Efficacy of recombinant thrombomodulin for poor prognostic cases of acute exacerbation in idiopathic interstitial pneumonia: secondary analysis of the SETUP trial
Background Acute exacerbation (AE) in idiopathic pulmonary fibrosis and other idiopathic interstitial pneumonias (IIPs) are poor prognostic events although they are usually treated with conventional therapy with corticosteroids and immunosuppressants. Previously, we demonstrated the safety and effic...
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BMJ Publishing Group
2020-09-01
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| Series: | BMJ Open Respiratory Research |
| Online Access: | https://bmjopenrespres.bmj.com/content/7/1/e000558.full |
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| author | Yoshikazu Inoue Satoshi Marumo Toru Arai Hiroshi Kida Yoshitaka Ogata Hiroto Matsuoka Iwao Gohma Suguru Yamamoto Masahide Mori Chikatoshi Sugimoto Kazunobu Tachibana Masanori Akira |
| author_facet | Yoshikazu Inoue Satoshi Marumo Toru Arai Hiroshi Kida Yoshitaka Ogata Hiroto Matsuoka Iwao Gohma Suguru Yamamoto Masahide Mori Chikatoshi Sugimoto Kazunobu Tachibana Masanori Akira |
| author_sort | Yoshikazu Inoue |
| collection | DOAJ |
| description | Background Acute exacerbation (AE) in idiopathic pulmonary fibrosis and other idiopathic interstitial pneumonias (IIPs) are poor prognostic events although they are usually treated with conventional therapy with corticosteroids and immunosuppressants. Previously, we demonstrated the safety and efficacy of recombinant human soluble thrombomodulin (rhTM) for AE-IIP in the SETUP trial. Here, we aimed to clarify the efficacy of rhTM for poor-prognosis cases of AE-IIP.Methods In this study, we included 85 patients, in whom fibrin degradation product (FDP)/d-dimer was evaluated at AE, from the 100 patients in the SETUP trial. The AE-IIP patients in the rhTM arm (n=39) were diagnosed using the Japanese criteria from 2014 to 2016 and treated with intravenous rhTM for 6 days in addition to the conventional therapy. The AE-IIP patients in the control arm (n=46) were treated with the conventional therapy without rhTM between 2011 and 2013. The subjects were classified into higher and lower FDP/d-dimer groups based on the Japanese Association for Acute Medicine Disseminated Intravascular Coagulation scoring system. A multivariate Cox proportional hazard regression analysis with stepwise selection was performed to reveal the prognostic factors of AE-IIP.Results We developed a prognostic scoring system using two significant prognostic factors, higher FDP/d-dimer at AE and prednisolone therapy before AE, with 3 and 2 points assigned for each parameter, respectively. The prognostic scores ranged from 0 to 5. Survival of AE-IIP patients with a prognostic score=0 was significantly better than that of patients with score ≥2. Survival was improved with the rhTM therapy (p<0.05) in the poor prognostic cases (score ≥2), but not in the good prognostic cases (score=0).Conclusions Treatment with rhTM might improve survival in AE-IIP cases with poor prognoses.Trial registration numberUMIN000014969,date: 28 August 2014. |
| format | Article |
| id | doaj-art-2dfdc477e62d4eb29b84817d944cbcf1 |
| institution | Kabale University |
| issn | 2052-4439 |
| language | English |
| publishDate | 2020-09-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open Respiratory Research |
| spelling | doaj-art-2dfdc477e62d4eb29b84817d944cbcf12024-11-24T19:30:08ZengBMJ Publishing GroupBMJ Open Respiratory Research2052-44392020-09-017110.1136/bmjresp-2020-000558Efficacy of recombinant thrombomodulin for poor prognostic cases of acute exacerbation in idiopathic interstitial pneumonia: secondary analysis of the SETUP trialYoshikazu Inoue0Satoshi Marumo1Toru Arai2Hiroshi Kida3Yoshitaka Ogata4Hiroto Matsuoka5Iwao Gohma6Suguru Yamamoto7Masahide Mori8Chikatoshi Sugimoto9Kazunobu Tachibana10Masanori Akira11Clinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, JapanRespiratory Disease Center, Tazuke Kofukai Medical Research Institute, Kitano Hospital, Osaka City, Osaka, JapanClinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai City, Japan1 Department of Respiratory Medicine, National Hospital Organization Osaka Toneyama Medical Center, Toyonaka, JapanDepartment of Critical Care Medicine, Yao Tokushukai General Hospital, Osaka, JapanDepartment of Respiratory Medicine, Osaka Prefectural Hospital Organization Osaka Habikino Medical Center, Habikino City, JapanDepartment of Respiratory Medicine, Sakai City Medical Center, Sakai City, Osaka, JapanDepartment of Respiratory Medicine, National Hospital Organization Osaka Minami Medical Center, Kawachinagano City, JapanDepartment of Respiratory Medicine, National Hospital Organization Osaka Toneyama Medical Center, Toyonaka City, JapanClinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai City, JapanClinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai City, JapanClinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai City, JapanBackground Acute exacerbation (AE) in idiopathic pulmonary fibrosis and other idiopathic interstitial pneumonias (IIPs) are poor prognostic events although they are usually treated with conventional therapy with corticosteroids and immunosuppressants. Previously, we demonstrated the safety and efficacy of recombinant human soluble thrombomodulin (rhTM) for AE-IIP in the SETUP trial. Here, we aimed to clarify the efficacy of rhTM for poor-prognosis cases of AE-IIP.Methods In this study, we included 85 patients, in whom fibrin degradation product (FDP)/d-dimer was evaluated at AE, from the 100 patients in the SETUP trial. The AE-IIP patients in the rhTM arm (n=39) were diagnosed using the Japanese criteria from 2014 to 2016 and treated with intravenous rhTM for 6 days in addition to the conventional therapy. The AE-IIP patients in the control arm (n=46) were treated with the conventional therapy without rhTM between 2011 and 2013. The subjects were classified into higher and lower FDP/d-dimer groups based on the Japanese Association for Acute Medicine Disseminated Intravascular Coagulation scoring system. A multivariate Cox proportional hazard regression analysis with stepwise selection was performed to reveal the prognostic factors of AE-IIP.Results We developed a prognostic scoring system using two significant prognostic factors, higher FDP/d-dimer at AE and prednisolone therapy before AE, with 3 and 2 points assigned for each parameter, respectively. The prognostic scores ranged from 0 to 5. Survival of AE-IIP patients with a prognostic score=0 was significantly better than that of patients with score ≥2. Survival was improved with the rhTM therapy (p<0.05) in the poor prognostic cases (score ≥2), but not in the good prognostic cases (score=0).Conclusions Treatment with rhTM might improve survival in AE-IIP cases with poor prognoses.Trial registration numberUMIN000014969,date: 28 August 2014.https://bmjopenrespres.bmj.com/content/7/1/e000558.full |
| spellingShingle | Yoshikazu Inoue Satoshi Marumo Toru Arai Hiroshi Kida Yoshitaka Ogata Hiroto Matsuoka Iwao Gohma Suguru Yamamoto Masahide Mori Chikatoshi Sugimoto Kazunobu Tachibana Masanori Akira Efficacy of recombinant thrombomodulin for poor prognostic cases of acute exacerbation in idiopathic interstitial pneumonia: secondary analysis of the SETUP trial BMJ Open Respiratory Research |
| title | Efficacy of recombinant thrombomodulin for poor prognostic cases of acute exacerbation in idiopathic interstitial pneumonia: secondary analysis of the SETUP trial |
| title_full | Efficacy of recombinant thrombomodulin for poor prognostic cases of acute exacerbation in idiopathic interstitial pneumonia: secondary analysis of the SETUP trial |
| title_fullStr | Efficacy of recombinant thrombomodulin for poor prognostic cases of acute exacerbation in idiopathic interstitial pneumonia: secondary analysis of the SETUP trial |
| title_full_unstemmed | Efficacy of recombinant thrombomodulin for poor prognostic cases of acute exacerbation in idiopathic interstitial pneumonia: secondary analysis of the SETUP trial |
| title_short | Efficacy of recombinant thrombomodulin for poor prognostic cases of acute exacerbation in idiopathic interstitial pneumonia: secondary analysis of the SETUP trial |
| title_sort | efficacy of recombinant thrombomodulin for poor prognostic cases of acute exacerbation in idiopathic interstitial pneumonia secondary analysis of the setup trial |
| url | https://bmjopenrespres.bmj.com/content/7/1/e000558.full |
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