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硝苯地平/考来烯胺组合在肝肾功能受损患者中的临床药代动力学。

Clinical pharmacokinetics of the nifedipine/co-dergocrine combination in impaired liver and renal function.

作者信息

Kirch W, Nokhodian A, Halabi A, Weidinger G

机构信息

I. Medizinische Klinik, Christian-Albrechts-Universität, Kiel, Germany.

出版信息

Eur J Drug Metab Pharmacokinet. 1992 Jan-Mar;17(1):33-8. doi: 10.1007/BF03189985.

Abstract

Following a single oral dose of 20 mg nifedipine combined with 2 mg co-dergocrine to 24 subjects, the pharmacokinetics of this drug were studied. 8 normotensive subjects had normal renal and hepatic function, 8 patients had chronic renal insufficiency (creatinine clearance less than 30 ml.min-1) and 8 patients had liver cirrhosis which was confirmed by liver biopsy. The area under the plasma level time curve (AUC infinity) of co-dergocrine increased from 0.59 +/- 0.41 ng.ml-1. (mean +/- SD) in the normals to 1.24 +/- 0.95 ng.ml-1.h in liver cirrhosis (P less than 0.05) and to 1.81 +/- 0.9 ng.ml-1.h in renal failure (P less than 0.05 compared with the control group). Corresponding values for the nifedipine AUC infinity were 564.5 +/- 268 ng.ml-1.h, 1547.5 +/- 1134 (P less than 0.05) and 929 +/- 533 ng.ml-1.h (P less than 0.05; gas chromatographic method). The incidence of adverse effects was lower in patients with renal failure than in subjects with normal renal and liver function as well as in those with liver cirrhosis.

摘要

对24名受试者单次口服20毫克硝苯地平与2毫克可乐定的组合后,对该药物的药代动力学进行了研究。8名血压正常的受试者肝肾功能正常,8名患者患有慢性肾功能不全(肌酐清除率低于30毫升·分钟⁻¹),8名患者患有经肝活检确诊的肝硬化。可乐定的血浆水平时间曲线下面积(AUC∞)从正常组的0.59±0.41纳克·毫升⁻¹·小时(平均值±标准差)增加到肝硬化组的1.24±0.95纳克·毫升⁻¹·小时(P<0.05),肾衰竭组增加到1.81±0.9纳克·毫升⁻¹·小时(与对照组相比P<0.05)。硝苯地平AUC∞的相应值分别为564.5±268纳克·毫升⁻¹·小时、1547.5±1134(P<0.05)和929±533纳克·毫升⁻¹·小时(P<0.05;气相色谱法)。肾衰竭患者的不良反应发生率低于肝肾功能正常的受试者以及肝硬化患者。

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