Heparin was administered to 113 patients at risk of thrombosis classified to abdominal surgery either alone (subcutaneously or in inhalation) or in combination with anabolic steroid (nandrolone). No pharmaco-prophylaxis was used in 10 patients. On the day of surgery, heparin activated plasma fibrinolytic activity, prior to an introduction to anesthesia. Measurements of euglobulins clot lysis have shown an increase in endogenous fibrinolytic activity dependent and independent on Hageman's factor and an increase in exogenous fibrinolysis, tested after venous stasis was produced. Heparin had profibrinolytic activity, stimulating plasminogen activators in the blood plasma without the signs of hyperplasminemia. Fibrinolytic system response was the same following subcutaneous injection and heparin inhalations. Administration of heparin combined with anabolic steroid has no additional effect on plasma fibrinolytic activity.
In a prospective multicenter trial, 149 consecutive patients with. phlebographically proven proximal and/or distal deep vein thrombosis of the leg were randomly allocated to receive subcutaneously for 10 days either low molecular weight heparin CY 216 (Fraxiparine) in a fixed dose or unfractionated heparin (UFH) in doses adjusted according to the activated partial thromboplastin time. Pre- and post-treatment phlebograms were assessed blindly using the Arnesen's score system in 134 patients available for analysis of the treatment efficacy. The mean phlebographic score after 10 days of treatment was significantly decreased in both groups (p <0.001) in comparison with the baseline score but the difference in score changes between the two groups was not statistically significant. There was an improvement in 45/68 patients (66%) in the Fraxiparine group and in 32/66 patients (48%) in the UFH group, and an increase in the thrombus size in 10/68 (15%) and 12/66 (18%), respectively. One symptomatic non-fatal pulmonary embolism and one major bleeding episode were observed in the UFH group. During a follow-up period of 3 months, two rethromboses had occurred in the UFH group and none in the Fraxiparine group. It is concluded that subcutaneous fixed dose Fraxiparine is safe and at least as effective as subcutaneous adjusted UFH in the treatment of deep vein thrombosis.
In a multicenter randomized trial, the efficacy and safety of two streptokinase (SK) dosage regimens have been evaluated in patients with proximal deep vein thrombosis of inferior limbs. Twenty-nine patients received SK by a continuous intravenous infusion (250,000 IU as initial dose, 100,000 IU/h as maintenance dose), and 26 patients were treated with intermittent SK administration (500,000 IU as initial dose, followed by 250,000 IU every 12 h). Thrombolytic therapy was continued for 4 days, then the patients received heparin for 5 days and oral anticoagulant for 3 months. The results of treatment as judged by phlebographic examinations were similar in the two groups. Complete, substantial or partial thrombolysis was achieved in 52% of patients in the continuous infusion group and in 58% of patients in the intermittent treatment group. During SK administration, major bleeding complications occurred in 6 patients treated by continuous infusion and in 2 of the second group. The results showed that the intermittent SK administration is as effective and safe as the method of continuous SK infusion in the treatment of deep vein thrombosis.
Ninety-four patients with deep vein thrombosis of inferior limbs were randomly allocated to receive sodium heparin either by subcutaneous injections or by continuous intravenous infusion for six days. No significant difference was observed in the therapeutic efficiency as judged by phlebographic examinations and in rate of symptomatic pulmonary embolism between the two groups. There was one instance of major bleeding in the subcutaneous group. Minor bleedings occurred in 10 of the 48 patients treated with subcutaneous heparin and in 13 of the 46 patients receiving intravenous heparin. The results showed that subcutaneous injections of sodium heparin are as effective and safe as continuous intravenous infusion of this drug in the treatment of deep vein thrombosis.
The haemostatic parameters were studied within 14 days of acute myocardial infarction (AMI) in 103 patients randomly allocated into a group receiving low-dose heparin or into a group treated without anticoagulants. Patients with isotopic evidence of deep vein thrombosis were excluded from the analysis. An important formation of thrombin-antithrombin III complex (TAT) in the plasma was detected in the early stage of the disease. It was accompanied by an activation of plasma intrinsic fibrinolysis (IF), an elevation of fibrinogen and its degradation products (FDP) and a reduction of extrinsic plasma fibrinolytic activity (EF) together with normal levels of factor X, antithrombin III (AT III), protein C and alpha-2-antiplasmin. Sequentially studies periods of the disease revealed a diminution of TAT complex concentration in the plasma on the seventh day of AMI together with a rise of the both plasma fibrinolytic activities (IF, EF) as well as an elevation of fibrinogen and its degradation products, returning to the initial values on the 14 day of AMI. In the patients treated with heparin the augmentation of TAT complex in the plasma was prolonged until the fifth day of AMI. Moreover, heparin administration was connected with significantly higher levels of AT III and protein C along with a lower concentration of factor X and FDP on the seventh day of the disease. The fluctuation of fibrinolytic activities (IF, EF) in the plasma was heparin-independent. The present results indicate that low-dose heparin treatment modulates the plasmatic fluctuation of TAT complex as well as factor X, AT III and protein C levels in patients with acute myocardial infarction.
One hundred eighty three patients, all over 40 years old, who underwent major abdominal surgery, were randomized into 3 groups: Group I received a single dose of nebulized heparin (800 IU per kg b.w.) administered by inhalation one day prior to surgery. Group II besides the above, also received a single injection of 50 mg of long acting anabolic steroid (nandrolone phenylpropionate) intramuscularly. Group III received 5000 IU heparin subcutaneously on hr prior to surgery as well as every 12 h for the next 5 postoperative days. Postoperatively the patients were evaluated for deep vein thrombosis (DVT) using the 125-I-fibrinogen test. The occurrence of DVT was determined as: in Group I--16%, in Group II--7.9%, in Group III--7.8%. Haemorrhagic complications (clinically important) were observed in 7.8% of patients from Group III, but only in 1.7% of patients in Group I and 1.6% in Group II. For DVT prophylaxis following abdominal surgery a single application of nebulized heparin and long acting anabolic steroid is as effective as conventional low-dose subcutaneous heparin administration, but gives less haemorrhagic complications. This method is also more advantagenous in term of acceptance by the patients and represents considerable saving of nursing time.
150 patients over 40 years old undergoing major abdominal surgery were divided into 3 groups: 1/ group I - receiving a single injection of long acting anabolic steroid /nandrolone phenylpropio-nate, 50 mg intramusculary/ a day prior to surgery 2/ gropup II - receiving the same dose of anabolic steroid plus a single dose of heparin /800 U/kg of body weight/ intrapulmonary a day prior to surgery 3/ group III - receiving only a single dose of heparin /800 U/kg of body weight/ intrapulmonary a day prior to surgery. The deep vein thrombosis /DVT/ was detected using the 125 I-fibrinogen test. The occurence of DVT was: in group I - 14% in group II - 4% in group III - 8% There were no detectable haemorrhagic complications in patients of group I and III, in 6% of patients of group II a sgliht increase of intraoperative bleeding and/or wound hematoma appeared. We conclude that prophylaxis of DVT in the postoperative period with the single dose of anabolic steroid and intrapulmonary heparin is an effective, safe and easy to handle procedure.