Zippe C, Pandrangi L, Potts J M, Kursh E, Novick A, Agarwal A
Cleveland Clinic Foundation, Department of Urology, OH 44195, USA.
Anticancer Res. 1999 Jul-Aug;19(4A):2621-3.
This study was designed to determine the clinical utility of NMP22 as a urinary marker for the early detection of transitional cell carcinoma (TCC) of the bladder in patients with hematuria or other indications for risk of malignancy. Its utility will be measured by sensitivity and specificity estimates as compared to cystoscopy. Since urine cytology is normally collected in this population of patients, it will also be analyzed and compared to cystoscopy.
Each patient submitted a single voided urine which was stabilized with the NMP22 urine collection kit or preserved in the appropriate cytology medium for cytopathologic testing. All patients provided the urine samples before cystoscopic exam. Of the 146 patients, there were 43 patients with microscopic hematuria and 13 with gross hematuria. Other indications for cystoscopy included unexplained or medically refractory voiding. There were 8 patients with biopsy confirmed bladder cancer and 138 patients with benign conditions of the bladder.
The median NMP22 value for the bladder cancer malignancies was 27.8 U/mL (95% Confidence interval: 10.5-32.1 U/mL). The median NMP22 value for the benign conditions of the bladder was 3.25 U/mL (95% Confidence interval: 2.5-3.8 U/mL). The urinary NMP22 values from the bladder cancer group was statistically different (p < .000001 Mann-Whitney U test) than the NMP22 values in the benign conditions group. Using a reference value of 10.0 U/mL, the sensitivity of NMP22 was 100% with a specificity of 90%, while cytology had a sensitivity of 25% and a specificity of 100%. Due to its high negative predictive value, using NMP22 alone could have eliminated 124 cystoscopies with total savings ranging from $24,824 to $63,264 depending on the type of insurance carrier.
This study indicates that urinary NMP22 is a useful, cost-effective marker for the early detection of bladder cancer.
本研究旨在确定NMP22作为血尿或其他恶性肿瘤风险指征患者膀胱移行细胞癌（TCC）早期检测的尿液标志物的临床效用。将通过与膀胱镜检查相比的敏感性和特异性估计来衡量其效用。由于通常在此类患者群体中收集尿液细胞学样本，因此也将对其进行分析并与膀胱镜检查进行比较。
每位患者提交一份晨尿，用NMP22尿液收集试剂盒进行稳定处理，或保存在适当的细胞学培养基中用于细胞病理学检测。所有患者在膀胱镜检查前提供尿液样本。146例患者中，43例为镜下血尿，13例为肉眼血尿。膀胱镜检查的其他指征包括无法解释的或药物难治性排尿。8例患者经活检确诊为膀胱癌，138例患者为膀胱良性疾病。
膀胱癌恶性肿瘤患者的NMP22中位数为27.8 U/mL（95%置信区间：10.5 - 32.1 U/mL）。膀胱良性疾病患者的NMP22中位数为3.25 U/mL（95%置信区间：2.5 - 3.8 U/mL）。膀胱癌组的尿液NMP22值与良性疾病组的NMP22值在统计学上有差异（曼-惠特尼U检验，p <.000001）。以10.0 U/mL作为参考值，NMP22的敏感性为100%，特异性为90%，而细胞学检查的敏感性为25%，特异性为100%。由于其高阴性预测值，仅使用NMP22就可以避免124次膀胱镜检查，根据保险载体类型，总节省费用在24,824美元至63,264美元之间。
本研究表明，尿液NMP22是早期检测膀胱癌的一种有用且具有成本效益的标志物。
