Denning David W, Marr Kieren A, Lau Wendi M, Facklam David P, Ratanatharathorn Voravit, Becker Cornelia, Ullmann Andrew J, Seibel Nita L, Flynn Patricia M, van Burik Jo-Anne H, Buell Donald N, Patterson Thomas F
Education and Research Centre, Wythenshawe Hospital and University of Manchester, Academic Department of Medicine and Surgery, Southmoor Road, Manchester M23 9LT, UK.
J Infect. 2006 Nov;53(5):337-49. doi: 10.1016/j.jinf.2006.03.003. Epub 2006 May 6.
Micafungin (FK463) is a new lipopeptide compound (echinocandin) with activity against Aspergillus and Candida species. This study evaluated the safety and efficacy of micafungin in patients with proven or probable invasive aspergillosis (IA).
A multinational, non-comparative study was conducted to examine proven or probable (pulmonary only) Aspergillus species infection in a wide variety of patient populations. The study employed an open-label design utilizing micafungin alone or in combination with another systemic antifungal agent. Criteria for IA and therapeutic responses were judged by an independent panel.
Of the 331 patients enrolled, only 225 met diagnostic criteria for IA as determined by the independent panel and received at least one dose of micafungin. Patients included 98/225 who had undergone hematopoietic stem cell transplantation (HSCT) (88/98 allogeneic), 48 with graft versus host disease (GVHD), and 83/225 who had received chemotherapy for hematologic malignancy. A favorable response rate at the end of therapy was seen in 35.6% (80/225) of patients. Of those only treated with micafungin, favorable responses were seen in 6/12 (50%) of the primary and 9/22 (40.9%) of the salvage therapy group, with corresponding numbers in the combination treatment groups of 5/17 (29.4%) and 60/174 (34.5%) of the primary and salvage treatment groups, respectively. Of the 326 micafungin-treated patients, 183 (56.1%) died during therapy or in the 6-week follow-up phase; 107 (58.5%) deaths were attributable to IA.
Micafungin as primary or salvage therapy proved efficacious and safe in high-risk patients with IA, although patient numbers are small in the micafungin-only groups.
米卡芬净（FK463）是一种新型脂肽化合物（棘白菌素），对曲霉属和念珠菌属具有活性。本研究评估了米卡芬净在确诊或疑似侵袭性曲霉病（IA）患者中的安全性和有效性。
开展了一项多国、非对照研究，以检查各种患者群体中确诊或疑似（仅肺部）曲霉属感染情况。该研究采用开放标签设计，单独使用米卡芬净或与另一种全身性抗真菌药物联合使用。IA和治疗反应的标准由独立小组判定。
在纳入的331例患者中，只有225例符合独立小组确定的IA诊断标准并接受了至少一剂米卡芬净。患者包括98/225例接受过造血干细胞移植（HSCT）的患者（88/98例为异基因移植），48例患有移植物抗宿主病（GVHD），以及83/225例接受血液系统恶性肿瘤化疗的患者。35.6%（80/225）的患者在治疗结束时出现了良好反应率。在仅接受米卡芬净治疗的患者中，初始治疗组有6/12（50%）出现良好反应，挽救治疗组有9/22（40.9%）出现良好反应，联合治疗组中初始治疗组和挽救治疗组相应的比例分别为5/17（29.4%）和60/174（34.5%）。在326例接受米卡芬净治疗的患者中，183例（56.1%）在治疗期间或6周随访期内死亡；107例（58.5%）死亡归因于IA。
尽管仅使用米卡芬净的组中患者数量较少，但米卡芬净作为初始或挽救治疗在高危IA患者中证明是有效且安全的。
