泸州地区健康成人糖化血红蛋白一致性参考区间的建立及验证  

Development and validation of consistency reference interval for hemoglobin HbA1c in healthy adults in Luzhou area

作　　者：郭永灿 张帮林[2] 杨清明[2] 刘靳波 黎金凤[4] 陈坚[5] 蒋春阳[6] 陈美舟 

机构地区：[1]西南医科大学附属中医医院检验科,四川泸州646000 [2]四川省泸州市中医医院检验科,646000 [3]西南医科大学附属医院检验科,四川泸州646000 [4]四川省泸州市人民医院检验科,646000 [5]四川省泸州市叙永县人民医院检验科,646400 [6]四川省泸州市古蔺县人民医院检验科,646500 [7]四川省泸州市合江县人民医院检验科,646200

出　　处：《检验医学与临床》2017年第21期3148-3151,共4页Laboratory Medicine and Clinic

基　　金：四川省卫生和计划生育委员会基金资助项目(100206)

摘　　要：目的建立适用于泸州地区临床实验室健康成人糖化血红蛋白(HbA1c)一致性参考区间,并验证其适用性。方法选择代表泸州地区地理区域的7个临床实验室,选取2012年5月至2014年6月体检的健康成人4 163例(各医院参考人群总数不低于500例),所有健康成人分为男、女2组,每组按年龄分别分为≤44岁(青年组)、>44~59岁(中年组)、>59岁(老年组),检测所有人群全血HbA1c水平和血清生化指标。结果不同实验室不同性别和年龄组基础数据基本正常,符合HbA1c生物参考区间对参考人群的要求;不同实验室间同性别、同年龄组人群HbA1c水平差异无统计学意义(P>0.05);对不同实验室间同组HbA1c数据进行合并后,不同性别、年龄组进行多个独立样本秩和检验,结果显示6组数据间差异有统计学意义(χ~2=28.079,P<0.05);经Spearman相关分析,HbA1c数据分布与性别无明显相关性(r=0.086,P>0.05),与年龄有较弱相关性(r=0.253,P<0.05)。按年龄分组,泸州地区HbA1c一致性生物参考区间分别为青年组4.40%~6.30%;中老年组(>44岁)4.70%~6.50%。新建立参考区间经7个实验室验证符合要求。结论推荐将青年组4.40%~6.30%、中老年组4.70%~6.50%作为泸州地区HbA1c一致性的参考区间。Objective To develop the consistency reference interval for hemoglobin A1c（HbA1c）in healthy adults in Luzhou area and verify its applicability.Methods Seven clinical laboratories that represent the region＇s geographical area were chosen,4 163 healthy individuals were recruited in 7 hospitals from May 2012 to June 2014 according to unified inclusion criteriaand the total number of healthy individualswere not less than 500 people in every hospital.All selected healthy individuals were divided into male and female groups,then two groups were divided into≤44 years old（young group）,44-59 years old（middle-aged group）,59 years old（elderly group）in accordance with their age.HbA1cand serum biochemical indexes of all individuals were detected.Results The difference of serum biochemical indexes among the laboratories werenot significant,which complied with their quirements of hemoglobin HbA1creference interval.The difference of HbA1camong the same group in different laboratories were not significant（P〈0.05）,then same group data of HbA1camong 7 laboratories were merged,and the merged data were performed by multi-independent samples Kruskal-Wallis test,the results showed that the difference among 6 groups were significant（χ-2=28.079,P〈0.05）.All samples were tested by Spearman correlation analysis,there was not significant correlation between the HbA1cdata and gender,thus there was poor correlation between the HbA1cdata and age（r=0.253,P〈0.05）.Consequently,consistency reference interval for hemoglobin HbA1cin healthy adults in our area was developed,young group was 4.40%-6.30%,middle-aged group and elderly group were 4.70%-6.50%,and their＇s applicability were verified by 7 laboratories.ConclusionThe consistency reference interval for HbA1cin healthy adults in Luzhou area could be suggested as young group was 4.40%-6.30%,middle-aged group and elderly group were 4.70%-6.50%.

关 键 词：糖化血红蛋白 参考区间 多中心 

分 类 号：R446.1[医药卫生—诊断学]