만성 간질환 환자에 대한 고덱스 캅셀의 유효성.안정성에 관한 다기관, 무작위할당, 이중맹검 3상 비교임상시험

Oral Godex Capsule for Chronic Liver Disease : A Double-blind, Randomized, Multicenter Controlled Trial

Background/Aims : Godex is a mixture of PMC(diphenyl-dimethyl-dicarboxylate) and Hepadif, each of which has been used for managing chronic liver disease in Korea and other countries. The purpose of this study was to evaluate the efficacy and safety of Godex in Korean patients with chronic liver disease. Methods : In this study, 154 patients with chronic hepatitis, who showed increased level of serum alanine aminotransferase(ALT), were randomly allocated into three groups. Fifty-two patients were administered 100mg/day of PMC, 48 patients were administered low dose of Godex(PMC 100mg+hepadif 600mg/day) and 53 patients were administered high dose of Godex(PMC 150mg+hepadif 900mg/day) orally for 8 weeks. To evaluate the efficacy and safety of Godex capsule, we considered primary variable as the proportion of patients who showed normal ALT blood level after treatment for 8 weeks and second variable as a proportion of patient who showed normal ALT at 4 weeks, the degree of difference of serum ALT level between 0 and 8 weeks, and incidence of adverse events during treatment period. Results : The percentage of subjects whose serum ALT levels decreased below upper normal level in control, low-dose and high-dose group were 64.54%, 67.35%, 81.13% after 8 weeks-treatment(p=0.0407) and 59.62%, 63.27%, 81.13% after 4 weeks-treatment of Godex(p=0.0790) using ITT analysis. There were no significant difference in incidence of adverse events among three groups. Conclusions : Response rate of high-dose group was significantly higher than those of low-dose group and control group. It is suggested that Godex 6 capsules per day(PMC 150mg+hepadif 900mg/day) is optimal dose for Korean patients with chronic liver disease who show elevated serum alanine aminotransferase(ALT) level.