title: Study on Perioperative Administration of a Neutrophil Elastase Inhibitor for Interstitial Pneumonias.
abstract: BACKGROUND
  Although acute exacerbation of idiopathic interstitial pneumonias (IIPs) is a lethal complication after pulmonary resection for lung cancer with IIPs, there are no established methods to prevent its occurrence. This prospective randomized study was conducted to evaluate whether perioperative administration of the neutrophil elastase inhibitor sivelestat prevents acute exacerbation after surgery.
  
  
  METHODS
  The IIP patients with suspected lung cancers were randomly assigned to two groups before surgery: in group A (n = 65), sivelestat was perioperatively administered for 5 days; in group B (n = 65), no medications were administered. The primary endpoint was the frequency of acute exacerbation of IIPs. The secondary endpoints were perioperative changes in the lactate dehydrogenase, C-reactive protein, sialylated carbohydrate antigen, surfactant protein D and surfactant protein A values, and the safety of preoperative administration of sivelestat. Multivariate analyses were performed using a logistic regression model to identify the factors that predicted acute exacerbation.
  
  
  RESULTS
  Acute exacerbation developed in 2 patients in group A and 1 patient in group B (p = 0.559). Administration of sivelestat did not contribute to decreasing the acute exacerbation as well as short- and long-term mortality. The differences were not statistically significant in perioperative lactate dehydrogenase, C-reactive protein, sialylated carbohydrate antigen, and surfactant protein D and A levels. No subjective adverse events were observed. A preoperative partial pressure oxygen level of less than 70 mm Hg was the only predictive factor identified in the logistic analysis (p = 0.019, hazard ratio 19.2).
  
  
  CONCLUSIONS
  Perioperative administration of neutrophil elastase inhibitor appeared to be safe; however, it could not prevent the development of acute exacerbation after surgery in lung cancer patients with IIPs.
authors.affiliation: Department of General Thoracic Surgery, Juntendo University School of Medicine, Tokyo, Japan.
authors.forename: Mariko
authors.initials: M
authors.lastname: Fukui
authors.affiliation: Department of General Thoracic Surgery, Juntendo University School of Medicine, Tokyo, Japan.
authors.forename: Kazuya
authors.initials: K
authors.lastname: Takamochi
authors.affiliation: Department of General Thoracic Surgery, Juntendo University School of Medicine, Tokyo, Japan.
authors.forename: Shiaki
authors.initials: S
authors.lastname: Oh
authors.affiliation: Department of General Thoracic Surgery, Juntendo University School of Medicine, Tokyo, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Matsunaga
authors.affiliation: Department of Radiology, Juntendo University School of Medicine, Tokyo, Japan.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Suzuki
authors.affiliation: Department of Respiratory Medicine, Juntendo University School of Medicine, Tokyo, Japan.
authors.forename: Katsutoshi
authors.initials: K
authors.lastname: Ando
authors.affiliation: Department of General Thoracic Surgery, Juntendo University School of Medicine, Tokyo, Japan. Electronic address: kjsuzuki@juntendo.ac.jp.
authors.forename: Kenji
authors.initials: K
authors.lastname: Suzuki
mesh_terms: D000368:Aged; D015415:Biomarkers / Q000378:metabolism; D005260:Female; D005998:Glycine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D054988:Idiopathic Interstitial Pneumonias / Q000401:mortality / Q000517:prevention & control*; D008175:Lung Neoplasms / Q000401:mortality / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D019990:Perioperative Care; D011013:Pneumonectomy / Q000009:adverse effects*; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies; D053491:Proteinase Inhibitory Proteins, Secretory / Q000009:adverse effects / Q000627:therapeutic use*; D055502:Secondary Prevention; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*; D016019:Survival Analysis
chemical_list: D015415:Biomarkers; D053491:Proteinase Inhibitory Proteins, Secretory; D013449:Sulfonamides; C069195:sivelestat; D005998:Glycine