红色诺卡菌细胞壁骨架膀胱灌注预防非肌层浸润性膀胱癌术后复发的疗效和安全性  

The value of intravesical instillation of Nocardiarubra cell wall skeleton in preventing recurrent after transurethral resection for the treatment of non-muscle invasive bladder cancer

作　　者：于顺利 顾朝辉[1] 罗彬杰 寇一平 翟天元 金志波[1] 贾占奎[1] 杨锦建[1] Yu Shunli;Gu Chaohui;Luo Binjie;Kou Yiping;Zhai Tianyuan;Jin Zhibo;Jia Zhankui;Yang Jinjian(Department of Urology,First Affiliated Hospital of Zhengzhou University,Henan Institute of Urology,Zhengzhou 450052,China)

机构地区：[1]郑州大学第一附属医院泌尿外科河南省泌尿外科研究所,450052

出　　处：《中华泌尿外科杂志》2019年第7期521-525,共5页Chinese Journal of Urology

摘　　要：目的探讨红色诺卡菌细胞壁骨架(N-CWS)膀胱灌注预防非肌层浸润性膀胱癌(NMIBC)术后复发的有效性及安全性。方法回顾性分析2013年10月至2018年11月118例分别接受N-CWS和表柔比星膀胱灌注治疗的NMIBC患者的临床资料,男77例,女41例。年龄(65.1±11.9)岁。所有患者均行经尿道膀胱肿瘤切除术(TURBT)。根据膀胱灌注方案将患者分为N-CWS组和表柔比星组。N-CWS组55例,男37例,女18例;年龄(64.9±12.1)岁;初发患者48例(87.3%),复发患者7例(12.7%);肿瘤单发38例(69.1%),多发17例(30.9%);肿瘤直径≤3cm49例(89.1%),>3cm6例(10.9%);病理分期Ta期36例(65.5%),T1期19例(34.5%);病理分级G1级38例(69.1%),G2级13例(23.6%),G3级4例(7.3%);危险度分层低危14例(25.5%),中危16例(29.1%),高危25例(45.5%)。表柔比星组63例,男40例,女23例;年龄(65.3±11.2)岁;初发患者52例(82.5%),复发患者11例(17.5%);肿瘤单发44例(69.8%),多发19例(30.2%);肿瘤直径≤3cm56例(88.9%),>3cm7例(11.1%);病理分期Ta期37例(58.7%),T1期26例(41.3%);病理分级G1级44例(69.8%),G2级12例(19.0%),G3级7例(11.1%);危险度分层低危13例(20.6%),中危19例(30.2%),高危31例(49.2%)。两组一般资料比较差异均无统计学意义(P>0.05)。N-CWS组应用注射用红色诺卡菌细胞壁骨架800μg加生理盐水50ml稀释后膀胱灌注,膀胱内保留2h;表柔比星组应用注射用盐酸表柔比星50mg加生理盐水50ml稀释后膀胱灌注,膀胱内保留1h。比较两组膀胱灌注后的肿瘤复发、进展及不良反应情况。结果118例均获得随访,平均随访(33.7±5.4)个月。N-CWS组和表柔比星组的5年复发率分别为25.5%(14/55)和42.8%(27/63),差异有统计学意义(χ^2=3.922,P=0.048)。N-CWS组5年无复发生存率(74.2%)高于表柔比星组(56.5%),差异有统计学意义(χ^2=4.609,P=0.044)。N-CWS组和表柔比星组的5年进展率分别为5.5%(3/55)和7.9%(5/63),差异无统计学意义(χ^2=0.028,P=0.867)。N-CWS组9例(16.4%)出现不良反应,其中�Objective To investigate the efficacy and safety of Nocardiarubra cell wall skeleton(N-CWS)bladder irrigation in prevention of recurrence after transurethral resection for the treatment of non-muscle invasive bladder cancer(NMIBC).Methods The clinical data of patients with NMIBC treated by N-CWS and epirubicin collected between October 2013 and November 2018 at the First Affiliated Hospital of Zhengzhou University were retrospectively analyzed.All patients underwent TURBT.Among the 118 NMIBC patients,the average age was(65.1±11.9)years,and the sex ratio(male/female)was 1.9∶1(77/41).Patients were divided into two group:N-CWS group(n=55)and epirubicin group(n=63)according to different instillation regimens.N-CWS was given as an instillation of 800μg in 50 ml of saline and maintained in the bladder for 2 h in the N-CWS group.Epirubicin was given as an instillation of 50 mg in 50 ml of saline and maintained in the bladder for 1 h in the epirubicin group.In the N-CWS group,mean age was(64.9±12.1)years and 37(67.3%)were male.Multiple tumors were present in 17(69.1%)patients.Tumor size was≤3 cm in 49(89.1%)and 7(12.7%)had a history of NMIBC.Stage was Ta and T1 in 36(65.5%)and 19(34.5%),respectively.Grade 1,Grade 2 and Grade 3 were the primary grades in 38(69.1%),13(23.6%)and 4(7.3%),respectively.Low risk,intermediate risk and high risk were present in 14 patients(25.5%),16(29.1%)and 25(45.5%),respectively.In the epirubicin group,mean age was(65.3±11.2)years and 40(63.5%)were male.Multiple tumors were present in 19(30.2%)patients.Tumor size was≤3 cm in 56(88.9%)and 11(17.5%)had a history of NMIBC.Stage was Ta and T1 in 37(58.7%)and 26(41.3%),respectively.Grade 1,Grade 2 and Grade 3 were the primary grades in 44(69.8%),12(19.0%)and 7(11.1%),respectively.Low risk,intermediate risk and high risk were present in 13(20.6%),19(30.2%)and 31(49.2%),respectively.The tumor recurrence,progression and adverse reactions after Intravesical Instillation in both groups were followed up and recorded.No significant differences w

关 键 词：非肌层浸润性膀胱癌 红色诺卡氏菌细胞壁骨架 膀胱灌注 

分 类 号：R737.14[医药卫生—肿瘤]