[Clinical efficacy and safety of itraconazole injection/oral solution sequential therapy for treatment of invasive fungal infection in intensive care unit].
OBJECTIVE
To investigate the therapeutic efficacy and safety of itraconazole injection/oral sequential therapy on invasive fungal infection (IFI) in ICU.


METHODS
In this multicenter, post-marketing, open-label study, ICU patients who have met the inclusion IFI criteria will be enrolled in this study. Itraconazole intravenous injection is administered 200 mg twice a day in day 1 - 2, then 200 mg once a day at least for 5 days, and maintenance itraconazole oral solution as sequential therapy, itraconazole oral solution 200 mg twice a day sequential therapy lasts for 2 weeks. Clinical efficacy and adverse reaction were record.


RESULTS
A total of 159 patients were enrolled and completed this trial. (1) At the end of first week, total clinical cure rate was 35.2%, and increased to 73.6% after the second week. Clinical cure rate were 72.9% and 72.2% in possible and probable IFI patients, and 78.9% in proven IFI patients at the end of second week. (2) At the end of first week, total fungal clearance was 40.9%, and increased to 75.9% and 92.9% at the end of second and fourth week. Fungal clearance were 90.0% and 64.6% in possible and probable IFI patients, and 84.2% in proven IFI patients at the end of second week respectively. (3) Combined clinical cure rate and fungal clearance, the total clinic efficacy was 44.1% at the end of first week, and increased to 92.9% and 100.0% at the end of second and fourth week. (4) No severe adverse reaction was found.


CONCLUSIONS
Itraconazole injection/oral sequential therapy is an effective and safe antibiotic for the treatment of IFI in ICU.
Department of Critical Care Medicine, Zhong-Da Hospital and School of Clinical Medicine, Southeast University, Nanjing 210009, China. haiboq2000@yahoo.com.cn
Qui
Hai-bo
HB
D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D016638:Critical Illness; D005260:Female; D006801:Humans; D007362:Intensive Care Units; D017964:Itraconazole / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009181:Mycoses / Q000188:drug therapy*; D016896:Treatment Outcome
D000935:Antifungal Agents; D017964:Itraconazole