[The clinical efficacy and safety of itraconazole injection in treatment of invasive fungal infection in intensive care unit].
OBJECTIVE
To investigate the efficacy and safety of itraconazole injection for the treatment of invasive fungal infection (IFI) in ICU.


METHODS
In this multicenter, prospective open-label study, ICU patients who had met the IFI inclusion criteria were enrolled. Itraconazole intravenous injection was administered 200 mg twice daily. Clinical efficacy and adverse events were recorded.


RESULTS
A total of 495 patients from 33 centers were enrolled with 62.02% clinical diagnosis, 30.69% probable diagnosis and 7.29% confirmed diagnosis. The infection sites were mostly from the lung (86.51%) and the urinary tract and bloodstream stood for the second place (4.07%). Of all the infections, 82.66% were candida whereas 14.63% were aspergillus. Broad-spectrum antibiotics usage, severe illness and long-term hospitalization were the most common risk factors for IFI (70.47%, 69.45% and 62.12% respectively). The clinical cure rate was 53.91% at day 7 and increased to 78.53% at the end of treatment. Total fungal clearance increased from 58.62% at day 7 to 86.27% at the end of treatment. The rate of total adverse event was 8.48% with 6.87% drug-related.


CONCLUSIONS
Itraconazole injection was an effective and safe drug for the treatment of IFI in ICU.
D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007362:Intensive Care Units; D017964:Itraconazole / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009181:Mycoses / Q000188:drug therapy*; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult
D000935:Antifungal Agents; D017964:Itraconazole