[Efficacy and safety of Cytoflavin in the treatment of diabetic polyneuropathy: results of a multicenter, double-blind, placebo-controlled, randomized CYLINDER study]. / Effektivnost' i bezopasnost' primeneniya Tsitoflavina v terapii diabeticheskoi polineiropatii: rezul'taty mnogotsentrovogo dvoinogo slepogo platsebo-kontroliruemogo randomizirovannogo issledovaniya TsILINDR.

OBJECTIVE: The purpose of the present double-blind, placebo-controlled, randomized clinical trial was to evaluate the efficacy and safety of Cytoflavin in patients with diabetic polyneuropathy (DPN). MATERIAL AND METHODS: Investigational therapy was administered in two steps: intravenous infusions of experimental drug/placebo for 10 days followed by oral administration for 75 days. In 10 clinical centers, 216 patients aged 45-74 years with a diagnosis of type 2 diabetes mellitus, symptomatic distal sensorimotor DPN, confirmed no earlier than 1 year before screening, on stable therapy (no change of drugs and doses) by oral hypoglycemic drugs, intermediate-acting, long-acting or extra-long-acting insulin, and/or GLP-1 receptor agonists. RESULTS: By the end of treatment, the change of the Total Symptom Score (TSS) in the experimental group was -2.65 points, in the placebo group -1.73 points (p<0.001). Improvement of symptoms in the experimental group was achieved regardless of the degree of compensation for type 2 diabetes (both in those with Hb1Ac <8.0% and in those with Hb1Ac ≥8.0%), but demonstrated better results in patients with less severe baseline symptoms (TSS <7.5). Improvement in the components of the TSS scale «paresthesia¼ and «numbness¼ occurred as early as on day 11 of therapy; by the end of treatment, a significant decrease in the «burning¼ component was also demonstrated. The experimental drug had a positive safety profile. CONCLUSION: Cytoflavin, intravenous solution and enteric-coated tablets (SPTF Polysan Ltd.) is indicated for the symptomatic treatment of DPN.

[Effect of the Cytoflavin on the distal polyneuropathy severity in patients with diabetic foot syndrome with arteries mediacalcinosis]. / Vliianie tsitoflavina na vyrazhennost' distal'noi polineiropatii u bol'nykh sindromom diabeticheskoi stopy s mediakal'tsinozom arterii.

The aim of the study was to evaluate the effectiveness of cytoflavin in the complex treatment of patients with diabetic foot syndrome. MATERIAL AND METHODS: The research is based on the results of a comprehensive survey of 140 people with diabetic foot syndrome. Depending on the treatment, all patients were divided into 2 groups. The first group (n=35) received basic therapy. The second group (n=35) in addition to basic therapy received cytoflavin 10 ml (+200 ml 0.9% NaCl) for 10 days, followed by switching to the tablet form of the drug 2 tablets twice a day for 1 month. RESULTS: Analyzing the severity of polyneuropathy after treatment, we noted a more positive dynamic in patients who in addition to standard therapy received cytoflavin.

[Efficiency of cytoflavin in the treatment of somatoform disorders]. / Issledovanie éffektivnosti tsitoflavina v lechenii somatoformnykh rasstroistv.

AIM: To study the efficacy of cytoflavin in patients with somatoform disorders (SD). MATERIAL AND METHODS: The study included 60 patients with SD, aged from 27 to 43 years. The efficacy was assessed by the results of psychological and neurophysiological examinations. RESULTS AND CONCLUSION: The higher efficacy of cytoflavin (the improvement of patient's condition in 63,3% of cases) compared to that of ethylmethylhydroxypyridine succinate (56,7% of cases) was found. Patient's state was more stable after treatment with cytoflavin.

[Efficacy of antioxidant energocorreсtion in brain infarction (results of a multicenter randomized trial)].

OBJECTIVE: To determine the optimal duration of energy corrective treatment of ischemic stroke (II) with cytoflavin or ascorbic acid. MATERIAL AND METHODS: A multicenter randomized clinical trial included 185 patients, aged 40-75 years. Patients were randomized into 3 groups: the control group (n=64) received ascorbic acid; cytoflavin group 1 (n=72) was treated for 10 days and cytoflavin group 2 (n=49) for 20 days. In all groups, mean NIHSS score was 13, 42.2% of patients scored ≥14 and on admission, 42.2% of patients had consciousness impairment of different severity. RESULTS: Cytoflavin treatment was more efficient than ascorbic acid that can be explained by different pharmacologic mechanisms. Treatment with cytoflavin for 10 days resulted in a significant decrease of ischemia zone volume by 25.2%, treatment with cytoflavin for 20 days - by 29.0%, which was associated with better outcomes in neurologic and functional status. Ascorbic acid demonstrated no effect on morphologic parameters. Prolonged treatment with cytoflavin in critically ill patients led to significant improvement in clinical and morphologic variables compared to the 10-day course. In patients with less severe condition comparable results were obtained. CONCLUSION: Our data justify the need for personalized integrated antioxidant and energy correction therapy.

[Brain functional state and cytoprotective potential in model of acute cerebral hypoxia (experimental research)].

The functional state of the brain and the potential of pharmacologic cytoprotection after an acute cerebral hypoxia were studied. The experiment involved 186 adult male rats. The rats in experimental groups underwent acute thromboembolism of the right carotid artery. The functional state of the brain and the efficacy and safety of the Cytoflavin complex cytoprotective drug treatment had been analyzed over the 10 days following the thromboembolism. A neurological examination was accomplished daily, the serum levels of NSE, GFAP, S100beta and brain cytolysate levels of NSE were measured on the 1st, 3rd, 10th day. The NSE brain cytolysate level went up on the 1st day and the NSE serum level was up on the 3rd day following the thromboembolism, which may have indicated an acute delayed alteration of neurons and an increase of the blood-brain barrier permeability on the 3rd day after the thromboemboIism. Neuroglial biomarkers went up on the 1st (GFAP), 3rd and 10th (S100beta) day, which indicated an acute delayed alteration and/or activation of glial cells. Therefore, the applied experimental model promotes acute delayed alteration of neurons and neuroglia with a possible activation of the latter. The Cytoflavin proved to have a cytoprotective effect on neurons and to diminish the alteration and/or activation of glial cells over the observed period after the acute thromboembolism of the carotid artery.

[Assessment of multimodal effect of cytoflavin in the acute brain stroke in patients with metabolic syndrome].

Sixty patients were randomized to treatment with cytoflavin (n=30) or nootropil (n=30). Patients of the main group received cytoflavin along with standard treatment for correction of hemodynamics. The treatment scheme was as follows: intravenous injections during 10 days, tablets - from 11 to 35 days. The same scheme of treatment was used in the comparison group. The total duration was 35 days. Patients were assessed with NIHSS, the Rankin scale, the Barthel index, MMSE. MRI was used to verify ischemic lesions. The therapeutic efficacy of cytoflavin was significantly higher compared to nootropil in respect to the restoration of neurological functions and self-service abilities as well as to the reduction of cognitive deficit.

[Dynamics of the symptoms of chronic ischemia during the treatment with cytoflavin].

Sixty patients with chronic brain ischemia (discirculatory encephalopathy, I and II stages) were enrolled in the study. Patients of the first group (n=30) were treated with cytoflavin and patients of the second group (n=30) received piracetam prescribed first as injections and then in pills. The treatment duration was 35 days. Standard neurological examination and psychometric assessment of patients and dopplerography of cerebral vessels were carried out. Cytoflavin was shown to have a positive effect on the neurological status. It decreases asthenic, cephalgia and vestibulo-cerebellar syndromes as well as neurological and emotional disturbances reducing the symptoms of depression and anxiety and improving cognitive functions and memory as well as quality of life of patients. The changes were significant compared to those in the group of patients treated with piracetam.

[Efficacy of cytoflavin in patients with hypertonic encephalopathy and constitutional venous insufficiency].

We examined 60 patients with constitutional venous insufficiency, suffering from hypertensive encephalopathy of I and II stages, mean age 43,4± 6,3 years. Patients of the main group (n=30) received Cytoflavin (2 tablets twice a day) and standard therapy (acetylsalicylic acid and antihypertensive drugs). Thirty patients of the parallel group received only standard therapy. At the 25th day of the study, there were the decrease in the number of complaints, including specific "venous complaints", the reduction of cephalalgia syndrome, asthenic and autonomic disorders; the improvement of quality of life and better cerebral hemodynamics on all structural and functional levels.

[The immune activity of cytoflavine in the treatment of the diffuse septic peritonitis].

Influence of citoflavin on dynamics of functional condition of mitogen-induced immunocompetent blood cells at patients with widespread purulent peritonitis is studied. It is established that investigated immunocompetent cells have regulating effect on migration of neutrophil leukocytes at widespread purulent peritonitis during all postoperative period. PHA-activated mononuclear cells don't cause inhibition of migration of neutrophil granulocytes, observed in norm. At the same time the LPS-activated monocytes lead to migration strengthening of neutrophil granulocytes, in comparison with the data received in norm. Usage of citoflavin at patients with widespread purulent peritonitis renders corrective action on immunocompetent cells, changing their properties of regulation of migratory activity of neutrophil granulocytes. It is revealed that such action of citoflavin is connected with function restoration of mononuclear cells to inhibit migration of neutrophil leukocytes and with restoration of stimulation of migration of neutrophil leukocytes under the influence of the LPS-activated monocytes to the values received in norm. The revealed effects at use of citoflavin are most expressed by the 5th day of the postoperative period.

[Cytoflavin in polychemotherapy of breast cancer].

The efficacy of cytoflavin as a supporting drug in the CAF chemotherapy of breast cancer was studied. It was estimated by the tolerability, the peripheric blood index dynamics, the patients general condition (Karnovsky Index) and the frequency of the side effects. For the immediate estimation of the polychemotherapy and cytoflavin effects on the cytoprotection natural system state, the dynamics of the glutathione metabolism and the lipid peroxidation in the erythrocytes was investigated.

[Efficacy of the complex drug cytoflavin in the treatment of consequences of mild brain injury].

Sixty outpatients, aged 18-50 years, with mild cranial-brain trauma (brain concussion, mild brain injury), occurred 21-180 days before the enrollment in the study, were examined. Patients of the main group received cytoflavin in dose 425 mg, 2 tablets twice a day during 25 days, patients of the control group received aminalon in dose 500 mg, 2 tablets 3 times a day during 25 days. The therapeutic efficacy was assessed on days 1, 30 and 60 with the battery of neuropsychological scales. The efficacy and safety of cytoflavin in the monotherapy of patients with remote consequences of mild cranial-brain trauma was shown. The effect of cytoflavin was developed significantly more rapidly compared to aminalon. There were positive changes on scales of pain severity, psychoemotional disorders (anxiety, depression, asthenia), sleep quality, autonomic dysfunctions as well as in the performance on neurocognitive tests assessing memory, sustained attention, information processing speed, productivity. The duration of using analgesics and sedatives as add-on drugs was reduced significantly. The drug remained effective till the 60th day after the 30 day withdrawal. Side-effects of cytoflavin (the short-term rise of arterial pressure, insomnia and abdominalgia) did not last long and no additional treatment, withdrawal or reduction of cytoflavin dose was needed.

[Efficacy of cytoflavin in the treatment of vertebrobasilar insufficiency].

Neurology symptoms and Doppler figures before and after cytoflavin course therapy have been studied in a group of 52 patients with chronical insufficiency of cerebral blood circulation mostly in the vertebrîbasilar vessel region. Cytoflavin infusions reliably reduced neurologic disorder symptoms, improved cerebrovascular reaction, and extended compensation possibilities of blood circulation in the vertebrobasilar region. The results of investigation proved the efficacy, safety and good tolerance of cytoflavin in patients.