消痔灵联合羟基喜树碱膀胱灌注预防膀胱癌术后复发的临床研究

Hemorrhoid and hydroxycamptothecin prevent the recurrence of postoperative bladder tumor

目的比较消痔灵注射液联合不同剂量羟基喜树碱(HCPT)膀胱灌注预防非肌层浸润性膀胱癌术后复发的临床疗效及安全性。方法将90例患者随机分成三组,每组30例。A组:HCPT正常剂量(20mg);B组:消痔灵(10ml)+HCPT小剂量(10mg);C组:消痔灵(10ml)+HCPT正常剂量(20mg)。经尿道膀胱肿瘤切除(transurethral resection of bladder tumor,TURBT)术后常规灌注化疗,评判患者灌注后肿瘤复发情况、不良反应和生存质量(KPS评分)。结果 B、C两组的KPS评分均优于A组(P<0.05)、复发率均显著低于A组(P<0.05),而B、C两组间的差异无统计学意义(P>0.05);三组间不良反应发生率的差异无统计学意义(P>0.05);三组灌注前后以及三组之间相比较,血清血管内皮细胞生长因子(VEGF)水平的差异均无统计学意义。结论消痔灵联合HCPT膀胱灌注安全有效,作用机制可能与VEGF无关。

Objective To compare the availability and safety of using various dose of hemorrhoid injection with hydroxycamptothecin on preventing the postoperative recurrence of superficial bladder tumor.Methods90 patients were divided into three groups ad libitum,30 patients per group.Each patient received irrigation of bladder after operation with a single dose of 20 mg hydroxycamptothecin in group A,10 ml hemorrhoid injection and 10 mg hydroxycamptothecin in group B,10 ml hemorrhoid injection and 20 mg hydroxycamptothecin in group C,respectively.The irrigation was repeated once a week for two months and once a month in the next ten months.The recurrence,side-effect and the KPS were observed.ResultsThe KPS of group B and group C were better than that in group A（P=0.03）,the recurrence of group B and group C were less than that in group A（P=0.04）,significantly.But the difference between group B and group C was not statistically significant（P=0.1）.The incidence of side-effect among three teams was not statistically significant（P=0.12）.Neither the level of serum VEGF among three teams before and after irrigation nor inter-group was statistically significant.ConclusionsIrrigation of bladder with hemorrhoid injection and hydroxycamptothecin is safe and available,whose mechanism of action is probably not relative with the VEGF.