|
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)
|
- (St): Student's t test; (MW): Mann-Whitney's U test; all binary variable comparisons were with the Fisher's exact test.
-
(a) All overall responses were complete except for one IFN group case at month 6 with partial response.
-
(b) General clinical status improvement if the patient passed from "bad" to "moderate" or from "moderate" to "good".
- Adv: Advanced; Mod: Moderate; Min: Minimum; (c) Combining advanced-moderate;
-
dOne of them had lesions disappearance at this time.
