成年人血清细胞角质蛋白19可溶性片段地区性参考区间的建立与探讨  

Establishment and discussion of regional reference interval of serum soluble Cytokeratin 19 fragment in adult serum

作　　者：顾玉兰[1] 丘佳明[2] 陈丽芳 宛传丹 GU Yulan;QIU Jiaming;CHEN Lifang;WAN Chuandan(Department of Oncology,Second People′s Hospital of Changshu City,Changshu,Jiangsu 215500,China;Department of Pathology,the Second People′s Hospital of Changshu City,Changshu,Jiangsu 215500,China;Changshu Medical Laboratory,Changshu,Jiangsu 215500,China)

机构地区：[1]江苏省常熟市第二人民医院肿瘤科,215500 [2]江苏省常熟市第二人民医院病理科,215500 [3]江苏省常熟市医学检验所,215500

出　　处：《重庆医学》2019年第23期4027-4030,共4页Chongqing medicine

摘　　要：目的 比较分析两种建立成年人血清细胞角质蛋白19可溶性片段(CYFRA21-1)参考区间方案,探讨适用于常熟地区成年人血清CYFRA21-1的实验室参考区间。方法 调取2017年6月至2018年6月江苏省常熟市医学检验所实验室信息管理系统(LIS)中存储的所有CYFRA21-1检验数据,筛选有效数据,其中男9 624例,女6 926例,以年龄段分为青年组(≤45岁)和老年组(>45岁)。采用统计学线性拟合法建立成年人血清CYFRA21-1间接参考区间。选取2018年1-6月送检的健康体检者(n=806)CYFRA21-1检测数据以同样分组法,采用非参数方法建立各分组的成年人血清CYFRA21-1参考区间。结果 线性拟合建立的成年人血清CYFRA21-1间接参考区间分别为男青年组(0~3.49ng/mL)、女青年组(0~2.74ng/mL)、男老年组(0~3.84ng/mL)、女老年组(0~3.03ng/mL)。健康体检者非参数方法建立的成年人血清CYFRA21-1参考区间分别为男青年组(0~3.35ng/mL)、女青年组(0~3.18ng/mL)、男老年组(0~3.52ng/mL)、女老年组(0~3.21ng/mL)。两种参考区间之间差异无统计学意义(P>0.05)。结论 利用已存储数据线性拟合建立的间接参考区间与健康体检者非参数法建立参考区间同等有效。初步建立了适用于常熟地区成年人血清CYFRA21-1的参考区间。Objective To compare and analyze the regional reference interval of soluble Cytokeratin 19 fragment(CYFRA21-1)in adult serum established by two methods,and to explore their application to Changshu area.Methods All the CYFRA21-1 test data stored in the laboratory information management LIS system of Changshu Medical Laboratory from June 2017 to June 2018 were collected and valid data were screened,including 9624 cases of male and 6926 cases of female.All the cases were divided into the young group(≤45 years)and the elderly group(>45 years).The indirect reference interval of adult CYFRA21-1 was established by statistical linear fitting method.The health checkers were selected and the same grouping method were applied on them,the reference intervals of adults CYFRA21-1 for each group were established by non-parametric method.Results The indirect reference interval of adult CYFRA21-1 established by linear fitting method was 0-3.49 ng/mL for the male youth group,0-2.74 ng/mL for the female youth group,0-3.84 ng/mL for the male elderly group and 0-3.03 ng/mL for the female elderly group,respectively.The adult CYFRA21-1 reference interval for adults established by non-parametric methods for healthy subjects was 0-3.35 ng/mL for the male youth group,0-3.18 ng/mL for the female youth group,0-3.52 ng/mL for the male elderly group,and 0-3.21 ng/mL for the female elderly group,respectively,there was no significant difference between the two reference intervals(P>0.05).Conclusion The indirect reference interval established by linear fitting method of the stored data is as effective as the reference interval established by non-parametric method of health subjects.The CYFRA21-1 reference interval for adults in this area has been preliminarily established.

关 键 词：细胞角蛋白19可溶性片段 参考值 生物标记 肿瘤 

分 类 号：R446.1[医药卫生—诊断学]