrected disorders, caused by long-term exposure to abnormal gravitation vector in head-down tilt (hanging) test in rats. The preparations produced systemic and polyorgan protective effects consisting in correction of the blood prooxidant/antioxidant balance, energy metabolism in musculus soleus, and minimization of morphological changes in the liver and kidneys.


Subject(s)
Energy Metabolism , Gravitation , Head-Down Tilt , Mitochondria/metabolism , Animals , Antioxidants/metabolism , Energy Metabolism/drug effects , Malates/pharmacology , Male , Oxidants/blood , Rats , Rats, Wistar , Succinic Acid/pharmacology
12.
Bull Exp Biol Med ; 142(3): 327-32, 2006 Sep.
Article in English, Russian | MEDLINE | ID: mdl-17426841

ABSTRACT

Energy metabolism regulator Amber-anti-tox had a systemic effect under experimental conditions of vibration-induced dysregulation. Whole-body vibration was accompanied by nonlinear changes in energy metabolism in the heart, liver, kidneys, and lymphocytes and impairment of intra-systemic inter-organ relationships between mitochondria. Amber-anti-tox prevented vibration-induced de-energization of mitochondria and contributed to the preservation of multidimensional relationships of energy metabolism in vital internal organs.


Subject(s)
Energy Metabolism , Animals , Antitoxins/pharmacology , Factor Analysis, Statistical , Kidney/metabolism , Liver/metabolism , Lymphocytes/metabolism , Male , Myocardium/metabolism , Rabbits , Vibration
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