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目的:应用有限采样法(Limited Sampling Strategy,LSS)估算肾移植患者口服环孢素后药时曲线下面积(AUC)。方法:12名肾移植患者单剂量口服CsA微乳制剂,荧光免疫偏振法测定各采样时间点CsA的血药浓度,以多元线性逐步回归法建立数学模型。结果:单个血药浓度-时间点预测AUC0-12的回归模型,线性关系较差,2点和3点预测AUC0-12的回归模型较单点预测好(r2>0．9,P<0．05)。其中C2,C6预测AUC0-12的回归模型(AUC0-12=1017．029+3．047 C2+3.121 C6,r2=0．960, P<0．05)线性关系佳且准确性好。结论:以LSS法估算口服CsA微乳制剂AUC0-12准确性好,临床上可用作CsA治疗药物监测的手段。
OBJECTIVE: To estimate the area under the curve (AUC) of oral cyclosporine after renal transplant recipients by Limited Sampling Strategy (LSS). Methods: Twelve CsA microemulsions were administered orally to a single dose of CsA microemulsion in renal transplant recipients. The plasma concentration of CsA at each sampling time was determined by fluorescence immuno-polarization method. The mathematical model was established by multivariate linear stepwise regression. Results: Regression model of AUC0-12 at single plasma concentration-time point showed a poor linearity. AUC0-12 at 2 and 3 points was better than single point prediction (r2> 0.9, P <0). 05). The regression model of AUC0-12 predicted by C2 and C6 (AUC0-12 = 1017.029 + 3.047 C2 + 3.121 C6, r2 = 0.960, P <0.05) showed good linearity and good accuracy. Conclusion: The accuracy of LSC method for the determination of AUC0-12 in oral CsA microemulsion is good and can be used clinically as a means of monitoring CsA.