TABLE 1.
Patient detailsa
| Characteristic | Value(s) |
|---|---|
| Median (IQR) age (yr) | 38 (27–50) |
| No. (%) of male patients | 1,291 (68) |
| Median (IQR) BMI (kg/m2) | 18.7 (16.4–21.6) |
| Median (IQR) body wt (kg) | 48 (42–55) |
| Nondiabetes patients | 46 (40–54)b |
| Diabetes patients | 53 (47–60)b |
| No. (%) of patients who were: | |
| Smokers | 612 (32) |
| Alcohol users | 742 (39) |
| Smear positive | 887 (46) |
| HIV seropositive | 19 (1.0) |
| No. (%) of patients who had: | |
| Diabetes mellitus | 452 (24) |
| Extrapulmonary TB | 671 (35) |
| Baseline INH resistance | 53 (8)c |
| Category I ATT | 1,659 (87) |
| Median (IQR) concn in clinical investigations | |
| Hemoglobin (g/dl) | 12.0 (10.9–13.3) |
| Glucose (mg/dl) | 96 (84–127) |
| Creatine (mg/dl) | 0.7 (0.6–0.9) |
| Urea (mg/dl) | 16 (13–20) |
| AST (U/liter) | 19.0 (16.0–25.0) |
| ALT (U/liter) | 13 (10–19) |
| Median (IQR) dose (mg/kg of body wt) | |
| RMP | 9.6 (8.7–10.7) |
| Nondiabetes patients | 10.0 (8.8–11.3)b |
| Diabetes patients | 9.0 (8.3–10.0)b |
| PTB patients | 10.0 (9.0–11.3)b |
| EPTB patients | 9.0 (8.3–10.0)b |
| Patients with RMP concn of <8 μg/ml | 9.6 (8.7–10.7)b |
| Patients with RMP concn of ≥8 μg/ml | 10.0 (9.0–11.3)b |
| INH | 12.5 (10.9–14.3) |
| Nondiabetes patients | 13.0 (11.1–15.0)b |
| Diabetes patients | 11.3 (10.0–12.8)b |
| PTB patients | 13.3 (11.3–15.0)b |
| EPTB patients | 11.3 (9.7–13.3)b |
| Patients with INH concn of <3 μg/ml | 12.0 (10.3–14.3)b |
| Patients with INH concn of ≥3 μg/ml | 12.5 (10.9–14.3)b |
| PZA | 31.3 (27.3–35.7) |
| Nondiabetes patients | 32.6 (27.8–37.5)b |
| Diabetes patients | 28.3 (25.0–31.9)b |
| PTB patients | 33.3 (28.3–37.5)b |
| EPTB patients | 28.3 (24.2–33.3)b |
| Patients with PZA concn of <20 μg/ml | 30.0 (26.3–35.7)b |
| Patients with PZA concn of ≥20 μg/ml | 31.3 (27.3–35.7)b |
| Median (IQR) drug concn (μg/ml) at 2 h postdosing | |
| RMP | 2.3 (0.6–5.0) |
| INH | 7.5 (4.5–11.0) |
| PZA | 33.5 (24.0–41.7) |
| No. (%) of patients with subtherapeutic level | |
| RMP (<8 μg/ml) | 1,740 (91) |
| INH (<3 μg/ml) | 309 (16) |
| PZA (<20 μg/ml) | 333 (17) |
| No. (%) of patients with the following treatment outcome: | |
| Favorable | 1,648 (86) |
| Cured | 687 (36) |
| Treatment completed | 961 (50) |
| Unfavorable | 264 (14) |
| Death | 31 (2) |
| Treatment failure | 20 (1) |
| Default | 213 (11) |
a
Data are for 1,912 patients unless indicated otherwise. BMI, body mass index; ATT, antitubercular treatment; AST, aspartate transaminase; ALT, alanine transaminase; PTB, pulmonary tuberculosis; EPTB, extrapulmonary tuberculosis; RMP, rifampin; INH, isoniazid; PZA, pyrazinamide.
b
P < 0.05 between the subgroups.
c
Data were available only for culture-positive cases (n = 651 patients).