Efficacy and safety of Itraconazole injections and capsules in deep mycosis uncontrolled multicenter open-label trial

  • Kohno Shigeru
    Department of Molecular Microbiology and Immunology, Nagasaki University Graduate School of Biomedical Sciences
  • Yamaguchi Hideyo
    Teikyo University Institute of Medical Mycology
  • Mori Takeshi
    Department of Hematology, Juntendo University School of Medicine
  • Hirai Hisamaru
    University of Tokyo Hospital, Department of Cell Therapy and Transplantation Medicine
  • Oritsu Masaru
    Department of Respiratory Medicine, Japanese Red Cross Medical Center
  • Niki Yoshihito
    Department of Respiratory Medicine, Kurashiki First Hospital
  • Yoshida Minoru
    Fourth Department of Internal Medicine, Teikyo University School of Medicine University Hospital
  • Maesaki Shigefumi
    First Department of Internal Medicine, Saitama Medical University Hospital
  • Hiraoka Akira
    Fifth Department of Internal Medicine, Osaka Medical Center for Cancer and Cardiovascular Diseases
  • Kurashima Atsuyuki
    Division of Clinical Research, National Sanatorium (currently National Hospital Organization), Tokyo Hospital

Bibliographic Information

Other Title
  • 深在性真菌症患者に対するitraconazole注射薬およびカプセル薬順次投与の有効性
  • Itraconazole-Deep Mycosis Research Group
  • Itraconazole深在性真菌症研究班

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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.<BR>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.<BR>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.<BR>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.<BR>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.

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