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两性霉素B脂质复合物的肾脏效应。

Renal effects of amphotericin B lipid complex.

作者信息

Luke R G, Boyle J A

机构信息

Department of Internal Medicine, University of Cincinnati Medical Center, OH 45267-0557, USA.

出版信息

Am J Kidney Dis. 1998 May;31(5):780-5. doi: 10.1016/s0272-6386(98)70046-0.

Abstract

A study was conducted to compare the renal effects of amphotericin B lipid complex (ABLC), a lipid formulation of the widely used antifungal medication, with conventional amphotericin B (AmB) in the treatment of serious fungal infections, including invasive candidiasis, cryptococcal meningitis, and aspergillosis. The clinical experience of ABLC includes two types of open-label studies: randomized comparative (ABLC 5 mg/kg/d compared with AmB 0.6 to 1 mg/kg) and emergency use. In the comparative studies, changes in serum creatinine were evaluated three ways: doubling of the baseline value, an increase from < or = 1.5 mg/dL at baseline to > or = 1.5 mg/dL, and an increase from < or = 1.5 mg/dL at baseline to > or = 2.0 mg/dL. More patients in the AmB group reached these end points than in the ABLC group (P < or = 0.007), and the time needed to reach each of these end points was significantly shorter for the AmB group (P < or = 0.02). Increased serum creatinine was reported as an adverse event more frequently by patients receiving AmB than by patients receiving ABLC. In the emergency use study, a steady and statistically significant decrease in serum creatinine was observed among patients who started ABLC treatment with serum creatinine greater than 2.5 mg/dL due to prior AmB treatment. ABLC offers the physician a valuable, less-nephrotoxic alternative to AmB for the treatment of patients with severe, invasive fungal infections.

摘要

开展了一项研究,比较两性霉素B脂质复合体(ABLC,一种广泛使用的抗真菌药物的脂质制剂)与传统两性霉素B(AmB)在治疗包括侵袭性念珠菌病、隐球菌性脑膜炎和曲霉病在内的严重真菌感染时对肾脏的影响。ABLC的临床经验包括两种开放标签研究:随机对照研究(ABLC 5mg/kg/天与AmB 0.6至1mg/kg对比)和紧急使用研究。在对照研究中,通过三种方式评估血清肌酐的变化:基线值翻倍、从基线时≤1.5mg/dL增至≥1.5mg/dL、从基线时≤1.5mg/dL增至≥2.0mg/dL。与ABLC组相比,AmB组有更多患者达到这些终点(P≤0.007),且AmB组达到每个终点所需时间显著更短(P≤0.02)。接受AmB治疗的患者比接受ABLC治疗的患者更频繁地报告血清肌酐升高为不良事件。在紧急使用研究中,对于因先前使用AmB治疗而血清肌酐大于2.5mg/dL开始接受ABLC治疗的患者,观察到血清肌酐持续且有统计学意义的下降。对于治疗严重侵袭性真菌感染的患者,ABLC为医生提供了一种有价值的、肾毒性较小的AmB替代药物。

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