卡介苗与丝裂霉素C膀胱灌注预防国人膀胱癌复发的比较的Meta分析

A Meta-analysis of the comparative studies of intravesical bacillus Calmette-Guerin versus Mitomycin C for chinese bladder cancer

目的:比较卡介苗与丝裂霉素C膀胱灌注预防国人膀胱癌复发的疗效及毒性。方法:检索国内已公开发表的关于卡介苗与丝裂霉素C膀胱灌注治疗国人膀胱癌复发的比较性研究资料,对纳入研究的资料进行统计学综合(Meta分析)。结果:共有16个研究符合标准被纳入,涉及总病例数1242例,其中进行卡介苗灌注治疗708例,丝裂霉素C治疗534例;最大随访期内分别有23.4%(166/708),30.7%(164/534)出现复发。Meta分析结果提示卡介苗组预防肿瘤复发作用统计学上显著优于丝裂霉素C组(OR0.63,95%CI0.48～0.83,P=0.001);9个研究报道了治疗毒性主要是膀胱炎的比较,Meta分析结果提示卡介苗组膀胱炎发生率明显高于丝裂霉素C组(OR4.52,95%CI1.11～18.36,P=0.03)。结论:卡介苗膀胱灌注预防国人膀胱癌复发作用优于丝裂霉素C,但其毒性(膀胱炎发生率)较丝裂霉素C高。

Objective：To compare the prophylactic efficacy and toxicity of intravesical bacillus Calmette-Guerin （BCG） versus mitomycin C （MMC） on recurrence of Chinese bladder cancer. Methods： We retrieved published Chinese comparative studies on intravesical BCG versus MMC for bladder cancer of Chinese people, and pooled the data from eligible studies （Meta-analysis）. Results： 16 trials including 1242 patients were eligible to the inclusion criteria. Of these patients 708 were treated with BCG and 534 with MMC. Within the maximum follow-ups, 23.4% （166/708） of the patients treated with BCG and 30.7% （164/534）of those with MMC had recurrence of bladder tumor. Pooling data of a meta-analysis indicated that 13CG was statistically significantly superior to MMC in the prophylaxis of tumor recurrence （OR 0.63, 950% CI 0.48～0.83, P =0. 001）. 9 studies reported comparative data on toxicity mainly cystitis, combined result of these studies showed that the incidence of cystitis were significantly higher in I3CG group than MMC group （OR 4.52, 95% CI 1.11～18.36, P =0.03）. Conclusions：The results of this meta-analysis suggest the significant superiority of intravesical BCG therapy compared with MMC for the prevention of tumor recurrence. However, the toxicity of BCG therapy, especially the incidence of cystitis, is significantly higher than that of MMC therapy.