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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.