中国药物警戒 ›› 2016, Vol. 13 ›› Issue (4): 226-228.

• 安全性评估与合理用药 • 上一篇    下一篇

CMIA法与FPIA法测定癫痫患者血浆中丙戊酸及卡马西平药物浓度的一致性评价

张新建,海鑫,马妍妍,李业雨,郭美华   

  1. 哈尔滨医科大学附属第一医院药学部,黑龙江 哈尔滨 150001
  • 收稿日期:2015-08-26 修回日期:2016-06-30 出版日期:2016-04-20 发布日期:2016-06-30
  • 通讯作者: 郭美华,女,硕士,主管药师,临床药学。E-mail:justgoguo@126.com
  • 作者简介:张新建,男,硕士,副主任药师,医院药学。

Consistency Evaluation of CMIA and FPIA Method in Determination of Valproic Acid and Carbamazepine Drug Concentration in Epileptic Patients’ Plasma

ZHANG Xin-jian, HAI Xin, MA Yan-yan, LI Ye-yu, GUO Mei-hua   

  1. Department of Pharmacy, First Affiliated Hospital of Harbin Medical University, Heilongjiang Harbin 150001, China
  • Received:2015-08-26 Revised:2016-06-30 Online:2016-04-20 Published:2016-06-30

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摘要： 目的 以丙戊酸为例,评价化学发光微粒子免疫检测法（CMIA）与荧光偏振免疫检测法（FPIA）测定癫痫患者血浆中抗癫痫药物浓度的一致性。方法 将同一样本在同一天内分别采用CMIA法和FPIA法测定,测定值用Passing-Bablok回归法、Bland- Altman法及配对t检验进行一致性分析。结果 CMIA法（y）和FPIA法（x）丙戊酸的回归方程为y =1.0049x-0.9851 (R2=0.978, n=318),显示2种方法相关性良好; Bland- Altman法结果表明CMIA法和FPIA法对丙戊酸的检测偏倚在在临床允许范围内,具有较好的一致性;配对t检验显示2种方法有差异。结论 CMIA法和FPIA法测定癫痫患者血浆中丙戊酸浓度具有较好的相关性与一致性, 2种测定方法可以相互替代。但存在系统误差,在临床治疗中,应注意校正、调整和选择。

关键词: 化学发光微粒子免疫检测法, 荧光偏振免疫检测法, 抗癫痫药物, 血药浓度, 一致性

Abstract: Abstract Objective To evaluate the consistency of chemiluminescence microparticle immunoassay (CMIA) and fluorescence polarization immunoassay assay (FPIA) in determination of antiepileptic plasma drugs concentration with valproic acid as an example. Methods CMIA and FPIA methods were applied to determine the plasma concentration of valproic acid in the same sample, respectively. Then the consistency of the two methods with Passing-Bablokregression and Bland-Altman method was investigated. Results The regression equation of the two determination results by CMIA (y) and FPIA (x) was y =1.0049x-0.9851(R2=0.978,n=318), which showed the correlation of the two methods was good. Bland-Altman analysis showed that the consistency of the two methods for determining was good. Conclusion CMIA and FPIA methods for determination of valproate plasma concentrations had good correlation, but there was systematic error. In the clinical treatment, we should pay attention to make some adjustment and choice.

Key words: CMIA, FPIA, anti-epileptic drugs, plasma concentration, consistency

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