Bombardieri E, Seregni E, Bogni A, Ardit S, Belloli S, Busetto A, Caniello B, Castelli M, Cianetti A, Correale M
Istituto Tumori, Milano, Italy.
Int J Biol Markers. 1994 Apr-Jun;9(2):89-95. doi: 10.1177/172460089400900205.
Recently, a new immunometric assay (Cyfra 21-1) was developed to measure serum concentrations of a soluble fragment of cytokeratin subunit 19. With this method, supplied by Boehringer Mannheim (EIA Test Cyfra 21-1), an Italian multicenter trial was performed in patients with lung cancer. Cyfra 21-1 serum levels were determined in 568 normal subjects (blood donors), 607 patients with non-malignant diseases (491 respiratory diseases) and 730 patients with malignancies. In the latter group 584 had lung cancer. All these 584 patients had pathologically confirmed disease; 314 were epidermoid tumors, 166 adenocarcinomas, 88 small cell cancers and 16 large cell cancers. In the 568 healthy blood donors the mean Cyfra 21-1 value was 0.91 ng/ml (SD 0.47 ng/ml; range 0.05-2.90 ng/ml). A threshold of 1.9 ng/ml was chosen as the upper limit of normality. High levels of Cyfra 21-1 were observed in patients with chronic hepatitis (positivity rate: 17/51-33.3%) and with pancreatitis (positivity rate 5/16-31.3%). In 114 out of 491 (23.2%) patients with respiratory diseases Cyfra 21-1 showed values greater than 1.9 ng/ml. The overall sensitivity (all stages) of Cyfra 21-1 in lung cancer was 65.6% (383/584). When the histology was considered the highest positivity rates were found in patients with squamous cell tumors (226/314; 72%) followed by adenocarcinomas (105/166; 63%). In patients with SCLC the global sensitivity was 52.3% (46/88). Higher sensitivity of Cyfra 21-1 was observed from stage I to stage IV (53.9% vs 85.7%; Chi square: p < 0.01).(ABSTRACT TRUNCATED AT 250 WORDS)
最近，一种新的免疫测定法（细胞角蛋白片段21-1，Cyfra 21-1）被开发用于测量细胞角蛋白亚基19可溶性片段的血清浓度。采用由勃林格殷格翰公司提供的这种方法（EIA Test Cyfra 21-1），在肺癌患者中进行了一项意大利多中心试验。测定了568名正常受试者（献血者）、607名非恶性疾病患者（491名呼吸系统疾病患者）和730名恶性肿瘤患者的Cyfra 21-1血清水平。后一组中有584人患有肺癌。所有这584例患者均经病理确诊；其中314例为鳞状细胞癌，166例为腺癌，88例为小细胞癌，16例为大细胞癌。568名健康献血者的Cyfra 21-1平均水平为0.91 ng/ml（标准差0.47 ng/ml；范围0.05 - 2.90 ng/ml）。选择1.9 ng/ml作为正常上限阈值。在慢性肝炎患者（阳性率：17/51 - 33.3%）和胰腺炎患者（阳性率5/16 - 31.3%）中观察到Cyfra 21-1水平升高。491例呼吸系统疾病患者中有114例（23.2%）的Cyfra 21-1值大于1.9 ng/ml。Cyfra 21-1在肺癌中的总体敏感性（所有分期）为65.6%（383/584）。考虑组织学类型时，鳞状细胞肿瘤患者的阳性率最高（226/314；72%），其次是腺癌患者（105/166；63%）。小细胞肺癌患者的总体敏感性为52.3%（46/88）。从I期到IV期观察到Cyfra 21-1的敏感性更高（53.9%对85.7%；卡方检验：p < 0.01）。（摘要截选至250字）
