Acta Medica Nagasakiensia
Print ISSN : 0001-6055
ORIGINAL ARTICLES
Intravenous liposomal amphotericin B versus voriconazole for chronic pulmonary aspergillosis: a multicenter trial in Japan
Shigeru KohnoKoichi IzumikawaKenji OgawaAtsuyuki KurashimaNiro OkimotoKatsuhiro SuzukiHiroshi KakeyaYoshihito NikiKiyoshi IchiharaYoshitsugu Miyazaki
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2018 Volume 61 Issue 4 Pages 167-176

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Abstract

Chronic pulmonary aspergillosis (CPA) is slowly progressive inflammatory pulmonary syndrome due to infection of Aspergillus spp. We conducted a randomized, multicenter, open-label trial comparing intravenous liposomal amphotericin B (L-AMB) of 2.5-5.0 mg/kg once daily with intravenous voriconazole (VRCZ) of 6 mg/kg twice on Day 1 followed by 4 mg/kg twice daily. Treatment effectiveness was defined by clinical, and radiological improvement at both 2 weeks after the initial administration and at the end of therapy. The total of 166 patients were recruited and 83 patients for each drug group were assigned. Total of 51 and 59 cases of L-AMB and VRCZ, respectively were assessed as per-protocol populations. The difference in efficacy rates between L-AMB and VRCZ was not significant, either after 2 weeks [49.0% vs. 59.3%; the absolute difference, 10.3% with a 95% confidence interval (CI), -8.4 to 29.00, P=0.279] or at the end of therapy (52.9% vs. 67.8%; the absolute difference, 14.9% with a 95% CI, -3.4 to 33.2, P=0.111). In the safety evaluation, no statistical difference of occurrence rates in both LAMB and VRCZ group (54.2% vs. 59.0%, P=0.531). L-AMB was as effective as VRCZ with no significant difference of adverse effects in the treatment of CPA. (UMIN Clinical Trials Registry number, UMIN000002236.)

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© 2018 by Nagasaki University School of Medicine
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