Objective: We performed this study to investigate the efficacy and safety of sequential intravenous and oral itraconazole in the treatment of invasive fungal infection (IFI) in the patients with hematological diseases.
Methods: All the patients fit for the diagnostic criteria of IFI (proven diagnosis, probable diagnosis and possible diagnosis) with hematological diseases were entered into this study. The trial was designed as an open labeled, multi-centered study, with the total treatment duration of 4 - 6 weeks including intravenous and oral period. Intravenous itraconazole was given at the dose of 200 mg, twice a day in the first two days, and adjusted to 200 mg/d for subsequent 12 days. Sequential oral itraconazole was given at the dose of 200 mg, twice a day, for 2 - 4 weeks for maintenance therapy. Efficacy and safety evaluation was performed every 1 - 2 weeks according to the physician's decision.
Results: Two hundred and twenty seven patients were enrolled into this study. The overall response rate was 75.33% and the cure rate was 47.14%. Two hundred and five patients (205/227, 90.3%) defervesced after a median of 5 days (2 - 20 days). One hundred and eighty six patients were applicable for microbiological evaluation, among them, 69.89% responded to the treatment. Eleven treatment-related adverse events occurred during the study and none of them were severe adverse events.
Conclusion: Sequential intravenous and oral itraconazole therapy was effective for IFI and tolerated well in patients with hematological diseases.