TABLE 2.
Parameter | All (n = 918) | Oral (n = 795, 86.6%) | Intravenous (n = 123, 13.4%) | p |
---|---|---|---|---|
Cmin (mg l−1) | <0.001 | |||
Median (IQR) | 1.64 (0.90, 3.00) | 1.51 (0.85, 2.60) | 4.00 (2.30, 5.80) | |
Range | 0.04–20.4 | 0.04–20.4 | 0.08–16.17 | |
Cmin level, n (%) a | <0.000 | |||
>0.5 | 105 (11.4%) | 99 (12.5%) | 6 (4.9%) | |
[0.5, 5] | 714 (77.8%) | 639 (80.4%) | 75 (61.0%) | |
>5 | 99 (10.8%) | 57 (7.2%) | 42 (34.1%) | |
Cmin/dose [(mg l−1)/(mg d−1)] | <0.001 | |||
Median (IQR) | 4.25 (2.25, 8.25) | 3.88 (2.10, 6.93) | 10.25 (5.4, 14.50) | |
Range | 0.08–51.0 | 0.08–51.0 | 0.40–42.50 | |
Cmin/dose level, n (%) b | <0.000 | |||
<1.25 | 108 (11.8%) | 102 (12.8%) | 6 (4.9%) | |
[1.25, 12.5] | 702 (76.5%) | 626 (78.7%) | 76 (61.8%) | |
>12.5 | 108 (11.8%) | 67 (8.4%) | 41 (33.3%) |
p was calculated comparing oral administration with intravenous administration by the Mann–Whitney U test or chi-squared test, accordingly.
The therapeutic index of VRC Cmin is in accordance with the practice guideline for individualized medication of VRC reported by the Chinese Pharmacological Society. The lower limit of VRC Cmin was set above 0.5 mg d−1 maintained-treatment response, and the higher limit was set as lowest concentration of hepatotoxicity.
The therapeutic index of the VRC Cmin/dose ratio was calculated by VRC trough concentration divided by the most commonly used dose (400 mg d−1).