A clinical trial of intravenous itraconazole followed by itraconazole capsule in the treatment of 25 cases of systemic fungal infection / 中国感染与化疗杂志

ABSTRACT

Objective To evaluate the efficacy and safety of intravenous itraconazole followed by itraconazole capsule.Methods An open-label,randomized,non-controlled study was conducted.Itraconazole was administered intravenously at a dose of 200 mg,q12h for the first 2 days,then once daily from the 3rd to the 14th day and followed by itraconazole capsule,200 mg,q12h for 2 to 4 weeks.Results A total of 25 patients were enrolled in the study,including 12 documented cases of invasive fungal in- fection,11 probable cases and 2 possible cases.Twenty-two patients were eligible for clinical efficacy analysis,of which 11 were cured,4 significant improved,2 improved and 5 failed.The effective rate was 68.2%(15/22),and the cure rate was 50.0%(11/22).Twenty-four strains of fungus were obtained,including 22 strains of Candida spp.and one each of Aspergil- lus and Histoplasma capsulatum.Eighteen strains of fungus were eradicated after itraconazole treatment.The eradication rate was 75.0%(18/24).In the 25 cases who received at least one dose of intravenous itraconazole,itraconazole-related or proba- bly-related clinical adverse event was reported in 3 patients,including drug fever,chest discomfort,palpitation and decreased appetite,Itraconazole-related or probably-related laboratory abnormality was reported in 4 cases.AST or ALT elevation was the most common laboratory abnormality.One patient was found to have increased blood creatinine,BUN and hemolysis.Most adverse effects were mild and tolerable except one serious adverse effect.Conclusions Intravenous itraconazole followed by itraconazole capsule therapy has good efficacy in the treatment of systematic fungal infection.The regimen is well-tolerated in most patients.