Intravenous liposomal amphotericin B versus voriconazole for chronic pulmonary aspergillosis: a multicenter trial in Japan

DOI 機関リポジトリ 機関リポジトリ (HANDLE)
  • Kohno Shigeru
    President, Nagasaki University
  • Izumikawa Koichi
    Department of Infectious Diseases Nagasaki University Graduate School of Biomedical Sciences
  • Ogawa Kenji
    Department of Pulmonary Medicine, National Hospital Organization Higashinagoya National Hospital
  • Kurashima Atsuyuki
    Department of Respiratory Diseases, National Hospital Organization Tokyo National Hospital
  • Okimoto Niro
    Center of Respiratory Diseases, Kawasaki Hospital
  • Suzuki Katsuhiro
    Department of Respiratory Medicine, National Hospital Organization Kinki-Chuo Chest Medical Center
  • Kakeya Hiroshi
    Department of Infection Control Science, Osaka City University Graduate School of Medicine
  • Niki Yoshihito
    Department of Clinical Infectious Diseases, Showa University
  • Ichihara Kiyoshi
    Yamaguchi University Graduate School of Medicine Faculty of Health Sciences
  • Miyazaki Yoshitsugu
    Department of Chemotherapy and Mycoses, National Institute of Infectious Diseases, Tokyo– all in Japan

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説明

Chronic pulmonary aspergillosis (CPA) is slowly progressive inflammatory pulmonary syndrome due to infection of Aspergillus spp. We conducted a randomized, multicenter, open-label trial comparing intravenous liposomal amphotericin B (L-AMB) of 2.5-5.0 mg/kg once daily with intravenous voriconazole (VRCZ) of 6 mg/kg twice on Day 1 followed by 4 mg/kg twice daily. Treatment effectiveness was defined by clinical, and radiological improvement at both 2 weeks after the initial administration and at the end of therapy. The total of 166 patients were recruited and 83 patients for each drug group were assigned. Total of 51 and 59 cases of L-AMB and VRCZ, respectively were assessed as per-protocol populations. The difference in efficacy rates between L-AMB and VRCZ was not significant, either after 2 weeks [49.0% vs. 59.3%; the absolute difference, 10.3% with a 95% confidence interval (CI), -8.4 to 29.00, P=0.279] or at the end of therapy (52.9% vs. 67.8%; the absolute difference, 14.9% with a 95% CI, -3.4 to 33.2, P=0.111). In the safety evaluation, no statistical difference of occurrence rates in both LAMB and VRCZ group (54.2% vs. 59.0%, P=0.531). L-AMB was as effective as VRCZ with no significant difference of adverse effects in the treatment of CPA. (UMIN Clinical Trials Registry number, UMIN000002236.)

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