Ki Tae Suk, MD 1, Dong Joon Kim, MD 1, Chang Hoon Kim, BS 2, Seung Ha Park, MD 3, Jai Hoon Yoon, MD 1, Yeon Soo Kim, MD 1, Gwang Ho Baik, MD 1, Jin Bong Kim, MD 1, Young Oh Kweon, MD 4, Byung Ik Kim, MD 5, Seok Hyun Kim, MD 6, In Hee Kim, MD 7, Ju Hyun Kim, MD 8, Soon Woo Nam, MD 9, Yong Han Paik, MD 5, Jeong Ill Suh, MD 10, Joo Hyun Sohn, MD 11, Byung Min Ahn, MD 12, Soon Ho Um, MD 13, Heon Ju Lee, MD 14, Mong Cho, MD 15, Myoung Kuk Jang, MD 16, Sung Kyu Choi, MD 17, Seong Gyu Hwang, MD 18, Ho Taik Sung, BS 19, Jong Young Choi, MD 20 and Kwang Hyub Han, MD 21 Am J Gastroenterol 2012; 107:1380–1387; doi: /ajg ; published online 26 June 2012 소화기내과 R1 김다래

 Drug-induced liver injury (DILI)  liver injury caused by medications, herbs, or other causes  leading to abnormalities in liver test or liver dysfunction with the reasonable exclusion of other etiologies  result of idiosyncratic metabolic responses or unexpected reactions to medication : host genetic, immunological, and environmental factors  DILI is one of the leading causes of acute liver failure in the United States, accounting for 13 % of cases of acute liver failure; these events pose a major challenge for drug development and safety

 In a previous retrospective multi-center study, annual incidence of hospitalization of patients with DILI at a university hospital in Korea was estimated to be 2,629.  DILI is most important health problem in Korea.  Unfortunately, in both Korea and other Asian countries, there is limited prospective data regarding not only the epidemiology and clinical course of DILI but also the social burden and mortality of patients. This nation-wide multicenter study was performed prospectively to investigate the significance and epidemiology of DILI in Korea.

 Inclusive criteria  From May 2005 to May 2007, 17 university hospitals  Liver injury caused by medications, herbs, health foods or dietary supplements, traditional remedies, or others  ALT > 3xUNL or TB > 2xUNL  Exclusive criteria  Viral infection related liver injury or autoimmune disease  Inaccurate drug administration time  not meet the time-to-onset criteria of the RUCAM scale

 Patient selection Inclusion !

RUCAM (Roussel Uclaf Causality Assessement Method)

 Patients characteristics < Female 63.3%

 371 cases of DILI, age distribution was varied  There was no significant difference in the proportion of etiology between age groups Herbs !

 Type of DILI and RUCAM score RUCAM >

 Classification of DILI Most common causative agent was Herbal medications ! 40.1% total : 371

9 cases !

Total : 5/371 Mortality: 1.34%

 Limitation of this study  Different medical circumstances, time criteria for the RUCAM score or different diagnostic criteria may have affected the results.  Only cases from 17 university hospitals in Korea were collected, this may not constitute a representative sample in the study of DILI.  A standard needs to be established for the classification and definition of herbal drugs or traditional remedies.

 Drug-induced Liver Injury  highly relevant health problem in Korea  most common cause of DILI : herbal medications ! more objective and reproducible tool for the assessment of causality is strongly needed, especially in the context of linking “herbs” or “folk remedies” with DILI