Neoral吸收期血药浓度和药物暴露量在中国成人肝移植受体中的变异性分析

目的通过分析中国成人肝移植受体中Neoral吸收期血药浓度与药物暴露量的变异性，为临床上发展新的Neoral治疗药物监测方法提供理论依据。方法通过定期测定22例中国成人肝移植受体口服Neoral前及服药后1、2、3、4h的血药浓度，采用个体及群体药代动力学的方法计算出个体内和个体间变异系数(CV）。结果Neoral血药浓度和AUC0～4的个体内和个体间变异系数均在服药头2h达到高峰，此后逐渐下降。术后10～11d个体间的浓度及AUC变异系数均最高。结论Neoral吸收期的变异性主要集中在服药后头2h。服药后1w左右是变异性最大的时期。

Analysis of variability of drug exposure and blood concentration during Neoral absorption phase in Chinese adult liver transplant recipients

Objective To analyze the variability of drug exposure and blood concentration during Neoral absorption phase in Chinese adult liver transplant recipients and to provide some useful evidence for exploring new therapeutic drug monitoring (TDM) strategies. Methods We monitored Neoral levels at 0, 1, 2, 3 and 4 hours after morning dose for 22 de novo Chinese adult liver transplant recipients during different periods after transplantation. AUC_(0-4)s was calculated. We also calculated intra- and inter-patient variability (CV) by using population pharmacokinetic methods. Results The intra- and inter-patient variability in CsA blood levels and AUC_(0-4)s were the highest in the first 2 hours and then declined to a low level. From the 10th d to 11th d after the transplantation, the inter-patient variability reached its peak value. Conclusions The intra- and inter-patient variability in Neoral blood levels and AUC_(0-4)s are the highest in the first 2 hours after absorption. The inter-patient variability reaches its peak value 1 week after administration of Neoral.