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肝肾功能对血液系统恶性肿瘤患者米卡芬净处置的影响。

Effect of liver and kidney function on migafungin disposition in patients with hematologic malignancies.

作者信息

Nakagawa Yasunori, Ichii Yoko, Saeki Yasuhiro, Kodama Masanobu, Kishino Satoshi, Suzuki Kenshi

机构信息

Department of Hematology, Japanese Red Cross Medical Center, 4-1-22, Hiroo, Shibuya, Tokyo, 150-8935, Japan.

出版信息

Eur J Drug Metab Pharmacokinet. 2008 Jul-Sep;33(3):191-8. doi: 10.1007/BF03191118.

DOI:10.1007/BF03191118
PMID:19007046
Abstract

The plasma concentration of micafungin (MCFG) after intravenous infusion of MCFG at 150 or 300 mg/day over 1 hour to 49 patients with hematologic malignancies were determined, and the relationship between the plasma concentrations and the patients' laboratory parameters of liver and kidney function was analyzed. Plasma samples were obtained at the end of the initial administration of MCFG, 5 to 6 hours after the start of the initial administration, immediately before the second dosing, immediately before the fourth dosing, and the end of the fourth dosing. The plasma concentration of MCFG was measured by high performance liquid chromatography. The plasma concentration of MCFG was correlated with the doses of MCFG per kilogram body weight. The peak concentration after the initial administration was 3.8 times higher than the trough level after the initial administration. The steady-state peak and trough levels were 1.4-1.5 times higher than those after the initial administration. There was no correlation between the laboratory parameters of liver/kidney function and the dose-normalized plasma concentration of MCFG. These results suggest that MCFG can be administered safely to patients with liver or kidney dysfunction without adjusting the dose.

摘要

对49例血液系统恶性肿瘤患者静脉输注150或300mg/日米卡芬净(MCFG)1小时后,测定其血浆米卡芬净浓度,并分析血浆浓度与患者肝肾功能实验室参数之间的关系。在米卡芬净首次给药结束时、首次给药开始后5至6小时、第二次给药前即刻、第四次给药前即刻以及第四次给药结束时采集血浆样本。米卡芬净血浆浓度采用高效液相色谱法测定。米卡芬净血浆浓度与每千克体重米卡芬净剂量相关。首次给药后的峰浓度比首次给药后的谷浓度高3.8倍。稳态峰浓度和谷浓度比首次给药后高1.4 - 1.5倍。肝/肾功能实验室参数与米卡芬净剂量标准化血浆浓度之间无相关性。这些结果表明,米卡芬净可安全地用于肝或肾功能不全患者,无需调整剂量。

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本文引用的文献

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Micafungin versus liposomal amphotericin B for candidaemia and invasive candidosis: a phase III randomised double-blind trial.米卡芬净与脂质体两性霉素B治疗念珠菌血症和侵袭性念珠菌病:一项III期随机双盲试验
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Biol Pharm Bull. 2005 Mar;28(3):477-80. doi: 10.1248/bpb.28.477.
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A multicenter, open-label clinical study of micafungin (FK463) in the treatment of deep-seated mycosis in Japan.在日本进行的一项关于米卡芬净(FK463)治疗深部真菌病的多中心、开放标签临床研究。
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