A multicenter, open-label clinical study of micafungin (FK463) in the treatment of deep-seated mycosis in Japan
A multicenter, open-label clinical study of micafungin (FK463) in the treatment of deep-seated mycosis in Japan
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DOI：
10.1080/00365540410020406
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发表时间：
2004-05-01
影响因子：
--
通讯作者：
Ikemoto, H
中科院分区：
文献类型：
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作者：
Kohno, S;Masaoka, T;Ikemoto, H
米卡芬净（FK 463）是一种新型棘白菌素类脂肽类抗真菌药，对曲霉菌和念珠菌均有活性，本研究在深部真菌病患者中研究了其疗效和安全性。70例患者用米卡芬净12.5 ~ 150 mg/d静滴，疗程56 d。侵袭性肺曲霉病、慢性坏死性肺曲霉病、肺曲霉瘤、念珠菌血症和食管念珠菌病的临床有效率分别为60%（6/10）、67%（6/9）、55%（12/22）、100%（6/6）和71%（5/7）。既往接受过被认为无效或有毒的抗真菌治疗的患者的应答率与既往未接受过治疗的患者的应答率相似。在感染烟曲霉、黄曲霉、土曲霉、黑曲霉、白色念珠菌、光滑念珠菌或克柔念珠菌的患者中观察到真菌学根除。21例患者（30%）报告了与米卡芬净相关的不良事件，未发生任何剂量相关的不良事件。结论：米卡芬净单药治疗深部真菌病有效且安全。
The efficacy and safety of micafungin (FK463), which is a new lipopeptide antifungal agent of the echinocandin class and is active against both Aspergillus and Candida species, were investigated in patients with deep-seated mycosis in this study. 70 patients were treated with micafungin 12.5-150 mg/d intravenously for up to 56 d. The overall clinical response rates were 60% (6/10) in invasive pulmonary aspergillosis, 67% (6/9) in chronic necrotizing pulmonary aspergillosis, 55% (12/22) in pulmonary aspergilloma, 100% (6/6) in candidemia, and 71% (5/7) in esophageal candidiasis. The response rates for patients with prior antifungal treatment which was considered ineffective or toxic, were similar to rates for patients without prior treatment. Mycological eradication was observed in patients infected with Aspergillus fumigatus, Aspergillus flavus, Aspergillus terreus, Aspergillus niger, Candida albicans, Candida glabrata, or Candida krusei. Adverse events related to micafungin were reported in 21 patients (30%), and there was no dose-related occurrence of any adverse event. It is concluded that treatment with micafungin as monotherapy seems to be effective and safe in patients with deep-seated mycosis.