title: Usefulness of a selective neutrophil elastase inhibitor, sivelestat, in acute lung injury patients with sepsis.
abstract: BACKGROUND
  Neutrophil elastase plays a crucial role in the development of acute lung injury (ALI) in patients with systemic inflammatory response syndrome (SIRS). The clinical efficacy of the neutrophil elastase inhibitor, sivelestat, for patients with ALI associated with SIRS has not been convincingly demonstrated. The aim of this study was to determine if there are clinical features of patients with this condition that affect the efficacy of sivelestat.
  
  
  METHODS
  This was a retrospective study of 110 ALI patients with SIRS. Clinical information, including the etiology of ALI, the number of organs failing, scoring systems for assessing the severity of illness, and laboratory data, was collected at the time of diagnosis. Information on the number of ventilator-free days (VFDs) and changes in PaO(2)/F(I)O(2) (ΔP/F) before and 7 days after the time of ALI diagnosis was also collected. The effect of sivelestat on ALI patients was also examined based on whether they had sepsis and whether their initial serum procalcitonin level was ≥0.5 ng/mL.
  
  
  RESULTS
  There were 70 patients who were treated with sivelestat and 40 control patients. VFDs and ΔP/F were significantly higher in the treated patients than in the control patients. However, there was no significant difference in the patient survival rate between the two groups. Sivelestat was more effective in ALI patients with a PaO(2)/F(I)O(2) ratio ≥ 140 mmHg or sepsis. Sivelestat significantly prolonged survival and led to higher VFDs and increased ΔP/F in septic patients and patients with initial serum procalcitonin levels ≥ 0.5 ng/mL.
  
  
  CONCLUSIONS
  The results may facilitate a future randomized controlled trial to determine whether sivelestat is beneficial for ALI patients with sepsis.
authors.affiliation: Department of Integrated Medicine and Informatics, Ehime University, Graduate School of Medicine, Toon.
authors.forename: Seigo
authors.initials: S
authors.lastname: Miyoshi
authors.forename: Hironobu
authors.initials: H
authors.lastname: Hamada
authors.forename: Ryoji
authors.initials: R
authors.lastname: Ito
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Katayama
authors.forename: Kazunori
authors.initials: K
authors.lastname: Irifune
authors.forename: Toshimitsu
authors.initials: T
authors.lastname: Suwaki
authors.forename: Norihiko
authors.initials: N
authors.lastname: Nakanishi
authors.forename: Takanori
authors.initials: T
authors.lastname: Kanematsu
authors.forename: Kentaro
authors.initials: K
authors.lastname: Dote
authors.forename: Mayuki
authors.initials: M
authors.lastname: Aibiki
authors.forename: Takafumi
authors.initials: T
authors.lastname: Okura
authors.forename: Jitsuo
authors.initials: J
authors.lastname: Higaki
mesh_terms: D055371:Acute Lung Injury / Q000188:drug therapy* / Q000503:physiopathology; D000368:Aged; D002116:Calcitonin / Q000097:blood; D015740:Calcitonin Gene-Related Peptide; D005260:Female; D005998:Glycine / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D010100:Oxygen / Q000378:metabolism; D011498:Protein Precursors / Q000097:blood; D053491:Proteinase Inhibitory Proteins, Secretory / Q000494:pharmacology / Q000627:therapeutic use*; D012189:Retrospective Studies; D018805:Sepsis / Q000188:drug therapy* / Q000503:physiopathology; D015842:Serine Proteinase Inhibitors / Q000494:pharmacology / Q000627:therapeutic use; D013449:Sulfonamides / Q000494:pharmacology / Q000627:therapeutic use*; D015996:Survival Rate
chemical_list: C000606589:CALCA protein, human; D011498:Protein Precursors; D053491:Proteinase Inhibitory Proteins, Secretory; D015842:Serine Proteinase Inhibitors; D013449:Sulfonamides; D002116:Calcitonin; C069195:sivelestat; D015740:Calcitonin Gene-Related Peptide; D010100:Oxygen; D005998:Glycine
keywords: neutrophil elastase; procalcitonin; systemic inflammatory response syndrome; ventilator-free days