1. Recombinant thrombomodulin for acute exacerbation in idiopathic interstitial pneumonias.
- Author
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Arai T, Kida H, Ogata Y, Marumo S, Matsuoka H, Gohma I, Yamamoto S, Mori M, Sugimoto C, Tachibana K, Akira M, Edahiro R, Hamasaki T, and Inoue Y
- Subjects
- Aged, Female, Humans, Idiopathic Interstitial Pneumonias diagnosis, Idiopathic Interstitial Pneumonias mortality, Japan epidemiology, Male, Prognosis, Prospective Studies, Recombinant Proteins, Survival Rate trends, Tomography, X-Ray Computed, Treatment Outcome, Idiopathic Interstitial Pneumonias drug therapy, Propensity Score, Thrombomodulin therapeutic use
- Abstract
Background and Objective: Acute exacerbation (AE) in idiopathic pulmonary fibrosis (IPF) or other idiopathic interstitial pneumonias (IIP) is a poor prognostic event despite conventional therapy with corticosteroids and/or immunosuppressants. We aimed to evaluate the efficacy and safety of recombinant human soluble thrombomodulin (rhTM) for AE-IIP., Methods: For this prospective single-arm open-label multicentre cohort study, we retrospectively registered 61 cases of AE-IIP treated with conventional therapy between 2011 and 2013 (control arm), and prospectively enrolled 39 cases of AE-IIP treated with conventional therapy and rhTM (380 U/kg/day for 6 days) between 2014 and 2016 (rhTM arm). To reduce potential confounding in treatment comparisons, an adjusted mortality analysis for 90-day survival was conducted with weighted Cox proportional hazards regression models using inverse probability of treatment weighting. Weights were derived from propensity scores estimated using a multivariable logistic regression analysis including potential confounders., Results: The 90-day survival rates of AE-IIP patients treated with/without rhTM were 66.7% (26/39) and 47.5% (29/61), respectively. After adjusting for imbalances, rhTM therapy was significantly associated with reduced mortality (adjusted hazard ratio (HR): 0.453; 95% CI: 0.237-0.864; P = 0.0163). The frequencies of adverse events with/without rhTM were 17.9% (7/39) and 19.7% (12/61), which were similar in both arms (P = 1.0). Two bleeding-related adverse events occurred in the rhTM arm., Conclusion: Safety and efficacy were observed for rhTM treatment of AE-IIP. A future randomized controlled trial is required to draw final conclusions., (© 2019 Asian Pacific Society of Respirology.)
- Published
- 2019
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