A multicentre clinical trial of itraconazole for systemic mycoses was carried out in 25 hospitals in Japan. The clinical efficacy and safety of itraconazole in 41 cases of systemic aspergillosis are reported here. Of the patients, 9 were diagnosed as having bronchopulmonary aspergillosis, 30 had pulmonary aspergilloma, 1 had chronic necrotizing pulmonary aspergillosis and 1 had pleural aspergillosis. The diagnosis was established by microscopy, culture, histology, serology, biopsy, radiography and/or endoscopy. The mean age of the patients was 59.0 ± 14.5 years (range, 11-88 years). Itraconazole, 50-200 mg/day, was given for a mean of 150.5 days. Eradication of the fungus was observed in 17 patients out of the 22 cases examined mycologically. The overall clinical efficacy (cure or improvement) was 88.9% (8/9) in bronchopulmonary aspergillosis and 83.3% (25/30) in pulmonary aspergilloma, determined by clinical symptoms, mycological effects and radiographic observation. Radiographic evidence of the disappearance or improvement in size of the fungal ball was observed in 10 patients (33.3%) with aspergilloma. Itraconazole was clinically well tolerated; only 1 patient had pruritus, 1 had constipation, and in 1 elevation of serum aspartate aminotransferase, serum alanine aminotransferase and serum alkaline phosphatase was observed. The minimum inhibitory concentration (MIC) of itraconazole for isolates of Aspergillus from 9/13 cases was below 0.08 µg/ml. As only a few antifungal agents show any activity against Aspergillus spp., itraconazole was considered to be a useful oral agent for treatment of systemic aspergillosis, including pulmonary aspergilloma.

Keywords:
Itraconazole, Systemic aspergillosis
This content is only available via PDF.
© 1992 S. Karger AG, Basel
1992
Copyright / Drug Dosage / Disclaimer
Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.