[Results of a clinical and experimental study of the safety and efficacy of Cytoflavin in combination with reperfusion therapy for ischemic stroke]. / Rezul'taty kliniko-eksperimental'nogo izucheniya bezopasnosti i effektivnosti primeneniya Tsitoflavina v sochetanii s reperfuzionnoi terapiei ishemicheskogo insul'ta.

OBJECTIVE: To study the efficacy and safety of Cytoflavin in combination with thrombolytic therapy. MATERIAL AND METHODS: At the first preclinical stage, the effect of Cytoflavin, solution for intravenous administration, on the fibrinolytic activity of alteplase (Actilyse) was studied in vitro. At the second, clinical stage, the safety and efficacy of Cytoflavin treatment, initiated within in the first 24 hours from the stroke onset and continued for 10 days, was evaluated in patients with acute stroke who received reperfusion therapy. At the clinical stage of the study, 200 patients were examined: 100 subjects of the main group who received reperfusion therapy in combination with Cytoflavin; 100 control subjects who received reperfusion therapy in combination with other drugs from the neuroprotective group as part of routine clinical practice. RESULTS: The preclinical study has demonstrated that alteplase in the studied concentrations debulks the mass of a thrombus by 2131%. There were no statistically significant differences in the reduction of thrombus weight with addition of Cytoflavin at various concentrations combined with alteplase to the incubation medium. The addition of Cytoflavin to the incubation medium with alteplase had no effect on the concentration of D-dimer in the rat's plasma. In the clinical study, there were no statistically significant differences in the frequencies of intracranial hemorrhages of various types between the study groups. In the multivariable analysis, significant predictors of intracranial hemorrhage were baseline NIHSS score, systolic blood pressure, history of diabetes and anticoagulant use, baseline CT ASPECTS score, but not the treatment group. CONCLUSION: The use of Cytoflavin in combination with thrombolytic therapy is safe. Up-to-date treatment of stroke which includes timely reperfusion and neurometabolic support of recovery leads to the rapid manifest regression of the neurological deficit and to the improvement in functioning and activity of patients with cerebral infarction.