单剂量司他夫定（d4T）在严重肝功能损害患者中的药代动力学及安全性
Pharmacokinetics and safety of a single dose of stavudine (d4T) in patients with severe hepatic impairment.
作者信息
Schaad H J, Petty B G, Grasela D M, Christofalo B, Raymond R, Stewart M
机构信息
Division of Clinical Pharmacology, The Johns Hopkins University School of Medicine, Baltimore, Maryland 21287-5554, USA.
出版信息
Antimicrob Agents Chemother. 1997 Dec;41(12):2793-6. doi: 10.1128/AAC.41.12.2793.
Abstract
This open-label study enrolled five subjects with biopsy-proven cirrhosis and moderate to severe hepatic impairment (Child-Pugh classification grade B or C) and five age- and gender-matched controls. All subjects received a single 40-mg oral dose of stavudine (d4T). Stavudine pharmacokinetics in subjects with hepatic impairment were similar to those in age- and gender-matched control subjects and were not substantially different from those previously observed in human immunodeficiency virus-infected patients. Based on these findings, stavudine use does not require modification of the dose or dosing interval for patients with liver disease.
摘要
这项开放标签研究招募了5名经活检证实患有肝硬化且有中度至重度肝功能损害（Child-Pugh分级为B级或C级）的受试者以及5名年龄和性别匹配的对照者。所有受试者均接受了一次40毫克司他夫定（d4T）的口服给药。肝功能损害受试者中的司他夫定药代动力学与年龄和性别匹配的对照受试者相似，且与先前在人类免疫缺陷病毒感染患者中观察到的情况无实质性差异。基于这些发现，对于肝病患者，使用司他夫定时无需调整剂量或给药间隔。
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