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Table 1 Patient demographics in 3 treatment groups

From: Double-blind controlled trial of lecithinized superoxide dismutase in patients with idiopathic interstitial pneumonia – short term evaluation of safety and tolerability

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††
  1. *Parameters other than sex, medical history, concomitant disease, corticosteroid use, and immunosuppressant use are expressed as mean ± SD.
  2. #Fisher’s exact test.
  3. §> 5 mg/day prednisone.
  4. Pearson’s χ 2 test.
  5. An immunosuppressant was chosen from ciclosporin, cyclophosphamide or azathioprine.
  6. ††One-way analysis of variance (ANOVA).
  7. Definition of abbreviations: IPF = idiopathic pulmonary fibrosis; NSIP = nonspecific interstitial pneumonia, PC-SOD = lecithinized superoxide dismutase; FVC = forced vital capacity; VC = vital capacity; TLC = total lung capacity; DLCO = diffusing capacity for carbon monoxide; KL-6 = Krebs von den Lungen-6; SP-D = surfactant protein-D; SP-A = surfactant protein-A; LDH = lactate dehydrogenase.
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