吡柔比星与丝裂霉素膀胱内灌注预防膀胱癌术后复发的随机对照研究

Intravesical therapy with pirarubicin versus mitomycin for superficial bladder cancer:a randomized controlled trial

目的:比较吡柔比星与丝裂霉素膀胱灌注对预防浅表性膀胱移行细胞癌术后复发的疗效与副反应。方法:根据随机数字表87例浅表性膀胱癌术后的患者,随机分成两组,分别用吡柔比星和丝裂霉素作膀胱灌注化疗,灌注化疗期间行血常规、肝肾功能检查。定期随访行膀胱镜或B超观评价肿瘤复发时间。结果:吡柔比星组41例,平均随访18.8个月,7例(17.1%)复发,丝裂霉素组46例,平均随访时间19.4个月,10例(21.7%)复发。两组患者随访期间复发风险比较Hazard Ratio(HR)=0.71(95%CI:0.27～1.84,P=0.48);吡柔比星组局部副反应发生率为41.5%(17/41),全身副反应发生率为7.3%(3/41),膀丝裂霉素组局部副反应发生率为40.0%(17/46),全身副反应发生率为8.7%(4/46),两组比较差异无统计学意义(P>0.05)。结论:吡柔比星与丝裂霉素膀胱灌注在预防浅表性膀胱癌术后复发及副反应方面无差异。

Objective The objective of this study is to compare the effects of intravesical infusions of pirarubicin（THP） and mitomycin（MMC） on recurrence prevention and safety after transurethral resection of superficial bladder transient cell carcinoma.Methods Eighty seven patients with superficial bladder cancer were randomly divided into two groups.and were treated with intravesical infusions of THP or MMC after transurethral resection,respectively.Results Seven（17.1%） cases of recurrence were observed in THP group,with a mean 18.8-month follow-up.Ten（21.7%） cases of recurrence were observed in MMC group,with a mean 19.4-month follow-up.The hazard ratio（HR） for recurrence of two groups was 0.71（95% confidence interval,0.27 to 1.84,P = 0.48）.In THP group,the incidence of localized and systematic side effects was 41.5%（17/41） and 7.3%（3/41）,respectively.In MMC group,the incidence of localized and systematic side effects was 40.0%（17/46） and 8.7%（4/46）,respectively.There was no statistics difference in localized and systematic side effects between the two groups（P 0.05）.Conclusion No differences were observed on the effects of recurrence prevention and safety of intravesical infusions of pirarubicin and mitomycin after transurethral resection of superficial bladder transient cell carcinoma.