My5-FUTM免疫比浊法快速测定胃癌患者口服替吉奥后血浆中5-FU浓度

目的：分析免疫比浊法（My5-FUTM法）和LC-MS/MS法测定胃癌患者服用替吉奥（S-1）后血浆中5-FU浓度，构建My5-FUTM法测定服用替吉奥后5-FU的血药浓度。方法：30例初治胃癌患者首次服用替吉奥50 mg，分别采用My5-FUTM法和LC-MS/MS法测定口服替吉奥0、2、4、6、8、12 h血浆中5-FU的浓度，获得患者的AUC0-12、AUC0-∞、Tmax、Cmax、T1/2。结果：My5-FUTM法获得AUC0-12、AUC0-∞、Tmax、Cmax、T1/2分别为：（1109±488） ng·mL-1·h，（1240±589） ng·mL-1· h，（3.64±1.34） h，（196±69） ng·mL-1和（2.52±1.34） h；LC-MS/MS法为：（614±280） ng·mL-1·h，（656±318） ng·mL-1·h，（3.58±1.27） h，（119±43） ng·mL-1，（2.28±1.03） h。两种方法所获得药代动力学参数具有显著的相关性，血浆中5-FU的均值浓度变化差异显著（P=0.0045）。结论：My5-FUTM法可以用于检测胃癌患者口服替吉奥后5-FU的血浆浓度，具有操作简便、快速、稳定性高等优点，也可用于服药替吉奥后5-FU药代动力学研究。

Immune Turbidimetry My5-FUTM Method for Monitoring Plasma Concentration of 5-FU in Gastric Cancer Patients Given S-1

Objective: To compare biological immune turbidimetry (My5-FUTM method) and LC-MS/MS method for monitoring plasma concentration of 5-FU in patients with gastric cancer given S-1. Methods:Thirty gastric cancer patients with initial treatment of S-1 50 mg monitored by My5-FUTM and LC-MS/MS parallelly for the concentrations of 5-FU in plasma at 0 h, 2 h, 4 h, 6 h, 8 h and 12 h, respectively. And corresponding AUC0-12, AUC0-∞, Tmax, Cmax and T1/2. Results: The main pharmacokinetic parameters of 5-FU obtained by My5-FUTM and LC-MS/MS method were respectively as follows: AUC0-12, (1109±488) and (614± 280) ng·mL-1·h; AUC0-∞, (1109±488) and (614±280) ng·mL-1·h; AUC0-∞, (1240±589) and (656±318) ng·mL-1· h; Tmax, (3.64 ±1.34) and (3.58 ±1.27) h; Cmax, (196 ±69) and (119 ±43) ng·mL-1; T1/2, (2.52 ±1.34) and (2.28 ± 1.03) h. Parameters by the two methods showed good correlation with each other. The changes of 5-FU av-erage concentrations in plasma by the two methods showed significant difference (P=0.0045). Conclusion:My5-FUTM method can be used to monitor the concentration of 5-FU in plasma in gastric cancer patients given S-1. It has the advantages of easy and fast operation, high stability, etc. It can also be used for 5-FU pharmacokinetic study.