Stampfer D S, Carpinito G A, Rodriguez-Villanueva J, Willsey L W, Dinney C P, Grossman H B, Fritsche H A, McDougal W S
Department of Urology, Boston University Medical Center, Massachusetts, USA.
J Urol. 1998 Feb;159(2):394-8. doi: 10.1016/s0022-5347(01)63930-2.
Urinary nuclear matrix protein (NMP22) was evaluated for detection of new and recurrent bladder tumors in patients with a history of transitional cell carcinoma. Our objective was to determine sensitivity and specificity of this marker for tumors of various stages and grades, as well as its use as an adjunct to or substitute for urinary cytology.
A total of 231 patients with a history of transitional cell carcinoma provided 288 voided urine samples before cystoscopic examination at 1 of 3 institutions (53 patients were reevaluated at least once). Urine samples were assayed for NMP22 using the NMP22 Test Kit. Select patients underwent biopsy with appropriate additional therapy. Voided urinary cytology was obtained in 200 cases. End points for determination of the absence and presence of tumor were negative cystoscopy and positive biopsy, respectively. A receiver operating characteristics curve was constructed to determine the optimal NMP22 threshold for detection of transitional cell carcinoma. For positive biopsies NMP22 values were also correlated with tumor stage and grade. Comparison to cytology was limited to patients with complete data.
There were 208 negative cystoscopies (158 with cytology) and 66 positive cystoscopies with biopsy (42 with cytology). Of the cases 14 were eliminated from statistical analysis due to incomplete data. Receiver operating characteristics curve interpretation determined that 6.4 units per ml. was an optimal reference value for detection of transitional cell carcinoma in this patient group. Sensitivity and specificity for all pathological groupings was 68 and 80%, respectively. When compared to cytology the sensitivities of NMP22 and cytology were 67 versus 31 or 40% (depending on the definition of positive cytology).
NMP22 values represented significant improvement over urinary cytology for detection of transitional cell carcinoma. The sensitivity of NMP22 for detection of transitional cell carcinoma in bladder cancer patients was as much as twice that of cytology when a reference value of 6.4 units per ml. was used. NMP22 analysis was less costly than cytology and operator independent. While NMP22 has previously been shown to be a strong predictor of recurrence after tumor resection, it is an effective and sensitive screening test for detecting tumors in patients with transitional cell carcinoma.
评估尿核基质蛋白（NMP22）在检测有移行细胞癌病史患者的新发和复发性膀胱肿瘤中的作用。我们的目标是确定该标志物对不同分期和分级肿瘤的敏感性和特异性，以及其作为尿液细胞学检查的辅助手段或替代方法的用途。
共有231例有移行细胞癌病史的患者在3家机构中的1家进行膀胱镜检查前提供了288份晨尿样本（53例患者至少接受了一次重新评估）。使用NMP22检测试剂盒对尿液样本进行NMP22检测。选择部分患者进行活检并给予适当的额外治疗。200例患者进行了晨尿细胞学检查。确定肿瘤有无的终点分别为膀胱镜检查阴性和活检阳性。构建受试者工作特征曲线以确定检测移行细胞癌的最佳NMP22阈值。对于活检阳性的患者，NMP22值也与肿瘤分期和分级相关。与细胞学检查的比较仅限于数据完整的患者。
膀胱镜检查阴性208例（158例进行了细胞学检查），活检阳性66例（42例进行了细胞学检查）。由于数据不完整，14例病例被排除在统计分析之外。受试者工作特征曲线分析确定，每毫升6.4单位是该患者组检测移行细胞癌的最佳参考值。所有病理分组的敏感性和特异性分别为68%和80%。与细胞学检查相比，NMP22和细胞学检查的敏感性分别为67%和31%或40%（取决于阳性细胞学检查的定义）。
NMP22值在检测移行细胞癌方面比尿液细胞学检查有显著改善。当使用每毫升6.4单位的参考值时，NMP22检测膀胱癌患者移行细胞癌的敏感性高达细胞学检查的两倍。NMP22分析的成本低于细胞学检查，且不依赖操作人员。虽然NMP22此前已被证明是肿瘤切除后复发的有力预测指标，但它是检测移行细胞癌患者肿瘤的一种有效且敏感的筛查试验。
