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持续性中性粒细胞减少性发热患者静脉注射伊曲康唑的群体药代动力学

Population pharmacokinetics of intravenous itraconazole in patients with persistent neutropenic fever.

作者信息

Lee D-G, Chae H, Yim Dong-Seok, Park S H, Choi S-M, Kim S, Choi J-H, Yoo J-H, Shin W-S

机构信息

Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seocho-gu, Seoul, Korea.

出版信息

J Clin Pharm Ther. 2009 Jun;34(3):337-44. doi: 10.1111/j.1365-2710.2008.00999.x.

DOI:10.1111/j.1365-2710.2008.00999.x
PMID:19646080
Abstract

PURPOSE

Empirical use of intravenous (IV) itraconazole (ITZ) for febrile neutropenic patients has recently been introduced in Korea. This study was designed to investigate the population pharmacokinetics (PK) of IV-ITZ.

METHODS

Sparse PK data were collected from febrile neutropenic patients undergoing empirical ITZ therapy at 200 mg/day after loading doses. NONMEM (Version. 5.1.1) was used to estimate population PK parameters.

RESULTS

Forty-two patients were enrolled in the study. Mean population CL and V of IV-ITZ were 10 L/h and 1050 L, respectively. Body weight was the only contributing covariate of CL. The median simulated trough concentration of ITZ after 10 days was predicted to be about 700 ng/mL.

CONCLUSIONS

In this study, we explored the population PK profile of ITZ given in IV formulation. We found that the current dosage regimen of IV-ITZ (200 mg/day) was appropriate to obtain therapeutic trough concentrations for neutropenic patients in Korea.

摘要

目的

韩国最近开始对发热性中性粒细胞减少症患者经验性使用静脉注射(IV)伊曲康唑(ITZ)。本研究旨在调查静脉注射伊曲康唑的群体药代动力学(PK)。

方法

从接受经验性ITZ治疗、负荷剂量后每日200mg的发热性中性粒细胞减少症患者中收集稀疏的PK数据。使用NONMEM(版本5.1.1)估算群体PK参数。

结果

42例患者纳入本研究。静脉注射伊曲康唑的平均群体清除率(CL)和分布容积(V)分别为10L/h和1050L。体重是CL的唯一影响协变量。预计10天后伊曲康唑的模拟谷浓度中位数约为700ng/mL。

结论

在本研究中,我们探讨了静脉注射剂型伊曲康唑的群体PK特征。我们发现,目前静脉注射伊曲康唑的给药方案(每日200mg)适合在韩国为中性粒细胞减少症患者获得治疗性谷浓度。

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