Vol.56 No.3 May 2008
Clinical effects of micafungin, a novel echinocandin antifungal agent, on systemic fungal infections in surgery, emergency, and intensive-care medicine; Evaluation using the AKOTT algorithm
1)Emergency and Critical Care Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
2)Third Department of Surgery, Toho University School of Medicine
3)Department of Emergency and Critical Care Medicine, Graduate School of Medicine, Chiba University
4)Department of Infection Control and Prevention, Hyogo College of Medicine
5)Kokushikan University Physical Education Sport and Medical Science
Abstract
The clinical efficacy of micafungin(MCFG), the first echinocandin antifungal agent approved in Japan, in surgery, emergency, and intensive-care medicine has only been studied in a limited number of cases, with no large-scale reports filed as of this writing. We conducted a postmarketing surveillance study to evaluate MCFG efficacy and safety at 63 medical departments in Japan. MCFG was given to patients with a fever exceeding 37.5°C, either diagnosed with a proven fungal infection based on mycological or histopathological examination, or diagnosed with a suspected fungal infection with high risk factors, based on surveillance culture or serum β-D glucan testing. Efficacy was evaluated using the AKOTT algorithm created by our group for objectively evaluating antifungal agent efficacy in patients with both fungal and bacterial infections. Of the 180 patients enrolled, 68 were excluded by exclusion criteria or other reasons and 112 patients (58 with proven candidiasis, 1 with proven aspergillosis, and 53 with suspected fungal infection) were evaluated for efficacy. MCFG was administered at a mean maximum daily dose of 104 mg for a mean duration of 14.2 days. It was effective in 72 patients, ineffective in 28, and of undeterminable efficacy in 12, for overall clinical efficacy of 72.0%. Classified by diagnosis, MCFG was effective in 78.6% of those with proven candidiasis (44/56) and 65.1% with suspected fungal infection (28/43), but ineffective in 1 patient with aspergillosis. MCFG successfully eradicated 77.6% (52/67) of fungi isolated in patients. Some 69 drug-related adverse reactions, mainly abnormal hepatic function, occurred in 37 of 178 patients in safety evaluation (20.8%), but the event incidence was not dose-dependent. One adverse reaction, skin eruption, had a probable causal relationship to drug treatment. In conclusion, MCFG shows high clinical efficacy and safety in the treatment of deep-seated fungal infection in surgery, emergency, and intensive-care medicine, indicating good potential as a first-line drug for both targeted and empirical therapies.
Key word
micafungin, antifungal therapy, AKOTT algorithm, surgery, emergency and intensive-care
Received
November 30, 2007
Accepted
March 4, 2008
Jpn. J. Chemother. 56 (3): 330-343, 2008
