等剂量不同浓度吡柔比星即刻膀胱灌注疗效及安全性分析

The efficacy and safety analysis of immediately intravesical instillation of same dose variable concentration of pirarubicin for superficial bladder cancer

目的：分析相同剂量下，不同浓度吡柔比星对表浅性膀胱癌即刻膀胱灌注的疗效以及安全性。方法将2010年12月至2012年12月期间在该院治疗的行表浅性肿瘤电切（TUR-BT）的表浅性膀胱癌患者56例分为高浓度组（H组25例）和低浓度组（L组31例）。即刻膀胱灌注吡柔比星灌注剂量30mg，H组浓度为1．0g/L，L组浓度为0．6g/L。术后24h内膀胱灌注1次，此后每周灌注1次，8周后，改为每月灌注1次，至术后1年。随访患者，比较两组患者的复发时间、复发率以及并发症发生率。结果除L组2例患者失访外，其余病例均获得满意随访，时间为6～30个月，平均17．6个月。其中 H组随访期内1例复发，复发率4．0％，复发时间为术后12．4月；L组随访期内3例复发，复发率10．3％，平均复发时间为9．8月。两组复发率以及平均复发时间比较差异均有统计学意义（P＜0．05），两组患者出现的不良反应主要为尿路刺激症状，两组患者的不良反应差异无统计学意义（P＞0．05）。结论高浓度吡柔比星膀胱癌灌注化疗能有效降低浅表性膀胱肿瘤的复发率，延长复发时间；两组患者均能够较好地接受治疗。

Objective To compare the efficacy and safety of intravesical instillation of pirarubicin （T HP） to prevent the post -operative recurrence of superficial bladder cancer with same dose variable concentration .Methods A tota1 of 56 cases of superficial bladder cancer after transurethral resection （TURBT ） were randomly divided into two groups（High concentration group ：25 cases , Low concentration group ：31 cases） .Infusion dose of THP is 30 mg .The concentration of THP is 1 .0 g/L in H group ,0 .6 g/L in L group .Both groups were installed within 24 hours after operation .Both groups were installed once a week for 8 weeks after the first installation ,then once a month until 1 year after operation .All cases were followed up ,the tumor recurrence time ,recurrence rates and complications were compared .Results All cases except 2 in L group received 6 -30 months follow up ,with an average time of 17 .6 months .In H group ,1 patients recurred during the follow-up period ,with a recurrence rate of 4 .0% and recurrence time of 12 .4 months ,while in L group ,3 cases recurred ,with a recurrence rate of 10 .3% and an average recurrence time of 9 .8 months .Adverse reactions were main1y Urinary irritation symptoms .The difference of recurrence rate and average recurrence time in each group were statistically significant （P〈 0 .05） ,while the difference of adverse reactions were not statistically significant （P〉0 .05） .Conclusion This study shows that high concentration THP intravesical instillation could effectively reduce the recur-rence rate and delay the recurrence time .Each concentration was well tolerated .