全国150家实验室心肌损伤标志物参考区间来源及决定限的分布  

Sources and distribution decision on reference values of myocardial injury markers in China： results from 150 laboratories

作　　者：张妍[1] 王薇[1] 何法霖[1] 王治国[1] 钟堃[1] 

机构地区：[1]北京医院卫生部临床检验中心,100730

出　　处：《中华心血管病杂志》2014年第3期193-196,共4页Chinese Journal of Cardiology

摘　　要：目的 统计并描述2012年全国150家参加室间质量评价计划心肌损伤标志物各项目决定限回报结果以及来源.方法 提取卫生部临床检验中心2012年全国心肌损伤标志物肌钙蛋白Ⅰ（cTn-I）、肌钙蛋白T（cTn-T）、肌酸磷酸激酶同工酶（CK-MB）和肌红蛋白（Mb）室间质量评价回报结果中各项目参评单位的决定限信息,剔除所有妇幼保健院、儿童医院和各类公司的结果,再剔除所有异常值和错误数据,使用Microsoft Excel 2007对剩余的150家实验室进行统计分析描述,包括平均值、中位数、最小值、最大值、百分位数P2.5和P97.5.统计各项目参考区间来源,同时对数据进行筛选,将所有使用试剂厂家说明书作为参考区间来源的数据保留,其他剔除,再根据不同的试剂进行分组,若某一单位按性别年龄进行分组的统一采用成年男性的参考区间.试剂使用单位数小于5家的不统计.结果 对参考区间来源的调查显示,大部分采用的是试剂厂家说明书,各检验项目的比例分别为：CK-MB（μg/L）91.30％,Mb（μg/L）88.44％,cTn-I（μg/L）86.29％,cTn-T（μg/L）92.00％,CK-MB（U/L） 70.65％.对参考区间决定限情况的调查显示：各检验项目的均值和中位数较为接近（CK-MB：3.74与4.94 μg/L,Mb：76.09与72.00 μg/L,cTn-I：0.06与0.09 μg/L,cTn-T：0.01与0.02 μg/L,CK-MB：23.00与25.00 U/L）,各项目P2.5和P97.5分布范围为：CK-MB 2.48 ～ 7.09 μg/L,Mb 46.00 ～140.03μg/L,cTn-I 0.01 ～ 1.68 μg/L,cTn-T 0.01 ～12.61 μg/L,CK-MB 6.00 ～ 30.60 U/L,差异明显.对使用不同试剂决定限情况的调查显示,不同试剂间P2.5和P97.5分布差异大.结论 本次研究各个检验项目决定限的均值和中位数较为接近,各项目P25和P975分布一致性很差.目前各医疗单位心肌损伤标志物参考区间差异明显、来源不统一,应尽快进行中国人群自己参考区间的建立并进行更加规范化的管理.Objective To analyze the sources and distribution decision limits on reference values of myocardial injury markers based on the feedback results of 150 laboratories which participated the 2012 external quality assessment （EQA） programs in China. Methods Decision limits on myocardial injmy markers from EQA programs were analyzed. Data from maternal and child care service center, children＇s hospital and corporations were excluded. Abnormal values and errors were eliminated. Mean, median, maximum value, minimum value, Pz 5 and P97. ~ were calculated. Sources of decision limits were summarized and data were filtered and only values obtained according to the reagent manufacturer＇s instructions as a reference source were used and grouped based on reagent characteristics. Results According to the surveys on reference interval sources, most of reference sources were derived from reagent manufacturer＇s instructions and the ratio of each item was： CK-MB（μg/L） 91.30% ,Mb（μg/L） 88.44% ,cTn-I（μg/L） 86. 29% ,cTn-T （μg/L）92. 00% ,CK-MB（U/L）70. 65%. According to the surveys, the mean and median values of each test parameter were close to each other （ CK-MB ： 3.74,4. 94 μg/L ; Mb ： 76. 09,72. 00 μg/L; CTn-I ： 0. 06, O. 09 μg/L;cTn-T：0. 01,0. 02 μg/L;CK-MB ：23.00,25.00 U/L）. There were significant variations on P2.5 and P97.5 distribution ranges： CK-MB 2. 48 -7. 09 μg/L,Mb 46. 00 - 140. 03μg/L,cTn-I 0. 01 - 1.68μg/ L,cTn-T 0. 01 - 12. 61 μg/L, CK-MB 6. 00 - 30. 60 U/L. According to the surveys on using various reagents, there were also significant variations on P2. 5 and P97. 5 reagent distributions. Conclusions The decision limit of the mean and median for each test item is close to each other while the P2.5 and P97.5 distribution of each test item consistency is poor. There is therefore an urgent need to establish an uniform reference values for cardiac markers in China.

关 键 词：肌钙蛋白 肌红蛋白 参考区间 

分 类 号：R542.2[医药卫生—心血管疾病]