Hemoglobin A1c measurements over nearly two decades: Sustaining comparable values throughout the diabetes control and complications trial and the epidemiology of diabetes interventions and complications study
Hemoglobin A1c measurements over nearly two decades: Sustaining comparable values throughout the diabetes control and complications trial and the epidemiology of diabetes interventions and complications study
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DOI：
10.1373/clinchem.2004.042143
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发表时间：
2005-04-01
影响因子：
9.3
通讯作者：
Nowicki, M
中科院分区：
文献类型：
--
作者：
Steffes, M;Cleary, P;Nowicki, M
背景：临床试验需要在研究过程中提供一致结果的分析。方法：糖尿病控制和并发症试验(DCCT)及其后续研究糖尿病干预和并发症流行病学(EDIC)需要20年来HBA(1c)结果的一致性，通过三种不同的离子交换高效液相色谱程序进行测量。为了保持和记录DCCT和EDIC中心生化实验室测量的一致的HBA(1c)结果，备份实验室使用冷冻溶血物作为长期校准物，并使用带有单一批次Bio-Rex 70树脂的高效液相色谱法。结果：20多年来，长期质控值保持不变。四项关于非糖尿病范围的研究得出了几乎相同的数值[平均值(SD)、5.1(0.5)%、4.9(0.3)%、5.0(0.4)%和5.0(0.3)%]。结论：DCCT和EDIC 20年期间HBA(1c)测定的总体一致性对于确定强化治疗的益处以及了解长期血糖与糖尿病并发症的发展和进展之间的关系至关重要。(C)2005年美国临床化学协会。
Background: Clinical trials require assays that provide consistent results during the course of a study. The hemoglobin A(1c) (HbA(1c)) assay, a measure of chronic glycemia, is critical to the study of diabetes control and complications.Methods: The Diabetes Control and Complications Trial (DCCT) and its follow-up study, the Epidemiology of Diabetes Interventions and Complications (EDIC), required 20 years of consistent HbA(1c) results, measured by three different ion-exchange HPLC procedures. To maintain and document consistent HbA(1c) results measured in the DCCT and EDIC Central Biochemistry Laboratory, a backup laboratory used frozen hemolysates as long-term calibrators and a HPLC method with a single lot of Bio-Rex 70 resin.Results: Over 20 years, long-term quality-control values have remained constant. Four studies of nondiabetic ranges produced nearly identical values [mean (SD), 5.1 (0.5)%, 4.9 (0.3)%, 5.0 (0.4)%, and 5.0 (0.3)%].Conclusion: The overall consistency of the HbA(1c) assays during the 20-year course of the DCCT and EDIC has been critical in establishing the benefits of intensive therapy and in understanding the relationship between long-term glycemia and the development and progression of the complications of diabetes. (c) 2005 American Association for Clinical Chemistry.