Table 5.
Laboratory profiles of study participants assigned to the DW2009 and placebo groups.
| Laboratory Profiles | Baseline | Follow-up | ||||
|---|---|---|---|---|---|---|
| Placebo (n = 50) |
DW2009 (n = 50) |
p | Placebo (n = 47) |
DW2009 (n = 45) |
p | |
| Complete blood cell count | ||||||
| WBC (109/L) | 5.43 (1.16) | 5.63 (1.19) | 0.39 | 5.77 (1.51) | 5.77 (1.45) | 0.99 |
| RBC (1012/L) | 4.33 (0.33) | 4.43 (0.33) | 0.12 | 4.29 (0.32) | 4.41 (0.30) | 0.06 |
| Hemoglobin (g/L) | 134 (10.4) | 137 (10.7) | 0.23 | 133 (10.2) | 136 (8.92) | 0.11 |
| Hematocrit (proportion of 1.0) | 0.40 (0.03) | 0.41 (0.03) | 0.29 | 0.40 (0.03) | 0.41 (0.03) | 0.13 |
| Platelet (109/L) | 239 (53.9) | 246 (56.7) | 0.55 | 241 (54.9) | 248 (55.3) | 0.57 |
| Neutrophil (proportion of 1.0) | 0.54 (0.08) | 0.57 (0.09) | 0.11 | 0.55 (0.09) | 0.57 (0.08) | 0.25 |
| Blood chemistry | ||||||
| Total Protein (g/L) | 73.1 (4.16) | 73.6 (3.76) | 0.55 | 73.4 (3.75) | 72.7 (3.62) | 0.37 |
| Albumin (g/L) | 42.3 (1.88) | 42.9 (2.14) | 0.15 | 42.4 (1.75) | 42.4 (1.84) | 0.95 |
| AST (µkat/L) | 0.42 (0.11) | 0.41 (0.11) | 0.74 | 0.43 (0.13) | 0.40 (0.10) | 0.12 |
| ALT (µkat/L) | 0.33 (0.17) | 0.35 (0.16) | 0.47 | 0.34 (0.13) | 0.32 (0.11) | 0.63 |
| ALP (µkat/L) | 1.23 (0.32) | 1.33 (0.50) | 0.24 | 1.25 (0.31) | 1.32(0.45) | 0.43 |
| Total Bilirubin (µmol/L) | 14.4 (5.20) | 15.1 (6.06) | 0.58 | 13.1 (4.05) | 14.4 (6.98) | 0.26 |
| Total Cholesterol (mmol/L) | 5.23 (0.81) | 5.02 (0.98) | 0.26 | 5.08 (0.64) | 4.97 (0.88) | 0.51 |
| Glucose (mmol/L) | 5.32 (0.79) | 5.30 (0.71) | 0.92 | 5.36 (0.83) | 5.31 (0.69) | 0.79 |
| Creatinine (µmol/L) | 61.7 (13.5) | 63.6 (13.3) | 0.48 | 61.5 (13.3) | 62.5 (14.3) | 0.74 |
| BUN (mmol/L) | 5.50 (1.19) | 5.56 (1.35) | 0.80 | 5.73 (1.57) | 5.89 (1.45) | 0.63 |
| Uric acid (µmol/L) | 286 (78.1) | 299 (71.0) | 0.40 | 286 (75.0) | 311 (69.8) | 0.11 |
Data are presented as mean (standard deviation). Analyses for secondary efficacy measures were performed using a mixed-effects model repeated-measures analysis. Treatment group, visit, and treatment group-by-visit interaction were included as fixed effects, while the within-subjects factor was included as a random effect. WBC, white blood cell; RBC, red blood cell; AST, aspartate aminotransferase; ALT, alanine aminotransferase; ALP, alkaline phosphatase; BUN, blood urea nitrogen.