人体生理参数参考区间的制定方法和应用

doi:10.16352/j.issn.1001-6325.2022.01.030

基础医学与临床 ›› 2022, Vol. 42 ›› Issue (1): 154-158.doi: 10.16352/j.issn.1001-6325.2022.01.030

人体生理参数参考区间的制定方法和应用

何慧婧, 单广良^*

中国医学科学院基础医学研究所北京协和医学院基础学院流行病学与卫生统计学系, 北京 100005

收稿日期:2020-11-12 修回日期:2021-04-09 出版日期:2022-01-05 发布日期:2022-01-05
通讯作者: ^* guangliang_shan@163.com
基金资助:
北京市自然科学基金(7204279); 科技部基础性工作专项(2013FY114100);国家自然科学基金(82003531)

Methodology and application of human physiological reference intervals estimation

HE Hui-jing, SHAN Guang-liang^*

Department of Epidemiology and Statistics, Institute of Basic Medical Sciences CAMS; School of Basic Medicine PUMC, Beijing 100005, China

Received:2020-11-12 Revised:2021-04-09 Online:2022-01-05 Published:2022-01-05
Contact: ^* guangliang_shan@163.com

摘要/Abstract

摘要： 生理参数参考区间(RI)估计对于健康评估、疾病筛查与诊断,以及治疗效果评价具有指导意义。目前中国尚无生理参数RI估计的方法学综述。本文拟通过对RI估计方法学的系统梳理,系统介绍生理参数RI制定的意义、方法和应用。RI估计方法主要有3类:非参数法、参数法和稳健估计法。研究者需结合研究目的和数据特点进行选择。本文可为制定生理参数RI提供方法学参考,也为实际工作中如何客观合理解读生理参数区间提供指导。

关键词: 参考区间, 生理参数, 方法学

Abstract: Establishment of physiological reference interval (RI) is important for health status evaluation, disease screening and diagnosis, and the effect assessment of clinical therapy. Currently, there is no review on methodology of RI establishment in China. Therefore, by reviewing of literatures on methodology of RI establishment, this article comprehensively described the purpose and significance of RI establishment,its statistical methods of calculation and its application. Three methods are commonly used for RI calculation: the nonparametric, parametric and robust estimate. Researchers may use a specific method based on research purpose and the characteristics of the data. This review provides methodological reference for RI establishment in China and also some guidelines to better understand the meaning of physiological constant RI in health practices.

Key words: reference interval, physiological constants, methodology

中图分类号:

R-33

何慧婧, 单广良. 人体生理参数参考区间的制定方法和应用[J]. 基础医学与临床, 2022, 42(1): 154-158.

HE Hui-jing, SHAN Guang-liang. Methodology and application of human physiological reference intervals estimation[J]. Basic & Clinical Medicine, 2022, 42(1): 154-158.

参考文献

[1]王恒,单广良. 中国国民健康状况和基本生理参数本底调查(二期)[J]. 中国科技成果, 2016,17:30.
[2]Pan L, Dong F, Wang K, et al. Towards better clinical laboratory diagnostic criteria for haemoglobin concentra-tion: results from the survey on health examination and physiological constants in China[J]. Lancet,2015, 386: S59.doi:org/10.1016/s01040-6736(15)00640-6.
[3]Horowitz GL, Altaie S, Boyd JC, et al. Defining, establishing, and verifying reference intervals in the clinical laboratory[R]. Wayne: Clinical and laboratory standards institute, 2010: 8-33.
[4]Peng X, Lv Y, Feng G, et al. Algorithm on age partitioning for estimation of reference intervals using clinical laboratory database exemplified with plasma creatinine[J]. Clin Chem Lab Med,2018,56:1514-1523.
[5]Achila OO, Semere P, Andemichael D, et al. Bioche-mistry reference intervals for healthy elderly population in Asmara, Eritrea[J]. BMC Res Notes, 2017,10:748.doi:10.1186/s13104-017-3087-6.
[6]Zhao B, Zhang M, Lin F, et al. Establishment of the reference interval for serum pro-gastrin-releasing peptide in healthy adults of Chinese han ethnicity[J]. Int J Biol Markers, 2018,33: 487-491.
[7]Kim M, Kim TY, Kim SH, et al. Reference interval for thyrotropin in a ultrasonography screened Korean popula-tion[J]. Korean J Intern Med, 2015, 30: 335-344.
[8]Ozarda Y. Reference intervals: current status, recent developments and future considerations[J]. Biochem Med, 2016, 26:5-16.
[9]Horn PS, Feng L, Li Y, et al. Effect of outliers and nonhealthy individuals on reference interval estimation[J]. Clin Chem,2001,47:2137-2145.
[10]陶庄,金水高. Box-Cox变换及其在SAS软件中的实现[J]. 中国卫生统计, 2007, 24:541-542.
[11]Wu X, Zhao M, Pan B, et al. Complete blood count reference intervals for healthy han Chinese adults[J]. PLoS One, 2015,10: e119669. doi: 10.1371/journal.pone.0119669.
[12]Rustad P, Felding P, Lahti A. Proposal for guidelines to establish common biological reference intervals in large geographical areas for biochemical quantities measured frequently in serum and plasma[J]. Clin Chem Lab Med, 2004, 42: 783-791.
[13]Boedec KL. Reference interval estimation of small sample sizes: a methodologic comparison using a computer-simulation study[J]. Vet Clin Pathol, 2019, 48: 335-346.
[14]Budd JR, Durham AP, Gwise TE, et al. Measurement procedure comparison and bias estimation using patient samples: approved guideline (3rd edition) [R]. Wayne: Clinical and Laboratory Standards Institute, 2018: 7-8.

人体生理参数参考区间的制定方法和应用

Methodology and application of human physiological reference intervals estimation

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