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서지반출
만성 간질환 환자에서 고덱스 캅셀의 단기간(8주) 유효성.안전성에 대한 연구
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  • 만성 간질환 환자에서 고덱스 캅셀의 단기간(8주) 유효성.안전성에 대한 연구
저자명
강주섭,홍정희,박문승,이정복,이재원,이민호,Kang. Ju-Seop,Hong. Jung-Hee,Park. Moon-Seung,Lee. Jung-Bok,Lee. Jae-Won,Lee. Min-Ho
간행물명
臨床藥理學會誌= The journal of Korean Society for Clinical Pharmacology and Therapeutics
권/호정보
2001년|9권 1호|pp.81-96 (16 pages)
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대한임상약리학회
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
서지반출

기타언어초록

Background/Aims: To evaluate the effect and safety of Godex(hepadif+PMC, diphenyl-dimethyl-dicarboxylate) in 95 patients with chronic liver disease, a prospective randomized double blind controlled clinical trial of a short-term(8 weeks) therapy with Godex was performed in a total 95 patients with chronic hepatitis who was diagnosed by liver biopsy or recently have a abnormal serum transaminase(ALT and/or AST) concentrations during longer than 6 months. Methods : In this clinical trial, 95 patients with chronic hepatitis patients were enrolled and allocated by a table of random digits in three groups. 32 patients received 150mg/day of PMC(control group), 30 patients received low dose of Godex(low-dose group, PMC 150mg+hepadif 600mg/day) and 33 patients received high dose of Godex(high-dose group, PMC 150mg+hepadif 900mg/day) orally for 8 weeks, and they were followed until 2 weeks without drugs to evaluate rebounding phenomenon of liver enzymes. We evaluate the effect and safety by biochemical laboratory test variables such as liver enzymes and clinical observed data at each visit date such as before(0) and 4, 8 weeks after drug treatment and 2 weeks after 8 weeks treatment. Compliance and side effects were evaluated at the same time. Results : After 4 weeks-treatment of Godex, the percentage of decrease of serum ALT levels within normal range in the low-dose and high-dose groups are about 63.6 and 80.8%, respectively and were significantly(p<0.05) lower than that of control group, 29.6%. Otherwise, after 8 weeks-treatment of Godex, those of low-dose and high-dose groups are about 54.6 and 88.5%, respectively and were significantly(p<0.05) lower compared of control group, 44.4% and that of high-dose group were more significant than low-dose group. But after 2 weeks without drugs, the rebounding phenomenon of serum ALT levels were not different within three groups and adverse effects were negligible and transient during 10 weeks. Conclusions : It is suggested that Godex is more effective and safe than PMC in the short-term treatment of chronic liver disease in Korean patients, but further evaluation about efficacy and safety of Godex for adequate duration of treatment in the large population of patients are needed.