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The efficacy and safety of a newly developed miconazole preparation (MJR-1761) for intravenous drip infusion were evaluated in 22 patients with hematological diseases complicated by documented or suspected deep-seated fungal infections. They consisted of 15 patients with fungemia, 2 patients with pulmonary mycosis, and 5 patients with mycosis of the digestive tract. Of the 5 patients, 3 had a complication of fungemia and 1 a complication of urinary tract mycosis. Of the 22 patients, 21 were clinically evaluable. All the patients were included in safety evaluation. The effective rate was 86% (18/21) when moderately improved or better evaluations were included, and the usefulness rate was 81% (17/21) when moderately or more useful evaluations were taken into consideration. Side effects occurred in 4 patients, and abnormal laboratory values were obtained in 4 patients. All these changes, which were previously reported, improved after the discontinuation of the treatment. The results presented indicate that the miconazole intravenous drip infusion solution used in this study is as effective as conventional similar preparations. Since the infusion solution need not be diluted immediately before use, it is simple to use, and its safety may be highly rated. The purpose can be met with less volume of solution per use than before because the preparation contains as much as 200 mg of miconazole in 75 ml of solution. This preparation seems to lend itself better to clinical application than conventional similar infusion solutions.

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Clinical Studies of a Newly Developed Miconazole Preparation for Intravenous Drip Infusion (MJR-1761) in Hematologic Disease Patients with Deep-Seated Fungal Infection