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[血清胃泌素释放肽前体诊断小细胞肺癌界值的建立及临床诊断效能评价]

[Establishment of cut-off value of serum pro-gastrin-releasing peptide for diagnosis of small cell lung cancer and evaluation on the clinical diagnosis efficiency].

作者信息

Shen D, Han B B, Chen F, Wei B J, Cui C J, Wang G J, Cui W

机构信息

Department of Laboratory, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.

出版信息

Zhonghua Yi Xue Za Zhi. 2017 Sep 12;97(34):2657-2662. doi: 10.3760/cma.j.issn.0376-2491.2017.34.004.

DOI:10.3760/cma.j.issn.0376-2491.2017.34.004
PMID:28910952
Abstract

To determine critical reference value (cut-off value) of serum pro-gastrin-releasing peptide (ProGRP) and neuron specific enolase(NSE) in the diagnosis of small cell lung cancer(SCLC). To evaluate the clinical significance of serum levels of ProGRP and NSE in diagnosis and differential diagnosis in SCLC. Three hundred and fifty-two SCLC patients, 163 non small cell lung cancer(NSCLC)patients , 193 benign pulmonary disease patients and 140 healthy people visiting in National Cancer Hospital were analyzed retrospectively from January 2014 to July 2017.The levels of serum ProGRP and NSE of people were determined using electrochemiluminescent immunoassay respectively . Reference value ranges of the makers were determined by using the method of ROC curves. In NSCLC group, benign lung disease group, healthy control group and mixed group (NSCLC+ lung benign diseases+ healthy control group) as a reference, the cut-off values were 58.3, 62.3, 57.8, 61.3 ng/L. In the diagnosis and differential diagnosis of SCLC and NSCLC, benign lung diseases, healthy controls and mixed group, AUC of ProGRP was 0.940 (0.919-0.961), 0.941 (0.921-0.960), 0.959 (0.944-0.975), 0.946 (0.928-0.963) respectively. The sensitivities of ProGRP were 86.4%, 84.9%, 86.4% and 84.7% respectively. The specificities of ProGRP were 95.7%, 96.9%, 99.3%, 98% respectively. In all groups the Youden's index of ProGRP and NSE were 0.821 vs 0.612, 0.818 vs 0.674, 0.857 vs 0.810, 0.827 vs 0.674. In healthy controls, no statistically significant difference was found between ProGRP and NSE (>0.05) in the diagnosis of AUC. However, in the remaining 3 groups, the ProGRP diagnosis of AUC was significantly greater than that of NSE (<0.01). Compared with single marker detection, the sensitivity of combined detection of ProGRP and NSE in diagnosis of SCLC increased to 95.5%, 94%, 96.6% and 94% in each group. There was no significant difference between ProGRP and ProGRP+ NSE in the diagnosis of AUC when compared with the NSCLC group and the mixed group (>0.05). However, when combined with a healthy control group and a benign lung disease group, the ProGRP+ NSE combination was the highest for AUC diagnosis, compared with ProGRP and NSE (<0.01). In the SCLC ED group serum ProGRP and NSE levels[776.33(3 103.4)ng/L, 52.14(60.59)μg/L]were higher than those in the SCLC LD group[295.59(799.65)ng/L, 23.36(22.97)μg/L], respectively (all <0.001). The serum ProGRP levels of N0, N1, N2 and N3 in TNM staging were 113.0(343.65), 167.04(724.56), 427.42(1 388.62), 735.99(1 709.95)ng/L respectively (all <0.001). Serum ProGRP and NSE levels were not statistically different between the sex groups and the age groups (all >0.05). To establish the cut-off value of serum ProGRP is helpful for the diagnosis and differential diagnosis of SCLC.

摘要

确定血清胃泌素释放肽前体(ProGRP)和神经元特异性烯醇化酶(NSE)在小细胞肺癌(SCLC)诊断中的临界参考值(截断值)。评估血清ProGRP和NSE水平在SCLC诊断及鉴别诊断中的临床意义。回顾性分析2014年1月至2017年7月在国家癌症医院就诊的352例SCLC患者、163例非小细胞肺癌(NSCLC)患者、193例良性肺疾病患者和140例健康人。分别采用电化学发光免疫分析法测定人群血清ProGRP和NSE水平。采用ROC曲线法确定标志物的参考值范围。以NSCLC组、良性肺疾病组、健康对照组和混合组(NSCLC + 肺良性疾病 + 健康对照组)为参照,截断值分别为58.3、62.3、57.8、61.3 ng/L。在SCLC与NSCLC、良性肺疾病、健康对照及混合组的诊断与鉴别诊断中,ProGRP的AUC分别为0.940(0.919 - 0.961)、0.941(0.921 - 0.960)、0.959(0.944 - 0.975)、0.946(0.928 - 0.963)。ProGRP的敏感性分别为86.4%、84.9%、86.4%和84.7%。ProGRP的特异性分别为95.7%、96.9%、99.3%、98%。在所有组中,ProGRP和NSE的约登指数分别为0.821对0.612、0.818对0.674、0.857对0.810、0.827对0.674。在健康对照组中,ProGRP和NSE在AUC诊断方面差异无统计学意义(>0.05)。然而,在其余3组中,ProGRP诊断的AUC显著大于NSE(<0.01)。与单一标志物检测相比,ProGRP和NSE联合检测在SCLC诊断中的敏感性在各分组中分别提高到95.5%、94%、96.6%和94%。与NSCLC组和混合组相比,ProGRP与ProGRP + NSE在AUC诊断方面差异无统计学意义(>0.05)。然而,与健康对照组和良性肺疾病组联合时,ProGRP + NSE组合诊断的AUC最高,与ProGRP和NSE相比(<0.01)。SCLC ED组血清ProGRP和NSE水平[776.33(3103.4)ng/L,52.14(60.59)μg/L]分别高于SCLC LD组[295.59(799.65)ng/L,23.36(22.97)μg/L](均<0.001)。TNM分期中N0、N1、N2和N3的血清ProGRP水平分别为113.0(343.65)、167.04(724.56)、427.42(1388.62)、735.99(1709.95)ng/L(均<0.001)。血清ProGRP和NSE水平在性别组和年龄组之间差异无统计学意义(均>0.05)。建立血清ProGRP的截断值有助于SCLC的诊断和鉴别诊断。

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