THE TOPICAL TREATMENT OF INFUSION THROMBOPHLEBITIS WITH PENTOSAN POLYSULFATE SODIUM OINTMENT - A RANDOMIZED DOUBLE-BLIND-STUDY

In a 7 day randomised double-blind trial, the equivalence of efficacy of pentosan polysulfate sodium ointment (PPS ointment, 0.5%) in compar ison to mucopolysaccharide ointment (MPS ointment, 0.445%) was studied in 110 adult stationary patients suffering from acute infusion thromb ophlebitis in one arm. The study medication was applied three times da ily. Antithrombotic and antiinflammatory efficacy were evaluated by da ily monitoring of the severity of the symptoms (induration, swelling, erythema, temperature, pain) as defined by scores on a rive-stage scal e. In addition, I-125-fibrinogen was injected on the day before the on set of treatment and radioactivity was measured over the inflamed vein s on day 1, 3 and 7 of the treatment period. All patients concluded th e treatment according to the protocol. Both ointments reduced the radi oactivity in the thrombus and the global severity of symptoms to 50% a fter 3 days. By day 7 most patients had recovered completely from the inflammation. Thus, both ointments were equivalent in their efficacy. However, the symptom attenuation with the pentosan polysulfate sodium ointment appeared to be somewhat faster and, since this formulation is prepared from plant origin, this preparation was free from any risk o f BSE infection. No adverse events were reported and the treatment was well tolerated by all patients.