Article is devoted to a pilot study to assess the clinical efficacy and relative frequency of large cardiac adverse events – recurrent angina, recurrent myocardial infarction (MI), the emergence or exacerbation of congestive heart failure – when applying domestic product – Flenox (active ingredient – enoxaparin) – in comparison with the unfractionated heparin (UFH) in ST-elevation MI patients received thrombolytic therapy with streptokinase. Aim of this study was to confirm the Flenox clinical efficacy and safety compared with unfractionated heparin in ST-elevation MI patients. Objectives of the study were: 1. Rating Flenox efficiency of clinical data (in the incidence of recurrent angina and functional class heart failure in NyHA on the 7th day of ACS. 2. Evaluating the effectiveness of Flenox functional data (results of echocardiography on the 14th day of ACS). 3. Rating Flenox influence on the hemostatic system (platelet count determination, determination of blood co- agulation system, the occurrence of adverse events – large, small bleeding). 4. Comparison of mortality in Flenox and UFH groups. Statistical analysis showed no significant differences in clinical, laboratory and functional performance comparisons between groups (t-test) in all respects, except the platelet count on the 7th day of the disease. Significantly fewer platelets in patients receiving UFH compared with patients receiving Flenox determined on the 7th day of AMI. Methods and result. The 1st investigated group was composed of 21 men (86%) and 3 women (14%), mean age (68 ± 11,39) years. ST-elevation MI patients were treated in the ICU of Institute of Therapy at the 2003 year. Patients received 1. 5 million units of streptokinase followed UFH during 2 days. UFH to patients with acute myo-cardial infarction with ST segment elevation administered as follows: bolus – 60 U / kg body weight of the patient (maximum – 4000 U) followed by an infusion of 12-15 IU / kg / hour for 48 hours maintaining the activated partial thromboplastin time (aPTT) at 50-70ms within 2 days. Monitoring of the platelet count is necessary every 6 hours. The 2st investigated group was composed of 30 patients – 23 men (77%) and 7 women (23%), mean age (63 ± 12,7) years. Patients were received streptokinase followed Flenox: 30mg / in bolus, subsequent infusions – 1mg/kg patient’s weight every 12 hours until their hospital discharge or a maximum of 8 days, the first two doses should not exceed 100mg. Patients older than 75 years did not receive a bolus, and Flenox administered at a dose of 0. 75 mg / kg twice daily intravenously, the maximum dose should not exceed 75 mg for the first two s / c injection. Statistical analysis showed no significant differences in clinical, laboratory, and functional performance com-parisons between groups (t-test) in all respects, except the platelet count on the 7th day of the disease. Signifi-cantly fewer platelets in patients receiving UFH, compared with patients receiving flenox, on the 7th day of AMI determined. Mean platelet counts in patients receiving UFH did not reach the values characteristic of thrombocyto-penia (<10 000/mkl), but the tendency to decrease in their number was observed. Thus, the efficacy and safety established clinical equivalence of Flenox to UFH when used in ST-elevation MI patients received thrombolytic therapy with streptokynase. Prospects for further researches. For further research are invited to study the effectiveness of the drug fondaparinux (Arixtra) with current models of risk stratification of patients with ACS to personalize therapy.
acute myocardial infarction with ST segment elevation, thrombolytic therapy, unfractionated hepa-rin, Flenox (enoxaparin)
«Bulletin of problems biology and medicine» Issue 2 part 3 (109), 2014 year, 133-137 pages, index UDK 616. 127-005. 5-085:612. 155. 85
