Table 1.
Demographic, clinical, and laboratory parameters of the subjects.
| DILI | Healthy control (n = 38) | P | |||
|---|---|---|---|---|---|
| All patients (n = 128) | Non-severe group (n = 68) | Severe group (n = 60) | |||
| Age (year, mean [SD]) | 50.61 (14.8) | 50.2 (15.6) | 51.1 (14.1) | 44.0 (13.2) | 0.792 |
| Female (%) | 89 (69.5) | 49 (72.1) | 40 (66.7) | 21 (55.3) | 0.508 |
| Alcohol use | 20 (15.6) | 8 (11.8) | 12 (20.0) | – | 0.200 |
| Preexiting liver disease | 28 (21.9) | 16 (23.5) | 12 (20.0) | – | 0.630 |
| Hypertension | 22 (17.2) | 12 (17.6) | 10 (16.7) | – | 0.883 |
| Diabetes mellitus | 20 (15.6) | 16 (23.5) | 4 (6.7) | – | 0.009 |
| Jaundice | 52 (40.6) | 12 (17.6) | 40 (66.7) | – | < 0.001 |
| Causative drugs-HDS | 98 (76.6) | 46 (67.6) | 52 (86.7) | – | 0.011 |
| Latency | 0.258 | ||||
| < 5 days | 9 (7.0) | 5 (7.4) | 4 (6.7) | – | |
| 5–90 days | 111 (86.7) | 61 (89.7) | 50 (83.3) | – | |
| > 90 days | 8 (6.3) | 2 (2.9) | 6 (10.0) | – | |
| RUCAM | 0.649 | ||||
| Highly probable (> 8) | 74 | 39 | 35 | – | |
| Probable (6–8) | 46 | 21 | 25 | – | |
| Pattern of liver injury (%) | 0.453 | ||||
| Hepatocellular | 102 (79.7) | 54 (79.4) | 48 (80.0) | – | |
| Cholestatic | 8 (6.3) | 4 (5.9) | 4 (6.7) | – | |
| Mixed | 18 (14.1) | 10 (14.7) | 8 (13.3) | – | |
| Death by 90th day | 1 (0.8) | 0 | 1 (3.9) | – | 0.285 |
| Liver biochemistries at admission | |||||
| Chronic DILI | 25 (19.5) | 14 (20.6) | 11 (18.3) | – | 0.748 |
| ALT (U/L) | 665.02 (486.1) | 535.12 (342.9) | 812.2 (580.8) | 20.6 (9.9) | 0.022 |
| AST (U/L) | 382.9 (311.1) | 272.6 (169.8) | 507.9 (383.4) | 19.7 (5.6) | 0.004 |
| ALP (U/L) | 68.9 (15.7) | 158.4 (75.2) | 183.3 (90.7) | 68.9 (15.7) | 0.235 |
| TBIL (mg/dL) | 5.8 (5.9) | 1.8 (1.3) | 10.4 (5.7) | 0.7 (0.3) | < 0.001 |
| GGT (U/L) | 206.7 (183.2) | 186.5 (166.3) | 228.2 (200.2) | 25.1 (15.7) | 0.379 |
| ALB (g/L) | 38.9 (4.2) | 39.9 (3.7) | 37.7 (4.4) | 46.5 (3.4) | 0.036 |
| INR | 1.0 (0.2) | 1.0 (0.1) | 1.0 (0.2) | – | 0.079 |
| AOPPs (μmol/L) | 176.8 (92.6) | 124.8 (61.8) | 235.7 (86.5) | 40.1 (14.2) | < 0.001 |
| AOPPs/Albumin (μmol/g) | 5.1 (3.1) | 3.1 (1.2) | 7.4 (2.9) | 0.8 (0.3) | < 0.001 |
| IMA (ABSU) | 1.3 (0.8) | 0.7 (0.3) | 1.8 (0.7) | 0.3 (0.1) | < 0.001 |
| IMA/Albumin (ABSU*dL/g) | 0.3 (0.2) | 0.2 (0.1) | 0.5 (0.2) | 0.07 (0.02) | < 0.001 |
| Liver biochemistries on discharge | |||||
| ALT (U/L) | 205.4 (161.1) | 193.4 (123.8) | 219.8 (198.4) | – | 0.518 |
| AST (U/L) | 96.6 (71.4) | 85.3 (63.7) | 109.5 (78.2) | – | 0.184 |
| ALP (U/L) | 139.0 (62.1) | 145.5 (74.3) | 131.2 (43.0) | – | 0.364 |
| TBIL (mg/dL) | 3.1 (3.2) | 1.4 (1.4) | 5.1 (3.7) | – | < 0.001 |
| GGT (U/L) | 172.4 (185.8) | 155.1 (147.1) | 193.3 (224.8) | – | 0.418 |
| ALB (g/L) | 37.09 (4.0) | 38.0 (3.7) | 36.0 (4.2) | – | 0.518 |
| INR | 1.0 (0.1) | 0.9 (0.1) | 1.0 (0.2) | – | 0.014 |
| AOPPs (μmol/L) | 96.6 (52.2) | 77.8 (30.3) | 118.0 (62.8) | – | < 0.001 |
| AOPPs/Albumin (μmol/g) | 2.7 (2.0) | 1.9 (0.6) | 3.5 (2.5) | – | < 0.001 |
| IMA (ABSU) | 0.8 (0.5) | 0.6 (0.2) | 1.1 (0.5) | – | < 0.001 |
| IMA/Albumin (ABSU*dL/g) | 0.2 (0.1) | 0.1 (0.06) | 0.3 (0.1) | – | < 0.001 |
Data are mean ± SD, or number (percentage). P-values for comparisons between non-severe group and severe group.
DILI drug-induced liver injury, SD standard deviation, HDS herbal or dietary supplements, RUCAM Roussel Uclaf causality assessment method, ALT alanine aminotransferase, AST aspartate aminotransferase, ALP alkaline phosphatase, TBIL total bilirubin, GGT γ-glutamyl transpeptidase, ALB albumin, INR international normalized ratio, AOPPs advanced oxidation protein products, IMA ischemia-modified albumin.