摘要
目的探讨泉州地区健康成人糖化血红蛋白（HbA1c）水平的分布并制定参考区间。方法在检测的标准化和质量保证前提下,应用日本TOSOH公司的HLC-723 G 8全自动糖化血红蛋白分析仪,检测1 931例健康成人的HbA1c水平,分析比较不同性别、5个年龄组（18～30岁、31～40岁、41～50岁、51～60岁、〉60岁）之间HbA1c水平的差异,并根据《WS/T 402-12-2012.临床实验室检验项目参考区间的制定》和C 28-A 3文件制定泉州地区健康成人HbA1c水平参考区间。结果泉州地区健康成人HbA1c总体水平为3.8%～6.4%（5.31%±0.40%）,男、女两组总体HbA1c水平分别为5.55%±0.36%和5.47%±0.43%,男女两组差异具有统计学意义（P≤0.01）。男女之间相应5个年龄组的比较：18～30岁、31～40岁HbA1c水平差异具有统计学意义（P≤0.05）,其余三组HbA1c水平差异无统计学意义。男性各年龄组之间两两比较：除31～40岁和41～50岁HbA1c水平差异无统计学意义（P〉0.05）外,其余各年龄组两两比较,差异均具有统计学意义（P≤0.05）;女性各年龄组两两比较,差异均具有统计学意义（P≤0.01）。健康成人总体HbA1c的95%参考区间为4.7%～6.3%,男性为4.8%～6.2%,女性为4.6%～6.3%,男女间差异具有统计学意义（P=0.000）。不同年龄组HbA1c的95%参考区间：18～30岁,男4.6%～6.0%、女4.4%～6.0%,差异具有统计学意义（P≤0.01）;31～40岁,男4.7%～6.0%,女4.7%～6.2%,差异具有统计学意义（P≤0.01）;41～50岁、51～60岁、〉60岁三组的HbA1c水平分布因性别差异无统计学意义（P〉0.05）,制定不分性别的参考区间分别为4.8%～6.2%、4.8%～6.4%和5.1%～6.4%。结果与美国糖尿病协会（ADA）和《全国临床检验操作规程》提供的参考区间相比较,差异均具有统计学意义（P=0.000）。结论在标准化测定的前提下,泉州地区性别、年龄别HbA1c水平部分差异显著;建立了本地区性别、年龄别HbA1c参考区间。
Objective To analyze the glycated hemoglobin A 1 c（HbA1c） level among healthy adults in Quanzhou area and explore distribution of HbA1c concentration by age and gender, and establish relevant reference range. Methods Under the standardized test of HbA1c, HbA1c concentrations of 1 931 healthy adults were determined by HLC- 723 G 8 HbA1c analyzer（TOSOH corp, Japan） and its agents. HbA1c levels of different age（ 18- 30, 31- 40, 41- 50, 51- 60,〉 60） and gender groups were compared, percentile was adopted to establish the corresponding HbA1c reference range of healthy adults in Quanzhou area according to ＂WS/T 402- 12- 2012. Define and Determine the Reference Interval in Clinical Laboratory＂ and CLSI C 28-A 3. Results The total HbA1c levels among healthy adults in Quanzhou area were 3. 8 %- 6. 4 %（ 5. 31 %± 0. 40 %）, and the total HbA1c levels among male and female healthy adults in Quanzhou area were 5. 55 %± 0. 36 % and 5. 47 %± 0. 43 %, respectively, HbA1c concentration between different gender were statistically significant（P≤ 0. 01）. Compared in HbA1c levels of different age（ 18- 30, 31- 40, 41- 50, 51- 60,〉 60） and gender groups： the difference of HbA1c concentration between different gender in 18- 30 years and 31- 40 years group was statistically significant（P〉0. 05） and on the contrary the remaining three age groups were no statistically significant. Compared in HbA1c levels of different age groups in male： the difference of HbA1c concentration between different age groups in 31- 40 years and 41- 50 years group were no statistically significant（P〉0. 05）, but statistically significant（P〈0. 05） in the remaining three age groups. The difference of HbA1c concentration between different age groups in female were statistically significant（all P values ≤ 0. 01）. The reference intervals of HbA1c for males and females were 4. 8 %- 6. 2 % and 4. 6 %- 6. 3 %, respectively, with statistically significant（P= 0. 000）; the reference intervals of HbA1c according to age and gender were： for 18- 30 years in males and females were 4. 6 %- 6. 0 % and 4. 4 %- 6. 0 %, respectively, with statistically significant（P≤ 0. 01）; for 31- 40 years in males and females were 4. 7 %- 6. 0 % and 4. 7 %- 6. 2 %, respectively, with statistically significant（P≤ 0. 01）; for 41- 50 years, 51-60 years,〉 60 years in males and females were no statistically significant（P〉0. 05）, the reference intervals were 4. 8 %- 6. 2 %, 4. 8 %- 6. 4 %, and 5. 1 %- 6. 4 %, respectively. Compared in HbA1c reference intervals in this paper with ADA and Chinese Clinical Operating Program, the difference were statistically significant（P= 0. 000）. Conclusion Under the standardized test of HbA1c, HbA1c concentrations of age and gender groups of 1 931 healthy adults in Quanzhou area are partial different, the reference interval of HbA1c of age and gender groups for healthy adults in Quanzhou area are established.
出处
《中国循证医学杂志》
CSCD
2016年第10期1121-1126,共6页
Chinese Journal of Evidence-based Medicine
基金
2012年度泉州市社会发展领域科技计划项目(编号:2012 Z 19)
