Population Pharmacokinetics of Enteric-Coated Mycophenolate Sodium in Children after Renal Transplantation and Initial Dosage Recommendation Based on Body Surface Area
Table 1
Demographic, clinical, biochemical, and medication usage data of modeling and validation groups.
Variable
Group for modeling
Group for validation
values
Sex (M/F)
96 (52/44)
32 (15/17)
1
Age (years)
13.3 (4.3–18.0)
13.0 (3.6–18.3)
0.802
Height (cm)
147 (102–171)
148 (104–171)
0.908
Weight (kg)
39.0 (15.0–67.0)
36.5 (12.7–74.0)
0.486
BSA (m2)
1.26 (0.66–1.78)
1.22 (0.61–1.80)
0.577
Posttransplant days (days)
396 (13–2258)
600 (19–2158)
0.184
SCR (μmol/L)
65.0 (35.0–272.0)
63.0 (42.0–150.0)
0.754
CLCR (mL/min/1.73 m2)
78.8 (20.1–164.6)
75.6 (37.7–126.4)
0.809
BUN (mmol/L)
7.30 (3.10–28.50)
6.10 (3.30–12.40)
0.200
ALT (IU/L)
12.1 (4.5–140.3)
13.5 (6.5–68.2)
0.488
AST (IU/L)
22.0 (12.0–60.2)
22.7 (13.8–199.3)
0.338
DBIL (μmol/L)
2.70 (0.90–5.10)
2.75 (1.20–8.60)
0.657
TBIL (μmol/L)
7.60 (3.00–20.00)
6.60 (2.50–11.60)
0.046
ALB (g/L)
41.4 (31.0–49.8)
41.4 (36.6–54.9)
0.229
GLB (g/L)
28.1 (17.1–46.6)
26.6 (19.0–39.4)
0.122
TCH (mmol/L)
4.09 (2.30–7.20)
3.56 (2.73–5.55)
0.021
LDH (IU/L)
243 (141–485)
250 (166-2193)
0.509
PLT (×109/L)
240 (101-451)
259 (139-385)
0.690
WBC (×109/L)
6.65 (2.50–19.60)
6.00 (2.00–14.30)
0.364
RBC (×1012/L)
4.43 (2.18–7.36)
4.37 (2.83–6.87)
0.888
HGB (g/L)
116 (72–167)
119 (87–151)
0.974
Total number of samples
384
125
Dosing amount (mg/kg/day)
10.5 (3.4–24.0)
10.6 (3.7–19.8)
0.389
Dosing amount (mg/m2/day)
325 (117–605)
305 (124-514)
0.217
Comedications
Tacrolimus
94 (97.9%)
32 (100%)
0.429
Cyclosporin
2 (2.08%)
0 (0%)
1
Data are presented as (percentage) or median (range). BSA: body surface area; SCR: serum creatinine; CLCR: creatinine clearance; BUN: blood urea nitrogen; ALT: alanine aminotransferase; AST: aspartate aminotransferase; DBIL: direct bilirubin; TBIL: total bilirubin; ALB: albumin; GLB: globulin; TCH: total cholesterol; LDH: lactate dehydrogenase; PLT: platelet; WBC: white blood cell; RBC: red blood cell; HGB: hemoglobin; IVIG: intravenous immune globulin. For continuous variables, Mann–Whitney test was used to compare the difference between the two groups. For categorical variables, chi square test was used.