Japanese diagnostic criteria for drug-induced liver injury (DILI) emphasize drug lymphocyte stimulation test data (DLSTD). The diagnostic scales of Maria and CIOMS, which give priority to clinical findings and previous DILI reports, are used in Europe and the United States. This study compared DLSTD for these two diagnostic scales in 58 patients with suspected DILI. The sensitivity, specificity and positive and negative predictive value of DLSTD were, respectively, 59.5%, 100%, 100% and 48.5% (Japanese criteria), and 43.4%, 60%, 92% and 9.1% (CIOMS). The CIOMS scale has a wider diagnostic range than the Japanese criteria and includes all compatible cases in Maria's scale. No significant association existed between any criterion and the clinical type of DILI or the causal drug type. Thus, DLSTD are useful for DILI diagnosis but their sensitivity is inadequate. The Japanese diagnostic criteria for DILI require revision giving priority to clinical information.
View full abstract