title: Safety of aerosolized amphotericin B lipid complex in lung transplant recipients.
abstract: BACKGROUND
  Fungal infections remain an important cause of morbidity and mortality in lung transplant recipients. Aerosolized amphotericin B lipid complex (ABLC) may be more efficacious than conventional amphotericin B in the prevention of fungal infections in animal models, but experience with aerosolized ABLC in humans is lacking.
  
  
  METHODS
  We conducted a prospective, noncomparative study designed to evaluate safety of aerosolized ABLC in lung or heart-lung transplant recipients.
  
  
  RESULTS
  A total of 381 treatments were administered to 51 patients. Complete spirometry records were available for 335 treatments (69 in intubated patients, 266 in extubated patients). ABLC was subjectively well tolerated in 98% of patients. Pulmonary mechanics worsened by 20% or more posttreatment in less than 5% of all treatments. There were no significant adverse events related to study medication in any patient, and 1-year survival for all enrolled patients was 78%.
  
  
  CONCLUSIONS
  Administration of nebulized ABLC is safe in the short-term and well-tolerated in lung transplant recipients. Additional prospective, randomized studies are needed to determine the efficacy of aerosolized ABLC alone or in conjunction with systemic therapies in the prevention of fungal infections in lung transplant recipients.
authors.affiliation: Division of Pulmonary and Critical Care Medicine, Duke University Medical Center, Durham, NC 22710, USA.
authors.forename: S M
authors.initials: SM
authors.lastname: Palmer
authors.forename: R H
authors.initials: RH
authors.lastname: Drew
authors.forename: J D
authors.initials: JD
authors.lastname: Whitehouse
authors.forename: V F
authors.initials: VF
authors.lastname: Tapson
authors.forename: R D
authors.initials: RD
authors.lastname: Davis
authors.forename: R R
authors.initials: RR
authors.lastname: McConnell
authors.forename: S S
authors.initials: SS
authors.lastname: Kanj
authors.forename: J R
authors.initials: JR
authors.lastname: Perfect
mesh_terms: D000328:Adult; D000336:Aerosols; D000666:Amphotericin B / Q000008:administration & dosage* / Q000627:therapeutic use; D000935:Antifungal Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D002177:Candidiasis / Q000453:epidemiology; D004338:Drug Combinations; D016041:Heart-Lung Transplantation / Q000009:adverse effects; D006801:Humans; D015994:Incidence; D008171:Lung Diseases / Q000209:etiology / Q000517:prevention & control*; D016040:Lung Transplantation / Q000009:adverse effects*; D008875:Middle Aged; D009181:Mycoses / Q000209:etiology / Q000517:prevention & control*; D010538:Peritonitis / Q000453:epidemiology / Q000382:microbiology; D010713:Phosphatidylcholines / Q000008:administration & dosage* / Q000627:therapeutic use; D010715:Phosphatidylglycerols / Q000008:administration & dosage* / Q000627:therapeutic use; D011184:Postoperative Period; D011446:Prospective Studies; D015656:Respiratory Mechanics; D012449:Safety; D016019:Survival Analysis
chemical_list: D000336:Aerosols; D000935:Antifungal Agents; D004338:Drug Combinations; D010713:Phosphatidylcholines; D010715:Phosphatidylglycerols; C068538:liposomal amphotericin B; D000666:Amphotericin B