Research Article

Drug-Induced Liver Injury during Consolidation Therapy in Childhood Acute Lymphoblastic Leukemia as Assessed for Causality Using the Updated RUCAM

Table 3

Demographic and laboratory characteristics of DILI and non-DILI in SR/IR cases.

DILI (n = 38)Non-DILI (n = 1501)Statistics value

Age, years5.4 ± 2.86.4 ± 3.6−1.4330.152
Gender, n (%)
Male23 (2.3)958 (97.7)0.174#0.676
Female15 (2.7)543 (97.3)
Han ethnicity, n (%)21 (55.3)856 (57.0)0.290#0.865
Treatment course ≥5, n (%)12 (31.6)117 (7.8)24.291#<0.001
BMI, kg/m215.9 ± 1.616.2 ± 2.1−0.4180.676
MTX dose per BSA, g/m24.3 ± 1.14.0 ± 1.3−1.5120.131
48 h MTX concentration, μmol/L0.62 ± 0.531.14 ± 3.72−0.2860.775
Prophylactic agents, n (%)30 (78.9)1019 (67.9)2.089#0.148
Baseline renal function
Creatinine, mg/dl0.33 ± 0.110.37 ± 0.13−1.9650.049
Cystatin C, mg/L0.78 ± 0.160.73 ± 0.15−1.7680.077
Urea, mmol/L4.0 ± 1.53.9 ± 1.4−0.6970.486
Uric acid, μmol/L225.5 ± 72.0226.6 ± 82.5−0.6680.504
Baseline liver function
Albumin, g/L44.3 ± 3.746.6 ± 3.4−4.074<0.001
Total bilirubin, μmol/L7.4 ± 4.96.3 ± 3.7−1.8340.067
ALT, U/L38.6 ± 24.925.7 ± 26.3−5.540<0.001
GGT, U/L40.9 ± 64.422.5 ± 20.4−3.4430.001
AST, U/L35.3 ± 15.728.3 ± 12.0−3.827<0.001
ALP, U/L218.0 ± 78.2202.1 ± 65.9−1.0710.284
Baseline blood routine
White blood cell count, ×109/L5.7 ± 3.35.8 ± 3.8−0.2020.840
Red blood cell count, ×1012/L3.8 ± 0.53.8 ± 0.6−0.3030.762
Platelet count, ×109/L260.7 ± 122.6297.2 ± 131.2−1.7960.073
Hemoglobin, g/L110.1 ± 14.1107.3 ± 14.2−1.3610.174

Z value, statistics of the Mann–Whitney U test; #χ2 value, statistics of the chi-square test. DILI, drug-induced liver injury; SR/IR, standard risk/intermediate risk; BMI, body mass index; MTX, methotrexate; BSA, body surface area; AST, aspartate aminotransferase; ALT, alanine aminotransferase; GGT, gamma-glutamyl transpeptidase; ALP, alkaline phosphatase.