摘要目的:建立并验证我国健康儿童血清维生素K参考区间。方法:横断面研究，根据我国东部、中部、西部、东北各区域0~14岁儿童人口分布比例，于2020年1月至2023年5月分层随机抽取807名0~14岁健康儿童作为研究对象，由12个省、自治区、直辖市16家医院完成样本收集。通过统一自制调查问卷收集儿童基本信息，采用液相色谱串联质谱法测定样本中血清维生素K 1、维生素K 2［四烯甲萘醌（MK-4）和甲萘醌-7（MK-7）］水平，直接法建立参考区间。按年龄分组，采用非参数检验Kruskal Wallis进行组间比较，采用非参数法确定参考区间（ P2.5~ P97.5）。另选取40名健康儿童（东部25名、中部10名、西部5名）进行小样本验证。 结果:807名儿童年龄5.00（2.00，9.81）岁，男495名（61.3%）、女312名（38.7%）。纳入795名1月龄至14岁儿童建立参考区间，其中1月龄至3岁（303名）、4~14岁（492名），参考区间血清维生素K 1分别为0.09~4.54、0.10~1.73 μg/L，MK-7分别为0.07~1.42、0.19~2.03 μg/L。1月龄至14岁儿童MK-4参考区间为0~0.42 μg/L。验证样本血清维生素K 1、MK-4和MK-7测定值落在参考限外均未超过2个。 结论:建立1月龄至14岁健康儿童维生素K 1、MK-4、MK-7参考区间并通过验证，可应用于评估儿童维生素K营养状况。

abstractsObjective:To establish and validate reference intervals of serum vitamin K for healthy children in China.Methods:A cross-sectional study was conducted from January 2020 to May 2023, involving 807 healthy children aged 0 to 14 years, selected by stratified random sampling based on the population distribution of children in eastern, central, western, and northeastern China. Sample collection was carried out in 16 hospitals across 12 provinces, autonomous regions, and municipalities. Basic information of the children was collected using a standardized self-design questionnaire. Serum levels of vitamin K 1 and vitamin K 2 (menaquinone-4 (MK-4), menaquinone-7 (MK-7)) were measured using liquid chromatography-tandem mass spectrometry. The reference intervals was established by direct approach. The children were divided into different groups by age. Inter-group comparisons were conducted using the Kruskal-Wallis non-parametric test, and the reference intervals ( P2.5- P97.5) were determined using non-parametric methods. Screening 40 healthy children for small sample validation based on age groups within the reference range(25 from eastern, 10 from central, and 5 from western regions). Results:The age of the 807 children was 5.00 (2.00, 9.81) years, and 495 (61.3%) were males and 312 (38.7%) females. Reference intervals were established for 795 children, of whom 303 children were aged 1 month to 3 years and 492 were aged 4 to 14 years. The reference intervals for serum vitamin K 1 were 0.09-4.54 μg/L for children aged 1 month to 3 years, and 0.10-1.73 μg/L for 4-14 years. For MK-7, the intervals were 0.07-1.42 μg/L for 1 month to 3 years and 0.19-2.03 μg/L for 4-14 years. The reference intervals for MK-4 in children aged 1 month to 14 years were 0-0.42 μg/L. The measured values of serum vitamin K 1, MK-4, and MK-7 in the validation samples did not exceed the reference limit in more than 2 samples. Conclusion:Reference intervals for vitamin K 1, MK-4, and MK-7 in healthy children aged 1 month to 14 years have been established and validated, and can be used to assess vitamin K nutritional status in children.