A four-state nonlinear model describing a radiopharmacokinetic system for a hepatic receptor-binding radiopharmaceutical, [99mTc]-galactosyl-neoglycoalbumin (TcNGA), was tested for goodness-of-fit and local identifiability using scanning data from nine healthy subjects and seven patients with severe liver disease. Based on standard deviations of liver and heart imaging data at equilibria as a measure of observational error, the reduced chi-square ranged from 0.5 to 2.6. Values above 1.2 occurred when the subject moved during the 30 min study. Relative standard errors for each parameter were: TcNGA-receptor forward binding rate constant kb, 13-54%; extra-hepatic plasma volume Ve, 0.8-15.0%; hepatic plasma volume Vh, 0.2-6.5%; hepatic plasma flow F, 54----greater than 1000%; and receptor concentration [R]o, 0.3-13%. The highest standard errors occurred when the amount of TcNGA injected exceeded the total amount of receptor. Therefore, when TcNGA functional imaging was performed without excess patient motion and receptor saturation, the kinetic model provided data fits of low systematic error and yielded high precision estimates of receptor concentration and forward binding rate constant. In summary, optimal performance of the kinetic model occurred when the amount of injected TcNGA resulted in the nonlinear operation of the pharmacokinetic system.

译文

:使用来自9个健康受试者和7个健康受试者的扫描数据,测试了描述肝受体结合放射性药物[99mTc]-半乳糖基-新糖蛋白(TcNGA)的放射性药物动力学系统的四态非线性模型患有严重肝病的患者。根据平衡时肝脏和心脏成像数据的标准偏差(作为观察误差的量度),减少的卡方介于0.5到2.6之间。当受试者在30分钟的研究过程中移动时,出现1.2以上的值。每个参数的相对标准误差为:TcNGA-受体正向结合率常数kb,13-54%;肝外血浆体积Ve,0.8-15.0%;肝血浆体积Vh为0.2-6.5%;肝血浆流量F,54 ----大于1000%;受体浓度[R] o为0.3-13%。当注射的TcNGA的量超过受体的总量时,发生最高的标准误。因此,当进行TcNGA功能成像而没有过多的患者运动和受体饱和时,动力学模型提供了低系统误差的数据拟合,并产生了受体浓度和前向结合速率常数的高精度估算值。总之,当注射的TcNGA的量导致药代动力学系统发生非线性操作时,动力学模型的最佳性能就出现了。

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