PETINIA与液相色谱-串联质谱法（LC-MS/MS）在测定日本肺移植受者血浆中霉酚酸浓度方面的比较。
Comparison of PETINIA and LC-MS/MS for determining plasma mycophenolic acid concentrations in Japanese lung transplant recipients.
作者信息
Kikuchi Masafumi, Tanaka Masaki, Takasaki Shinya, Takahashi Akiko, Akiba Miki, Matsuda Yasushi, Noda Masafumi, Hisamichi Kanehiko, Yamaguchi Hiroaki, Okada Yoshinori, Mano Nariyasu
机构信息
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.
出版信息
J Pharm Health Care Sci. 2018 Apr 2;4:7. doi: 10.1186/s40780-018-0101-7. eCollection 2018.
BACKGROUND
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.
METHODS
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.
RESULTS
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%.
CONCLUSION
The measurement of MPA by the PETINIA in Japanese lung transplant patients should evaluate the result with attention to positive bias.
背景
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。
方法
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。
结果
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%。
结论
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。
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