EQUIVALENT EFFICACY OF 1.5-PERCENT PENTOSAN POLYSULFATE SODIUM GEL AND HEPARIN SODIUM GEL IN THE TREATMENT OF SUPERFICIAL THROMBOPHLEBITIS - A CONTROLLED RANDOMIZED DOUBLE-BLIND-STUDY

In a controlled randomized double-blind study including 109 surgical p atients above 18 years of age of either sex suffering from superficial infusion thrombophlebitis the efficacy and compatibility of the 3 t.i .d. application over a mean period of 6.33 days with 1.5% pentosan pol ysulfate sodium gel (Na-PPS) was studied in comparison to heparin-Na g el 60.000 (Thrombophob((R))-60.000 Gel). According to a randomized sch edule 54 patients received Na-PPS, the remaining 55 patients received heparin-Na. All patients suffered from medium thrombophlebitis persist ing over apt. 17 hours, which was mostly localized in the cubital area of the left arm. On days 0 (baseline), 1, 3 and 7 the extent of the t enderness, reddening, temperature, hardening and swelling were rated u sing a four-point scale, on which value ''1'' corresponded to the cond ition ''not present'', ''2'' the condition ''light'', ''3'' the condit ion ''medium'' and ''4'' the condition ''severe''. In addition, on day s 0, 3 and 7 leucocytes and blood sedimentation rate (BSR) were determ ined, and the compatibility was analysed upon completion of the therap y using a three-point scheme with ''good'', ''medium'' and ''poor''. T he main efficacy criterion was the total score of all five symptoms of thrombophlebitis to be rated or the respective alteration on days 3 a nd 7 of therapy. On both days Na-PPS and heparin-Na proved equivalent efficacy,vith a significant advantage for Na-PPS on day 3, pointing to the somewhat higher efficacy of Na-PPS specifically during the first days. Leucocyte levels and blood sedimentation rate (BSR) underwent co mparable changes with both therapies. Both treatments were well tolera ted by the patients; over the total observation time no adverse events whatsoever were observed in any of the patients. Thus 1.5% pentosan p olysulfate sodium gel proved its efficacy in the treatment of infusion thrombophlebitis to be at least equal to heparin-Na gel 60.000. There fore, 1.5% Na-PPS is an alternative bearing less in the percutaneous t reatment of infusion thrombophlebitis risk compared to heparin-Na gel made of animal starting material.