Comparative clinical study of FOY and Trasylol in acute pancreatitis

Abstract

In order to evaluate the efficacy and safety of FOY injectable ([ethyl-4-(6-guanidinohexanoyloxy) benzoate] methane sulfonate) on acute pancreatitis, a comparative clinical study was carried out using Trasylol as the control at 38 hospitals in Japan. Favourable results were obtained in 60 (71%) out of 84 patients in the FOY group and 29 (44%) out of 66 patients in the Trasylol group. The results showed that these both drugs were effective and the statistical analysis revealed considerable difference (X2 = 10.464, p less than 0.005) between the two groups in this condition of clinical trial. In addition, a double blind trial was carried out at 4 hospitals using FOY-305 ([n.n-dimethylcarbamoylmethy 4-(4-guanidinobenzoyloxy)-phenylacetate] methane sulfonate) oral capsule and inactive placebo. Favourable results were obtained in 18 (69%) out of 26 patients in the FOY-305 group and 8 (32%) out of 25 patients in the inactive placebo group, indicating a significant difference between the two groups (X2 = 8.930, p less than 0.01). The results of the present study suggest that synthetic protease inhibitor, FOY or FOY-305, is beneficial in the treatment of acute pancreatitis.