两种检测骨髓移植患者环孢素A血药浓度方法的比较

doi:10.3877/cma.j.issn.2095-5820.2017.04.010

中华临床实验室管理电子杂志 ›› 2017, Vol. 05 ›› Issue (04) : 240 -244. doi: 10.3877/cma.j.issn.2095-5820.2017.04.010

所属专题：文献；

实验研究

两种检测骨髓移植患者环孢素A血药浓度方法的比较

王磊¹, 王红春¹, 李培余¹, 孙文利¹, 刘红星¹^,^†(

)

^1. 065201　河北燕达陆道培医院临床药理室

收稿日期:2017-07-25 出版日期:2017-11-28
通信作者: 刘红星

Comparison of blood concentration monitoring of Cyclosporine A in bone marrow transplant patients by two methods

Lei Wang¹, Hongchun Wang¹, Peiyu Li¹, Wenli Sun¹, Hongxing Liu¹^,^†()

^1. Department of Clinical Pharmacology, Hebei Yanda Ludaopei Hospital, Sanhe 065201, China

Received:2017-07-25 Published:2017-11-28
Corresponding author: Hongxing Liu
About author:
Corresponding author: Liu Hongxing, Email: lhongxing@outlook.com

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目的

探讨化学发光微粒子免疫(chemiluminescence microparticle immunoassays, CMIA)法与电化学发光(Elecsys)法检测骨髓移植患者全血中环孢素A(Cyclosporine A, CSA)浓度的相关性，为临床用药方案调整提供依据。

方法

分别用CMIA法和Elecsys法检测简单随机直抽法收集的骨髓移植患者服药后有效的83份全血标本中CSA水平，并分析两种方法检测CSA的相关性及差异。

结果

CMIA法和Elecsys法检测结果线性相关性方程为Y=1.4618 X-2.2309，相关性较好(r=0.9105)；CMIA法测定CSA(195.75 ng/ml)>Elecsys(135.44 ng/ml)；CMIA测定CSA的最佳均值为181.97 ng/ml，Elecsys法为117.49 ng/ml。且两种方法检测CSA呈对数正态分布，其换算系数为1.55。据骨髓移植患者CMIA法的临床参考范围150~250 ng/ml，可得Elecsys临床参考范围为100~200 ng/ml。

结论

两种方法检测CSA血药浓度均具有临床应用价值，但结果存在差异，临床调整用药时应注意根据不同的检测方法选用不同的参考区间。

关键词: 电化学发光法, 化学发光微粒子免疫法, 环孢素A, 血药浓度

Objective

To discuss the correlation of chemiluminescence microparticle immunoassays and Elecsys for the determination of blood concentration of cyclosporine A (CSA) in bone marrow transplant patients, providing the basis for the adjustment of clinical medication regime.

Methods

Whole blood samples of 83 patients underwent bone marrow transplant were randomly collected and determined by CMIA and Elecsys respectively. The difference and correlation of 2 kinds of determination methods were investigated.

Results

The linear correlation of CMIA and Elecsys results was good and the regression equation was Y=1.4618X-2.2309 (r=0.9105). CSA determination results by CMIA (195.75 ng/ml)>Elecsys(135.44 ng/ml); CSA mean best estimate by CMIA (181.97 ng/ml) and Elecsys(117.49 ng/ml); The results of the two methods are logarithmic normal distribution, and the conversion coefficient is 1.55. According to the clinical reference range (150-250 ng/ml) of CMIA method of bone marrow transplant patients, the clinical reference range of Elecsys was 100-200 ng/ml.

Conclusions

Both methods are feasible for blood concentration monitoring of CSA but there are difference in determination result. Great importance should be paid to CSA monitoring method reference interval in the adjustment of medication method in the clinic.

Key words: Elecsys, Chemiluminescence microparticle immunoassays, Cyclosporin A, Drug concentration

图1 两种方法检测CSA血药浓度质控图

图2 两种方法测定CSA的结果散点图

图3 两种方法检测CSA浓度结果经对数转换后的频率分布直方图

图4 加权残差(WRES)对CMIA法测定值的散点图(n=83)

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Comparison of blood concentration monitoring of Cyclosporine A in bone marrow transplant patients by two methods

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Comparison of blood concentration monitoring of Cyclosporine A in bone marrow transplant patients by two methods