Vol.54 No.S-1 October 2006
Efficacy and safety of Itraconazole injections and capsules in deep mycosis -uncontrolled multicenter open-label trial-
1)Department of Molecular Microbiology and Immunology, Nagasaki University Graduate School of Biomedical Sciences, 1-12-4 Sakamoto, Nagasaki, Japan
2)Teikyo University Institute of Medical Mycology
3)Department of Hematology, Juntendo University School of Medicine
4)University of Tokyo Hospital, Department of Cell Therapy and Transplantation Medicine
5)Department of Respiratory Medicine, Japanese Red Cross Medical Center
6)Department of Respiratory Medicine, Kurashiki First Hospital
7)Fourth Department of Internal Medicine, Teikyo University School of Medicine, University Hospital, Mizonokuchi
8)First Department of Internal Medicine, Saitama Medical University Hospital
9)Fifth Department of Internal Medicine, Osaka Medical Center for Cancer and Cardiovascular Diseases
10)Division of Clinical Research, National Sanatorium (currently National Hospital Organization), Tokyo Hospital
Abstract
We investigated the efficacy and safety of Itraconazole (ITCZ) in patients with deep mycosis, evaluating intravenous injection of ITCZ (200 mg) for 2 weeks (twice a day for the first two days, then once a day for the remaining 12 days) prior to the oral administration of ITCZ capsules (200 mg) twice a day.
Total efficacy was 67.7% (21/31 cases). The efficacy in aspergillosis patients was 57.9% (11/19 cases), 71.4% (5/7) in candidiasis patients, and 100% (5/5) in cryptococcosis patients. No difference was seen in the incidence of adverse events in injection and capsule administration, and most observed adverse events of ITCZ were already known.
ITCZ plasma trough concentration after two days of injection (200 mg twice a day) reached a level (811.3±316.0 ng/mL, Mean±S.D., n=42) efficient in treating conditions caused by primary underlying mycoses (Aspergillus, Candida, Cryptococcus), and high plasma was maintained continuously through administration of ITCZ capsules.
ITCZ injection reaches efficient plasma concentration rapidly compared to ITCZ capsules. ITCZ injection is effective for serious and acute conditions but the approved maximum dose of 200 mg/day for ITCZ capsules is not effective in treating deep mycosis.
Plasma concentration reached by ITCZ injection is continuously maintained through the administration of ITCZ capsules (200 mg, twice a day). We concluded that the first 2 weeks of injection prior to oral administration is effective in treating deep mycosis.
Key word
itraconazole, injection, aspergillosis, candidiasis, cryptococcosis
Received
August 14, 2006
Accepted
September 13, 2006
Jpn. J. Chemother. 54 (S-1): 32-47, 2006
