Parameter* | Placeo (n = 16) | 40 mg PC-SOD (n = 17) | 80 mg PC-SOD (n = 17) | P-value |
---|---|---|---|---|
Disease category, n (%) | ||||
IPF | 16 (100.0) | 12 (70.6) | 16 (94.1) | 0.037 |
NSIP | 0 (0.0) | 5 (29.4) | 1 (5.9) | |
Sex, n (%) | ||||
Male | 14 (87.5) | 14 (82.4) | 14 (82.4) | 1.000# |
Female | 2 (12.5) | 3 (17.6) | 3 (17.6) | |
Medical history, n (%) | ||||
No | 3 (18.8) | 3 (17.6) | 6 (35.3) | 0.537# |
Yes | 13 (81.3) | 14 (82.4) | 11 (64.7) | |
Concomitant disease, n (%) | ||||
No | 0 (0.0) | 0 (0.0) | 1 (5.9) | 1.000# |
Yes | 16 (100.0) | 17 (100.0) | 16 (94.1) | |
Corticosteroid use§, n (%) | ||||
No | 9 (56.2) | 5 (29.4) | 9 (52.9) | 0.286† |
Yes | 7 (43.8) | 12 (70.6) | 8 (47.1) | |
Immunosuppressant use¶, n (%) | ||||
No | 10 (62.5) | 10 (58.8) | 12 (70.6) | 0.900† |
Yes | 6 (37.5) | 7 (41.2) | 5 (29.4) | |
Age (years) | 66.8 ± 8.1 | 66.4 ± 7.0 | 67.4 ± 9.0 | 0.943†† |
Body weight (kg) | 65.2 ± 10.6 | 61.9 ± 10.7 | 62.1 ± 10.5 | 0.608†† |
FVC (mL) | 2158 ± 706 | 1819 ± 481 | 1857 ± 471 | 0.177†† |
%VC (%) | 68.2 ± 17.3 | 61.5 ± 12.7 | 59.6 ± 11.2 | 0.197†† |
TLC (mL) | 3113 ± 825 | 2834 ± 719 | 2842 ± 667 | 0.501†† |
%DLCO (%) | 32.67 ± 7.95 | 32.01 ± 16.08 | 34.88 ± 15.45 | 0.827†† |
SpO2 (%) | 94.94 ± 2.21 | 95.06 ± 2.14 | 93.76 ± 2.97 | 0.254†† |
KL-6 (U/mL) | 1312.8 ± 473.0 | 1656.8 ± 932.5 | 1348.1 ± 555.9 | 0.290†† |
SP-D (ng/mL) | 300.6 ± 200.49 | 272.53 ± 124.18 | 314.84 ± 301.20 | 0.852†† |
SP-A (ng/mL) | 90.34 ± 46.99 | 92.41 ± 43.36 | 90.58 ± 38.49 | 0.988†† |
LDH (IU/L) | 245.6 ± 63.6 | 241.8 ± 41.0 | 287.2 ± 88.4 | 0.104†† |
Borg scale | 3.2 ± 2.1 | 3.5 ± 2.6 | 2.8 ± 2.2 | 0.672†† |