糖化血紅蛋白檢測結果的置信區間_West China Medical Journal

Authors：

羅開宏 , 何訸 , 張玫 , 徐克和 , 唐書強 ,  黃亨建

四川大學華西醫院實驗醫學科（成都 610041）;

Corresponding?author：

黃亨建, Email: huanghenjian@sina.com

Keywords：

糖化血紅蛋白; 實驗室測量固有分析變異; 個體內生物學變異; 置信區間

DOI：

10.7507/1002-0179.201607121

Video：

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目的應用生物學變異和分析變異探討糖化血紅蛋白（glycosylated hemoglobin，HbA1c）測定結果對糖尿病診斷治療的影響。方法以三級質量規范為標準，應用 HbA1c 生物學變異和參考變化值，分析實驗室測量固有分析變異（analytical variance，CV_A）、個體內生物學變異（within-individual variation，CV_I）以及偏倚對 HbA1c 測定結果的影響。結果 HbA1c 的測定結果隨 CV_A 的增加而導致的額外偏倚不呈線性增加。不同的生物學變異質量規范要求對 HbA1c 測定結果的影響有差異。不同的 CV_A 對非糖尿病個體和糖尿病患者的 HbA1c 測定結果離散范圍影響不同。HbA1c 檢測要求分析方法的 CV_A<3%。結論糖尿病診斷和治療并不能單獨依賴 HbA1c 測定結果的實際數值為判斷標準。應結合 CV_A 及 CV_I 對于 HbA1c 測定值偏倚的影響給出測定值，并附上置信區間。

Citation： 羅開宏, 何訸, 張玫, 徐克和, 唐書強, 黃亨建. 糖化血紅蛋白檢測結果的置信區間. West China Medical Journal, 2017, 32(7): 1057-1059. doi: 10.7507/1002-0179.201607121 Copy

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1. American Diabetes Association. Standards of medical care in diabetes--2010. Diabetes Care, 2010, 33(Suppl 1): S11-S61.
2. Standards of medical care in diabetes--2015: summary of revisions. Diabetes Care, 2015, 38(Suppl): S4.
3. Ricós C, Iglesias N, García-Lario JV, et al. Within-subject biological variation in disease: collated data and clinical consequences. Ann Clin Biochem, 2007, 44(Pt 4): 343-352.
4. Braga F, Dolci A, Mosca A, et al. Biological variability of glycated hemoglobin. Clin Chim Acta, 2010, 411(21-22): 1606-1610.
5. Harris EK, Yasaka T. On the calculation of a " reference change” for comparing two consecutive measurements. Clin Chem, 1983, 29(1): 25-30.
6. Fraser CG, Hyltoft Petersen P, Libeer JC, et al. Proposals for setting generally applicable quality goals solely based on biology. Ann Clin Biochem, 1997, 34(Pt 1): 8-12.
7. Ricós C, Cava F, García-Lario JV, et al. The reference change value: a proposal to interpret laboratory reports in serial testing based on biological variation. Scand J Clin Lab Invest, 2004, 64(3): 175-184.
8. Lenters-Westra E, Weykamp C, Schindhelm RK, et al. One in five laboratories using various hemoglobin A1c methods do not meet the criteria for optimal diabetes care management. Diabetes Technol Ther, 2011, 13(4): 429-433.

West China Medical Journal

糖化血紅蛋白檢測結果的置信區間

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