Boelaert J, Valcke Y, Dammekens H, De Vriese G, Ahr G, Schurgers M, Daneels R, Bogaert M G
Algemeen Ziekenhuis St. Jan, Brugge, Belgium.
Eur J Clin Pharmacol. 1988;34(2):207-9. doi: 10.1007/BF00614560.
The pharmacokinetics of nisoldipine have been studied after oral administration of one 10 mg tablet to 3 groups of patients: Group A (n = 8) with a mean creatinine of 90 ml/min, Group B (n = 8) with a mean creatinine clearance of 12 ml/min and Group C of 12 patients on maintenance haemodialysis. All of them were studied off-dialysis and 7 were also studied on a dialysis day. No significant differences were observed between Groups A, B and C (on an interdialysis day) in AUC (0-7h), tmax, Cmax and plasma protein binding. Unchanged nisoldipine could not be recovered from the urine in any patient. Haemodialysis did not significantly affect AUC, tmax and Cmax, and nisoldipine could not be detected in the dialysate. The results indicate that the dose of nisoldipine need not be changed in patients with renal dysfunction, and that a supplementary dose is not required after haemodialysis. Blood pressure in the uraemics fell more than in the patients with good renal function.
已对三组患者口服一片10毫克尼索地平后的药代动力学进行了研究:A组(n = 8),平均肌酐清除率为90毫升/分钟;B组(n = 8),平均肌酐清除率为12毫升/分钟;C组为12名维持性血液透析患者。所有患者均在非透析日进行研究,其中7名患者也在透析日进行了研究。A、B、C组(在非透析日)在AUC(0 - 7小时)、达峰时间(tmax)、峰浓度(Cmax)和血浆蛋白结合率方面未观察到显著差异。任何患者的尿液中均未检测到未代谢的尼索地平。血液透析对AUC、tmax和Cmax无显著影响,透析液中未检测到尼索地平。结果表明,肾功能不全患者无需改变尼索地平剂量,血液透析后也无需补充剂量。尿毒症患者的血压下降幅度大于肾功能良好的患者。