Table 3 Clinical, radiological, bacteriological and overall outcomes during the trial.
Evaluation | Month | IFN gamma | Placebo | P (test) | |
|---|---|---|---|---|---|
Overall response | |||||
Responders (a) (intention-to- treat) | 6 | 13/18 (72.2%) | 5/14 (35.7%) | 0.037 (χ2) | |
18 | 12/18 (66.7%) | 4/14 (28.6%) | 0.030 (χ2) | ||
Responders (last evaluation) | 15/18 (83.3%) | 5/14 (35.7%) | 0.005 (χ2) | ||
Clinical | |||||
Dyspnea | 0 | 15/18 (83.3%) | 13/14 (92.9%) | ||
6 | 1/15 (6.7%) | 3/9 (33.3%) | 0.27 (FE) | ||
18 | 1/13 (7.7%) | 3/8 (37.5%) | 0.25 (FE) | ||
BMI (kg/m2), mean ± SD | 0 | 21.1 ± 3.5 (N = 18) | 18.7 ± 2.8 (N = 14) | ||
6 | 21.8 ± 3.7 (N = 14) | 19.4 ± 3.0 (N = 9) | 0.88 (St) | ||
18 | 22.9 ± 4.4 (N = 13) | 19.9 ± 3.9 (N = 8) | 0.15 (St) | ||
Good general status (intention-to-treat) | 0 | 3/18 (16.7%) | 4/14 (28.6%) | ||
6 | 13/18 (72.2%) | 5/14 (35.7%) | 0.037 (χ2) | ||
18 | 12/18 (66.7%) | 4/14 (28.6%) | 0.03 (χ2) | ||
Improvement (b) (intention-to-treat) | 6 | 13/18 (72.2%) | 5/14 (35.7%) | 0.037 (χ2) | |
18 | 12/18 (66.7%) | 4/14 (28.6%) | 0.03 (χ2) | ||
Radiological | |||||
Lesion extension | 0 | Adv | 12 (66.7%) | 11(78.6%) | |
Mod | 5 (27.8%) | 3 (21.4%) | |||
Min | 1 (5.6%) | 0 | |||
6 | Adv | 2 (13.3%) | 5 (55.6%) | 1.00c (FE) | |
Mod | 12 (80.0%) | 3 (33.3%) | |||
Min | 1 (6.7%) | 1 (11.1%) | |||
18 | Adv | 1 (7.7%) | 2 (25.0%) | 0.085c (FE) | |
Mod | 5 (38.5%) | 5 (62.5%) | |||
Min | 7 (53.8%)d | 1 (12.5%) | |||
Improvement (intention to treat) | 6 | 12/18 (66.7%) | 6/14 (42.8%) | 0.32 (χ2) | |
18 | 13/18 (72.2%) | 4/14 (28.6%) | 0.036 (χ2) | ||
Cavitary lesions disappearance | 5/12 (41.7%) | 1/12 (8.3%) | 0.15 (FE) | ||
Bacteriological | |||||
Sputum- Direct (+) | 0 | 14/18 (77.8%) | 10/14 (71.4%) | ||
Cod. | 7 ± 4 | 8 ± 8 | |||
6 | 1/15 (6.7%) | 2/10 (20.0%) | 0.54 (FE) | ||
Cod. | 0 ± 0 | 0 ± 2 | 0.28 (MW) | ||
18 | 1/13 (7.7%) | 3/8 (37.5%) | 0.253 (FE) | ||
Cod. | 0 ± 0 | 0 ± 7 | 0.112 (MW) | ||
Relapse | 1/13 (7.7%) | 3/8 (37.5%) | 0.25 (FE) | ||
Sputum- Culture (+) | 0 | 18 (100%) | 14 (100%) | ||
Cod. | 8 ± 2 | 9 ± 4 | |||
6 | 2/15 (13.3%) | 2/10 (20.0%) | 1.00 (FE) | ||
Cod. | 0 ± 0 | 0 ± 2 | 0.60 (MW) | ||
18 | 1/13 (7.7%) | 4/8 (50.0%) | 0.11 (FE) | ||
Cod. | 0 ± 0 | 0 ± 8 | 0.042 (MW) | ||
Relapse | 1/13 (7.7%) | 3/8 (37.5%) | 0.25 (FE) | ||