目的：建立1,5脱水山梨醇（1, 5-anhydroglucitol,1,5AG）的正常人群参考区间,并验证其临床适用性。方法：选取2015年8月至2017年12月,上海市宝山区中西医结合医院的健康体检人群1 175名（其中男性510名,女性665名）作为参考区间建立组,分析年龄、性别间的1,5AG水平差异,建立1,5AG正常人群参考区间;另选取同期上海市宝山区中西医结合医院内分泌科就诊的患者,根据糖尿病诊断标准（WHO 1999年）将患者分为验证疾病组（300例,其中男性136例）及验证对照组（169例,其中男性75例）,以自建参考区间对验证疾病组及验证对照组进行判断,1,5AG检测结果在参考区间内判为阴性,小于参考区间判为阳性,比较2个验证组间的阳性率用以验证自建1,5AG参考区间的临床适用性。结果：1,5AG水平在不同年龄及性别间存在差异,小于30岁男性的参考区间为86~418 μmol/L,女性为37~382 μmol/L;30~59岁男性的参考区间为79~406 μmol/L,女性为43~297 μmol/L;大于等于60岁阶段男性的参考区间为86~404 μmol/L,女性为27~278 μmol/L。根据自建参考区间判断,验证疾病组中糖尿病患者的1,5AG水平低于验证对照组（非糖尿病患者）,验证疾病组糖尿病患者的1,5AG阳性率高于验证对照组（71% 比5%）,提示自建的1,5AG参考区间适用于临床应用。结论：本研究以上海地区人群为基础,建立了1,5AG的参考区间,其有性别、年龄差异,为今后设计大规模人群参考区间提供参考。
Objective: To establish a normal reference range for 1,5-anhydroglucitol (1,5AG) and to verify its clinical application. Methods: A total of 1 175 healthy people undergone physical examination during August 2015 to December 2017 were enrolled to establish a normal reference range and the differences in 1,5AG level between different age and sex were analyzed. According to the diabetes diagnostic criteria (WHO 1999), the subjects used for verifying the self-built refe-rence range were divided into the verified diabetes disease group (300 cases, 136 males) and the verified control group (169 cases, 75 males). When the 1,5AG level was within the self-built reference range, it would be regard as negative result, otherwise as positive result; the positive rates between the 2 verified groups were compared. Results: There were differences in 1,5AG level between different age groups, so were between male and female. For people under 30 years of age, normal reference range was 86-418 μmol/L in male, and was 37-382 μmol/L in female, and for people aged 30 to 59 years, were 79-406 μmol/L and 43-297 μmol/L, while for people older than 60 years were 86-404 μmol/L and 27-278 μmol/L. The level of 1,5AG of diabetes patients was lower than that of non-diabetic patients, and the positive rate according to the self-built reference range in diabetes patients was higher than that in non-diabetic patients (71% vs 5%）. Conclusions: A reference interval of 1,5AG is established based on the population in Shanghai area, which has gender and age differences. This study will provide a reference for future large-scale population study.
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