Kikuchi Masafumi, Tanaka Masaki, Takasaki Shinya, Takahashi Akiko, Akiba Miki, Matsuda Yasushi, Noda Masafumi, Hisamichi Kanehiko, Yamaguchi Hiroaki, Okada Yoshinori, Mano Nariyasu
1Department of Pharmaceutical Sciences, Tohoku University Hospital, 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574 Japan.
2Department of Organ Transplantation Center, Tohoku University Hospital, 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574 Japan.
J Pharm Health Care Sci. 2018 Apr 2;4:7. doi: 10.1186/s40780-018-0101-7. eCollection 2018.
Mycophenolic acid (MPA) treatment requires therapeutic drug monitoring to improve the outcome after organ transplantation. The aim of this study was to compare two methods, a particle enhanced turbidimetric inhibition immunoassay (PETINIA) and a reference liquid chromatography tandem mass spectrometry (LC-MS/MS) for determining plasma MPA concentrations from Japanese lung transplant recipients.
Plasma MPA concentrations were determined from 20 Japanese lung transplant recipients using LC-MS/MS and the PETINIA on the Dimension Xpand Plus-HM analyzer.
The mean MPA concentration measured by PETINIA was significantly higher than that measured by LC-MS/MS (3.26 ± 2.73 μg/mL versus 2.82 ± 2.71 μg/mL, < 0.0001). The result of the Passing Bablok analysis was a slope of 1.104 (95% confidence interval [CI], 1.036-1.150) and an intercept of 0.229 (95%CI, 0.144-0.315). Bland-Altman analysis revealed PETINIA overestimates plasma MPA concentration by 26.25% and 95%CI from 21.43 to 31.07%.
The measurement of MPA by the PETINIA in Japanese lung transplant patients should evaluate the result with attention to positive bias.
霉酚酸（MPA）治疗需要进行治疗药物监测以改善器官移植后的疗效。本研究旨在比较两种方法，即颗粒增强比浊抑制免疫测定法（PETINIA）和参考液相色谱串联质谱法（LC-MS/MS），用于测定日本肺移植受者的血浆MPA浓度。
使用LC-MS/MS和Dimension Xpand Plus-HM分析仪上的PETINIA，对20名日本肺移植受者的血浆MPA浓度进行测定。
PETINIA测定的MPA平均浓度显著高于LC-MS/MS测定的浓度（3.26±2.73μg/mL对2.82±2.71μg/mL，<0.0001）。Passing Bablok分析结果显示斜率为1.104（95%置信区间[CI]，1.036-1.150），截距为0.229（95%CI，0.144-0.315）。Bland-Altman分析显示，PETINIA高估血浆MPA浓度26.25%，95%CI为21.43%至31.07%。
在日本肺移植患者中，用PETINIA测定MPA时，应注意阳性偏差来评估结果。
