间接法建立上海地区人群血清铁蛋白参考区间

doi:10.3969/j.issn.1673-8640.2024.06.002

摘要/Abstract

摘要：

目的采用间接法建立上海地区人群血清铁蛋白参考区间。方法选取2021年1月—2022年10月复旦大学附属中山医院行铁蛋白检测的27 775名受试者，采用Turkey法剔除离群值，最终纳入18 264名受试者用于建立参考区间。采用Hoffmann法建立铁蛋白的参考区间。选取2023年3—4月同院2 486名表观健康者，用于验证铁蛋白自建参考区间。依据性别和年龄将参考区间建立人群和验证人群分别分为男性组、≤50岁女性组和>50岁女性组。另选取2022年3月—2023年4月复旦大学附属中山医院>50岁女性贫血患者207例，用于血清铁蛋白自建参考区间的临床应用评估。采用线性回归分析评估铁蛋白水平与性别和年龄的相关性。结果男性组、≤50岁女性组和>50岁女性组之间铁蛋白水平差异均有统计学意义（P<0.001）。男性铁蛋白水平与年龄无相关性（r²=0.003，P>0.05），女性铁蛋白水平与年龄呈正相关（r²=0.125，P<0.05）。采用Hoffmann法依据年龄和性别分别建立参考区间。建立的男性、≤50岁女性和>50岁女性铁蛋白参考区间分别为33.4~1 000.0、4.8~341.0、27.4~765.0 μg·L^-1。自建参考区间的上、下限与现用参考区间有一定差异。自建参考区间的验证通过率（男性组98.59%、≤50岁女性组95.82%、>50岁女性组97.38%）显著高于现用参考区间（85.89%、78.76%、60.26%）（P<0.001）。依据自建参考区间能更好地区分女性贫血人群铁代谢指标异常者。结论血清铁蛋白具有性别和年龄差异。采用间接法建立的铁蛋白参考区间较现用参考区间更适用于上海地区人群。

关键词: 铁蛋白, 间接法, 参考区间, 贫血, 上海

Abstract:

Objective To establish a reference interval of serum ferritin in adults in Shanghai by indirect method. Methods A total of 27 775 individuals with ferritin determination from January 2021 to October 2022 in Zhongshan Hospital of Fudan University were enrolled. By the Turkey method to eliminate outliers，18 264 individuals were enrolled ultimately，and a reference interval of ferritin was established by the Hoffmann method. Totally，2 486 apparently healthy adults from March 2023 to April 2023 in Zhongshan Hospital of Fudan University were enrolled to validate the ferritin reference interval. The reference interval establishment population and validation population were classified into male group，female ≤50 years old group and female >50 years old group based on sex and ages. Additionally，207 females >50 years old with anemia from March 2022 to April 2023 in Zhongshan Hospital of Fudan University were enrolled to evaluate the application value of the reference interval of ferritin. The correlation between ferritin and sex，ages was evaluated by linear-regression analysis. Results There was statistical significance in ferritin levels among male group，female ≤50 years old group and female >50 years old group（P<0.001）. There was no correlation between male ferritin levels and ages（r²=0.003，P>0.05），while female ferritin levels were positively correlated with ages（r²=0.125，P<0.05）. The reference intervals were established for males，females ≤50 years old and females >50 years old，respectively，by the Hoffmann method. The reference intervals were 33.4-1 000.0 μg·L^-1 for males and 4.8-341.0 μg·L^-1 for females ≤50 years old，27.4-765.0 μg·L^-1 for females >50 years old. The upper and lower limits of the established reference intervals were different from those of the current reference intervals. The validation pass rates of established reference intervals were 98.59% for males and 95.82% for females ≤50 years old，97.38% for females >50 years old，which were higher than those of the current reference intervals（85.89%，78.76% and 60.26%，respectively）（P<0.001）. The established reference intervals can better distinguish individuals with abnormal iron metabolism indicators. Conclusions Serum ferritin exhibits sex and age differences. Serum ferritin reference intervals established by indirect method is suitable for the population in Shanghai than the current reference intervals.

Key words: Ferritin, Indirect method, Reference interval, Anemia, Shanghai

中图分类号:

R446.1

刘晓文, 邵文琦, 朱晶, 杨静, 张春燕, 潘柏申, 王蓓丽, 郭玮. 间接法建立上海地区人群血清铁蛋白参考区间[J]. 检验医学, 2024, 39(6): 524-529.

LIU Xiaowen, SHAO Wenqi, ZHU Jing, YANG Jing, ZHANG Chunyan, PAN Baishen, WANG Beili, GUO Wei. Establishment of reference interval of serum ferritin in adults in Shanghai by indirect method[J]. Laboratory Medicine, 2024, 39(6): 524-529.

图/表 6

参考文献 19

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组别	例数	铁蛋白/（μg·L^-1）	自建参考区间		现用参考区间（μg·L^-1）
组别	例数	铁蛋白/（μg·L^-1）	下限（95%可信区间）/（μg·L^-1）	上限（95%可信区间）/（μg·L^-1）	现用参考区间（μg·L^-1）
男性组	9 737	327.0（172.0，573.0）	33.4（23.4，43.4）	1 000.0（612.0，1 388.0）	30.0~400.0
≤50岁女性组	3 630	47.4（16.7，107.0）	4.8（2.8，6.8）	341.0（293.0，389.0）	13.0~150.0^①
>50岁女性组	4 897	213.0（111.0，382.0）	27.4（16.5，38.3）	765.0（690.0，840.0）

组别	例数	铁蛋白/（μg·L^-1）	自建参考区间		现用参考区间（μg·L^-1）
组别	例数	铁蛋白/（μg·L^-1）	下限（95%可信区间）/（μg·L^-1）	上限（95%可信区间）/（μg·L^-1）	现用参考区间（μg·L^-1）
男性组	9 737	327.0（172.0，573.0）	33.4（23.4，43.4）	1 000.0（612.0，1 388.0）	30.0~400.0
≤50岁女性组	3 630	47.4（16.7，107.0）	4.8（2.8，6.8）	341.0（293.0，389.0）	13.0~150.0^①
>50岁女性组	4 897	213.0（111.0，382.0）	27.4（16.5，38.3）	765.0（690.0，840.0）

组别	例数	铁蛋白/（μg·L^-1）	自建参考区间验证通过率/[例（%）]	现用参考区间验证通过率/[例（%）]	χ²值	P值
男性组	1 060	198.3（59.0，511.6）	98.58（1 045）	85.89（900）	130.95	<0.001
≤50岁女性组	739	36.8（5.2，133.8）	95.82（710）	78.76（582）	100.76	<0.001
>50岁女性组	687	127.5（37.6，294.6）	97.38（670）	60.26（414）	286.44	<0.001

组别	例数	铁蛋白/（μg·L^-1）	自建参考区间验证通过率/[例（%）]	现用参考区间验证通过率/[例（%）]	χ²值	P值
男性组	1 060	198.3（59.0，511.6）	98.58（1 045）	85.89（900）	130.95	<0.001
≤50岁女性组	739	36.8（5.2，133.8）	95.82（710）	78.76（582）	100.76	<0.001
>50岁女性组	687	127.5（37.6，294.6）	97.38（670）	60.26（414）	286.44	<0.001