Abstract
Background. Standard therapy for deep vein thrombosis of the lower extremities includes anticoagulants and antiaggregants. Dangerous complications seriously limit the use of thrombolytic plasminogen activators. We have developed an oral thrombolytic, wich is subtilisin immobilized on polyethylene glycol - Trombovazim, and present the main results of the study on the efficacy and safety of lower limbs deep vein thrombosis treatment with the inclusion of this thrombolytic in therapy.
Methods. A multicenter, randomized, double-blind, placebo-controlled clinical trial, "VETTER-1". All 154 volunteers received only conservative standard therapy. None of the participants underwent surgical intervention. The mode of mechanical compression was not taken into account. All participants were divided into 2 groups - control and observation. The control group (n=59) received a placebo, and the observation group was divided into 3 subgroups who received tested drug at a dose of 1600, 3200 and 4800 U/day. The drug effectiveness was determined by means of an objective control method - blood flow ultrasound angioscanning. Statistical treatment of the results was carried out after trial completion.
Results. Comparison of revascularization in the zone of compromised blood flow revealed a distinct dose-dependent effect: subgroups that received drug at a dose of 1600, 3200 and 4800 U/day showed a relative frequency of positive dynamics of 0.7070 (+21%, p = 0.0535, n=28), 0.7257 (+24%, p = 0.0188, n=32) and 0.7470 (+28%, p = 0.0082, n=35) respectively. The study did not reveal any negative dynamics in the observation group, and recorded 3 such cases in the control group. The difference between frequency of thrombus lysis in the observation group was 0.87 versus 0.63 in the control group (p = 0.07). All participants who received tested drug at a dose of 4800 U/day demonstrated complete dissolution of thrombus. The safety assessment was based on the analysis of vital functions, laboratory and instrumental examination of subgroup receiving the maximum drug dosage, and did not reveal any undesirable events at all visits during trials.
Conclusions. Trombovazim at a dose of 3200 and 4800 U/day statistically significantly increases the effectiveness of the treatment, does not cause hemorrhagic complications and is well tolerated by patients.
