The Fourth Department of Internal Medicine, Teikyo University School of Medicine, Mizonokuchi Hospital, Mizonokuchi, Takatsu-ku, Kawasaki City, Kanagawa, Japan.
Ann Hematol. 2012 Mar;91(3):449-57. doi: 10.1007/s00277-011-1316-y. Epub 2011 Sep 6.
This prospective multicenter study was performed to clarify the efficacy and safety of micafungin (MCFG) as an empirical antifungal therapy for suspected fungal infection in patients with hematological disorders and neutropenia. Three hundred and eighty-eight patients were enrolled; 151 patients with possible fungal infection diagnosed by radiological imaging or serological testing and 237 patients with refractory fever were included in this study. The mean dose and duration of treatment with MCFG were 154.6 mg/day and 14.0 days, respectively. The clinical response rate for patients with possible fungal infection and refractory fever was 60.1% and 65.3%, respectively. Even in persistent neutropenic patients with a neutrophil count of <500/μL throughout the MCFG treatment, the clinical response rate was 46.9%. Ninety-one drug-related adverse events (DAEs) were observed in 56 patients (14.4%) and 9 serious DAEs were observed in 6 patients (1.5%). Neither daily dose nor duration of MCFG treatment affected the incidence of DAEs. It was confirmed that MCFG has adequate clinical efficacy and is safe for the treatment of suspected fungal infections in patients with hematological disorders and neutropenia.
这项前瞻性多中心研究旨在阐明米卡芬净（MCFG）作为血液病和中性粒细胞减少症患者疑似真菌感染的经验性抗真菌治疗的疗效和安全性。共纳入 388 例患者；151 例患者经影像学或血清学检查诊断为可能的真菌感染，237 例发热性中性粒细胞减少症患者纳入本研究。MCFG 的平均剂量和疗程分别为 154.6mg/天和 14.0 天。可能真菌感染和发热性中性粒细胞减少症患者的临床缓解率分别为 60.1%和 65.3%。即使在整个 MCFG 治疗过程中中性粒细胞计数<500/μL 的持续性中性粒细胞减少症患者中，临床缓解率也为 46.9%。56 例患者（14.4%）发生 91 例药物相关不良事件（DAE），6 例患者（1.5%）发生 9 例严重 DAE。MCFG 的日剂量和疗程均未影响 DAE 的发生率。证实 MCFG 对血液病和中性粒细胞减少症患者疑似真菌感染具有充分的临床疗效和安全性。
