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建立十种常用临床化学分析物的参考区间:中国的真实世界研究。

Establishment of reference intervals of ten commonly used clinical chemistry analytes: a real-world study in China.

机构信息

Department of Epidemiology & Biostatistics, School of Public Health, Peking University Health Science Center, Beijing, 100191, China.

Department of Epidemiology, Meinian Institute of Health, Beijing, 100191, China.

出版信息

Biomark Med. 2021 Aug;15(11):797-806. doi: 10.2217/bmm-2021-0233. Epub 2021 May 6.

Abstract

This real-world study was aimed at establishing reference intervals (RIs) of ten commonly used clinical chemistry analytes (total cholesterol, triglycerides, Apo A1, Apo B, creatine kinase (CK), CK isoenzyme MB, glucose, alkaline phosphatase, γ-glutamyltransferase and blood urea nitrogen) in an apparently healthy population in China.  A total of 17,356 healthy participants aged 18-79 years who underwent check-up at MJ Health Check-up Center were included. The establishment of RIs was performed according to the Clinical and Laboratory Standards Institute EP28-A3c guideline. Roche Cobas c701 automatic analyzer (Roche Diagnostics, Mannheim, Germany) was employed to measure the concentrations of analytes. Total cholesterol, triglycerides, Apo B, CK, alkaline phosphatase, glucose, γ-glutamyltransferase and blood urea nitrogen required gender and age-specific partitioning. The RIs established in this study were parallel to current national standards and previous RIs established in Chinese population. Real-world studies may play an important and practical role in the determination of RIs in the future.

摘要

本研究旨在建立中国健康人群十种常用临床化学分析物(总胆固醇、甘油三酯、载脂蛋白 A1、载脂蛋白 B、肌酸激酶(CK)、CK 同工酶 MB、葡萄糖、碱性磷酸酶、γ-谷氨酰转移酶和血尿素氮)的参考区间(RI)。共纳入 17356 名 18-79 岁在 MJ 健康体检中心进行体检的健康受试者。RI 的建立按照临床和实验室标准协会 EP28-A3c 指南进行。采用罗氏 Cobas c701 全自动分析仪(罗氏诊断公司,德国曼海姆)测定分析物浓度。总胆固醇、甘油三酯、载脂蛋白 B、CK、碱性磷酸酶、葡萄糖、γ-谷氨酰转移酶和血尿素氮需要按性别和年龄进行特定分区。本研究建立的 RI 与现行国家标准和既往中国人群建立的 RI 平行。真实世界研究可能在未来 RI 的确定中发挥重要而实际的作用。

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