表柔比星对比丝裂霉素行膀胱灌注治疗非肌层浸润性膀胱癌的系统评价

Systematic evaluation of epirubicin versus mitomycin C via intravesical instillation for therapy of non-muscle-invasive bladder cancer

目的系统评价表柔比星(EPI)对比丝裂霉素(MMC)行膀胱灌注治疗非肌层浸润性膀胱癌(NMIBC)的疗效和安全性。方法计算机检索PubMed、Cochrane Library、Ovid平台生物医学数据库(OVID)、SpringerLink、中国期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)、维普生物医学数据库(VIP)及万方数据库中2000年1月1日—2023年2月1日发表的EPI(试验组)与MMC(对照组)治疗术后NMIBC的临床随机对照试验(RCT),利用RevMan 5.3软件进行Meta分析。结果共纳入14项RCTs,1103例患者,其中试验组553例、对照组550例。试验组术后肿瘤复发率[OR=0.52,95%CI(0.38,0.71),P<0.0001]、膀胱刺激征发生率[OR=0.51,95%CI(0.32,0.81),P=0.004]、血尿发生率[OR=0.47,95%CI(0.28,0.78),P=0.004]均显著低于对照组,但是两种药物行术后膀胱灌注的其他不良反应(肝肾损害、皮疹、恶心呕吐、尿道狭窄)发生率比较,差异无统计学意义[OR=0.67,95%CI(0.36,1.27),P=0.22]。结论使用EPI行膀胱灌注治疗NMIBC患者的临床疗效略优于MMC,但是仍需谨慎对待本次研究结果。

Objective To systematically evaluate the efficacy and safety of epirubicin(EPI) and mitomycin C(MMC) intravesical instillation in the treatment of non muscle invasive bladder cancer(NMIBC).Methods This research searched PubMed,the Cochrane Library,Ovid platform biomedical database(OVID),SpringerLink,CBM,CNKI,VIP and Wanfang databases for randomized controlled trials(RCTs) of EPI(treatment group) and MMC(controll group) for the treatment of postoperative NMIBC published from January 1,2000 to February 1,2023.Meta-analysis was performed using RevMan 5.3 software.Results A total of 14 RCTs with 1 103 patients were included,including 553 in treatment group and 550 in controll group.The rates of recurrence [OR = 0.52,95%CI(0.38,0.71),P<0.000 1],bladder irritation sign [OR = 0.51,95%CI(0.32,0.81),P = 0.004],and hematuria [OR = 0.47,95%CI(0.28,0.78),P = 0.004] after bladder instillation with EPI were significantly lower than those treated with MMC instillation.However,there was no significant difference in the incidence of other adverse effects(hepatic and renal impairment,rash,nausea and vomiting,and urethral stricture) related to postoperative bladder perfusion between the two drugs [OR = 0.67,95%CI(0.36,1.27),P = 0.22].Conclusions Intravesical instillation with EPI showed slightly better clinical outcomes than MMC in patients with NMIBC,but the results of this study still need to be taken with caution.