Sensitivity and specificity of the new criteria for the diagnosis of drug-induced liver injury were examined among patients taking Kampo medicines. Examining the summaries of all admission records of patients from 1979 to 1999 in our department, we selected 30 summaries that described liver disorders suspected of being related to Kampo medicines. Causal relationship between lever injury and Kampo medicine was reexamined in each case. Specificity was examined using definitely unrelated group (8 cases), and sensitivity was examined using probably (2 cases) and definitely (4 cases) related groups. The sensitivity was 100% for the all criteria. The specificity was low for the all criteria, and was 25% for the original DDW-J criteria. These results suggest that the DDW-J criteria may be unreliable for the diagnosis of Kampo-medicine-induced liver injury.
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