Table 3. Characteristics, outcomes, and management of DILI.
| Characteristics | Value (n = 365) | |
|---|---|---|
| DILI inclusion criteria | ||
| ALT > 120 IU/L and TB > 2.4 mg/dL | 37 (10.1) | |
| ALT > 200 IU/L | 339 (92.9) | |
| Patients who met both criteria | 11 (3.0) | |
| Duration of medication (day) | 6 (1–45) | |
| Peak level of laboratory findings | ||
| ALT (IU/L) | 275 (120–3,637) | |
| AST (IU/L) | 207 (49–5,737) | |
| TB (mg/dL) | 5.4 (0.2–34.9) | |
| Liver injury pattern | ||
| Hepatocellular | 315 (86.3) | |
| Cholestasis | 6 (1.6) | |
| Mixed | 44 (12.1) | |
| DILI subgroup | ||
| DILI without skin rash | 358 (98.1) | |
| DILI with skin rash | 5 (0.3) | |
| DRESS | 2 (0.6) | |
| RUCAM score, mean (median) | 7.59 (8) | |
| Highly probable | 163 (36.1) | |
| Probable | 228 (50.1) | |
| Possible | 60 (13.3) | |
| Time to normalization of LFT results, day (median) | ||
| ALT | 12 (1–59) | |
| AST | 7 (1–90) | |
| TB | 5 (2–45) | |
| Outcomes | ||
| Unknown | 76 (20.8) | |
| Recovery | 273 (74.8) | |
| ICU care | 4 (1.1) | |
| In-hospital death | 15 (4.1) | |
| Management | ||
| Discontinuation of causative drug | 223 (61.1) | |
| Hepatotonics* | 171 (46.8) | |
| Unknown | 79 (21.6) | |
| Systemic corticosteroid | 11 (3.0) | |
Values are presented as number (%) or median (range).
DILI, drug-induced liver injury; ALT, alanine aminotransferase; AST, aspartate aminotransferase; DRESS, drug reaction with eosinophilia and systemic symptoms; LFT, liver function test; ICU, intensive care unit; RUCAM, Roussel Uclaf Causality Assessment Method; TB, total bilirubin.
*“Hepatotonics” included drugs commonly used for liver disease such as ursodeoxycholic acid, Carduus marianus extract (Legalon®), biphenyl dimethyl dicarboxylate-containing formulations (e.g., Godex®), and HepaMerz®.