间接法建立长春地区成人肝功能四项生化指标参考区间

王艺婷; 李雪文; 邢东洋; 何冰; 许建成

doi:10.3969/j.issn.1001-5256.2021.09.030

间接法建立长春地区成人肝功能四项生化指标参考区间

DOI: 10.3969/j.issn.1001-5256.2021.09.030

吉林大学第一医院检验科，长春 130021

基金项目:

吉林省科技发展计划项目医药健康专项 (20190304110YY)

利益冲突声明：本研究不存在研究者之间、伦理委员会成员、受试者监护人以及与公开研究成果有关的利益冲突。

作者贡献声明：王艺婷负责课题设计，资料分析，撰写论文；李雪文、邢东洋、何冰参与收集数据，修改论文；许建成负责拟定写作思路，指导撰写文章并最后定稿。

详细信息

通信作者:
许建成，xjc@jlu.edu.cn

中图分类号: R575
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出版历程
- 收稿日期: 2021-01-15
- 录用日期: 2021-02-09
- 出版日期: 2021-09-20

Establishment of the reference intervals of four biochemical parameters for liver function among adults in Changchun, China based on the indirect method

Department of Clinical Laboratory, The First Hospital of Jilin University, Changchun 130021, China

Research funding:

Special Project for Health and Medicine of Jilin Province Science and Technology Development Plan (20190304110YY)

摘要

摘要: 目的基于临床实验室信息系统(LIS)中体检者数据，使用间接法建立成人肝功能四项生化指标(AST、ALT、GGT、ALP)参考区间。方法收集吉林大学第一医院2019年10月-2020年10月LIS中体检中心健康成人数据。柯尔莫哥洛夫-斯米诺夫检验分析正态性，BOX-COX法转换正态性，Turkey法剔除离群值，Mann-Whitney U检验及Z检验比较组间差异，非参数法计算参考区间。结果剔除离群值后纳入体检者27 218例。四项指标均存在性别及年龄差异。AST参考区间为：14~39 U/L(男20~79岁)、12~32 U/L(女20~49岁)、14~39 U/L(女50~79岁)；ALT参考区间为：10~71 U/L(男20~54岁)、10~49 U/L(男55~79岁)、7~43 U/L(女20~49岁)、9~49 U/L(女50~79岁)；GGT参考区间为：11~70 U/L(男20~64岁)、10~64 U/L(男65~79岁)、6~45 U/L(女20~49岁)、7~54 U/L(女50~79岁)；ALP参考区间为：38~96 U/L(男20~79岁)、33~89 U/L(女20~49岁)、40~106 U/L(女50~79岁)。本研究建立的AST、ALT、GGT参考区间与我国行业标准无明显差异(相对偏差＜参考变化值)，四项生化指标参考区间均通过适用性验证。结论间接法建立肝功能四项生化指标的参考区间与直接法较为一致，适于临床实验室推广和应用。
- 肝功能试验 /
- 参考值 /
- 成年人
Abstract: Objective To establish the reference intervals (RIs) of the four biochemical parameters for liver function [aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transpeptidase (GGT), and alkaline phosphatase (ALP)] in adults by using the indirect method based on the data of subjects undergoing physical examination in laboratory information system (LIS). Methods With the help of the LIS, related data were collected from the healthy adults who underwent physical examination in Physical Examination Center of The First Hospital of Jilin University from October 2019 to October 2020. The Kolmogorov-Smirnov test was used to check the normal distribution of the original data; data with skewed distribution were transformed into data with approximate normal distribution using the BOX-COX method; the Turkey method was used to remove outliers; the Mann-Whitney U test or the Z-test was used for comparison between groups; the non-parametric method was used to calculate RIs. Results A total of 27 218 subjects were included after the removal of outliers. All four parameters showed age and sex differences. The RIs of AST were 14-39 U/L for male individuals aged 20-79 years, 12-32 U/L for female individuals aged 20-49 years, and 14-39 U/L for female individuals aged 50-79 years; the RIs of ALT were 10-71 U/L for male individuals aged 20-54 years, 10-49 U/L for male individuals aged 55-79 years, 7-43 U/L for female individuals aged 20-49 years, and 9-49 U/L for female individuals aged 50-79 years; the RIs of GGT were 11-70 U/L for male individuals aged 20-64 years, 10-64 U/L for male individuals aged 65-79 years, 6-45 U/L for female individuals aged 20-49 years, and 7-54 U/L for female individuals aged 50-79 years; the RIs of ALP were 38-96 U/L for male individuals aged 20-79 years, 33-89 U/L for female individuals aged 20-49 years, and 40-106 U/L for female individuals aged 50-79 years. The RIs of AST, ALT, and GGT established in this study were similar to those in the industry standards of China (relative deviation < reference change value), and the RIs of all four biochemical parameters were verified by applicability. Conclusion The RIs of the four biochemical parameters for liver function established by the indirect method are relatively consistent with those established by the direct method, which holds promise for application in clinical laboratory.
- Liver Function Tests /
- Reference Values /
- Adult

HTML全文

图 1 AST、ALT、GGT、ALP水平连续百分位数曲线

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表 1 BOX-COX变换及剔除前后数据分布

指标	数据类型	样本量(例)	均值	标准差	全距	中位数	P₂₅	P₇₅
AST (U/L)	原始数据	29 443	21.39	9.11	219.70	19.30	16.40	23.60
	转换后	29 443	0.09	0.02	0.33	0.09	0.08	0.11
	剔除后	27 218	20.58	6.14	40.10	19.20	16.40	23.10
ALT (U/L)	原始数据	29 443	22.69	17.08	385.90	17.80	12.60	26.70
	转换后	29 443	0.11	0.05	1.70	0.11	0.08	0.14
	剔除后	27 218	21.29	13.01	122.80	17.60	12.70	25.50
GGT (U/L)	原始数据	29 443	25.51	20.39	149.20	18.70	12.50	26.70
	转换后	29 443	2.17	0.37	2.59	2.09	1.89	2.37
	剔除后	27 218	22.91	14.51	75.80	18.20	12.50	28.90
ALP (U/L)	原始数据	29 443	60.38	17.50	313.90	58.00	48.30	69.70
	转换后	29 443	0.66	0.02	0.22	0.66	0.64	0.67
	剔除后	27 218	59.94	15.90	92.80	57.90	48.30	69.30
注：剔除部分为离群值。

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表 2 AST、ALT、GGT、ALP参考区间及适用性验证

指标	分组		样本量(例)	P_2.5	90%置信区间		P_97.5	90%置信区间		验证样本量(例)	验证通过率(%)
指标	性别	年龄(岁)	样本量(例)	P_2.5	下限	上限	P_97.5	下限	上限	验证样本量(例)	验证通过率(%)
AST (U/L)	男	20~79	12 210	13.50	13.40	13.60	39.30	38.60	39.90	6292	95.12
	女	20~49	10 035	12.20	12.10	12.30	32.40	31.61	33.20	2744	95.70
		50~79	4973	13.90	13.70	14.00	38.60	37.60	39.60	1562	96.16
ALT (U/L)	男	20~54	8714	10.39	10.10	10.50	70.53	69.13	72.24	4544	93.90
		55~79	3496	9.90	9.54	10.00	49.26	47.77	51.47	1748	94.79
	女	20~49	10 035	7.40	7.30	7.40	42.60	41.20	43.81	2744	93.95
		50~79	4973	9.00	8.84	9.20	49.27	48.03	50.80	1562	94.88
GGT (U/L)	男	20~64	11 195	10.50	10.39	10.80	69.90	69.11	70.50	5732	90.25
		65~79	1015	10.00	9.30	10.30	64.20	59.80	66.80	560	94.29
	女	20~49	10 035	6.20	6.10	6.30	44.90	43.50	46.59	2744	95.48
		50~79	4973	7.40	7.20	7.60	54.23	51.90	58.00	1562	94.30
ALP (U/L)	男	20~79	12 210	37.90	37.60	38.40	95.97	95.02	97.20	6292	92.39
	女	20~49	10 035	33.00	32.70	33.30	88.72	87.42	90.40	2744	93.11
		50~79	4973	40.20	39.70	41.00	106.30	105.30	107.43	1562	91.87

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表 3 本研究与其他研究结果比较

指标	本研究(间接法）			我国行业标准(直接法）				俄罗斯(直接法）				沙特阿拉伯(直接法）				我国上海(间接法）				RCV(%)
指标	年龄(岁）	男	女	年龄(岁）	男	女	相对偏差(%)	年龄(岁）	男	女	相对偏差(%)	年龄(岁）	男	女	相对偏差(%)	年龄(岁）	男	女	相对偏差(%)	RCV(%)
AST (U/L)	20~79	14~39		20~19	15~45	13~40	(7.14, 15.38)	18~64	15~41	14~32	(7.14, 5.13)	18~65	11~28	10~24	(21.43, 28.21)	20~79	15~46	13~38	(7.14, 17.95)	38.12
	20~49		12~32				(8.33, 25.00)				(16.67, 0)				(16.67, 25.00)				(8.33, 18.75)	38.12
	50~79		14~39				(7.14, 2.56)				(0, 17.95)				(28.57, 38.46)				(7.14, 2.56)	38.12
ALT (U/L)	20~54	10~71		20~19	9~60	1~45	(10.00, 15.49)	18~64	11~51	7~31	(10.00, 28.17)	18~65	7~39	5~18	(30.00, 45.07)	20~79	8~555	5~42	(20.00, 22.54)	60.12
	55~19	10~49					(10.00, 22.45)				(10.00, 4.08)				(30.00, 20.41)				(20.00, 12.24)	60.12
	20~49		7~43				(0, 4.65)				(0, 27.91)				(28.57, 58.14)				(28.57, 7.69)	60.12
	50~79		9~49				(22.22, 8.16)				(22.22, 36.73)				(44.44, 63.27)				(44.44, 2.33)	60.12
GGT (U/L)	20~64	11~70		20~19	10~60	1~45	(9.09, 13.m)	18~64	12~69	8~32	(9.09, 0)	18~65	11~65	7~21	(0, 5.80)	20~79	16~52	8~39	(45.45, 25.71)	41.53
	65~79	10~64					(0, 6.25)				(20.00, 7.81)				(10.00, 1.56)				(60.00, 18.75)	41.53
	20~49		6~45				(16.66, 0)				(33.33, 28.89)				(16.67, 53.33)				(33.33, 13.33)	41.53
	50~79		7~54				(0, 16.66)				(14.29, 40.74)				(0, 61.11)				(14.29, 27.78)	41.53
ALP (U/L)	20~79	38~96		20~19	45~125			(18.42, 30.21)	18~64	46~121		(21.05, 26.04)	18~65	39~114	(2.63, 18.75)					19.99
	20~49		33~89	20~49		35~100	(6.06, 12.36)	18~44		38~89	(15.15, 0)				(18.18, 28.09)					19.99
	50~79		40~106	50~19		50~135	(25.00, 27.36)	45~64		44~128	(10.00, 20.75)				(2.50, 7.55)					19.99

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