Tanaka N, Tsuchiya R, Ishii K
Adv Exp Med Biol. 1979;120B:367-78.
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.
为评估注射用FOY（[4-(6-胍基己酰氧基)苯甲酸乙酯]甲磺酸盐）治疗急性胰腺炎的疗效和安全性，在日本38家医院开展了一项以抑肽酶为对照的临床对照研究。FOY组84例患者中有60例（71%）取得良好疗效，抑肽酶组66例患者中有29例（44%）取得良好疗效。结果表明这两种药物均有效，统计学分析显示在该临床试验条件下两组间存在显著差异（X2 = 10.464，p < 0.005）。此外，在4家医院开展了一项双盲试验，使用FOY - 305（[4-(4-胍基苯甲酰氧基)-苯乙酸n,n-二甲基氨甲酰甲酯]甲磺酸盐）口服胶囊和无活性安慰剂。FOY - 305组26例患者中有18例（69%）取得良好疗效，无活性安慰剂组25例患者中有8例（32%）取得良好疗效，表明两组间存在显著差异（X2 = 8.930，p < 0.01）。本研究结果提示，合成蛋白酶抑制剂FOY或FOY - 305对急性胰腺炎的治疗有益。
