环孢素人体药品暴露量监测与血药浓度采样点的相关性研究  

Study on the Correlation of Cyclosporine Exposure Monitoring in Healthy Volunteers with Sampling Time Points of Blood

作　　者：唐崑[1] 张相林[1] 刘晓[1] 张镭[1] 张金泉[1] 

机构地区：[1]中日友好医院药学部,北京市100029

出　　处：《中国药房》2010年第26期2435-2437,共3页China Pharmacy

摘　　要：目的:通过健康人体环孢素药动学研究,了解不同环孢素制剂的药品暴露量与用药后采血时间的相关性。方法:采用24名健康男性生物等效性试验数据(受试制剂与参比制剂)中服药后前12个采血点的试验数据,将不同采血点的血药浓度值与药-时曲线下面积(AUC)进行多元线性回归分析。结果:以两点策略估算AUC,不同环孢素制剂的相关系数都可达到0.9,估算的偏差均<15%。受试制剂的AUC可用C8和C12估算,参比制剂的AUC可用C2.5和C12估算。结论:以两点策略估算AUC可满足临床需求,但制剂不同,估算点存在较大差异。OBJECTIVE：To study pharmacokinetics of cyclosporine in healthy volunteers, and to investigate the relationship of drug exposure with blood sampling time after treatment. METHODS： The data of trial at the first 12 blood sampling time points after medication were collected from bioequivalence test in 24 healthy volunteers （trial preparation vs. reference preparation）. Multiple linear regression analysis was used to study the blood concentrations of cyclosporine at different sampling time points and the area under the blood concentration-time curve （AUC）. RESULTS： The concentrations at two points were adopted to estimate AUC. The correlation coefficient of different cyclosporines could reach 0.9 with estimation deviations less than 15%. The AUC of cyclosporine of trial preparation could be estimated by C8 and C12, and that of reference preparation by C2.5 and C12. CONCLUSION： The AUC estimated by concentrations at two points can meet clinical demand. There is great difference in estimate point among different preparations.

关 键 词：环孢素 暴露量 治疗药物监测 采血时间 相关性 多元线性回归 

分 类 号：R978.11[医药卫生—药品] R969.1[医药卫生—药学]