肿瘤相关物质群(TSGF)联合检测的临床应用研究

Clinical study of tumor supplies group of factors (TSGF) kit in detecting of carcinomas

目的 :研究及评估商品化的肿瘤相关物质群 (TSGF)联合检测试剂盒对临床恶性肿瘤的诊断价值。方法 :应用我国福建新大陆生物技术股份有限公司研制的商品化 TSGF联合检测试剂盒检测 2 0 0例健康人 ,1 86 5例、2 0余种不同组织起源恶性肿瘤患者的血清 TSGF水平 ,并比较其不同临床分期、不同病理状态血清 TSGF水平的变化。结果 :以血清 TSGF水平 6 4 U/ m l、71 U/ ml为阳性阈值时 ,对 5 2 7例初治中晚期恶性肿瘤的临床检测符合率分别为 5 3.0 %和2 6 .8% ,对 98例治疗无效肿瘤的临床检测符合率分别为 6 9.4 %和 35 .7% ,对 30 9例复发转移肿瘤的检出率分别为70 .9%和 4 2 .7% ;血清 TSGF水平随着肿瘤病情进展而升高 ,但与患者年龄及性别无关。以 6 4 U/ ml为界值时 ,TSGF检测对初治恶性肿瘤的敏感度、特异度、阳性预测值及阴性预测值分别为 5 3.0 % ,98.0 % ,97.9%和 4 3.9% ,对复发转移肿瘤则分别为 70 .9% ,90 .8% ,80 .5 %及 85 .4 %。结论 :检测血清 TSGF水平对诊断恶性肿瘤及判断其转归具有广谱性、敏感性及特异性。建议供临床应用参考的 TSGF阳性临界值应定为 6 4 U/ ml,将 (6 4～ 71 ) U/ ml为弱阳性 ,>71 U/

Objective: To evaluate the clinical value of commercial tumor supplies group of factors (TSGF) kit for diagnosis of the malignant tumors. Methods:The serum levels of TSGF were assayed by spectrophotometry using commercial TSGF kit (Fujian Newland Bio. Co. China) in 1865 patients with carcinomas, which including more than 20 defferent kinds of tissue originally and 200 healthy controls.The serum TSGF levels were compared and analysed in clinical stages and clinipathological conditions. Results:At the bordline of 64U/ml and 71U/ml, the positive rates of TSGF were 53.0% and 26.8% for initiated tumors (n=527), 69.4% and 35.7% for non responders(n=98), 70 9% and 42.7% for recurrent and metastases (n=309), respectively.The serum TSGF levels were increased with the tumor progression. It was not found the TSGF levels correlated with ages and genders. At the level of 64U/ml, TSGF indicated new diagnosed tumors with a specificity of 98.0%, a sensitivity of 53.0%, a positive predictive value of 97.9%, and a negative predictive value of 43.9%. Moreover, the assay was able to detect distant metastasis and relapse with a specificity of 90.8%, a sensitivity of 70.9%, a positive predictive value of 80.5%, and a negative predictive value of 85.4%. Conclusions: The TSGF is a sensitive and specific as well as widely utility marker on diagnosis, monitoring response to treatment and prognosis of carcinomas. It is recommended that the clinical positive bordline of serum TSGF assay be 64U/ml, (64~71)U/ml be weakly positive, and over 71U/ml be strong positive.