The Use of Liposomal Heparin Spray-Gel in the Treatment of Superficial Thrombophlebitis: A Multicenter Clinical Investigation Analysis
The aim of the study was to evaluate the efficacy and safety of liposomal heparin spray-gel in the treatment of superficial thrombophlebitis.
Material and methods. The presented study is an analysis of two clinical investigations performed during the period between March 1999 and May 2002, which evaluate the efficacy and safety of liposomal heparin spray-gel (Lipohep) in the treatment of superficial thrombophlebitis, as well as a comparison with results obtained following subcutaneous enoxaparin injections. The study group comprised 88 patients, including 43 on Lipohep treatment and 45 on low molecular weight heparin.
Results. Two patients withdrew from the investigation before the control visit. After seven days, therapy was stopped in the case of 16 Lipohep patients and 18 low molecular weight heparin patients. After 14 days, therapy was stopped in 21 and 25 patients, respectively. One low molecular weight heparin and five Lipohep patients did not finish the investigation. This was connected with a lack of clinical improvement and development of side-effects. A statistically significant reduction of pain and the appearance of erythema was observed in both patient groups during the initial seven days of treatment. One patient on low molecular weight heparin was diagnosed with superficial thrombophlebitis recurrence. Ten patients developed complications, with deep venous thrombosis being most significant (two patients were treated with Lipohep and one with enoxaparin). One patient on Lipohep treatment developed superficial thrombophlebitis of the upper extremity.
Conclusions. Liposomal heparin spray-gel is safe and effective in the treatment of local superficial thrombophlebitis symptoms. The initial results considering the use of Lipohep are promising and should be confirmed in a larger group of patients.