Table 2.
Baseline characteristics of all randomized participants valid for evaluation of isoniazid-related liver injury and other adverse events on intention-to-treat bases
| Parameters | NAT2 genotype status | SA-type | IA-type | RA-type | p value | ||
|---|---|---|---|---|---|---|---|
| Treatments | STD | PGx | PGx/STD | PGx | STD | ||
| Patients (n) | 9 | 7 | 64 | 44 | 48 | ||
| Sex (M/F, n) | 4/5 | 4/3 | 44/20 | 25/19 | 35/13 | ||
| Age (years)a | 35.0 | 48.0 | 48.5 | 50.5 | 51.0 | 0.614 | |
| (35.0–43.0) | (36.0–58.0) | (34.0, 60.0) | (33.0, 57.8) | (30.0, 60.2) | |||
| Weight (kg)a | 55.0 | 59.5 | 54.1 | 50.0 | 57.5 | 0.058 | |
| (52.8–59.8) | (47.9–62.8) | (50.1–62.2) | (45.9–55.2) | (47.6–63.8) | |||
| AST (IU/L)a | 18 | 17 | 18 | 16 | 19 | 0.165 | |
| (15–22) | (17–27) | (15–24) | (13–20) | (15–22) | |||
| ALT (IU/L)a | 12 | 15 | 14 | 12 | 15 | 0.066 | |
| (10–19) | (9–24) | (10–21) | (8–16) | (11–21) | |||
| ALP (IU/L)a | 241 | 244 | 238 | 255 | 242 | 0.696 | |
| (214–305) | (195–329) | (184–285) | (208–304) | (205–288) | |||
| Total-bilirubin (mg/dL)a | 0.3 | 0.5 | 0.6 | 0.5 | 0.6 | 0.338 | |
| (0.3–0.6) | (0.5–0.8) | (0.4–0.7) | (0.4–0.6) | (0.4–0.7) | |||
| Creatinine (mg/dL)a | 0.6 | 0.6 | 0.7 | 0.7 | 0.7 | 0.462 | |
| (0.5–0.7) | (0.5–0.8) | (0.6–0.8) | (0.5–0.8) | (0.6–0.8) | |||
| Anti-tuberculosis drugs (Dose, mg/kg/day)b | |||||||
| Isoniazidb | 5.5 (0.8) | 2.6 (0.3) | 5.5 (0.9) | 8.8 (1.3) | 5.5 (1.0) | NA | |
| Rifampicinb | 8.7 (1.4) | 8.9 (1.7) | 8.7 (1.4) | 9.5 (1.4) | 9.4 (1.5) | 0.076 | |
| Pyrazinamideb | 23.7 (3.0) | 20.7 (4.3) | 22.1 (5.9) | 22.7 (2.7) | 22.8 (4.6) | 0.676 | |
| Ethambutolb | 14.5 (2.0) | 15.4 (3.2) | 14.4 (3.5) | 15.4 (2.5) | 15.3 (4.1) | 0.555 | |
| Concomitant drug (%) | |||||||
| Vitamin B6 | 44.4 | 50.0 | 40.6 | 43.2 | 43.8 | ||
| Primary sputum culture (n) of complex infection or INH resistance | |||||||
| Negative | 1 | 0 | 21 | 8 | 8 | ||
| Positive-low (< +++) | 7 | 6 | 26 | 22 | 26 | ||
| Positive-high (> = +++) | 1 | 1 | 9 | 9 | 10 | ||
aData are presented as the median (25 %, 75 %).
bData are presented as means (SD).
There was no statistical difference between PGx and STD in IA. Five groups were compared by ANOVA. PGx, NAT2 genotype-guided treatment group; STD, conventional standard treatment group; RA-type, rapid acetylator genotype homozygous for NAT2*4; IA-type, intermediate acetylator genotypes heterozygous for NAT2*4; SA-type, slow acetylator genotypes without NAT2*4. NA, not applied