Clinical Evaluation of an Oral Hemostatic Agent, Opthalm K® in Surgery for Paranasal Sinusitis

Abstract

In patients receiving radical surgery for chronic paranasal sinusitis, we compared the hemostatic effects of Opthalm K® (carbazochrome 10mg, phytonadion 5mg and ascorbic acid 100mg), with that of combinations of any two of the three ingredients in a double-blind controlled trial. The study involved a total of 219 patients from 13 institutions, and the medications were compared in 211 patients after 8 had been withdrown because of ineligibility. The overall efficacy of the drugs was assessed on the basis of the decrease in bleeding time, and the reduction of intra-operative and of post-operative blood loss. The overall usefulness was judged from the overall efficacy plus the overall safety. Both of the efficacy and the usefulness of Opthalm K® were superior to those of the products combining only two of the three ingredients.