尿核基质蛋白22试剂盒快速诊断膀胱癌的多中心临床研究  

Rapid detection of bladder cancer using a point-of-care nuclear matrix protein 22 BladderChek control kit： a multicenter clinical trial

作　　者：果宏峰[1] 李宁忱[1] 曹明[2] 薛蔚[2] 黄翼然[2] 贺大林[3] 张心如[4] 谷宝军[4] 那彦群[1] 

机构地区：[1]北京大学首钢医院泌尿外科北京大学吴阶平泌尿外科医学中心,100144 [2]上海交通大学医学院附属仁济医院泌尿外科 [3]西安交通大学医学院第一附属医院泌尿外科 [4]上海交通大学附属第六人民医院泌尿外科

出　　处：《中华泌尿外科杂志》2014年第12期909-912,共4页Chinese Journal of Urology

摘　　要：目的 探讨尿核基质蛋白22（nuclear matrix protein 22,NMP22）检测在快速诊断膀胱癌中的临床价值. 方法 在全国4家三级医院泌尿外科选取803例患者和200例健康人的尿液标本,以NMP22检测试剂盒（胶体金法）快速检测NMP22水平.803例患者中膀胱癌组392例,其他泌尿系良性疾病/有非膀胱癌肿瘤史或患非膀胱部位的活动期癌症患者组411例.结合膀胱镜检和术后病理检查结果,统计分析NMP22检测的敏感性和特异性. 结果 1003例受检者中NMP22检测膀胱癌的总体敏感性为69.6％（273/392,95％ CI 64.9％ ～ 74.0％）,特异性为84.9％（519/611,95％ CI 81.1％～87.6％）.337例膀胱癌患者获得病理分期结果,NMP22检测的敏感性分别为Ta～T1期69.6％（165/237）、T2～T4期82.0％ （82/100）;322例获得病理分级结果,NMP22检测的敏感性分别为G1级60.5％（72/119）、G2级66.2％（47/71）、G3级90.9％ （120/132）.NMP22检测对泌尿系良性疾病组、有非膀胱癌肿瘤史或患非膀胱部位的活动期癌症患者组、健康对照组的检测特异性分别为87.8％（324/369）、69.0％（29/42）和97.5％（195/200）. 结论 NMP22试剂盒检测膀胱癌具有较高的敏感性和特异性,可用于早期、快速辅助诊断膀胱癌.Objective To evaluate the clinical significance of nuclear matrix protein 22 （NMP22） test in rapid diagnosis of bladder cancer.Methods From February 2009 to November 2011,803 patients and 200 healthy individuals were included in this multicenter study from four urology centers in China.They provided a urine sample for test of NMP22 protein using a point-of-care NMP22 BladderChek control kit （colloidal gold method）.All tests were evaluated in a blinded fashion.Patients were divided into three groups.Group 1 included 392 patients of bladder cancer; group 2 included 411 patients who had benign urinary disease with non-bladder cancer history or non-bladder cancer; group 3 included 200 healthy individuals.The sensitivity and specificity of NMP22 test were analyzed compared with pathologic results using Pearson Chi-square test.Results The overall sensitivity and specificity of the NMP22 test were 69.6％ （273/392,95％ CI 64.9％-74.0％） and 84.9％ （519/611,95％CI 81.1％-87.6％）,respectively.In group 1,337 patients had pathologic stage data,and the sensitivities of the NMP22 test for each stage were Ta-T1 69.6％ （165/237） and T2-T4 82.0％ （82/100）,respectively; 322 patients had pathologic grade data,and the sensitivities for each grade were G1 60.5％ （72/119）,G2 66.2％ （47/71） and G3 90.9％ （120/132）,respectively.The specificities for patients of benign urinary disease,of non-bladder cancer history or nonbladder cancer and healthy individuals were 87.8％ （324/369）,69.0％ （29/42） and 97.5％ （195/200）,respectively.Conclusion NMP22 BladderChek control kit had high sensitivity and specificity in detection of bladder cancer,and it can be used in early detection and rapid diagnosis of bladder cancer.

关 键 词：核基质相关蛋白质类 膀胱肿瘤 诊断 试剂盒 诊断 多中心研究 

分 类 号：R737.14[医药卫生—肿瘤]