糖链抗原19-9参考范围设置对胰腺、胆囊疾病诊断的影响

Effect of CA19-9 reference range setting on the diagnosis of pancreatic gallbladder disease

目的检测糖链抗原19-9(CA19-9)在体检人群及胰腺、胆囊疾病中的表达水平,调查浙江地区CA19-9的参考范围,并探讨其在胰腺、胆囊疾病诊断中的意义。方法用化学发光免疫分析法检测正常人群及胰腺、胆囊良恶性疾病患者血清CA19-9水平,用ROC曲线分析比较CA19-9对胰腺、胆囊疾病的诊断能力。结果健康人群中的CA19-9的95%参考范围为0 U/ml^26.99 U/ml,低于现行的临界值37 U/ml。血清CA19-9浓度在胰腺癌中最高,胆管癌次之,胆囊良性疾病中第3,中位数分别为201.7 U/ml、164.4 U/ml和130.7 U/ml。ROC曲线分析显示,血清CA19-9对胰腺、胆囊系统疾病的诊断能力,胆囊良性疾病、胰腺癌、胆管癌的曲线下面积分别为91.7%、88.7%、86.7%。结论本研究确定了浙江省健康人群CA19-9的95%参考范围;CA19-9是胰腺癌及胆道良恶性疾病很好的诊断指标。

Objective To detect the serum CA19-9 level in normal people and patients with pancreatic and gallbladder disease,investigate the CA19-9 reference range,and evaluate its clinical value in diagnosing pancreatic and gallbladder diseases. Methods Serum CA19-9 levels of normal population and patients with benign and malignant disease of pancreas and gallbladder were measured by chemiluminescence immunoassay. Receiver operating characteristic（ ROC） curves were plotted to evaluate the diagnosis value of CA19-9 of pancreas. Results 95% reference range of serum CA19-9 in normal people was within 0 U/ml-26. 99 U/ml,lower than the current threshold（ 37 U/ml）. The median concentration of CA19-9 was the highest in pancreatic cancer（ 301. 9 U/ml）, cholangiocarcinoma（ 164. 4 U/ml）, and then benign cholecystic disease（ 130. 7 U/ml）. ROC curve showed that the diagnosing ability of CA19-9 was good for pancreatic cancer and benign cholecystic disease,and the area under curve（ AUC） was 91. 7%,88. 7% and 86. 7%,respectively. Conclusion This study identified 95% of the reference range of CA19-9 in healthy population in Zhejiang Province; CA19-9 is a good diagnostic indicator of pancreatic cancer and benign and malignant biliary tract disease.