BACKGROUNDInvasive pulmonary mycosis is the most common type of invasive fungal infection. It is often severe and difficult to treat, and is accompanied by high mortality. In this study, we aimed to evaluate the efficacy and safety of intravenous itraconazole followed by oral itraconazole solution in the treatment of invasive pulmonary mycosis and to determine the distribution of different fungi species.

METHODSThis was a multi-center, open-label study which enrolled 71 patients who were diagnosed as invasive pulmonary mycosis between July 2007 and January 2009. All patients received intravenous itraconazole therapy followed by oral itraconazole solution with a total treatment duration of 6 weeks. Intravenous itraconazole was given at a dose of 200 mg bid (intravenous infusion every 12 hours) for the first two days, 200 mg qd for the subsequent 12 days. Sequential oral itraconazole solution was given at a dose of 100 mg bid for 4 weeks. Efficacy and safety were assessed according to clinical as well as microbiological criteria.

RESULTSSeventy one patients participated in this study. Of the 60 patients in the full analysis dataset, the clinical response rate was 61.7% and the mycological eradication rate was 66.7%. The overall response rate was 66.7%. Drug-related adverse events occurred in 18.0% of patients: hypokalemia, liver function impairment and mild gastrointestinal side effects were the most common. One patient suffered from severe adverse event, with limb and facial swelling.

CONCLUSIONThis study showed that in patients with invasive pulmonary mycosis, intravenous itraconazole followed by oral itraconazole solution therapy was safe and effective.