长春市2～14岁汉族健康儿童临床常用肝功项目参考区间的建立

发布时间：2018-01-06 00:02

本文关键词：长春市2～14岁汉族健康儿童临床常用肝功项目参考区间的建立　出处：《吉林大学》2017年硕士论文　论文类型：学位论文

【摘要】：目的:参考区间是解释检验结果的基本尺度和依据,其准确性、适用性直接影响着疾病的诊疗效率。肝功检验项目的参考区间则是肝脏疾病诊断和健康评估最基本的依据。儿童作为与成人不同的参考人群,在年龄、生长发育、营养状态等因素上的差异造成其参考区间与成人不尽相同,因此有必要建立儿童肝功项目的参考区间。本研究旨在建立并验证长春市汉族健康儿童临床常用肝功项目的参考区间。方法:参考国际临床化学与检验医学联合会及美国临床和实验室标准化研究院制定的参考区间指南,在长春市某医院体检中心及某妇幼保健院选择2~14岁健康个体作为研究对象,通过问卷调查和体格检查,按照筛选标准选择参考个体进行标本采集及检测,采用日立7600-210全自动生化分析仪检测汉族健康儿童的血清丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、γ-谷胺酰基转肽酶(GGT)、碱性磷酸酶(ALP)、总蛋白(TP)、清蛋白(ALB)、总胆红素(TBIL)、直接胆红素(DBIL),试剂及标准品均采用上海科华生物工程股份有限公司产品。检测得到的数据使用EXCEL、R语言3.0、SPSS 21.0统计软件进行统计描述和分析。检查并剔除离群值后,判断数据是否服从正态分布,采用中间95%区间作为参考区间,非参数方法计算各实际参考样本组参考值的2.5百分位数和97.5百分位数,并计算各百分位数的90%置信区间。利用Z检验确定性别、年龄分组后的组间有无统计上的显著性差异从而获得性别、年龄分层的参考区间。分别在长春市不同区域的5家医院临床实验室对获得的儿童参考区间进行验证,绘制2~14岁儿童血清肝功随年龄变化的趋势图,对血清肝功与年龄、性别的相关性进行分析,将获得的参考区间与国家行业标准及不同地区儿童参考区间的调查结果进行比较。结果:本研究满足试验标准的研究对象共1394名,均为汉族,其中男649名,女745名,男女比例1:1.15。本研究建立了长春市2~14岁汉族健康儿童临床常用肝功项目参考区间,结果显示常用的肝功项目均有年龄差异,所有肝功项目均需要2个以上的年龄分组。酶类项目(ALT、AST、GGT、ALP)有性别差异。血清酶类水平在低年龄段无性别差异,高年龄段开始出现性别差异。而血清蛋白质(TP、ALB)、胆红素(TBIL、DBIL)水平在整个年龄段均无性别差异。2~14岁儿童不同的肝功项目随年龄呈现不同的变化趋势。2~14岁儿童TP、TBIL和DBIL水平随年龄增加逐渐增高,而AST水平随年龄增加明显降低;ALT、GGT、ALP水平随年龄的变化较复杂,11~14岁男孩ALT、GGT水平显著增高,13~14岁女孩ALP水平显著降低。ALT、AST、GGT、ALP、TP、ALB、TBIL、DBIL与年龄有明显的相关性(P0.05),AST、GGT与性别有明显的相关性,而TP、ALB、TBIL、DBIL与性别无相关性(P0.05)。长春市5家实验室健康儿童的肝功项目测定值与验证的参考区间比较,落在参考限以外的测定值个数均不超过验证例数的10%。本研究建立的2~14岁儿童肝功项目参考区间水平与行业标准制定的中国成年人群参考区间水平不同,2~14岁儿童血清ALT、GGT、TP参考上限明显低于成人,血清总胆红素的参考下限及参考上限均低于成人,血清ALP参考下限及参考上限均高于成人,2~6岁儿童AST参考下限及参考上限水平均高于成人,6~14岁降至与成人接近。本研究建立的长春市2~14岁儿童肝功项目参考区间在年龄、性别差异上的分段与国内外地区也不尽相同。结论:1.长春市2~14岁汉族健康儿童血清肝功项目均有年龄及性别差异,且年龄的差异较显著,应建立不同年龄、性别的儿童血清肝功参考区间。2.长春市2~14岁汉族健康儿童血清肝功项目的参考区间与成人存在差异,为防止临床判断失误,应建立儿童血清肝功参考区间。3.我们建立的长春市2~14岁汉族健康儿童肝功项目参考区间可适用于长春市大多数实验室。
[Abstract]:Objective: the reference interval is the basic criterion and basis, explain the test results whose accuracy directly affects the applicability of disease diagnosis efficiency. Liver function tests is the reference interval of liver disease diagnosis and health assessment based on the most basic. Children are different from adults as reference population growth in age, difference of nutrition such factors on the reference interval and adults are not the same, so it is necessary to establish the reference range of children liver projects. The purpose of this study was to establish and validate the commonly used clinical liver function in healthy children of Han Changchun city project reference interval. Methods: the reference range of guide International Federation of clinical chemistry and laboratory medicine and clinical laboratory institute of standardization to develop, in a hospital medical center Changchun city and a maternal and Child Health Hospital of 2~14 years old healthy individual as the research object, through the questionnaire The investigation and physical examination of specimen collection and testing according to the screening criteria for the selection of individual reference, using alanine Hitachi 7600-210 automatic biochemical analyzer to detect the Han healthy children transferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transpeptidase acyl (GGT), alkaline phosphatase (ALP), total protein (TP), albumin (ALB), total bilirubin (TBIL), direct bilirubin (DBIL), reagent and standard are used in Shanghai KELONG bio engineering Limited by Share Ltd products. The data obtained using the EXCEL language, R 3, SPSS 21 statistical software for statistical description and analysis. Check and remove outliers then, to determine whether the data obey the normal distribution, the middle of the 95% interval as the reference interval, the non parametric method to calculate the actual reference sample reference value of the 250 percentile and the 9 thousand and 750 percentile, and calculate the 90% percentile The letter range. By using the Z test to determine gender, age group between groups have no statistically significant differences and gender, age stratified reference interval. Respectively to verify the obtained pediatric reference intervals in different regions of the city Changchun clinical laboratories of 5 hospitals, 14 year old children drawing 2~ serum liver function changes with age the trends of serum liver function and age, gender correlation analysis, the investigation of the reference interval with the national industry standard and different areas in the reference range of results were compared. Results: the study object of study meet the test standard were 1394, all were Han nationality, including 649 men and 745 women. The proportion of men and women 1:1.15. based on the common clinical liver projects 2~14 healthy children of Han Changchun, reference interval, results showed that the liver has age differences in common, all liver projects require 2 The age group above. Enzymes (ALT, AST, GGT project, ALP) have gender differences. No gender differences in serum enzyme level in the low age, high age sex differences begin to appear. But the serum proteins (TP, ALB), bilirubin (TBIL, DBIL) levels showed no gender differences in the age.2~14 years old children in different age with liver projects show different trends of children aged.2~14 years in TP, TBIL and DBIL levels gradually increased with the increase of age, while the level of AST increased with age significantly decreased; ALT, GGT, ALP level changes with age is more complex, 11~14 boy ALT, GGT levels were significantly higher, 13~14 year old girl the level of ALP was significantly decreased.ALT, AST, GGT, ALP, TP, ALB, TBIL, DBIL were significantly correlated with age (P0.05), AST, GGT were significantly correlated with gender, TP, ALB, TBIL, DBIL have no correlation with gender (P0.05). 5 healthy children, liver function Changchun laboratories test items Setting and verification of the reference interval between the reference interval level China adults make a number of not more than the number of cases verified 10%. established in the study of children aged 2~14 liver project reference interval level and industry standard fall determination in reference limit values outside the blood of children aged 2~14, ALT, GGT, TP reference limit serum total bilirubin was significantly lower than that of adults, the lower limit and upper limit reference reference were lower than that of adults, the serum levels of ALP were higher than the upper limit and lower limit reference reference 2~6 AST adults, children reference and reference levels are higher than the upper limit of adults, aged 6~14 years and to get close to people. This study established Changchun 2~14 years old children in liver project reference interval age, gender differences on the segment with the domestic and foreign regions are not the same. Conclusion: 1. Changchun 2~14 years old Han healthy children serum liver function items were age and gender differences, and the age difference was significant That should be established in different age, gender of children and adults the reference range of serum liver function reference interval.2. 2~14 years old Han Changchun healthy children serum liver function project differences, in order to prevent clinical judgment, should establish the children's serum liver function reference interval.3. we established Han 2~14 years old healthy children in Changchun City project reference interval can be applied to liver function Changchun most of the laboratory.

【学位授予单位】：吉林大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R446.1;R72

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