恶性肿瘤相关物质群(TSGF)的测定及临床应用评价

Detection of Serum Tumor Supplied Group of Factors and Its Clinical Significance

背景与目的:恶性肿瘤相关物质(tumorsuppliedgroupoffactors,TSGF)是我国首个获国家批准上市的第一类癌症体外标记物,国外还未见此类报道。为了解其检测特异性及灵敏度,我们测定了肿瘤患者血清TSGF水平并评价其在肿瘤诊断中的临床应用价值。方法:定量分析测定523例肿瘤患者和400例正常人的血清TSGF水平并分析其与临床诊断符合率。结果:非恶性肿瘤(A组)、恶性肿瘤(B组)、恶性肿瘤根治治疗后(C组)及正常人(D组)其血清TSGF水平分别为66.57、71.24、60.78及53.56u/ml。经统计学分析,A组和B组、A组和D组、B组和C组、B组和D组、C组和D组有显著性差异(P<0.05),而A组和C组则无显著性差异(P>0.05)。诊断灵敏度为63.86%,特异性是90.89%,真阳性率是87.01%,假阳性率是13.00%。结论:TSGF在恶性肿瘤患者血清中的水平升高,对筛查肿瘤疾病有帮助。

Background & Objective: Tumor supplied group of factors (TSGF)is the first kind of tumor marker in vitro which was primarily obtained the approval by Chinese government to land the market, there was no any reports about it in abroad before. In order to know its specificity and sensitivity, we designed this study to detect the TSGF in serum of the patients with malignancies and evaluate its clinical significance for diagnosis. Methods: Serum TSGF in 523 cases with malignancies and 400 cases of normal control were detected with chemical colorimetry. The diagnostic accuracy was evaluated. Results: Mean levels of serum TSGF in the patients without malignancies (group A),the patients with malignancies (group B),the patients after curative treatment for malignancies (group C)and the normal control (group D) were 66.57,71.24,60.78, and 53.56 u/ml, respectively. After the statistical analysis, differences between the group A and group B, group A and group D, group B and group C, group B and group D, group C and group D were found (P< 0.05). But there was no obvious difference between the group A and group C (P >0.05). The sensitivity was 63.86%; the specificity was 90.89%; the truly negative rate was 87.01%; and the falsely negative rate was 13.00%. Conclusions: Serum TSGF increased in malignancies and may be helpful for screening and early detection of cancer.