肿瘤检测试纸的实验研究和临床应用

STUDY OF EXPERIMENT AND CLINIC FOR A DETECTIVE PAPER OF CANCER

我们根据酶化学原理，成功地探索了肿瘤检测试纸。通过方法学的实验表明，该法的标准曲线通过零点，酶活力抑制率与欲测物（多胺）含量成比例关系，符合Ｂｅｅｒ定律。灵敏度为８μｍｌ，回收率为１０３．４８％±３．５９％。批内精密度试验的ｓ＝２．５０００；批间精密度试验的相对平均偏差为１．２２８８％～５．９２４９％，符合方法学的标准要求。通过９３２例正常人、非癌病人、癌症病人的尿检测，正常值为１２９．５１％±５５．８９７０％（单位为酶活力抑制率），癌症病人的平均值为４９８．８４０５％±３４４．３７３８％，其临床病理诊断符合率达８８．６１％～９５．８７％，误诊率５．０６％～９．０９％，漏诊率４．１３％～１１．３８％。适用于鼻咽癌、肺癌、食管癌、胃癌、直结肠癌、肝癌、胰腺癌、卵巢癌、宫颈癌、乳腺癌、甲状腺癌、脑垂体瘤、淋巴肉瘤的检测诊断，并能作为癌手术、放化疗的疗效监测方法。主要优点是简单、快速、灵敏、准确、无痛苦，不失为现场普查初步筛检早期癌症病人的一种良好方法。

The detective paper of cancer is a new product has made by our institute,ac-cording to enzymochemical principle.A invention in the china and world.By way of the methodologic experiment,the results indicated that standard curved line has throughed the zero point,and the inhibitory effect rate of enzyme activity was directly proportional to the polyamine of urine,was compatible with beer′s law. The sensitivity was 8 μg/ml,and the av-erage recovery of polyamine was 103.48%with a standard deviation of ±3.59.The relative-average-deviation of accuracy was 1.2288～5.9249%according to the demand of method-ologic standard.According to the determination of more than 932 cases and the test of 33 units in the China,the normal value was 129.51%with a standard deviation of±55.8970(in-hibitory effect rate of enzyme activity) whereas the average value of cancer was 498.8405% with a standard deviation of ±344.3738,and has a diagnostic positive rate of 88.61～95.87%,was compatible with the clinicopathologic diagnosis,and has a misdiagnosis rate of 5.06～9.09%whereas missed diagnosis rate of 4.13～11.38%.The method applies not only the early diagnosis for the cancer of nose-larynx、lung、esophagus、stomach、colon-rectum、liver、pancreas、ovary、cervical、breast、thyroid and lym-phoma,but also to monitor the effect of the operation and radiochemotherapy,and relapse track,and can distingish the tumour whether benign or maglinant.These results suggest that such determination can be used to screen latent symptomless patients,is a simple,viable,sensitive,painless and accurated method.