再谈糖化血红蛋白

doi:10.3969/j.issn.1673-8640.2015.06.001

摘要/Abstract

摘要：

糖化血红蛋白(HbA_1c)作为被英国前瞻性糖尿病研究(UKPDS)、美国糖尿病控制和并发症试验(DCCT)两大流行病学调查结果证实的与糖尿病及其并发症密切相关的重要标志物,在临床上得到了越来越广泛的应用。但是,HbA_1c实验室检测技术的多样性导致其检测结果差异较大,无法满足临床诊治的需求。随着国际临床化学与医学实验室联盟(IFCC)和美国临床化学协会(AACC)HbA_1c标准化工作的开展,实验室HbA_1c的检测质量得到了显著提升。2010年起HbA_1c先后被美国糖尿病协会(ADA)、国际糖尿病联盟(IDF)、世界卫生组织(WHO)等组织列入糖尿病诊断标准。在我国,HbA_1c临床应用、检测质量管理和标准化工作启动相对较晚,但工作进展的速度和成绩也是有目共睹的。虽然暂时未被列入中国糖尿病诊断指南中,相信只要团结协作,必将开创出我国自己的HbA_1c标准化之路,更好地为临床医生和糖尿病患者服务。

关键词: 糖化血红蛋白, 质量管理, 标准化

Abstract:

Hemoglobin A_1c(HbA_1c)is confirmed by the 2 epidemiological surveys, the UK Prospective Diabetes Study(UKPDS)and the Diabetes Control and Complications Trial Research(DCCT), as an important marker which is closely related to diabetes and its complications. HbA_1c has been used more and more widely in clinical laboratories. Due to the diversity of HbA_1c detection technologies, there is large difference among results, and thus it is unable to meet the demand of clinical diagnosis and treatment. Along with the International Federation of Clinical Chemistry and Laboratory Medicine(IFCC)and American Association for Clinical Chemistry(AACC)to carry out the HbA_1c standardization, testing quality in laboratories has been significantly improved. Since 2010, HbA_1c has been included in the diagnostic criteria for diabetes by American Diabetes Association(ADA), the International Diabetes Federation(IDF) and World Health Organization(WHO). In China, HbA_1c detection begins relatively late in clinical application,quality management and standardization, but the rate of progress of work and performance are very obvious. Although HbA_1c has temporarily not been included in the Chinese diabetes diagnosis guide, we believe that as long as we keep the unity and cooperation, we will create standardization in our own way and serve the clinicians and patients with diabetes mellitus better.

Key words: Hemoglobin A1c, Quality management, Standardization

中图分类号:

R446.1

居漪. 再谈糖化血红蛋白[J]. 检验医学, 2015, 30(6): 547-552.

JU Yi. Talk about hemoglobin A_1c[J]. Laboratory Medicine, 2015, 30(6): 547-552.

图/表 4

参考文献 39

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样品类型	分析物	文献数	生物变异		期望规范
样品类型	分析物	文献数	个体内(%)	个体间(%)	不精密度(%)	不准确度(%)	允许总误差(%)
血浆	葡萄糖	1	4.5	5.8	2.3	1.80	5.50
血清	葡萄糖	15	5.6	7.5	2.8	2.34	6.96
全血	HbA_1c	8	1.9	5.7	0.9	1.50	3.00

样品类型	分析物	文献数	生物变异		期望规范
样品类型	分析物	文献数	个体内(%)	个体间(%)	不精密度(%)	不准确度(%)	允许总误差(%)
血浆	葡萄糖	1	4.5	5.8	2.3	1.80	5.50
血清	葡萄糖	15	5.6	7.5	2.8	2.34	6.96
全血	HbA_1c	8	1.9	5.7	0.9	1.50	3.00

序号	优势
1	已根据DCCT/UKPDS方法标准化和校准
2	反映长期血糖水平和慢性并发症风险的指标
3	生物变异较小
4	分析前的不稳定性较小
5	无需空腹或特定时时间抽血
6	受急性(如应激、疾病相关)血糖波动的影响较小
7	目前用于指导糖尿病的管理和治疗方案的调整

序号	优势
1	已根据DCCT/UKPDS方法标准化和校准
2	反映长期血糖水平和慢性并发症风险的指标
3	生物变异较小
4	分析前的不稳定性较小
5	无需空腹或特定时时间抽血
6	受急性(如应激、疾病相关)血糖波动的影响较小
7	目前用于指导糖尿病的管理和治疗方案的调整

方法	原理	HbA_1c计算	HbC/HbS/HbE/HbD干扰^#
离子交换色谱法	电荷差异	HbA_1c峰面积/∑ HbA峰面积	部分产品
电泳法	电荷差异	HbA_1c/(HbA_1c + HbA₀)^*	无
亲和色谱法	结构不同	总GHb/总 Hb	无
免疫浊度法	免疫反应	[HbA_1c]/[总Hb]	部分产品
酶化学法	生化反应	反应吸光度换算成浓度	未知
快速检测	结构免疫	光强度比例荧光染料分子斑点数	部分产品部分产品