An Efficacy Evaluation of the Oral Administration Metadoxine in Korean Alcoholic Liver Patients : a Randomized, Placebo-Controlled Trial

알코올성 간질환을 가진 한국인에서 경구 메타독신 투여 효과 : 대조군을 이용한 연구

Background : To investigate the effectiveness of metadoxine (pyridoxol L-2 pyrrolidone-5-carboxylate) in the treatment of Korean alcoholic patients with liver diseases. Method : A randomized, placebo-controlled trial involving 36 chronic active alcoholic liver disease patients diagnosed by clinical biochemical and ultrasonographic findings. Patients were treated with 1000mg/day of metadoxine(n=24) or placebo(n=12) for 2 months. Patients were clinically and biochemically evaluated every month. Abdominal ultrasonography was performed at the diagnosis. Results : At the end of the study there was a significant improvement in the liver function tests in both groups. However, the changes were more rapid and greater in patients treated with metadoxine. Almost all patients in both groups continued drinking through the study. Though alcohol intake was lower than initially and similar in both groups. Conclusion : In patients with alcoholic liver, metadoxine accelerates the normalization of liver function tests even in those who do not completely abstain from alcohol intake. We concluded that the metadoxine could be useful in the treatment of the alcoholic liver disease in Korea.

목 적 : 저자들은 알코올성 지방간 환자에서 효과가 입증된 메타독신을 한국인 알코올성 간질환 환자에 적용하여 약효, 투여내능 및 약물의 안정성을 알아보고자 연구를 시행하였다. 대상 및 방법 : 환자는 1일 알코올 섭취량이 90g 이상인 성인 36명을 대상으로 시행했으며 이 중. 24명은 하루 1000mg의 메타독신을, 대조군으로 12명은 모양이 같은 위약을 2개월 투여하였다. 환자들은 매달 임상적, 생화학적으로 평가되었다. 결 과 : 통계적으로 유의성은 없으나 메타독신 군에서 대조군에 비해 간기능 회복이 좀더 빨랐고 호전된 양의 차이가 큰 경향을 보였다. 결 론 : 한국인 알코올성 간질환 환자에서 메타독신은 부작용 없이 간기능 호전을 보였다.