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中华临床实验室管理电子杂志 ›› 2025, Vol. 13 ›› Issue (03) : 172 -177. doi: 10.3877/cma.j.issn.2095-5820.2025.03.007

调查研究

基于实验室数据建立血清骨钙素参考区间
姚少濠1,2, 江文豪1,(), 李云珍1, 缪金华1, 张玲1,2   
  1. 1 510005 广东 广州,广州金域医学检验中心有限公司
    2 510180 广东 广州,广州医科大学金域检验学院
  • 收稿日期:2024-03-21 出版日期:2025-08-28
  • 通信作者: 江文豪

Establishment of reference intervals of serum osteocalcin based on laboratory data

Shaohao Yao1,2, Wenhao Jiang1,(), Yunzhen Li1, Jinhua Miao1, Ling Zhang1,2   

  1. 1 Guangzhou KingMed Center for Clinical Laboratory, Guangzhou Guangdong 510005, China
    2 KingMed School of Laboratory Medicine, Guangzhou Medical University, Guangzhou Guangdong 510180, China
  • Received:2024-03-21 Published:2025-08-28
  • Corresponding author: Wenhao Jiang
引用本文:

姚少濠, 江文豪, 李云珍, 缪金华, 张玲. 基于实验室数据建立血清骨钙素参考区间[J/OL]. 中华临床实验室管理电子杂志, 2025, 13(03): 172-177.

Shaohao Yao, Wenhao Jiang, Yunzhen Li, Jinhua Miao, Ling Zhang. Establishment of reference intervals of serum osteocalcin based on laboratory data[J/OL]. Chinese Journal of Clinical Laboratory Management(Electronic Edition), 2025, 13(03): 172-177.

目的

利用实验室体检人群血清骨钙素(OST)数据,建立并验证不同年龄段人群血清OST参考区间。

方法

收集2017年1月至2023年6月期间各地送往广州金域医学检验中心进行健康体检标本的血清OST数据,使用Skewness-Kurtosis分析数据正态性,Tukey法和箱式图法剔除离群值,通过Mann-Whitney U、Kruskal-Wallis HZ 检验对数据进行分组判断,依据指南EP28-A3中的非参数法建立参考区间以及95%置信区间,筛选合格体检标本对参考区间进行验证。

结果

数据人群覆盖中国17个省、自治区、直辖市,男性10 294名,女性9664名。不同年龄段人群血清OST参考区间为男性:≤18岁为18.13~97.35 ng/ml,19~29岁为9.94~26.76 ng/ml,30~39岁为8.70~24.05 ng/ml,40~49岁为7.81~22.71 ng/ml,50~59岁为6.69~22.69 ng/ml,≥60岁为6.26~22.50 ng/ml;女性:≤18岁为10.17~107.23 ng/ml,19~29岁为7.63~24.45 ng/ml,30~39岁为6.91~22.37 ng/ml,40~49岁为6.47~22.83 ng/ml,≥50岁为7.73~30.38 ng/ml。各年龄段参考区间均验证通过。其中男性各年龄段组间血清OST水平差异均有统计学意义(均P<0.001),且随年龄增长呈逐步下降趋势。女性方面,≤18岁组至30~39岁组血清OST水平依次降低(均P<0.001),30~39岁组与40~49岁组差异无统计学意义(P>0.05),50~59岁组高于40~49岁组(P<0.001),而50~59岁组与≥60岁组差异无统计学意义(P>0.05),整体表现为先降后升。性别对比显示,19~29岁、30~39岁及40~49岁男性血清OST水平均高于同年龄段的女性(均P<0.001),而50~59岁及≥60岁组则低于同年龄段女性(均P<0.001)。

结论

本研究建立了不同年龄段人群血清OST参考区间,为血清OST在不同年龄段人群的应用提供了重要的参考依据。

Objective

To establish and verify the reference intervals of serum osteocalcin (OST) data were used in different age groups based on the serum OST data of physical examination population.

Methods

Serum OST data from health checkup specimens sent to Guangzhou KingMed Center for Clinical Laboratory from January 2017 to June 2023 were collected. Skewness-Kurtosis was used to analyze the normality of data, and Tukey method and box graph method were used to eliminate outliers. Data were grouped by Mann-Whitney U, Kruskal-Wallis H and Z tests. Reference intervals and 95% confidence intervals were established according to the non-parametric method in Guideline EP28-A3, and qualified physical specimens were screened for verification of the reference intervals.

Results

The data collected in this study encompassed individuals from 17 provinces or municipalities in China, including 10 294 males and 9664 females. The reference ranges of serum OST in different age groups were as follows: For males, ≤ 18 years old is 18.13-97.35 ng/ml, 19-29 years old is 9.94-26.76 ng/ml, 30-39 years old is 8.70-24.05 ng/ml, 40-49 years old is 7.81-22.71 ng/ml, 50-59 years old is 6.69-22.69 ng/ml, ≥ 60 years old is 6.26-22.50 ng/ml; for females,≤18 years old is 10.17-107.23 ng/ml, 19-29 years old is 7.63-24.45 ng/ml, 30-39 years old is 6.91-22.37 ng/ml, 40-49 years old is 6.47-22.83 ng/ml, ≥ 50 years old is 7.73-30.38 ng/ml. The reference ranges for each age group have been validated. Serum OST levels differed significantly across male age groups (all P<0.001), showing a progressive decline with age. Among females, serum OST levels decreased sequentially from the ≤18 years group to the 30-39 years group (all P<0.001), with no significant difference between the 30-39 years and 40-49 years groups (P>0.05). The 50-59 years group exhibited higher levels than the 40-49 years group (P<0.001), while no significant difference was observed between the 50-59 years and ≥60 years groups (P>0.05), indicating an overall pattern of initial decline followed by an increase. Gender comparisons revealed that males aged 19-29, 30-39, and 40-49 years had significantly higher serum OST levels than females in the same age groups (all P<0.001), whereas males aged 50-59 and ≥60 years had lower levels than their female counterparts (all P<0.001).

Conclusion

This study established reference ranges of serum OST in different age groups of Chinese, providing a valuable reference for the application of serum OST across various age brackets.

图1 体检人群所在省、自治区、直辖市的分布比例
表1 体检人群年龄特征
表2 不同性别和年龄段血清OST比较结果/ng/ml
表3 不同年龄段Z检验分析
表4 >18岁组血清OST的分布情况及参考区间
表5 ≤18岁组血清OST参考区间
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