遵循指南,安心肾选分析报告.ppt

在肾功能正常或不同程度的CKD患者，连续服用7天诺和龙（每天共服用2mg），发现各组人群，第7天和第1天相比，血药浓度并无明显改变。此外，肾功能正常组与轻中度CKD组及重度CKD组比较，血药浓度也没有明显改变。这个试验说明，诺和龙在CKD患者体内无蓄积。 Clin Pharmacol Ther. 2000 Jan;67(1):7-15. Pharmacokinetics of repaglinide in subjects with renal impairment. Marbury TC, Ruckle JL, Hatorp V, Andersen MP, Nielsen KK, Huang WC, Strange P. Orlando Clinical Research Center, Fla 32806, USA. Abstract OBJECTIVE: To evaluate the effect of renal impairment and renal failure on the pharmacokinetics and safety of repaglinide. METHODS: We conducted a phase I, multicenter, parallel-group, pharmacokinetic comparison trial with single and multiple doses of repaglinide in subjects with various degrees of renal impairment. Subjects with normal renal function (n = 6) and subjects with renal impairment (mild to moderate, n = 6; severe, n = 6) received treatment with 2 mg repaglinide for 7 days. Subjects in the hemodialysis group (n = 6) received two single doses of 2 mg repaglinide separated by a 7- to 14-day washout period. All subjects had repaglinide serum pharmacokinetic profiles measured for the first and last doses administered. Serum steady-state levels, urine levels, and dialysate levels were also measured. RESULTS: Pharmacokinetic parameters did not show significant changes after single or multiple doses of repaglinide, although the elimination rate constant in the group with severe renal impairment decreased after 1 week of treatment. Subjects with severe impairment had significantly higher area under the curve values after single and multiple doses of repaglinide than subjects with normal renal function. No significant differences in values for maximum serum concentration or time to reach maximum concentration were detected between subjects with renal impairment and those with normal renal function. Hemodialysis did not significantly affect repaglinide clearance. CONCLUSIONS: Repaglinide was safe and well tolerated in subjects with varying degrees of renal impairment. Although adjustment of sta