化学发光法测定血浆醛固酮和肾素浓度的参考区间及筛查原发性醛固酮增多症的价值  

The reference interval of Plasma Aldosterone and Renin Concentration Detected by Chemiluminescence Immunoassay and the Performance Evaluation in Screening Primary Aldosteronism

作　　者：王芳[1] 马文君[2] 丛洪瀛 陈曦[1] 蔡军[2] 

机构地区：[1]北京协和医学院中国医学科学院国家心血管病中心阜外医院实验诊断中心,北京100037 [2]北京协和医学院中国医学科学院国家心血管病中心阜外医院高血压中心,北京100037

出　　处：《中国分子心脏病学杂志》2017年第1期1970-1973,共4页Molecular Cardiology of China

摘　　要：目的探讨化学发光法测定血浆醛固酮和肾素浓度的参考区间以及醛固酮/肾素浓度比值筛查原发性醛固酮增多症(原醛)的适宜切点。方法依据美国临床实验室标准化协会的相关方案入选健康人127名建立血浆醛固酮和肾素浓度的参考区间。连续入选142例高血压查因病人,分别用放射免疫法(RIA)和化学发光免疫法(CLIA)检测肾素活性或肾素浓度及醛固酮浓度,以临床诊断为金标准,分析两种方法测得的醛固酮浓度/肾素活性比值(ARR)或醛固酮浓度/肾素浓度比值(ADRR)用于原醛筛查的受试者工作曲线(ROC),找出最佳切点。结果 CLIA测定的醛固酮和肾素浓度在健康人群中均呈偏态分布,按2.5%-97-5%建立参考区间,立位醛固酮浓度4.37-30.02ng/dl,立位肾素浓度4.08-61.14μIU/ml。肾素浓度与年龄呈负相关。CLIA测定ADRR的ROC曲线下面积(areaundercurve,AUC)为0.8388(95%CI 0.6465-1.031,P<0.001),而RIA测定所得ARR的AUC为0.9616(95%CI 0.9034-1.020,P<0.001)。CLIA测定ADRR的Youden's指数最大为0.763,对应切点为8.63(ng/d1)/(μIU/ml),敏感度为77.8%,特异度为98-5%。结论首次建立了化学发光法检测中国人血浆醛固酮和肾素浓度的参考区间。CLIA筛查原醛的灵敏度低于RIA,而特异性高于RIA,建议在使用ADRR进行原醛筛查时要考虑其敏感度偏低的问题,必要时使用RIA复查。Objective To validate the reference interval of plasma aldosterone and renin concentration detected by chemiluminescence immunoassay （CLIA） and evaluate the performance in screening primary aldosteronism （PA）. Methods 127 healthy adults were used to validate reference interval according to the protocols of CLSI.A total of 142 patients with indication for evaluationof the renin-angiotensin- aldosterone system were measured concentrationsof aldosterone, direct renin by CLIA and renin activity by radioimmunoassay （RIA）. Reveiver operating characteristic （ROC） curve was used to compare of aldosterone/renin concentration （ADRR） and aldosterone/renin activity （ARR） in distinguishing PA. Results The reference interval was 4.37-30.02ng/dl for aldosterone and 4.08-61.14μIU/ml for renin concentration. Renin concentration was negatively correlated with age. The AUC of ADRR and ARR in distinguishing PA from primary hypertension was 0.8388 （95% CI 0.6465-1.031, P 〈0.001） and 0.9616 （95% CI 0.9034-1.020, P 〈0.001） respectively. The best cutoff value of ADRR was 8.63（ng/dl）/（μIU/ml） （sensitivity： 77.8%, specificity： 98.5%）. Conclusions We validate the reference interval of plasma aldosterone and renin concentration for the first time. The sensitivity of ADRR in distinguishing PA from primary hypertension was lower than ARR, which suggest RIA is necessary in screen PA when ADRR is negative but the clinical symptoms strongly support the diagnosis of PA.

关 键 词：原发性醛固酮增多症 化学发光法 肾素浓度 醛固酮 

分 类 号：R586.24[医药卫生—内分泌]