[Evaluation of anti-thrombophilic properties of heparan sulfate in venous vascular pathology. A controlled clinical study versus active reference].
Forty adult patients (31 females and 9 males), mean age 48.41 years with chronic venous insufficiency of the lower limbs due to a variety of etiopathogenesis, were randomly divided into two groups of twenty subjects and treated with heparan sulphate and sulodexide. The experimental clinical protocol was formulated using a single blind model. The following dosages were used: a tablet of heparan sulphate in the morning and evening (200 mg/die), and one capsule of sulodexide in the morning and evening (500 ULS/die); treatment lasted 60 days. The aim of the study was to compare the two compounds in terms of efficacy and tolerability. The clinical effect of the two drugs was substantially similar: in particular the symptoms of itch, edema, spontaneous pain and nocturnal cramp responded significantly to (p less than 0.01) to both forms of treatment. The response of fibrin degradation products to heparan sulphate treatment was more positive and differed significantly from that obtained using sulodexide (p less than 0.001). Other parameters, namely erythrocytic filtration and blood viscosity, responded significantly to heparan sulphate treatment in comparison to sulodexide (p less than 0.001). Other blood coagulation and hemorheological parameters and Doppler response showed no change using either drug. With regard to side effects, five cases of digestive intolerance were observed using heparan sulphate and two with sulodexide. Two patients failed to complete heparan sulphate treatment, and one sulodexide treatment. In conclusion, heparan sulphate showed a marked pro-fibrinolytic and prohemorheological effect compared to the reference drug.
Ganassin
L
L
Divisione di Chirurgia Vascolare, Ospedale Civile di Treviso.
Sogaro
F
F
Galeazzi
E
E
D000293:Adolescent; D000328:Adult; D001780:Blood Coagulation Tests; D001809:Blood Viscosity; D004907:Erythrocyte Deformability; D005260:Female; D006025:Glycosaminoglycans / Q000008:administration & dosage / Q000627:therapeutic use; D006497:Heparan Sulfate / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D000960:Hypolipidemic Agents / Q000627:therapeutic use; D008875:Middle Aged; D016037:Single-Blind Method; D013997:Time Factors; D014689:Venous Insufficiency / Q000097:blood / Q000188:drug therapy*
D006025:Glycosaminoglycans; D006497:Heparan Sulfate; D000960:Hypolipidemic Agents; C007858:glucuronyl glucosamine glycan sulfate
Valutazione delle proprietà antitrombofiliche dell'eparansolfato in patologia vascolare venosa. Studio clinico controllato verso reference attivo.