Table 1.
Patient demographics
| Parameters | Control (n=46) | rhTM (n=39) | P value |
| Stable state | |||
| Sex, male/female | 37/9 | 28/11 | 0.64 |
| Smoking, y/n | 37/9 | 27/12 | 0.65 |
| Diagnosis, IPF/non-IPF | 22/24 | 12/27 | 0.29 |
| SLB, y/n | 5/41 | 3/36 | 0.74 |
| Honeycomb on HRCT, y/n | 24/22 | 13/26 | 0.30 |
| mMRC, ≤1/≥2 | 19/27 | 15/24 | 0.84 |
| Disease severity, I-III/IV | 34/12 | 24/15 | 0.25 |
| LTOT, y/n | 16/30 | 14/25 | 1.00 |
| Prednisolone, y/n | 17/29 | 15/24 | 1.00 |
| Prednisolone dose, mg/kg/day | 0.23 (0.04 to 0.55) | 0.16 (0.08 to 0.46) | 0.77 |
| Immunosuppressant, y/n | 6/40 | 5/34 | 1.00 |
| AZP/CyA/CPA/Tac | 2/4/0/0 | 2/2/0/1 | 0.74 |
| Pirfenidone, y/n | 4/42 | 6/33 | 0.50 |
| Nintedanib, y/n | 2/44 | 1/38 | 1.00 |
| Antifibrotic drugs, y/n | 5/41 | 6/33 | 0.75 |
| At the onset of AE | |||
| Age, years | 74 (43 to 94) | 74 (51 to 88) | 0.75 |
| Body weight, kg | 57.2 (39.0 to 87.8) | 59.0 (39.6 to 91.0) | 0.86 |
| HRCT pattern, diffuse/non-diffuse | 20/26 | 15/24 | 0.67 |
| PaO2/FiO2 ratio | 180.0 (36.8 to 388.1) | 161.0 (34.3 to 378.8) | 0.62 |
| PaO2/FiO2 ratio, ≤200/>200 | 26/20 | 23/16 | 0.83 |
| WBC, /μL | 970 (2900 to 16700) | 10 200 (1800 to 19780) | 0.28 |
| LDH, U/mL | 386 (159 to 652) | 349 (217 to 771) | 0.12 |
| KL-6, U/mL | 1580 (314 to 3828) | 1192 (289 to 5529) | 0.36 |
| CRP, mg/dL | 10.9 (0.2 to 30.7) | 12.4 (0.4 to 28.1) | 0.80 |
| DIC, y/n | 4/42 | 3/36 | 1.00 |
| FDP/d-dimer, lower/higher | 32/14 | 28/11 | 1.00 |
| BAL, y/n | 5/41 | 10/29 | 0.09 |
| Outcomes | |||
| 90-day survival, y/n | 22/24 | 26/13 | 0.12 |
AE, acute exacerbation; AZP, azathioprine; BAL, bronchoalveolar lavage; CPA, cyclophosphamide; CRP, C-reactive protein; CyA, cyclosporine A; DIC, disseminated intravascular coagulation; FDP, fibrin degradation product; FiO2, fraction of inspired oxygen; HRCT, high-resolution CT; IPF, idiopathic pulmonary fibrosis; KL-6, Krebs von den Lungen-6; LDH, lactate dehydrogenase; LTOT, long-term oxygen therapy; mMRC, modified Medical Research Council score; PaO2, partial pressure of oxygen; rhTM, recombinant human soluble thrombomodulin; SLB, surgical lung biopsy; Tac, tacrolimus; WBC, white blood cell counts; y/n, yes/no.