多种药物联合膀胱灌注预防膀胱癌复发的临床研究

Clinical study of irrigation of bladder with multiple drugs to preclude the recurrence of carcinoma of bladder

目的探讨多种药物联合膀胱灌注与单种药物膀胱灌注预防膀胱癌复发疗效的差异及其安全性。方法对符合入选标准的106例非肌层浸润性膀胱移行细胞癌患者,术后1周按随机数字法分为3组进行膀胱内灌注。羟基喜树碱(HCPT)组36例,HCPT20mg+生理盐水60ml膀胱灌注;顺铂(DDP)组32例,DDP60mg+生理盐水60ml膀胱灌注;HCPT+DDP组38例,DDP60mg+生理盐水60ml膀胱灌注,3d后HCPT20mg+生理盐水60ml膀胱灌注。每周1次,共8次;以后每个月1次,至满1年,每次药物在膀胱内保留60min。术后定期行膀胱镜检查,观察有无肿瘤复发。结果106例患者,术后随访6～30个月。HCPT组36例患者中复发12例,DDP组32例患者中复发11例,HCPT+DDP组38例患者中复发5例,3组相比差异具有统计学意义(P<0.05)。而各组之间不良反应的发生率差异无统计学意义(P>0.05)。结论HCPT联合DDP灌注化疗对预防膀胱癌术后复发的效果优于单用HCPT或DDP,但其不良反应以及是否适宜广泛应用还需作进一步的研究。

Objective To evaluate the difference of treatment effect of irrigation of bladder with multiple drugs（ HCPT and DDP） to prevent the recurrence of carcinoma of bladder. Methods One hun-dred and six patients with bladder cancer were prospectively enrolled and randomized into 3 group. Thirty six cases in HCPT group were treated with irrigation of HCPT 20 mg in normal sodium 60 ml. Thirty two cases in DDP group were treated with irrigation of DDP 60 mg in normal sodium 60 ml. Thirty eight cases in HCPT plus DDP group were treated with irrigation of DDP 60 mg in normal sodium 60 ml, and with irrigation of HCPT 20 mg in normal sodium 60 ml after 3 days. They were instilled within two weeks after operation, once a week for eight weeks, followed by once a month till one year. Regular cystoseopy was performed for the follow-up examination. Results All patients were followed up for 6 to 30 months. Among the 36 cases in HCPT group, recurrence was seen in 12 cases;Among the 35 cases in DDP group, recurrence was seen in 11 cases; Among the 38 cases in HCPT plus DDP group, recurrence was seen in 5 cases; The difference between the three groups is significant（P〈0.05）. And there was no significant difference between them in complication（P〉0.05）. Conclusions HCPT combined with DDP would be more effective than HCPT combined or DDP alone in prevention of recurrence of bladder cancer. Further study is needed for observation of their side effects and popularization in such way.