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为了对肺癌应用两种特异性单抗(KS1901和BM19021)所识别的肺癌新的相关标志CYFRA21-1、β_2-MG、CEA和NSE进行前瞻性规范的诊断试验对照研究、评价CYFRA-21-1及其联合检测诊断肺癌的价值,用免疫放射分析法测定62例肺癌(LC)、63例肺部良性疾病患者及63例正常健康人血清CYFRA21-1、CEA和NSE水平,采用ROC曲线选择CYFRA21-1界值为3.3U/ml。结果显示,CYFRA21-1、β_2-MG、CEA和NSE测得阈值诊断准确性:鳞癌分别为92.8％、86.7％、79.5％、78.3％,腺癌分别为88.2％、94.1％、85.8％、83.5％,小细胞肺癌分别为85％、88.7％、85％、86.2％,特异性为96.8％。各型的敏感性磷癌分别为80.0％、70％、20％、30％,腺癌为63.6％、100％、50％、54.5％,小细胞肺癌分别为41.2％、76.5％、35.3％、82.4％。4项特异性分别为96.8％、92％、98.4％、93.7％。CYFRA21-1、CEA、NSE诊断肺癌不同分化期的水平,鳞、腺癌以低分化期的水平最高,β_2-MG为鳞、腺癌以高分化期的水平最高。血清CYFRA21-1与肿瘤临床分期相关。诊断Ⅲ、Ⅳ期肺癌的敏感性显著高于Ⅰ、Ⅱ期,其中CYFRA21-1分别为75.0％(18/24)和33.3％(4/12)。提示CYFRA21-1是一项有价值的肺癌标志物,联合应用血清CYFRA21-1+β_2MG+NSE可将整体肺癌的阳性诊断率提高到91.9％,特
In order to perform a prospective normative diagnostic test on CYFRA21-1, β_2-MG, CEA, and NSE, which are new markers of lung cancer identified for lung cancer using two specific monoclonal antibodies (KS1901 and BM19021), CYFRA-21-1 was evaluated. The value of CYFRA21-1, CEA, and NSE in serum of 62 patients with lung cancer (LC), 63 patients with benign lung diseases, and 63 healthy individuals were determined by immunoradiometric assay. The ROC curve was used to select CYFRA21. The -1 cutoff is 3.3 U/ml. The results showed that the diagnostic accuracy of CYFRA21-1, β_2-MG, CEA, and NSE measured thresholds were 92.8%, 86.7%, 79.5%, and 78.3% for squamous cell carcinoma, 88.2%, 94.1%, and 85.8% for adenocarcinoma, respectively. 83.5%, small cell lung cancer were 85%, 88.7%, 85%, 86.2%, and the specificity was 96.8%. The sensitivity of various types of cancer was 80.0%, 70%, 20%, 30%, adenocarcinoma was 63.6%, 100%, 50%, 54.5%, and small cell lung cancer was 41.2%, 76.5%, 35.3%, respectively. 82.4%. The four specificities were 96.8%, 92%, 98.4%, and 93.7%, respectively. The levels of CYFRA21-1, CEA and NSE in the diagnosis of different stages of lung cancer were different. The level of squamous cell adenocarcinoma was the highest in the poorly differentiated stage. The level of β_2-MG in the highly differentiated stage was the highest. Serum CYFRA21-1 is associated with the clinical stage of the tumor. The sensitivity of diagnosis of stage III and IV lung cancer was significantly higher than that of stage I and II, with CYFRA21-1 being 75.0% (18/24) and 33.3% (4/12), respectively. It is suggested that CYFRA21-1 is a valuable lung cancer marker. Combined use of serum CYFRA21-1+β_2MG+NSE can increase the positive diagnosis rate of lung cancer to 91.9%.