密集膀胱灌注对抑制非肌层浸润性膀胱肿瘤术后复发的随机对照研究

Compact Intravesical Instillations of Anthracyclines as Prophylaxis for Recurrence after Transurethral Resection of Non-Muscle-Invasive Bladder Cancer:a Prospective,Randomized Controlled Study

目的:观察短期密集疗程膀胱腔内蒽环类药物灌注化疗对抑制非肌层浸润性膀胱肿瘤(non muscleinvasive bladder cancer,NMIBC)经尿道电切术(TUR)后复发的效果。方法:我院自2006年1月～2008年12月对221例NMIBC患者行TUR术,经随机分为两组,密集疗程组术后执行表柔比星(epirubicin,EPI)40 mg/40 ml每周1次,连续8次的腔内灌注方案;常规化疗组则在连续8次的密集灌注化疗后续行40 mg/40 ml每月1次,连续10次的灌注方案。记录患者每3个月1次膀胱镜检查情况至术后24个月或肿瘤复发。结果:共有141例获得完整资料。24个月随访期中,45例(31.9%)肿瘤复发。其中常规化疗组22例(30.1%),密集化疗组23例(33.2%)(P=0.64)。复发时间常规化疗组为(8.73±5.23)个月,密集化疗组为(8.74±4.42)个月(P=0.38)。15例(10.6%)复发肿瘤进展,其中常规化疗组7例(9.6%),密集疗程组8例(11.8%)(P=0.675)。对141例患者的肿瘤大小,单发多发,初发复发,肿瘤病理类型,以及临床分期方面进行分层研究,密集疗程组与常规化疗组的无肿瘤复发率差异均无统计学意义。结论:TUR术后短期密集蒽环类药物膀胱腔内灌注化疗可以获得与常规灌注化疗方案相间的降低NMIBC复发的效果。

Objective：To evaluate the effect of compact anthracyclines intravesical chemotherapy as prophylaxis for recurrence after transurethral resection （TUR） of non muscle invasive bladder cancer （NMIBC）. Methods： From 2006.1 to 2008.12,221 NMIBC patients underwent TUR in our hospital. Patients were randomized into＇two groups. Group A patients were treated with intravesical instillation of epirubicin （EPI） 40 mg/ 40 ml saline every week for 8 weeks. Group B patients were continuously administrated with same dose EPI every month for 10 months after the same schedule as group A was finished. The results of every 3 months regular cystoscopy exam were recorded. The follow up were ended when tumor recurred or no tumor recurrence was reported 24 months after TUR. Resuits：141 patients completed their documents. 45 cases （31.9/%） was found tumor recurrence,23 and 22 patients were found in each group, respectively. No statistical difference was found between two groups （P= 0.64）. The recurrence time of both groups was （8.73±5.23） mo and （8.74±4.42） mo,respectively. 8 patients （11.8%） were found tumor progressed in Group A while 7 patients （9.6%） were found in Group B （P=0.675）. Further stratified statistical analysis showed that there was no difference in free tumor recurrence rate between two groups, whatever in the aspect of the tumor size, solitary tumor or not, first occurred or recurred patients, the path-ologic findings and clinical staging in each group was compared. Conclusions：Compact anthracyclines intravesical instillation after TUR has the same recurrence prevention effectiveness as the regular intravesical schedule. The monthly intravesical instillation followed compact schedule seems unnecessary for recurrence prophylaxis.