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目的比较吡柔比星(pirarubicin,THP)与羟基喜树碱(hydroxycamptothecin,HCPT)膀胱灌注对膀胱癌复发的预防作用及安全性。方法收集关于THP与HCPT膀胱灌注治疗膀胱癌的比较性研究文献,进行系统分析。采用相对危险度(RR)及95%可信区间(CI)作为评价比较疗效及毒性差异的指标。统计软件为Rev Man 5.3。结果共入选18项临床研究包括1 597名患者,其中822例接受THP治疗,775例接受HCPT治疗。Meta分析结果提示,THP组与HCPT组6个月复发率无统计学差异[RR=0.69,95%CI(0.47,1.02),P>0.05],9个月复发率无统计学差异[RR=0.80,95%CI(0.42,1.54),P>0.05],而THP组1年内复发率低于HCPT组[RR=0.74,95%CI(0.56,0.99),P<0.05],2年内复发率也低于HCPT组[RR=0.74,95%CI(0.61,0.92),P<0.01]。2组间的膀胱刺激症状、血象无显著性差异;2组膀胱灌注预防血尿发生率的差异有统计学意义[RR=1.74,95%CI(1.11,2.72),P=0.02],HCPT组血尿发生率低于THP组。结论 THP与HCPT对肿瘤复发率的控制灌注后约6,9个月无明显差异,1年和2年THP组的复发率小于HCPT组,但血尿发生率高于HCPT组。在可以耐住不良反应的前提下,优选THP。
Objective To compare the preventive effect and safety of bladder infusion of pirarubicin (THP) and hydroxycamptothecin (HCPT) on the recurrence of bladder cancer. Methods A comparative study of THP and HCPT bladder irrigation for bladder cancer was collected and systematically analyzed. Relative risk (RR) and 95% confidence interval (CI) were used as indicators to evaluate the efficacy and toxicity differences. The statistical software is Rev Man 5.3. Results A total of 18 clinical studies enrolled 1 597 patients, of whom 822 received THP and 775 received HCPT. Meta-analysis showed no significant difference in relapse rate between THP group and HCPT group at 6 months [RR = 0.69,95% CI (0.47,1.02), P> 0.05]. There was no significant difference in recurrence rate at 9 months [RR = 0.80, 95% CI (0.42,1.54), P> 0.05]. The relapse rate in THP group was lower than that in HCPT group [RR = 0.74,95% CI 0.56,0.99, P <0.05] Also lower than the HCPT group [RR = 0.74, 95% CI (0.61, 0.92), P <0.01]. There was no significant difference in bladder irritation and blood between the two groups. There was significant difference in the incidence of hematuria between the two groups (RR = 1.74, 95% CI 1.11, 2.72, P = 0.02) The incidence was lower than THP group. Conclusions There is no significant difference between THP and HCPT on tumor recurrence rate about 6 and 9 months after perfusion. The recurrence rates of THP and HCPT at 1 year and 2 years are lower than that of HCPT group, but the incidence of hematuria is higher than that of HCPT group. THP is preferred on the premise that it can endure adverse reactions.