Table 1.
Baseline Characteristics and Outcome
| Nitrofurantoin (n = 42) | Minocycline (n = 28) | Methyldopa (n = 11) | Hydralazine (n = 7) | |
|---|---|---|---|---|
| Feature | ||||
| Age (y)a | 65 (36–84) | 19 (16–61) | 29 (18–43) | 60 (42–76) |
| Female sex | 42 (100%) | 22 (79%) | 11 (100%) | 5 (71%) |
| Race | ||||
| White | 38 (91%) | 22 (79%) | 4 (36%) | 4 (57%) |
| Black | 3 (7%) | 3 (11%) | 6 (55%) | 3 (43%) |
| Other | 1 (2%) | 3 (11%) | 1 (9%) | 0 |
| BMI (kg/m2)a | 27 (17–47) | 22 (18–30) | 36 (23–50) | 27 (24–45) |
| Latency (mo) | ||||
| <1 | 5 (12%) | 1 (4%) | 1 (9%) | 3 (43%) |
| 1–6 | 7 (17%) | 7 (25%) | 9 (82%) | 3 (43%) |
| 6–12 | 4 (9%) | 6 (21%) | 1 (9%) | 1 (14%) |
| >12 | 26 (62%) | 14 (50%) | 0 | 0 |
| Initial results | ||||
| ALT (U/L)a | 739 (106–1700) | 938 (74–2942) | 1414 (206–3319) | 558 (132–2018) |
| AST (U/L)a | 643 (106–2221) | 765 (80–2504) | 1601 (282–2077) | 1046 (184–1410) |
| Alk P (U/L)a | 190 (80–688) | 153 (74–783) | 125 (83–346) | 260 (188–607) |
| R ratioa,b | 7.1 (1.0–56.9) | 16.6 (0.4–50.7) | 21.4 (11.0–59.2) | 2.1 (1.1–28.9) |
| Bilirubin (mg/dL) | 4.7 (0.3–27.5) | 3.4 (0.2–16.7) | 7.3 (0.5–17.6) | 2.1 (0.3–29.7) |
| Pattern of injuryb | ||||
| Hepatocellular | 28 (67%) | 23 (82%) | 11 (100%) | 3 (43%) |
| Mixed | 11 (26%) | 2 (7%) | 0 | 2 (29%) |
| Cholestatic | 3 (7%) | 3 (11%) | 0 | 2 (29%) |
| Symptoms, signs | ||||
| Jaundice | 26 (62%) | 14 (50%) | 9 (82%) | 3 (43%) |
| Itching | 18 (43%) | 14 (50%) | 6 (55%) | 3 (43%) |
| Rash | 10 (24%) | 5 (18%) | 3 (27%) | 1 (14%) |
| Fever | 11 (26%) | 7 (25%) | 3 (27%) | 1 (14%) |
| Eosinophilia | 1 (2%) | 2 (7%) | 0 | 1 (17%) |
| Phenotype | ||||
| Immunoallergic | 8 (19%) | 3 (11%) | 3 (27%) | 1 (14%) |
| Autoimmune | 24/29 (83%) | 14/19 (74%) | 6/10 (60%) | 3/7 (43%) |
| Course and outcome | ||||
| Severity scorec | ||||
| Mild (1+) | 17 (41%) | 12 (43%) | 2 (18%) | 2 (29%) |
| Moderate (2+, 3+) | 9 (21%) | 14 (50%) | 7 (64%) | 3 (43%) |
| Severe (4+, 5+) | 16 (38%) | 2 (7%) | 2 (18%) | 2 (29%) |
| Severity scorea | 3 (1–5) | 2 (1–4) | 3 (1–4) | 3 (1–5) |
| Liver transplant | 3 (8%) | 0 | 0 | 1 (14%) |
| Death | 2 (5%) | 0 | 0 | 0 |
| Corticosteroid therapy | 20 (48%) | 14 (50%) | 3 (27%) | 4 (57%) |
| Chronicity (6 mo)d | 6/33 (18%) | 6/24 (25%) | 2/10 (20%) | 1/7 (17%) |
| Chronicity (last value)d | 3/33 (9%) | 2/24 (8%) | 0/10 (0%) | 1/7 (17%) |
BMI, body mass index.
a
Median (range).
b
Definitions: R ratio = (ALT/ULN) ÷ (Alk P/ULN). Hepatocellular, R ratio >5; Mixed, R ratio 2–5; Cholestatic, R ratio <2.
c
Severity scores: Mild, serum enzyme elevations without jaundice; Moderate, serum enzyme elevations and jaundice (bilirubin >2.5 mg/dL); Severe, evidence of hepatic failure, death, or liver transplantation within 6 months of onset.
d
Chronicity = abnormal ALT, Alk P, or bilirubin values at 6 months or thereafter.