title: Recombinant Human Thrombomodulin in Acute Exacerbation of Idiopathic Pulmonary Fibrosis.
abstract: BACKGROUND
  Acute exacerbation (AE) of idiopathic pulmonary fibrosis (IPF) presents as episodes of acute respiratory worsening closely associated with endothelial damage and disordered coagulopathy. Recombinant human soluble thrombomodulin (rhTM) regulates the coagulation pathway mainly by reducing thrombin-mediated clotting and enhancing protein C activation. We investigated the efficacy of rhTM for the treatment of patients with AE-IPF.
  
  
  METHODS
  This historical control study comprised 40 patients with AE-IPF. Twenty patients treated with rhTM (0.06 mg/kg/d) for about 6 days (rhTM group) and 20 patients treated without rhTM (control group) were evaluated. The predictors of 3-month mortality (logistic regression model) were evaluated.
  
  
  RESULTS
  There was no difference in baseline characteristics between the control group and the rhTM group. Three-month mortality of the rhTM group and control group was 30.0% and 65.0%, respectively. In univariate analysis, C-reactive protein and rhTM therapy were significant determinants for 3-month survival. In multivariate analysis, rhTM therapy (OR, 0.219; 95% CI, 0.049-0.978; P = 0.047) was an independent significant determinant for 3-month survival.
  
  
  CONCLUSIONS
  We found that rhTM therapy improved 3-month survival of AE-IPF. The results observed here warrant further investigation of rhTM in randomized control trials.
authors: Department of Respiratory Medicine and Allergy, Tosei General Hospital, Seto.
authors: Kensuke
authors: K
authors: Kataoka
authors: Department of Respiratory Medicine and Allergy, Tosei General Hospital, Seto. Electronic address: taniguchi@tosei.or.jp.
authors: Hiroyuki
authors: H
authors: Taniguchi
authors: Department of Respiratory Medicine and Allergy, Tosei General Hospital, Seto.
authors: Yasuhiro
authors: Y
authors: Kondoh
authors: Department of Respiratory Medicine and Allergology, Kinki University, Faculty of Medicine, Osaka.
authors: Osamu
authors: O
authors: Nishiyama
authors: Department of Respiratory Medicine and Allergy, Tosei General Hospital, Seto.
authors: Tomoki
authors: T
authors: Kimura
authors: Department of Respiratory Medicine and Allergy, Tosei General Hospital, Seto.
authors: Toshiaki
authors: T
authors: Matsuda
authors: Department of Respiratory Medicine and Allergy, Tosei General Hospital, Seto.
authors: Toshiki
authors: T
authors: Yokoyama
authors: Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya.
authors: Koji
authors: K
authors: Sakamoto
authors: Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Japan.
authors: Masahiko
authors: M
authors: Ando
mesh_terms: D000368:Aged; D002097:C-Reactive Protein / Q000378:metabolism; D018450:Disease Progression; D005260:Female; D065386:Historically Controlled Study; D006801:Humans; D054990:Idiopathic Pulmonary Fibrosis / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011994:Recombinant Proteins / Q000627:therapeutic use*; D018180:Thrombomodulin / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D011994:Recombinant Proteins; C546931:THBD protein, human; D018180:Thrombomodulin; D002097:C-Reactive Protein