テオフィリンの唾液試料を用いたTDMの可能性

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We investigated whether theophylline concentrations in saliva (Csaliva) are correlated with its serum concentrations (Cserum) to see if they may be used for the therapeutic drug monitoring (TDM) of theophylline when patients refuse blood sampling. Saliva and serum samples were obtained from 6 healthy adult volunteers after administration of single dose of theophylline, and 40 patients of 3 different age groups (infants group aged 0-3 years, n=10; childrens group aged 7-12 years, n=9; adults group aged 27-81 years, n=21). All patients had been taking theophylline for a time and blood concentrations had reached a steady state. Saliva samples were taken using a sampling pad (OraSure^<[○!R]>; Epitope inc.), and theophylline concentrations in the saliva and serum samples were measured by fluorescence polarization immunoassay (TDx). In the healthy adult volunteers, there was a very good correlation between Csaliva and Cserum (y=0.48 x-0.10, r=0.991, p<0.001), and the ratio of Csaliva to Cserum (Csaliva/Cserum) was 0.46±0.03. The pharmacokinetics parameters Cmax and AUC for saliva were about 0.46 times those for serum and thus their ratios were almost the same as for Csaliva/Cserum. Vd/F for saliva was about 2.2 times that for serum, which was almost the inverse of the ratio for Csaliva/Cserum. There were no significant differences between saliva and serum for Tmax MRT, Ka, Ke, and T_<1/2>. For the patients who had been taking theophylline for a time, there was also a very good correlation between Csaliva and Cserum (y=0.52 x-0.12, r=0.957, p<0.001). Csaliva/Cserum was 0.48±0.10 for the infants group, 0.51±0.07 for the childrens group and 0.50±0.08 for the adults group, so there were no significant differences among the patient groups in this respect. The results of this study show that Cserum can be estimated approximately from Csaliva measurements. Thus in the case of patients from whom it is difficult to obtain blood, it may be possible to check compliance and avoid overdosing using Csaliva. We therefore consider that the use of saliva samples for the TDM of theophylline is an important and convenient method for ensuring that drug therapy is conducted effectively.
日本医療薬学会の論文
2006-04-10

テオフィリンの唾液試料を用いたTDMの可能性

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