Table 2.
Demographics and screening parameters
| Variables | ELAD | Control | |||||
|---|---|---|---|---|---|---|---|
| n/N | Percentage | n/N | Percentage | P-valuea | |||
| Sex | |||||||
| Male | 31/32 | 96.9 | 15/17 | 88.2 | 0.273 | ||
| Female | 1/32 | 3.1 | 2/17 | 11.8 | |||
| Main diagnosis | |||||||
| Chronic hepatitis B | 23/32 | 71.9 | 9/17 | 52.9 | 0.219 | ||
| Chronic hepatitis B+alcohol | 4/32 | 12.5 | 5/17 | 29.4 | 0.244 | ||
| Alcohol-induced hepatitis | 1/32 | 3.1 | 1/17 | 5.9 | 1.000 | ||
| Acute/subacute hepatitis | 3/32 | 9.4 | 0/17 | 0.0 | 0.542 | ||
| Drug-induced hepatitis | 0/32 | 0.0 | 1/17 | 5.9 | 0.347 | ||
| Autoimmune hepatitis | 1/32 | 3.1 | 0/17 | 0.0 | 1.000 | ||
| Unknown etiology | 0/32 | 0.0 | 1/17 | 5.9 | 0.347 | ||
| Variables | N | Mean±SD | Range | N | Mean±SD | Range | P-value* |
| Demographics | |||||||
| Age (years) | 32 | 39.5±9.6 | 15.5–65.1 | 17 | 39.2±11.6 | 19.6–61.2 | 0.929 |
| Height (cm)b | 32 | 169±5 | 156–182 | 16 | 172±5 | 163–176 | 0.067 |
| Weight (kg)c | 32 | 67.3±11.9 | 45.0–95.0 | 15 | 71.1±9.7 | 58.0–89.0 | 0.285 |
| Signs/symptoms | |||||||
| Fatigue (0–3) | 32 | 2.31±0.59 | 1.00–3.00 | 17 | 2.29±0.77 | 0.00–3.00 | 0.926 |
| Flatulence (0–3) | 32 | 0.69±0.78 | 0.00–2.00 | 17 | 1.29±1.10 | 0.00–3.00 | 0.030 |
| MELD score | 32 | 28.0±3.5 | 21.4–36.7 | 17 | 30.8±5.6 | 22.1–40.5 | 0.040 |
| Hematology | |||||||
| RBCs (1012/L) | 32 | 3.53±0.90 | 1.47–5.30 | 17 | 3.77±1.12 | 1.90–6.10 | 0.411 |
| Hemoglobin (g/L) | 32 | 117.4±23.7 | 57.0–168.0 | 17 | 118.1±24.9 | 68.0–158.0 | 0.925 |
| WBCs (109/L) | 32 | 7.76±3.53 | 3.30–17.60 | 17 | 7.15±3.31 | 3.00–14.50 | 0.564 |
| Platelets (109/L) | 32 | 101.3±37.9 | 46.0–185.0 | 17 | 100.5±47.0 | 44.0–207.0 | 0.946 |
| Blood chemistry | |||||||
| Aspartate aminotransferase (U/L) | 32 | 163±1.28 | 41–644 | 17 | 188±1.57 | 36–523 | 0.548 |
| Alanine aminotransferase (U/L) | 32 | 229±376 | 15–1,817 | 17 | 164±1.34 | 16–393 | 0.495 |
| Total bilirubin (mg/dL) | 32 | 22.9±9.5 | 8.4–45.6 | 17 | 23.7±9.4 | 7.4–41.1 | 0.762 |
| Direct bilirubin (mg/dL) | 32 | 13.3±5.1 | 4.7–23.9 | 17 | 13.9±6.2 | 5.0–26.2 | 0.743 |
| Albumin (g/L) | 32 | 32.3±4.7 | 21.3–40.0 | 17 | 32.7±4.2 | 24.9–41.3 | 0.776 |
| Prealbumin (mg/L)d | 31 | 66.5±29.8 | 20.0–156.0 | 16 | 63.3±38.6 | 16.0–176.0 | 0.753 |
| Alkaline phosphatase (U/L) | 32 | 173.8±45.1 | 95.5–304.0 | 17 | 141.6±35.2 | 73.9–201.0 | 0.014 |
| Cholinesterase (U/L) | 32 | 2,637±959 | 1,026–4,231 | 17 | 2,619±930 | 955–4,682 | 0.951 |
| Creatinine (mg/dL) | 32 | 0.81±0.31 | 0.34–2.08 | 17 | 0.80±0.33 | 0.25–1.54 | 0.946 |
| Uric acid (mg/dL) | 32 | 2.16±1.29 | 0.59–7.27 | 17 | 2.08±1.02 | 0.64–4.47 | 0.827 |
| Glucose (mmol/L) | 32 | 4.55±3.83 | 0.92–22.17 | 17 | 6.69±4.23 | 2.07–18.79 | 0.079 |
| Cholesterol (mg/dL) | 32 | 74±23 | 43–136 | 17 | 58±19 | 16–84 | 0.019 |
| Coagulation status | |||||||
| Prothrombin time (s) | 32 | 22.7±4.2 | 17.4–36.6 | 17 | 27.2±8.5 | 18.3–45.4 | 0.016 |
| AP thromboplastin time (s) | 32 | 64.9±23.5 | 38.6–120.0 | 17 | 79.3±41.2 | 50.4–220.5 | 0.124 |
| Prothrombin activity (%) | 32 | 37.7±8.2 | 16.8–49.6 | 17 | 31.8±12.8 | 14.1–54.5 | 0.053 |
| International normalized ratio | 32 | 2.49±0.77 | 1.64–5.10 | 17 | 3.29±1.59 | 1.78–6.46 | 0.022 |
Notes:
a
ANOVA (continuous variables) or Fisher’s exact test (categorical variables).
b
Height at screening was not available for one control subject.
c
Weight at screening was not available for two control subjects.
d
Prealbumin measurement at screening was not available for one ELAD subject and one control subject.
Abbreviations: AP, activated partial; MELD, Model for End-Stage Liver Disease; RBCs, red blood cells; WBCs, white blood cells.