重庆地区孕妇HbA1c及早中孕空腹血糖正常参考区间的建立以及联合诊断妊娠期糖尿病的临床价值  

Reference intervals of HbA1c and fasting plasma glucose for pregnant women in Chongqing and the value of their combination in screening gestational diabetes mellitus

作　　者：雷国勤 徐欢[1] 黄畅晓 罗世福[2] 胡翠芳[2] 彭珠芸[2] 俞丽丽[2] 陈鸣[1] 

机构地区：[1]第三军医大学大坪医院野战外科研究所检验科,重庆400042 [2]第三军医大学大坪医院野战外科研究所妇产科,重庆400042

出　　处：《中华检验医学杂志》2016年第6期413-417,共5页Chinese Journal of Laboratory Medicine

基　　金：国家自然科学基金（81571459）

摘　　要：目的建立重庆地区孕妇糖化血红蛋白A1c（HbA1c）及早中孕空腹血糖正常参考区间，并探讨HbA1c联合早中孕空腹血糖（FPG）的方法用于诊断妊娠期糖尿病（GDM）的可行性，以提高孕妇的依从性。方法回顾性分析2014年9月至2015年8月在第三军医大学大坪医院妇产科产前检查及分娩的孕妇中，选取在孕10—13周“进行空腹血糖的检测，在孕24—28周同时进行75g口服葡萄糖耐量试验（OGTF）和HbA1c检查的孕妇，筛查出185例孕妇为GDM组，及随机抽取同期正常孕妇269名为对照组，检测两组早孕FPG、HbA1c中孕FPG及OGTT结果，将对照组检测结果按全国临床和实验室标准化研究院制定的C28-A3标准，计算并制定重庆地区孕妇24—28周HbA1c和早中孕空腹血糖的参考区间。采用t检验、符号秩合检验、NcMemar检验和κ检验、制作ROC曲线进行统计学分析。结果GDM组与对照组的早孕FPG、HbA1c中孕FPG水平分别为（5．06±0．37）与（4．85±0．32）mmoL／L（t=6．569，P=0．000）、5．3（5．1，5．4）％与5．2（5．0，5．3）％（z=-5．79，P=0．000）、5．23（5．11，5．4）与4．74（4．54，4．91）mmoL／L（z=-14．31，P=0．000）。早孕FPG、HbA1c中孕FPG的95％医学参考区间分别为4．21～5．49mmol／L、4．58％～5．52％和4．03～5．08mmol／L。早孕FPG、HbA。中孕FPG诊断GDM的AUC分别为0．659、0．655、0．890。而联合HbA1c与中孕FPG和三者联合诊断GDM效能无差异，AUC均为0．898。当分别以4．94mmol／L和5．35％作为早孕FPG和HbA1c诊断GDM的cut-off值时，其敏感度分别为64．7％和38．0％、特异度分别为62．2％和85．6％，阳性预测值分别为54．3％和65．1％，阴性预测值分别为72．1％和66．9％。而HbA1c联合中孕FPG诊断GDM的敏感度为83．8％，特异度为85．9％，阳性预测值为80．3％，阴性预测值为88．5％。联合诊断方法与传统OGTT诊断GDM的吻�Objective To establish the reference intervals of hemoglobin Alc （HbA1c） and fasting plasma glucose （FPG） in the first and second trimester of pregnancy in Chongqing , and to evaluate the viability of the combination of HbA1cand FPG in screening gestational diabetes mellitus （GDM）. Methods The study retrospectively selected the pregnant women seen at the Department of Obstetrics and Gynecology in Daping Hospital between September 2014 and August 2015. The results of FPG during 10-13 pregnant weeks and 75 g oral glucose tolerance test （OGTT） and HbA1c during 24-28 pregnant weeks were available. Totally 185 cases were assigned into GDM group, and 269 cases were assigned into normal groupbased on the American Diabetes Association （ADA） guidelines. Reference intervals of HbAio and FPG in normal pregnant woman were developed. The difference of HbA1c, FPG and OGTT results between two groups was analyzed. T-student test, NcMemar test, signed rank sum test, ROC curve were used for statistical analysis. Results The reference intervals of HbAlc and FPG in first and second trimester were 4. 58%- 5.52% ,4. 21-5.49 mmol/L and 4. 03-5.08 mmol/L. The FPG level in first and second trimester and HbA1c level in GDM group vs normal group were （ 5.06 ± 0. 37 ） vs （ 4. 85 ± 0. 32 ） mmol/L （ t = 6. 569, P = 0. 000 ）, 5.23（5.11,5.4） vs 4.74（4.54,4.91） mmol/L（z = - 14. 31,P =0. 000）and 5.3（5.1,5.4）% vs 5.2（5.0, 5.3 ） % （z = - 5.79,P = 0. 000） respectively. The area under receiver operating characteristic curve （ROC） of HbAlc, and FPG in first and second trimester was 0. 655, 0. 659 and 0. 890 respectively. When the cut-off value of HbAlo was 5.35%, the AUC of the combination of HbA1c and FPG in second trimester was 0. 898, the sensitivity was 0. 838 ,and the specificity was 0. 859. The kappa coefficient for identifying GDM between OGTF and the combined method was 0. 692 （P = 0. 000）. Conclusion HbA1c combined with FPG is of some value in screening GDM. （

关 键 词：糖尿病 妊娠 血红蛋白A  糖基化 血糖 参考值 

分 类 号：R714.256[医药卫生—妇产科学] R446.1[医药卫生—临床医学]