羟喜树碱对比丝裂霉素膀胱内灌注化疗临床随机对照研究  

Clinical effect comparison of hydroxycamptothecin and mitomycin instillation boadder on patients with superficial bladder cancer:a randomized controlled trial

作　　者：罗松涛[1] 王应洪[1] 李绪鲲[1] 柯井卫[1] 唐义权[1] 

机构地区：[1]泸州医学院附属中医医院外五科,四川泸州646000

出　　处：《中国临床药理学杂志》2013年第6期416-418,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：目的评价羟喜树碱(HCPT)和丝裂霉素(MMC)行膀胱内灌注对预防浅表性膀胱癌(SBC)术后复发的疗效。方法 2006年1月至2011年1月我科收治的浅表性膀胱肿瘤术后患者188例,随机分为HCPT组(96例)和MMC组(92例),2组患者经尿道膀胱癌电切术(TUR-BT)后24 h开始灌注化疗,分别将HCPT和MMC 30 mg溶于0.9%氯化钠注射液20 mL中并经导尿管注入膀胱。比较2组患者术后膀胱肿瘤复发情况及安全性。结果完成灌注化疗并获得完整随访者共131例,其中HCPT组65例,术后中位随访时间19.4个月,随访期间有9例(13.8%)复发;MMC组66例,术后中位随访时间为18.6个月,随访期间有11例(17.1%)复发。2组患者术后复发风险经Log-rank检验差别无统计学意义,风险比(HR)为0.82(95%CI:0.31～2.15,P=0.69)。HCPT组灌注化疗相关不良反应发生率为40.0%(26/65),MMC组为45.5%(30/66),2组间差异无统计学意义(P>0.05)。结论 HCPT和MMC浅表膀胱肿瘤术后膀胱灌注化疗临床疗效和安全性无明显差别。Objective To compare the recurrence and safety of hydroxycamptothecin （HCPT） and mitomycin （MMC） by bladder instillation af- ter transurethral resection of superficial bladder transient cell carcinoma. Methods There were 188 patients with superficial bladder cancer ran- domly were divided into two groups after transurethral resection bladder cancer （ TUR - BT） receiving HEPT （ n = 96） or MMC （ n = 92 ） 30 mg dissolved in 0. 9% sodium chloride injection 20 mL by bladder instilla- tion respectively. Results A total of 131 patients completed the chemo- therapy regimen and followed up. Nine （ 13.8 % ） cases were recurrent in HCPT group with an mean follow-up time of 19. 4 month, while 11 （ 17. 1% ） cases of recurrence was observed in MMC group with an mean fol- low -up time of 18. 6 month. The hazard ratio（HR） of recurrence was 0. 82 （95%CI： 0. 31 -2. 15, P =0. 69）. There was no statistically difference between localized and system side effects between the two groups （P 〉 0. 05）. Conclusion The clinical effect and safety of HCPT and MMC by bladder insticlation in patients with superfical bladder transient cell carcinoma transurethral resection are same.

关 键 词：羟喜树碱 丝裂霉素 膀胱肿瘤 

分 类 号：R737.14[医药卫生—肿瘤] R979.12[医药卫生—临床医学]