Full Text
Abstract
Introduction. The target therapy of thrombosis consists of thrombolytic therapy. At present in most of cases, the therapy of thromboses in patient is reduced to the prescribing of anticoagulants based on mechanism of own fibrinolysis/thrombolysis. The use of plasminogen activators is effective, but is associated with the risk of severe bleeding and is carried out only in hospital. The administration of drugs that based on immobilized subtilisins looks very promising for thromboses treatment. The immobilized subtilisins have a direct thrombolytic effect under oral administration. The drug Trombovazim is based on immobilized subtilisins and has been registered in Russia. Trombovazim has an indication — treatment of chronic venous insufficiency; thrombolytic action is the basis of its pharmacodynamics.
Aim: to show that Trombovazim in complex therapy of venous thromboses of the lower extremities improves the treatment outcomes.
Materials and methods. A multicenter randomized double-blind placebo-controlled clinical trial was carried out. At present Trombovazim is registered for medical use at a dose of 1600 U/day. The clinical study was undertaken according to 2 protocols: Рrotocol 1 — Trombovazim inclusion in complex therapy of thrombosis at a dose of 1600 U/day; Рrotocol 2 — Trombovazim inclusion in complex therapy of thrombosis in higher doses — 3200 and 4800 U/day.
Results. In patients taking Trombovazim at a dose of 1600–3200 U/day increased blood flow or vein recanalization was observed 1.6 times more often (60% more) than in patients receiving placebo. The effective thrombolytic dose of Trombovazim is 1600–3200 U/day.
Conclusion. Trombovazim has a thrombolytic action under oral administration. Thrombovazim in complex therapy of patients with venous thrombosis quickly restores the blood flow in a zone of compromised blood circulation.
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