Parameter (Units) | Baseline | Day 180 | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Normal range | Placebo (n = 58) | GC (n = 65) | UC-II (n = 63) | p value GC vs PBO | p value UC-II vs PBO | p value UC-II vs GC | Placebo (n = 53) | GC (n = 56) | UC-II (n = 53) | p value GC vs PBO | p value UC-II vs PBO | p value UC-II vs GC | |
Hematology | |||||||||||||
Hemoglobin (gm/dL) | 12.1–17.2 | 12.1 ± 0.22 | 11.9 ± 0.21 | 12.1 ± 0.20 | 0.7613 | 0.9948 | 0.8095 | 12.7 ± 0.24 | 12.4 ± 0.20 | 12.7 ± 0.18 | 0.4454 | 0.9727 | 0.5851 |
ESR (mm/h) | 0–29 | 21.1 ± 1.77 | 23.9 ± 2.18 | 17.5 ± 1.56 | 0.7629 | 0.1034 | 0.0144 | 15.1 ± 1.24 | 17.0 ± 1.91 | 13.6 ± 1.28 | 0.9424 | 0.5364 | 0.3387 |
RBC (million/mm3) | 4.7–6.1 | 4.29 ± 0.08 | 4.21 ± 0.08 | 4.33 ± 0.09 | 0.7747 | 0.9388 | 0.5498 | 4.32 ± 0.08 | 4.25 ± 0.08 | 4.37 ± 0.08 | 0.7935 | 0.8946 | 0.5129 |
WBC (/mm3) | 4500-10,000 | 7979 ± 234 | 8248 ± 222 | 7795 ± 249 | 0.7020 | 0.8483 | 0.3523 | 7984 ± 204 | 7981 ± 209 | 7769 ± 204 | 1.0000 | 0.7706 | 0.7639 |
Platelet count (x100000/mm3) | 1.5-4.5 | 2.77 ± 0.08 | 2.84 ± 0.08 | 2.78 ± 0.08 | 0.7837 | 0.9946 | 0.8319 | 2.77 ± 0.07 | 2.84 ± 0.07 | 2.77 ± 0.09 | 0.8304 | 0.9993 | 0.8113 |
Liver Function | |||||||||||||
Albumin (gm/dL) | 3.5–5.5 | 3.98 ± 0.06 | 4.02 ± 0.06 | 3.94 ± 0.06 | 0.8957 | 0.9089 | 0.6503 | 4.00 ± 0.05 | 4.03 ± 0.05 | 3.96 ± 0.04 | 0.8931 | 0.8902 | 0.6292 |
ALP (IU/L) | 44–147 | 117 ± 5.74 | 118 ± 5.84 | 115 ± 5.57 | 0.9871 | 0.9838 | 0.9404 | 123 ± 5.72 | 116 ± 5.49 | 115 ± 5.59 | 0.5622 | 0.4847 | 0.9890 |
SGOT (U/L) | 10–34 | 25.2 ± 0.93 | 24.0 ± 0.97 | 24.4 ± 0.60 | 0.5778 | 0.7796 | 0.9421 | 24.6 ± 0.73 | 23.9 ± 0.81 | 23.9 ± 0.65 | 0.7711 | 0.7930 | 0.9995 |
SGPT (U/L) | 5–35 | 25.9 ± 1.23 | 25.0 ± 1.40 | 24.1 ± 0.95 | 0.5977 | 0.6004 | 1.0000 | 24.5 ± 0.94 | 24.3 ± 1.00 | 23.3 ± 0.99 | 0.9688 | 0.7119 | 0.8427 |
Total bilirubin (mg/dL) | 0.3–1.9 | 0.78 ± 0.08 | 0.69 ± 0.03 | 0.72 ± 0.03 | 0.5376 | 0.9424 | 0.7343 | 0.72 ± 0.03 | 0.67 ± 0.03 | 0.78 ± 0.04 | 0.4243 | 0.6098 | 0.0718 |
Cardiac Function | |||||||||||||
Systolic BP (mm Hg) | <120 | 125 ± 1.28 | 127 ± 1.35 | 127 ± 1.21 | 0.5980 | 0.7320 | 0.9752 | 127 ± 1.18 | 125 ± 1.33 | 128 ± 1.22 | 0.7263 | 0.8949 | 0.4409 |
Diastolic BP (mm Hg) | < 80 | 81.2 ± 1.19 | 80.2 ± 0.83 | 81.7 ± 1.02 | 0.7544 | 0.9283 | 0.5094 | 80.2 ± 1.03 | 80.5 ± 1.07 | 78.9 ± 0.96 | 0.9877 | 0.6233 | 0.5180 |
Pulse rate (beats/min) | 60–100 | 80.0 ± 0.92 | 79.6 ± 0.98 | 80.3 ± 0.99 | 0.9149 | 0.9719 | 0.7956 | 80.0 ± 0.89 | 78.2 ± 0.82 | 79.2 ± 1.03 | 0.3201 | 0.8018 | 0.6989 |
Renal Function | |||||||||||||
Creatinine (mg/dL) | 0.6–1.3 | 1.00 ± 0.03 | 1.01 ± 0.04 | 0.96 ± 0.03 | 0.9995 | 0.5767 | 0.5778 | 0.96 ± 0.03 | 0.95 ± 0.02 | 0.96 ± 0.02 | 0.9904 | 0.9846 | 0.9508 |
BUN (mg/dL) | 6–24 | 18.1 ± 1.08 | 18.0 ± 1.11 | 18.0 ± 1.15 | 0.9929 | 0.9878 | 0.9992 | 18.6 ± 1.11 | 17.8 ± 1.09 | 17.9 ± 1.02 | 0.7602 | 0.7953 | 0.9985 |