四川高原地区健康人群肿瘤标志物水平调查及参考区间建立

The Investigation of Tumor Markers and Establishment of Reference Intervals in Healthy Population in Sichuan Plateau Area

目的检测四川高原地区(平均海拔3500m)健康人群肿瘤标志物(糖类抗原15-3(CA15-3)、糖类抗原19-9(CA19-9)、甲胎蛋白(AFP)、癌胚抗原(CEA))水平及影响因素,并建立参考区间。方法选取我院2021年1月至2022年2月收治的18~91岁的健康体检者6038例作为研究对象,采用迈瑞CL-6000i化学发光免疫分析仪检测血清CA15-3、CA19-9、AFP、CEA水平,并对数据进行正态性验证和离群值剔除。肿瘤标志物各项指标根据性别分为两组,比较男性与女性组间水平差异,并采用百分位法计算出CA15-3、CA19-9、AFP、CEA的中位数、P 25、P 75值,分析其与年龄的相关性,并建立参考值范围。结果CA15-3、CA19-9、AFP、CEA男性组与女性组间比较差异均有统计学意义(P<0.05),肿瘤标志物水平与年龄均呈正相关CA15-3(r=0.209,P<0.001)、CA19-9(r=0.105,P<0.001)、AFP(r=0.137,P<0.001)、CEA(r=0.129,P<0.001)。四川高原地区健康人群根据性别、年龄进行分组,CA15-3可以分为男性组、女性<60岁、≥60岁3个组,参考区间分别为:≤16.99、≤17.48、≤19.83U/mL;CA19-9、AFP、CEA均可按性别和年龄分男性<60岁、≥60岁、女性<60岁、≥60岁4个组,参考区间分别为:CA19-9(≤29.9、≤33.18、≤32.26、≤32.80U/mL)、AFP(≤5.98、≤5.68、≤5.45、≤5.9ng/mL)、CEA(≤3.79、≤4.16、≤3.02、≤3.7ng/mL)。结论四川高原地区(平均海拔3500m)健康人群CA15-3、CA19-9、AFP、CEA水平受性别和年龄影响,建立该地区参考区间,可以为当地肿瘤相关疾病的预防和早期诊疗提供参考依据,减少疾病恶化风险。

Objective To detect the levels of tumor markers(carbohydrate antigen-15-3(CA15-3),carbohydrate antigen-19-9(CA19-9),alpha-fetoprotein(AFP),carcinoembryonic antigen(CEA))and their influencing factors in healthy people in Sichuan Plateau area(the average altitude is 3500 meters),and to establish a reference interval.Methods A total of 6038 patients aged 18 to 91 years old who were admitted to our hospital from January,2021 to February,2022 were selected as the study objects.Serum CA15-3,CA19-9,AFP and CEA levels were detected by Mindray CL-6000i chemiluminescence immunoassay.The normalness of the data was verified and outliers were removed during data quality control process.Tumor markers were divided into two groups according to gender.The level between male and female groups was compared,and the median,P 25 and P 75 values of CA15-3,CA19-9,AFP and CEA were calculated by percentile method.The correlations between these markers and age were analyzed,and the reference ranges were established.Results There were statistically significant differences in CA15-3,CA19-9,AFP and CEA levels between male and female groups(P<0.05).The levels of tumor markers were positively correlated with age:CA15-3(r=0.209,P<0.001),CA19-9(r=0.105,P<0.001),AFP(r=0.137,P<0.001),and CEA(r=0.129,P<0.001).Healthy people in Sichuan Plateau area were grouped according to gender and age.CA15-3 was divided into male group,female group<60 years old and≥60 years old.The reference intervals were:≤16.99,≤17.48,≤19.83 U/mL,CA19-9,AFP and CEA were divided into four groups according to gender and age:male<60 years old,≥60 years old,female<60 years old,≥60 years old.The reference intervals were as following:CA19-9(≤29.9,≤33.18,≤32.26,≤32.80U/mL),AFP(≤5.98,≤5.68,≤5.45,≤5.9ng/mL),CEA(≤3.79,≤4.16,≤3.02,≤3.7ng/mL).Conclusion The levels of CA15-3,CA19-9,AFP and CEA in healthy people in Sichuan Plateau area(the average altitude is 3500 meters)are affected by gender and age.Establishing a reference interval in this region can provide reference for the prevention,early diagnosis and treatment of local cancer-related diseases,and reduce the risk of disease deterioration.