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Clinical efficacy and safety of micafungin in Japanese patients with chronic pulmonary aspergillosis: a prospective observational study
Author(s) -
Shigeru Kohno,
Koichi Izumikawa,
Hiroshi Kakeya,
Yoshitsugu Miyazaki,
Kenji Ogawa,
Ryoichi Amitani,
Yoshihito Niki,
Atsuyuki Kurashima
Publication year - 2011
Publication title -
medical mycology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.004
H-Index - 86
eISSN - 1460-2709
pISSN - 1369-3786
DOI - 10.3109/13693786.2011.561369
Subject(s) - micafungin , medicine , observational study , adverse effect , aspergillosis , clinical trial , incidence (geometry) , prospective cohort study , antifungal drug , intensive care medicine , surgery , antifungal , dermatology , amphotericin b , immunology , physics , optics
Aspergillosis has been the prevailing deep-seated mycosis in Japan since the 1990s. Although micafungin (MCFG) has been approved in Japan for the management of patients with such infections caused by Candida and Aspergillus species, there are relatively few reports on its use in patients with chronic pulmonary aspergillosis (CPA). Therefore, we conducted a prospective observational study to evaluate the efficacy and safety of the use of MCFG in Japanese patients with CPA. The efficacy of the antifungal was assessed on the basis of improvements in clinical symptoms and radiological findings. In addition, adverse events, including abnormal laboratory findings were determined. The overall clinical efficacy rate was 68.4% (26/38 patients), which is comparable to the results obtained in clinical trials for marketing approval conducted in Japan. Although adverse drug reactions were observed in six patients (15.8%), they were not serious. The most common of these reactions was abnormal liver functions. No relationship between the incidence of adverse drug reactions and age of the patients, MCFG dose, or duration of treatment was observed. Consequently, MCFG has favorable efficacy and safety profiles in Japanese CPA patients with various backgrounds.

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