广谱型恶性肿瘤尿液诊断试剂临床应用效果观察

Observing the clinical application effect of diagnostic reagent of broad-spectrum malignant tumor urine

目的：为观察验证华东师范大学研制的新型广谱型恶性肿瘤尿液诊断试剂临床应用效果。方法：选用临床已确诊的恶性肿瘤病人200例，同期非肿瘤器质性病变病人200例，以及健康青年人200例，分别取尿液2ml，用该试剂进行检测。结果：200例肿瘤病人中阳性149例，阳性率为74．5％（149／200），200例非肿瘤器质性病变病人中，阳性共86例，阳性率为43．0％（86／200），200例健康青年人中，阳性2例，阳性率仅为1％（2／200）；该试剂对恶性肿瘤检测的敏感性为74．5％［149／（149＋51）］，特异性为80．4％（363／451），正常人群假阳性率为1％。结论：该试剂对恶性肿瘤检出的敏感性和特异性较高，有临床应用及人群健康普查意义，且操作方便，无须特殊仪器，但有关其反应物的本质有待于进一步阐明。

Objective To observe the clinical application effect of new-type diagnostic reagent of broad-spectrum malignant tumor urine triturated by East-China Normal University. Methods We choose 200 cases of malignant tumor diagnosed in clinic, 200 patients of non-malignant tumor and 200 healthy youth. We collected 2ml urine each, then detected urine by this reagent. Result 149 cases of 200 malignant tumor patients had positive result,the positive rate was 74. 5% (149/200). 86 cases of 200 non-malignant tumor patients had positive reaction,the positive rate was 43. 0% (86/200). In the 200 healthy youth, 2 persons had positive result,the positive rate was 0. 1 % (2/200). The sensitivity of this reagent to detect malignant tumor was 74. 5 % [149/ (149+51)]. The specificity was 80. 48% (363/451)- False positive rate of normal people was 0. 1 %. Conclusion The sensitivity and specificity of this reagent to malignant tumor was higher,and it had the value of clinical application and screening,and its manipulation was convenience. It needn't special instruments, but the nature of its reaction need further explanation.