Abstract
Objective of the research – to assess efficacy and safety of drug Elkar® 100 mg/ml for intravenous and intramuscular injection in treatment of newborns with posthypoxic cardiopathy. Patients were randomized into 2 groups, comparable in age, gestational age, severity of cerebral ischemia. The main group (n=43) in addition to standard therapy received Elkar® intravenously at a dose of 50–100 mg/kg/day, the comparison group (n=40) received only standard therapy for posthypoxic cardiopathy. The control group consisted of 20 children without clinically significant CNS and cardiovascular system (CVS) lesions. Elkar® contributed to a significant improvement in clinical status and optimization of postnatal CVS adjustment, manifesting as effective reduction of electrical instability and myocardial ischemia, heart rate recovery, systolic and diastolic function normalization, size of right heart chambers, reduced the diameter and hemodynamic significance of fetal functioning communications, restored vegetative regulation of heart rate and its circadian organization, helped to reduce rhythm pauses duration and arrhythmias representation. Elkar® intravenous use was satisfactorily tolerated by newborns and had no clinically significant adverse effects. The most rapid and complete regression of posthypoxic cardiopathy manifestations revealed after intravenous drug use at a dose of 80–100 mg/kg/day and continuing oral administration up to 1 month.
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