Ninety consecutive patients, affected by venographically proven deep-vein thrombosis (DVT) of the lower limbs, were given full-dose heparin followed by oral anticoagulants for 12 weeks, and then selected randomly to receive, for one year, either mesoglycan (72 mg/day orally) or placebo with a double-blind protocol. All patients wore elastic graduated compression stockings, and were prospectively followed for a period ranging from 5 to 48 months. In each scheduled examination programmed every three months for one year and then twice per year, an accurate clinical evaluation was performed and a predetermined objective score was applied. Furthermore, impedance plethysmography and Doppler ultrasound tests were executed serially to assess the persistence of venous obstruction and/or the development of valve incompetence. After a mean follow-up of 3 years, 80% of the patients were totally asymptomatic, and severe post-thrombotic sequelae (ulcer and/or edema associated with skin induration) were recorded in only 6 patients (6.6%). We failed to identify any correlation between post-thrombotic sequelae and persistence of venous obstruction (as shown by impedance plethysmography) or development of valve incompetence (as shown by Doppler ultrasound test). The behaviour of patients treated with mesoglycan did not differ from that of patients treated with placebo. However, objectively documented recurrences of DVT and/or pulmonary embolism were less frequent in patients treated with mesoglycan (6.6 vs 11.1%, non-significant difference), and the only two deaths attributable to pulmonary embolism occurred among the patients treated with placebo.(ABSTRACT TRUNCATED AT 250 WORDS)
Adult Aged