Efficacy of thrombomodulin for acute exacerbation of idiopathic pulmonary fibrosis and nonspecific interstitial pneumonia: a nonrandomized prospective study
Authors Abe M, Tsushima K, Matsumura T, Ishiwata T, Ichimura Y, Ikari J, Terada J, Tada Y, Sakao S, Tanabe N, Tatsumi K
Received 18 June 2015
Accepted for publication 17 August 2015
Published 23 October 2015 Volume 2015:9 Pages 5755—5762
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Rekha Dhanwani
Peer reviewer comments 4
Editor who approved publication: Prof. Dr. Wei Duan
Mitsuhiro Abe, Kenji Tsushima, Takuma Matsumura, Tsukasa Ishiwata, Yasunori Ichimura, Jun Ikari, Jiro Terada, Yuji Tada, Seiichirou Sakao, Nobuhiro Tanabe, Koichiro Tatsumi
Department of Respirology, Graduate School of Medicine, Chiba University, Chiba, Japan
Purpose: Acute exacerbation (AE) is an important outcome of idiopathic pulmonary fibrosis (IPF) and nonspecific interstitial pneumonia (NSIP). Recombinant human soluble thrombomodulin (rhTM) is a new drug for the treatment of disseminated intravascular coagulation in Japan. The objective of this study was to evaluate the efficacy of rhTM for AE of IPF/NSIP.
Methods: Twenty-two patients with AE-idiopathic interstitial pneumonia (16 patients with IPF and six patients with NSIP) were enrolled in our study. Among them, eleven patients were treated with rhTM (rhTM group), and eleven patients were treated without rhTM (non-rhTM group). Patients admitted to our hospital prior to December 2013 were treated with rhTM, while those admitted after January 2014 were treated without rhTM. The primary endpoint was mortality at 90 days after AE treatment. The secondary endpoint was the safety of rhTM for AE-IPF/AE-NSIP. In addition, we examined prognostic factors of AE-IPF/AE-NSIP.
Results: The mortality rate was significantly lower in the rhTM group than in the non-rhTM group (mortality rate at 90 days: 36% vs 90%, P=0.023; median survival time: not reached vs 15.0 days, P=0.019). A univariate analysis revealed the respiratory rate (hazard ratio [HR] 1.09, 95% confidence interval [CI] 1.00–1.18, P=0.039) and rhTM administration (HR 0.21, 95% CI 0.06–0.77, P=0.013) as predictors of mortality at 90 days, and a multivariate analysis identified rhTM administration (HR 0.025, 95% CI 0.0006–0.94, P=0.046) as an independent predictor of mortality at 90 days. No serious adverse events were observed.
Conclusion: The administration of rhTM is associated with reductions in mortality in patients with AE-IPF/NSIP, without causing adverse events.
Keywords: recombinant human soluble thrombomoduline, acute exacerbation, idiopathic pulmonary fibrosis, nonspecific interstitial pneumonia
This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.Download Article [PDF] View Full Text [HTML][Machine readable]