Safety and pharmacokinetics of repeat-dose micafungin in young infants.
Safety and pharmacokinetics of repeat-dose micafungin in young infants.
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DOI：
10.1038/clpt.2009.200
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发表时间：
2010-01
影响因子：
6.7
通讯作者：
中科院分区：
文献类型：
--
作者：
由于中枢神经系统感染的风险，可能需要相对高的基于体重的棘白菌素剂量才能成功治疗婴幼儿侵袭性念珠菌病和念珠菌血症。这项开放标签研究评估了米卡芬净在13名疑似念珠菌血症或侵袭性念珠菌病的幼儿（年龄> 48小时，出生< 120天）中的安全性和药代动力学。体重≥ 1，000 g和<1，000 g的婴儿分别接受7 mg/kg/天和10 mg/kg/天，至少持续4至5天。7和10 mg/kg/天剂量组的平均基线体重和胎龄分别为2101 g和688 g，以及30周和25周。7和10 mg/kg/天剂量组的中位药代动力学值分别为：AUC 0 -24，258.1和291.2 μg·h/ml; Clss/wt，0.45和0.57 ml/min/kg; Cmax，23.3和24.9 μg/ml; Vdss/wt，341.4和542.8 ml/kg。未发生死亡或停止治疗。这些数据表明，7和10 mg/kg/天剂量的米卡芬净耐受性良好，并且在动物模型中证明暴露量足以覆盖中枢神经系统。
Due to the risk of central nervous system infection, relatively high weight-based echinocandin dosages may be required for successful treatment of invasive candidiasis and candidemia in young infants. This open-label study assessed safety and pharmacokinetics of micafungin in 13 young infants (> 48 hours of age and < 120 days of life) with suspected candidemia or invasive candidiasis. Infants weighing ≥ 1,000 g and < 1,000 g received 7 and 10 mg/kg/day, respectively, for a minimum of 4 to 5 days. Mean baseline weight and gestational age were 2101 g and 688 g, and 30 weeks and 25 weeks, in the 7 and 10 mg/kg/day groups, respectively. Median pharmacokinetic values for the 7 and 10 mg/kg/day groups, respectively, were: AUC0–24, 258.1 and 291.2 μg•h/ml; Clss/wt, 0.45 and 0.57 ml/min/kg; Cmax, 23.3 and 24.9 μg/ml; and Vdss/wt, 341.4 and 542.8 ml/kg. No deaths or discontinuations from treatment occurred. These data suggest that micafungin dosages of 7 and 10 mg/kg/day were well tolerated and provided exposure that was demonstrated in animal model to be adequate for central nervous system coverage.
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影响因子：
11.8
作者：
Pappas, Peter G.;Rotstein, Coleman M. F.;Buell, Donald N.
通讯作者：
Buell, Donald N.
影响因子：
8
作者：
Benjamin, DK;Stoll, BJ;Goldberg, R
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Goldberg, R
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作者：
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9.4
作者：
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影响因子：
9.4
作者：
Pfaller, M. A.;Boyken, L.;Diekema, D. J.
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