赣州人群血清HE4参考区间的探讨及其临床诊断效能的评价  

Study of reference interval of serum HE4 in Ganzhou population and evaluation of its clinical diagnostic efficiency

作　　者：江丽霞[1] 朱亚飞[1] 胡蓉[1] 何华[1] 陈晓红[1] 李峰[1] 

机构地区：[1]赣南医学院第一附属医院检验科,江西赣州341000

出　　处：《重庆医学》2015年第34期4799-4801,共3页Chongqing medicine

基　　金：江西省卫生厅基金资助项目(20141113);赣南医学院重点课题(ZD201301)

摘　　要：目的探讨赣州人群血清人附睾上皮分泌蛋白4(HE4)的参考区间,分析该参考区间在卵巢癌中的临床诊断效能。方法选取2013年1月至2014年12月期间在该院各项体检指标均正常的728例表面健康女性作为参考人群组,并选择同期住院治疗的80例卵巢恶性肿瘤患者、80例卵巢良性肿瘤患者作为病例研究组,采用罗氏电化学发光法测定研究对象血清HE4水平,分析参考人群中血清HE4水平的分布情况,计算血清HE4的参考区间,评价该参考区间在卵巢癌中的临床诊断效能。结果728例女性参考人群血清HE4平均水平为(52.04±10.83)pmol/L,40岁以上各年龄组与40岁以下各年龄组间比较,差异有统计学意义(P=0.000),而40岁以上各年龄组间及40岁以下各年龄组间比较,差异无统计学意义(P>0.05);血清HE4水平参考区间为小于40岁时,<70.42pmol/L,≥40岁时,<82.16pmol/L,均明显低于罗氏公司试剂说明书中推荐的小于140pmol/L的参考区间,但其在卵巢癌中的临床诊断灵敏度、阴性预测值、Youden′s指数均有明显提高(P<0.05),而临床诊断特异度、阳性预测值、准确度无明显变化(P>0.05)。结论赣州人群中血清HE4的参考区间明显低于罗氏试剂说明书推荐的参考区间,利用该研究所得的参考区间,明显提高了血清HE4在卵巢癌中的临床诊断效能。Objective To investigate the reference interval of HE4 in Ganzhou population and to evaluate its clinical efficien- cy in people with ovarian cancer. Methods 728 healthy females with all normal physical indexes of the comprehensive examination in hospital from 2013 January to 2014 December were collected, which regarded as control group. Moreover, 80 hospitalized patients with malignant ovarian tumor and 80 patients with benign ovarian tumor were selected as the experimental group. Serum levels of HE4 were measured by Roche electrochemical luminescence and the distribution of serum HE4 level of the reference population was analyzed. Reference interval of serum HE4 was calculated and the efficacy of its clinical diagnosis in ovarian cancer was evaluated. Results The average serum level of HE4 in 728 females was （52.04±10. 83） pmol/L. There existed statistical difference in serum HE4 level between the group age above 40 and the group age under 40 （P=0.000） ,but no significant difference in each age group between above 40-year-old and under 40-year-old （P〉0.05）;The serum level of HE4 reference interval was 〈70.42 when the patients were less than 40 years old,and was 〈82.16 pmol/L when the patients were more than 40 years old,both were significantly lower than the the reference interval recommended by Roche reagent （〈140 pmol/L）. But it increased significantly in clinical diag- nostic sensitivity, negative predictive value and Youden＇s index in ovarian cancer （P〈0. 05）, while the clinical diagnostic specificity,positive predictive value and accuracy had no obvious changes（P〉0.05）. Conclusion The reference interval of the serum HE4 in Ganzhou population is significantly lower than Roche＇s reference interval. It significantly increases the diagnostic effectiveness of serum HE4 in patients with ovarian cancer by using the reference interval in this study.

关 键 词：卵巢肿瘤 血清 人附睾蛋白4 参考区间 临床诊断 

分 类 号：R446.1[医药卫生—诊断学]