[An open, noncomparative multicenter study of the efficacy and safety of itraconazole injections and high dose capsules in chronic pulmonary aspergillosis].

Abstract

BACKGROUND:

Itraconazole (ITCZ) is a novel triazole antifungal with a broad spectrum including Aspergillus species. We conducted a three-month open, noncomparative multicenter study of the efficacy and safety of ITCZ injections and high dose capsules in chronic pulmonary aspergillosis.

METHODS:

Patients with chronic pulmonary aspergillosis received intravenous injection of ITCZ (200mg) (twice a day for the first two days, then once a day for the following 3-12 days) prior to the oral administration of ITCZ capsules (200mg) twice a day. Radiologic findings by chest CT and clinical symptoms were evaluated at baseline and 12 weeks later. We also measured ITCZ plasma trough concentrations after two weeks and four weeks of the study.

RESULTS:

Twenty patients were included in the study, among which 14 patients presented with chronic necrotizing pulmonary aspergillosis (CNPA) and 6 presented with pulmonary aspergilloma. The efficacy evaluation was available in 17 patients (CNPA, 12 patients; aspergilloma, 5 patients). Radiological improvement was observed in nine (52.9%, 95%CI: 31.0%-73.8%) patients (CNPA, 7 patients; aspergilloma, 2 patients). One patient with aspergilloma showed deterioration. The clinical symptoms showed significant improvement on expectoration, bloody sputum, and pyrexia. Two patients had to stop treatment with ITCZ because of congestive heart failure. Other adverse effects were reported but did not lead to the discontinuation of treatment, as follows: hepatic dysfunction, two patients; hypokalemia, nine patients. In two patients who combined pulmonary Mycobacterium avium complex disease coadministration of ITCZ and rifampicin was done. Their ITCZ plasma concentrations were extremely low, and one of them was the only deterioration case in the primarily radiologic evaluation.

CONCLUSION:

Itraconazole injections and high dose capsules maintenance therapy is effective in treating chronic pulmonary aspergillosis.

• Authors: Hiromi Tomioka, Toshihiko Kaneda, Yoko Kida, Masahiro Kaneko, Hiroshi Fujii, Michio Hayashi, Keisuke Tomii, Kimihide Tada, Yujiro Suzuki, Takayuki Karino
• Journal: Kansenshogaku zasshi. The Journal of the Japanese Association for Infectious Diseases (Kansenshogaku Zasshi) Vol. 85 Issue 6 Pg. 644-51 (Nov 2011) ISSN: 0387-5911 [Print] Japan
• PMID: 22250455 (Publication Type: Clinical Trial, English Abstract, Journal Article, Multicenter Study)

Chemical References

• Antifungal Agents
• Capsules
• Itraconazole

Topics

• Administration, Oral
• Adult
• Aged
• Aged, 80 and over
• Antifungal Agents (administration & dosage, adverse effects)
• Capsules
• Chronic Disease
• Female
• Humans
• Injections, Intravenous
• Itraconazole (administration & dosage, adverse effects)
• Male
• Middle Aged
• Pulmonary Aspergillosis (drug therapy)