高剂量米卡芬净治疗新生儿和婴幼儿侵袭性念珠菌病：一项 2 期研究结果。
High-Dose Micafungin in Neonates and Young Infants with Invasive Candidiasis: Results of a Phase 2 Study.
机构信息
Neonatal Intensive Care Unit, Bambino Gesù Children's Hospital, Rome, Italy
Biochemistry Laboratory, Department of Specialist Pediatrics, Bambino Gesù Children's Hospital, Rome, Italy.
出版信息
Antimicrob Agents Chemother. 2021 Mar 18;65(4). doi: 10.1128/AAC.02494-20.
Limited data are available on the most appropriate dosing, efficacy, and safety of micafungin in neonates and young infants with invasive candidiasis (IC). This study evaluated plasma levels, efficacy, and safety of micafungin at a dose of 8 mg/kg daily for a mean of 13.3 days (±5.2 days) in 35 neonates and young infants with IC. Micafungin plasma concentrations were 5.70 mg/liter preadministration and 17.23, 15.59, and 10.27 mg/liter after 1, 2, and 8 h, respectively. The resolution of the infection was achieved in 86.7% of patients treated for ≥14 days. In 20.0% of patients, we observed a transient hypertransaminasemia. Micafungin at a dose of 8 mg/kg daily is effective and well tolerated in neonates and young infants with IC. (This study has been registered at ClinicalTrials.gov under identifier NCT03421002 and in the EU Clinical Trials Register under number 2014-003087-20.).
关于米卡芬净在患有侵袭性念珠菌病（IC）的新生儿和婴儿中的最佳剂量、疗效和安全性，目前仅有有限的数据。本研究评估了 35 例患有 IC 的新生儿和婴儿每日接受 8mg/kg 米卡芬净治疗，平均疗程为 13.3 天（±5.2 天）的血药浓度、疗效和安全性。米卡芬净给药前的血药浓度为 5.70mg/L，分别在给药后 1、2 和 8 小时达到 17.23、15.59 和 10.27mg/L。治疗≥14 天的患者中，86.7%的感染得到缓解。20.0%的患者出现短暂性转氨酶升高。每日 8mg/kg 剂量的米卡芬净在患有 IC 的新生儿和婴儿中有效且耐受良好。（本研究已在 ClinicalTrials.gov 注册，标识符为 NCT03421002，并在欧盟临床试验注册中心注册，编号为 2014-003087-20。）
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