Parameters | Control (n=46) | rhTM (n=39) | P value |
Therapy for AE-IIPs | |||
Steroid pulse, y/n | 57/2 | 36/3 | 0.66 |
Prednisolone, y/n* | 43/3 | 38/1 | 0.62 |
Dose of prednisolone†, mg/kg/day | 0.9 (0.4 to 1.3) | 1.0 (0.5 to 1.1) | 0.07 |
Immunosuppressant, y/n | 14/32 | 7/32 | 0.22 |
AZP/CyA/CPA/Tac | 2/7/5/0 | 1/1/5/0 | 0.21 |
Pirfenidone, y/n | 2/44 | 4/35 | 0.41 |
Nintedanib, y/n | 2/44 | 0/39 | 0.50 |
Antifibrotic drugs, y/n‡ | 3/43 | 4/35 | 0.70 |
Empiric antibiotics, y/n | 43/3 | 39/0 | 0.25 |
Macrolide, y/n | 10/36 | 9/30 | 1.00 |
Antacids, y/n | 45/1 | 37/2 | 0.59 |
PMX-DHP therapy, y/n | 3/43 | 1/38 | 0.62 |
Anticoagulants, y/n§ | 12/34 | 6/33 | 0.29 |
Anti-platelet drugs, y/n¶ | 11/35 | 5/34 | 0.27 |
Management of respiratory failure | |||
IPPV, y/n | 4/42 | 6/33 | 0.50 |
NPPV, y/n | 19/27 | 15/24 | 0.83 |
IPPV or NPPV, y/n | 22/24 | 18/21 | 1.00 |
NHF, y/n | 8/38 | 12/27 | 0.20 |
NHF without IPPV, NPPV, y/n | 5/41 | 8/31 | 0.24 |
IPPV or NPPV or NHF, y/n | 27/19 | 26/13 | 0.51 |
*AE-IIP patients with deceased and with no administration of prednisolone during a high-dose methylprednisolone therapy.
†Prednisolone dose is described as the median (range) and it was compared between the control and rhTM arms using the Wilcoxon rank-sum test. All other parameters are presented as frequencies, and they were compared between the control and rhTM arms using the Fisher's exact test.
‡Nintedanib and/or pirfenidone.
§Warfarin, unfractionated heparin, rivaroxaban or nafamostat mesilate.
¶Aspirin, clopidogrel, ticlopidine, cilostazol or sarpogrelate.
AE, acute exacerbation; AZP, azathioprine; CPA, cyclophosphamide; CyA, cyclosporine A; IIPs, idiopathic interstitial pneumonias; IPPV, invasive positive pressure ventilation; NHF, nasal high flow therapy; NPPV, non-invasive positive pressure ventilation; PMX-DHP, direct haemoperfusion with polymyxin B-immobilised fibre column; rhTM, recombinant human soluble thrombomodulin; Tac, tacrolimus; y/n, yes/no.